Unlike sourcing many routine humanitarian relief items – such as durable goods or NFIs – the procurement of health items comes with many of its own caveats. 

Registration of Pharmaceutical Products - In most countries, companies that produce, import and sell pharmaceutical products are required to obtain prior evaluation and approval from a governing body, often called the national drug regulatory authority (NDRA), or a stringent regulatory authority (SRA). Products to be registered should be proven to be effective, safe, and of good quality. Registration is often also called Marketing Authorisation (MA). Due to the fact the quality of the medications is checked as part of the registration process, each brand (produced by different manufacturers) is registered independently. In most cases, not only the product, but also the packaging, is registered. National Marketing Authorisation often have limited validity and must be renewed with certain periodicity. Pharmaceuticals intended for import as part of the humanitarian assistance (for non-commercial use purpose) may be exempted from registration of pharmaceutical product in the host country. It is important not to assume this will be the case and verify details with respective authorities in country prior to the dispatch of goods.

Essential Medicines List - Each country defines its own essential list of medicines (EML), aiming to satisfy the priority health care needs of its own population. Essential medicines are selected with in reference to disease prevalence and public health relevance, evidence of efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be always available within the context of functioning health systems in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and community can afford.

The World Health Organisation (WHO) maintains what it calls the “Model List of Essential Medicines”, a list of formally recognised medications that WHO reviews and endorses for usage for populations around the world. The model list of essential medicines is reviewed every few years, and medication is either added or removed based on advice derived from the most up to date clinical data. The contents of the model list are searchable via an online database. The model list of essential medicines is not the definitive list of usable drugs in all contexts, nor is the list of all approved drugs – it merely serves as guide for national authorities, manufacturers and importers to reference. More information on now national level essential medicines are developed can be found in WHO’s guide on the Selection of Essential Medicines at Country Level.

The majority of countries in which humanitarian organisations operate have adopted at least part of the model list of essential medicines, but it is very common for countries or national authorities to add or remove medications to the list to cover their own importation needs. Countries may choose to add or remove medications for sociocultural or political reasons, and some countries or regions have extremely robust and complex regimes for defining acceptable medications and dosages.

“Many pharmaceutical products can be registered for use in a country, but they may not be on the national EML, or on the standard treatment guidelines. Products not on the EML, but used by the private sector, can still be registered if their efficacy, safety, and quality are acceptable to the regulatory authority. Failure to follow the pharmaceutical registration protocol could lead to products being held up by customs when they enter the country. Not only does this delay the delivery of important health care products, but it wastes time and money, and risks spoilage or expiry of products while at customs.”

(USAID - The Logistics Handbook, A Practical Guide for The Supply Chain Management of Health Commodities)

National Drug Regulatory Authorities may also normalise where health products are sourced, in what shape and dosages are presented, what minimal identification and use indications shall be provided, etc.

It is often considered that the procurement is the crucial point of Quality Assurance (QA) of medicines. The source of the raw materials (active ingredient, excipients - an inert substance used to give a pharmaceutical preparation a suitable form or consistency), as well as the way the final pharmaceutical product is manufactured determines the intrinsic quality of each medicine.

Donor Regulations

A significant portion of funds used to procure health related items in an emergency comes from large scale institutional donors. Many donors have well established procedures on what and how medicines and medical support devices can be purchased using their funds. 

Most major institutional donors only allow recipients of their funds to procure pharmaceuticals through pre-qualified suppliers. Pre-qualified suppliers must undergo thorough audits and must be regularly reviewed for their quality assurance standards. As a result:

• There are a limited number of pre-qualified suppliers globally, and frequently they are outside the areas of the emergency.
• Different donors don’t always pre-qualify the same supplier; If an aid organisation receives funds from more than one donor, they may be obliged to buy from different sources depending on the funding type.
• Some pre-qualified vendors function as non-profits, while others are commercial enterprises. This may impact product costs and availability.

The variability and geographic specificity of donor pre-qualified vendors mean that humanitarian organisations should research their relevant donor regulations prior to purchasing pharmaceuticals and other health items. The relatively small number of suppliers also means that procurements will likely need to be imported – please reference the section on Importation and Customs for more information. 

Product Names

“The selection of the medicines to be provided in a country affected by an emergency is of key importance because, if the medicine is not well known by the health professionals who will prescribe it, it will not achieve its intended use.”

(DG ECHO - Review of quality assurance (QA) mechanisms for medicines and medical supplies in humanitarian aid)

Sometimes pharmaceutical items can be referred to by a variety of names. When ordering drugs please consider the following points. 

International Non-proprietary Name - An international non-proprietary name is a unique name that is given to the product based pharmaceutical substances or active pharmaceutical ingredients and is generally globally recognised. 

Brand Name - For marketing purposes, brand names are generated by a particular manufacturer and will generally be trademarked. All brand name products will still carry an international non-proprietary name as well, as there should be no difference in chemical composition from one brand to the next. Some pharmaceuticals that hold brand names may still be under patent by one Manufacturer. These products are usually given patent protection for 20 years from the date the patent was submitted and provides protection for the innovator of the medicines to recover the initial costs incurred in research development and marketing expenses. 

Generic Drug - A generic drug is a pharmaceutical that is produced and distributed without patent protection. It has the same active ingredients as brand names, but it can be manufactured by a different producer.

It’s strongly recommended to use international non-proprietary names to refer to medicinal products. Using the international non-proprietary names enables you to purchase products from multiple suppliers, whether branded or generic, and manage them as the same product.

Health Kits

A common procurement strategy for health items in humanitarian emergencies is the design and use of emergency health kits. These standardised kits of medicines and medical supplies are developed by agencies to meet different health needs in humanitarian emergencies and disasters during the acute emergency phase, normally during the first 3 months, when a push model is critical to launch the operation. It’s key to note that after the acute phase of an emergency is over, or during chronic emergencies, the quantity of needed medicines should be reassessed base on operational needs, and a routine supply of health items should come from consumption-based demand. 

The most widespread and accepted emergency health kit is the Interagency Emergency Health Kit (IEHK) developed by WHO, however there a variety of other kits that support trauma surgery, maternal and reproductive health, newborn health, and specific infectious diseases produced and managed by different humanitarian organisations. Emergency health kits may include a mix of pharmaceuticals, medical devices and equipment, and are designed based on treatment of specific medical conditions common in emergencies. The contents of each kit are designed to attend specific diseases, for a specific number of patients during a given period of time using assumptions based on global standard treatment protocols.

The advantage of emergency health kits is that they are uniformly recognised and stocked across multiple organisations and vendors and are generally recognised by governments. A pharmaceutical manufacturer or supplier can assemble, or stock health kits based on known and pre-approved components, and customs and health officials at the national level have known documentation on what may be included. Depending on the organisation responsible for the specific kit(s), content is usually updated every few years to be compliant with updated clinical guidelines and based on other changes in the medical supply landscape.

Use of the word “kit” should not be mistaken as a singular box or bag. The majority of health kits consist of more than one box, and in some cases multiple pallets per single kit. Additionally, a number of health kits contain a mix of health product categories – such as temperature-controlled items, keep cool items, dangerous goods, or controlled substances – and management of health kits requires keen attention and the implementation of quality risk management throughout distribution. 

Some larger humanitarian organisations may choose to develop their own health kits, which may or may not be available to other agencies for procurement. Prior to developing health kits, agencies should consult what is available on the market, and keep in mind the need to conform to international standards, such as essential medicines lists, while doing so.

Donations of Medicines and Health Supplies

There are many different scenarios for medicine and health material donations – such as emergency aid, long‐ term aid, or assistance to national health systems or to individual health facilities. Donations may come from pharmaceutical companies (directly or through private voluntary organisations), they may come in the form of aid from governments, or they may be donations aimed directly at single health‐care facilities. The intended beneficiaries of donations of medicines range from individual facilities to entire health systems. Although there are legitimate differences between these scenarios, many basic rules for appropriate donation practice apply to them all. 

WHO in cooperation with major international agencies active in humanitarian relief and development assistance, developed the Guidelines for Medicine Donations. The guidelines are intended to improve the quality of medicine donations in international development assistance and emergency aid. 

The guidelines aim to describe a common core of good medicine donation practices based on a few core principles:

1. Donations of medicines should benefit the recipient to the maximum extent possible. All donations should be based on an expressed need. Unsolicited medicine donations are to be discouraged.
2. Donations should be given with due respect for the wishes and authority of the recipient, and in conformity with the government policies and administrative arrangements of the recipient country: all donated medicines or their generic equivalents should be approved for use in the recipient country and should appear on the national list of essential medicines or equivalent or in the national standard treatment guidelines, if the national list of essential medicines is not updated.
3. There should be effective coordination and collaboration between the donor and the recipient, with all donations made according to a plan formulated by both parties. 
4. There should be no double standard in quality. If the quality of an item is unacceptable in the donor country, it is also unacceptable as a donation. 
5. Items must not have less than minimum required shelf life upon arrival to allow timely distribution and consumption without causing unnecessary reverse logistics activities and related costs.

Different humanitarian organisations will have internal requirements and processes for the acceptance of donations of medical and health supplies which aim to ensure compliance with WHO guidelines for medicine donations. 

In addition to the regular procurement policies and procedures used for importing goods in any humanitarian context, there are additional components specific to the importation process of pharmaceuticals and health items that humanitarian organisations should be aware of. The importation of pharmaceutical products is normally done in compliance with national regulations established under the National Medicines Regulatory Authority (NMRA). In most countries, NMRA is the national agency responsible for the marketing authorisation of, and other regulatory activities concerning pharmaceutical products.

In principle, the NMRA will restrict the importation of unapproved and substandard medicines, as this poses a serious risk to public health. For controlling purposes, specific requirements are expected for the importation of goods such as medicines, vaccines and biologics and medical devices and other health supplies (not exhaustive: will depend on local regulations):

• Only designated ports or points of entry specifically authorised for importation may be used to channel consignments of pharmaceutical products.
• Only pharmaceutical products proved by appropriate documentation to be duly licensed for marketing or specific intended use such as clinical trials, personal use or other means as appropriate should be cleared by customs. When new products are required for importation, an emergency authorisation must be released by the local authorities.
• All importation of pharmaceutical products may be done by authorised importers only. 
• Quality sample testing may be required, being unable to release the goods until the results are provided. In some cases, testing occurs at the time the goods arrive, or even after they have cleared customs. 
• Specific requirements may be put in place related to minimum shelf life on importation.
• Additional restrictions and licenses may be imposed for importing different narcotics (controlled substances) and dangerous goods.

In addition to restrictions on importation, many times NMRAs or other authorities might also restrict the export of certain heal items as well. Requirements for restriction of exportation may vary, depending on sensitive local markets, politics, or regulations on controlled substances. Exportation restrictions may impact reverse logistics of removing drugs but may also impact drugs exported from manufacturing or prepositioning facilities in more developed countries as well. Importers/exporters should review legislation requirements prior to exporting any items and should consult with a knowledgeable customs broker. 

Emergency Procedures for Import

In emergencies, import regulations may change. Depending on the type of emergency and the political climate, the regulations on import might change substantially; when confronting a major natural disaster or health emergency such a pandemic, the authorities are prone to be more flexible with their importation procedures. By contrast, emergencies caused by political instability may cause the rules and regulations may become more challenging and the paperwork more burdensome. 

The type of registration obtained by the humanitarian organisation may affect its ability to import medicines in case of an emergency.

• If organisations are registered under the ministry of health as a medical NGO, importation of medicines and health products may become easier. 
• Declaration of non-commercial use of the products, or the donation to the Ministry of Health may also ease the process.     

Waivers in emergencies specific to health supply importation (depending on the context) may include:

• Waivers on importation based on NDML.
• Waivers on importation based on national registration.
• Reduction on documentation and testing requirements. 
• Waivers on restrictions to country of origin. 
• Waivers on restrictions of import to specific ports of entry. 
• Waivers on restrictions of authorised importers.
• Waivers on minimum shelf life requirements (If required for advocacy: see attached Appendix 2 to the WHO Points to consider for setting the remaining shelf-life of medical products upon delivery, which specifies for governments examples of minimum remaining shelf-life for emergency health kits for use as part of humanitarian response).

Customs Concepts Common to Health Items

Banned/Allowed Items

Prior to attempting to import any pharmaceutical or health item into any country, humanitarian organisations should research regulations on what can and cannot be imported. This is especially important in rapid emergencies where organisations may wish to import pre-made kits or prepositioned stock or undertake a rapid procurement that may or may not contain items that are not permitted to be imported for whatever reasons.

Methods that humanitarian organisations can use to identify banned/allowed items for import include:

• Speak with a registered customs broker. 
• Consult ministry of health websites or other online sources.
• Reference the database of approved essential medicines per country.

Documentation:

In addition to the regular documentation required to import any item, there are additional documentation or steps that may relate to health items, with particular emphasis on pharmaceutical and live vaccines. These might include:

• Certificate of Registration – Proof that the medicinal product is duly authorised by, to be marketed or otherwise so authorised for use in clinical trial or for personal use.
• Import License - Proof the importer is duly authorised to undertake the transaction.
• Certificates of Analysis (CoA) – CoAs include information on laboratory testing for specific batches or lots of pharmaceuticals and other health items. Sometimes CoAs can be provided by the manufacturer, but some national authorities require CoAs from recognised outside sources to prevent fraud.
• Laboratory Samples – Some customs and health authorities require laboratory testing on imported goods once they arrive in-country. This usually entails samples taken from supplies prior to clearing customs and being sent to state managed or mandated laboratory testing sites. 
• Other Common Forms – Safety Data Sheets (SDS), Certificates of Origin (CoO), Certificates of Inspection (CoI), Certificates of Conformity (CoC), Pre-shipment Inspection (PSI) as applicable. More information on other common forms can be found here. 

Cold Chain Items:

For cold chain products, there may be fast track procedures, enabling a preliminary reception of the goods while clearance procedures are concluded at a later stage. In any case, for any temperature-controlled range, it is strongly recommended to assess the customs facilities for their capacity to receive and properly handle items. 

Transit Regimes:

Many countries now have strict regulations on handling health items under their own national GDP, and health items may only be released to a limited number of pre-identified entities, such as central medical stores or state appointed companies. In instances where humanitarian organisations may wish to transit health items through one country into another neighbouring country, there may be limitations on the types, quantities, or time frame in which some or all health items can transit.

Physical Considerations:

Depending on the port of entry used for importation of medical items, there will be different infrastructure available and different levels of knowledge on the handling staff related to medical supplies. 

In larger centralised airports and sea ports, where the private/public sector have already been importing medical supplies, the likelihood is higher that the correct temporary storage infrastructure, handling equipment, standard operating procedures and capacity of handling staff is in place. 

In smaller air and sea ports, or in locations where the entry point operation has been impacted by the emergency - such as damage to infrastructure or displacement of handling staff - there may be gaps in the proper infrastructure, capacity, and processes related to maintaining the safeguarding and quality of medical supplies.

Bottlenecks or gaps, which need to be mitigated for, may include:

• Lack of available (or insufficient space in) covered storage location.
• Lack of available (or insufficient space in) temperature-controlled storage (or reefer connectors in sea ports).
• Lack of available (or insufficient space in) keep cool storage locations (or reefer connectors in sea ports).
• Lack of knowledge of handling staff on fragile goods handling.
• Lack of proper handling equipment.
• Lack of special operating procedures within standard operating procedures dedicated to offloading and immediate temporary storage of medical supplies in relevant storage locations.
• Lack of controlled access storage for controlled substances.
• Lack of process or infrastructure for segregation, destruction or movement of damaged/expired medical supplies (pre or post clearance).
• Lack of knowledge on preparation of keep cool items for onward dispatch when cleared.

Solutions, which will often require engagement with relevant national authorities and port operating agents may include capacity development of personnel, procurement of ad hoc infrastructure/equipment (temperature controlled MSUs, refrigerated containers, freezers, generators, etc.), or deployment of dedicated specialised personnel to the entry point. 

Temperature Mapping

Temperature mapping is the is process of identifying and marking temperature zones inside of a warehouse used for storage of temperature sensitive commodities, including all anticipated temperature ranges required for storage. Whether or not humanitarian agencies are utilising an outsourced storage facility, or they are managing their own facilities, it is advisable to conduct a temperature mapping exercise so that warehouse managers can best utilise the available space. For more information on evaluating commercial climate-controlled space, reference WHO’s guide on the qualification of temperature-controlled storage areas. For more information on conducting temperature mapping on self-managed spaces, please reference WHO’s guide on temperature mapping of storage areas.

An ideal temperature mapping exercise utilises automatic temperature loggers, however humanitarian organisations might utilise handheld devices such as digital thermometers, or even traditional thermometers. There are several things to consider when conducting a mapping exercise. 

Ensure that when the mapping exercise is conducted the warehouse is in same condition as it will ultimately be used to store items as:

• If the warehouse is meant to use air conditioning or other cooling solutions, ensure all temperature controls are enabled and running at the time of the mapping exercise. Note: agencies may wish to map the temperature of the facility without power as well to understand what conditions may be faced in case of a catastrophic power outage
• If the warehouse relies on passive cooling, ensure that conditions match the planned storage conditions, including all shading in place and all doors and windows are closed. 

For small storage spaces (single rooms with low ceiling):

• Take a temperature reading at each of the four corners of the storage space. 
• If the rooms are longer than four meters, then take a temperature reading along the edges of the floor and ceiling, with readings conducted once every two meters.

For large storage spaces, or locations with high ceilings:

• Take a temperature reading at every two- or three-meter interval both horizontally and vertically. Readings may not necessarily be conducted against a wall or surface – imagine the storage space is filled with invisible cubes of two to three meters in width stacked neatly on top of each other – temperature readings would be conducted at the corners of where each of these cubes intersect.
• If there are wide open areas where no cargo will be stored, it may not be necessary to take a reading – focus on known storage areas such as elevated racking, shelving, and packing/condition areas.

For all storage locations:

• Temperature readings should be recorded into a report or table. 
• Temperature readings should be taken at multiple times a day, including in the morning, afternoon and nighttime. Ideally, temperature mapping should also occur during different times of the year, however this may not be possible for a number of practical reasons. 
• If there are extreme temperature fluctuations throughout seasons, mapping should be conducted at different times of the year corresponding to seasonal changes. 

The outcomes of a mapping exercise will inform how cargo is stored. If there are known areas with significant temperature spikes:

• Managers can be instructed to not store sensitive items in specific areas of the facility.
• Managers can identify potential airflow issues that may be the cause of temperature variations, such as placement of doors.
• Agencies can invest in infrastructure upgrades, such as improved powered cooling equipment or passive cooling techniques such as insulation or shading.
• Planners may choose to simply find another storage facility that is more appropriate for their needs. 

Temperature Monitoring 

Temperature monitoring is the process of continually monitoring temperature inside of a warehouse or storage facility using some form of recording device. Temperature monitoring can be both automatic, and manual. 

All storage locations used to store time temperature sensitive temperature-controlled health commodities – whether they are freezer rooms, cold rooms or regular temperature regulated storages – should have some form continual monitoring of temperature. If there are specialised packing and loading spaces that are dedicated to health items, they should be monitored as well. In high capacity warehouses this can be an alarm based automatic notification when temperature deviates outside of the set range. More likely in a humanitarian environment it will either be tracked with a wall mounted thermometer or handheld thermometer with daily checks. It is recommended that daily checks are taken at different times to identify possible temperature diversions at different times of the day. 

It is important to note that temperature monitoring devices (including thermometers, freeze indicators, temperature recorders, alarm systems, event loggers and remote communication devices for monitoring temperatures at all levels of the cold chain) are internationally regulated by WHO PQS. Any use of electronic or automatic temperature monitoring should be done in line manufacturer specifications, including calibration, installation and routine use. Consult the manufacturer and/or qualified installer for more information before attempting to install or calibrate devices without professional support.

Automatic Monitoring

Automated temperature monitoring solutions are considered ideal for storage of temperature sensitive health commodities and should be utilised wherever possible. 

In an ideal setting, active monitor devices should be placed throughout the entire warehouse facility. The WHO Expert Committee on Specifications for Pharmaceutical Preparations suggests that electronic temperature monitors “should be arranged in a grid fashion along the width and length of the area so that the area is reasonably covered, […] located every 5–10 meters.”  However, many humanitarian operations function in less than ideal conditions, and the WHO guide on Maintenance of storage facilities indicates correct the correct locations are established in case of limited resources:

• Ambient and controlled ambient storage areas: Position sensors in the places where seasonal hot and cold spots have been observed during the mapping studies.
• Freezer rooms and cold rooms: Position sensors in the places where operational hot and cold spots have been observed during the qualification and/or mapping studies.

The overall layout and number of electronic monitoring devices will depend on the size of the space, and on the resources available to the humanitarian agency. General rules to consider:

Installation of automatic temperature monitors should take into account alcoves or irregular warehouse shapes. If more monitors are required because of lack of airflow or increased ambient heat in some areas of the facility, consider placing available monitors in those locations over wide-open areas with consistent temperature ranges.

Whatever active monitoring devices are used, ensure that:

• Humanitarian personnel using the devices are fully training in using and reading the equipment.
• The devices are in good working order, and if possible, covered under a warranty.
• Installed by knowledgeable persons. If no person working for the humanitarian organisation is capable of managing the install, utilise an outside service such as the warehouse provider or a private company. 
• There is a plan to check on and service the devices at a period defined by the manufacturer. 
• The automatic monitoring systems should provide a readout via software or website that is easy to understand, and ideally in a language spoken in the local context. 

The below arrows indicate the potential locations for temperature monitoring devices. 

Temperature monitors in warehouse with elevated storage:

Tempeature monitors in walk-in cold storage room:

Source: WHO - Temperature mapping of storage areas

Manual Monitoring

Manual temperature monitoring of health commodity storage spaces has been practiced for years and was prevalent in most locations until automated monitoring systems became more widely available. Even with advanced monitoring systems, manual monitoring is still used in many humanitarian settings, especially in rural areas, or in areas with heavily impacted infrastructure.

The concepts behind manual monitoring are not dissimilar to those of the automated monitoring systems: 

• Self-powered digital, non-digital, or non-powered thermometers can be hung at intervals throughout a climate-controlled storage space and will need to be checked on an ongoing basis. 
• Electronic handheld temperature readers can be used to manually check temperature readings in storage locations. This involves holding the manual temperature reader in different locations of the storage facility and recording the temperature at regular time intervals. 

Manual temperature monitoring routines are better suited for smaller storage facilities equal to a single room or a small storage site. Attempting to manually track temperatures in large warehouses, or storage facilities with ceilings taller than 3.5 meters may not be feasible. 

To facilitate manual monitoring, storekeepers should set a routine, ideally checking two times a day. To make things easier, if there is more than one thermometer in the storage facility, the storekeeper should record the highest temperature found in the room – trying to maintain records on every thermometer may be difficult and confusing. At a minimum each separate space – such as room or dedicated area of the warehouse - should have its own manual monitoring chart. Ideally, in large warehouse rooms multiple manual monitoring charts should be used, particularly if using multiple different active cooling systems, or where one side of the room is more exposed to possible deviations in temperature, such an open loading door. 

Below is an example manual monitoring chart:

Taken from: Immunizationacademy.com 

Once each monitoring chart has been completely filled, it should be backed up in a binder and stored in a safe location – this will enable planners and managers to look at historical trends and identify potential problems with individual storage facilities. 

Cold rooms and freezers rooms are typically custom built and meant to store cargo items that occupy traditionally low temperatures. This includes products below freezing temperatures, as well health items that occupy the +2°C to +8°C range. Rooms with cold storage or freezer capacity typically are custom built for the storage requirement, and are subject to higher degrees of control, such as continuous monitoring capacity or redundant power systems. Cold and freezer rooms also require specialised equipment and insulation. 

In the majority of operations, items requiring storage below +8°C usually make up a small portion of the overall volume of cargo items, and properly calibrated cold storage rooms often don’t need to be large, and ideally should only match the actual known requirements. In many cases, a standalone electric refrigerator/freezer will meet the storage requirements for most agencies. Cold storage rooms can represent a substantial financial investment and given the duration of both emergencies and available funding, such rooms are typically only planned when either the volume of the incoming cold storage items are substantial, or when the duration of project is known to be long.

Walk-in cold room:

In instances where humanitarian agencies require large, or even warehouse sized refrigerated storage, it is strongly suggested that agencies speak with a licensed professional or attempt to outsource the storage space to a third party commercial provider. Large scale refrigerated storage or refrigerated warehouse spaces are fairly common amongst large manufacturers, or amongst national authorities, and their overall functioning is not dissimilar to smaller refrigerated storage spaces, however the costs and complexities associated with constructing and maintaining these facilities should only be overseen by experienced professionals.

In addition to industrial scale refrigeration, other features of refrigerated warehouses might include:

• A kitting or packing area – an area used to assemble pallets or kits that is also contained within a refrigerated space.
• Specialised doors/loading bays – doors and loading bays will have proper insulation, plastic flaps, or even specially designed fans to prevent heat loss through openings to the external world. 

Temperature-controlled pallet standing storage area:

Temperature-controlled elevated racking storage with kitting/order assembly:

Temperature-controlled dock seal:

Taken from: WHO – Design and procurement of storage facilities 

Stand Alone Refrigerators and Freezers

Some health commodities and some humanitarian health related storage needs may only require the usage of stand-alone freezers or refrigerators. Refrigerators and freezers tend to useful for vaccines and other small volume pharmaceutical items, as the capacity of refrigerators is relatively small. However, refrigerators and freezers are good alternatives when the known quantities of stored items will be low volume, or when no other alternatives are available. Additionally, standalone refrigerator and freezers may be required for ice and cool packs if reconditioning of passive cold chain boxes is required.

Much like air conditioners, refrigerators and freezers also produce heat exhaust. If refrigerators/freezes are kept inside of a warehouse facility, there should be proper ventilation to avoid excessive heat built up, and planners should be aware of the impact increased temperatures might have on other collocated stocks. In instances where multiple freezers and/or refrigerators are in the same storage location, this may be come problem requiring dedicated attention. 

Configurations for Refrigerators and Freezers

Though only basic equipment may be available in many field contexts, there are still special configurations that humanitarian organisations maintaining cold chain medical items may wish to consider.

Medical Grade Refrigerators/Freezers – There are a variety of medical grade freezers and refrigerators that are purpose built for maintaining keep cool and frozen grade medical items. Medical grade refrigerators and freezers are internationally regulated by WHO prequalification. Some characteristics of these refrigerator/freezer units might include:

• Highly calibrated thermostats/cooling units.
• Clearly defined set points.
• Back up battery systems in case of power failures.
• Alarm systems in case of temperature excursions.
• Clear windows to make identifying contents easier without having to open doors.

Specialty freezers and refrigerators are often also right-size, designed to only accommodate the anticipated demand of those specific temperature ranges, meaning they can be purchased in relatively small sizes, and different temperature requirements can be stored in different units.

Wherever possible, humanitarian organisations should avoid regular consumer grade refrigerators and freezers for any health items that have highly specific temperature ranges, or for health items that can be easily damaged by excursions. For example, vaccines tend to have a very low threshold for temperatures above/below defined ranges, and without clearly defined set points or precise monitoring a regular consumer grade freezer may not be sufficient. 

If agencies plan on using regular consumer grade freezers or refrigerators, they will want to thoroughly assess the capacity of the units, including:

• Logging temperatures inside the for 5-7 days prior to storing temperature-controlled items to ensure that temperatures remain consistent and within the anticipated ranges. Monitoring should be done the same as a temperature-controlled warehouse – temperatures logged once every few hours.
• If possible, agencies should use temperature loggers inside refrigerators/freezers to map any temperature excursions for functions.
• Install a universal power supply (UPS) with an alarm system in case of power outage. 

Top Loading Refrigerators/Freezers – A common method for conserving power/preventing heat loss is the use of top-loading refrigerators and freezers.  Top-loading units open from the top instead of the side – as cool air sinks downward, there is less of chance of cold air escaping, maximising energy for the refrigerator or freezer. Much like consumer grade units, there are also medical grade top-loaded refrigerators and freezers that should be considered when procuring.

Persistent Power

Refrigerators and freezers require access to consistent power, especially when storing vaccines. Due to the fact that persistent power isn’t always available in all field locations where humanitarian actors may be operating, there are a variety of power options that should be considered.

Compression Refrigerators: Plug-in Power – Basic refrigerators and freezers will come in plug-in models only, not dissimilar to those used in home settings. Some freezers and refrigerators specifically designed for management of vaccines and other medical commodities may come with built in battery backup systems that enable the units to continue to maintain active cooling for periods of intermittent power outage. Built in power backups generally won’t provide power longer than a few hours, and users should consult manufacturer guidelines and compare against anticipated power outages in the areas of storage. 

Absorption Refrigerators: Kerosene/Gas Powered – Completely off-grid refrigerators and freezers traditionally have been powered with Kerosene and other forms of combustible gas. Gas powered refrigerators/freezers are typically powered using compressed gas cylinders or liquid gases – the gases are used to ignite a pilot light that heats permanently sealed coil that is chemically designed to produce a cooling effect. Gas powered refrigerators – though widely used – have slowly become less common due to the health risks and fire hazards associated with their use. Additionally, gas powered freezers/refrigerators will still require a supply of fuel, any disruption of which will cause the units to stop working. Depending on the size of the gas cylinder or the refrigerator units, gas powered refrigerators/freezers may need to be monitored and changed frequently. 

Solar Powered – As costs of batteries and solar panels have gone down, the use of solar powered refrigerator units has increased in many remote areas. The basics of using solar power for refrigeration are no different than the basics of using solar for any other electrical appliance. For more information, please reference the sections on solar powered systems and battery backup systems. The important things to note when using solar and battery systems for refrigerators and freezers is that refrigerators/freezers rely on electricity, and that the power is sufficient to match the consumption needs of the units – freezers and refrigerators tend to use a large amount of electricity, especially in warm climates. 

In many cases, humanitarian organisations may wish to install solar panels and/or batteries specifically for standalone freezers/refrigerators; many manufacturers produce self-contained solar powered freezers and refrigerators that humanitarian organisations may buy. When investigating solar powered or battery backup supported freezers/refrigerators, it’s important to note the difference between “Solar direct” power and “solar battery power”. 

• Solar Direct Power – the refrigerator/freezer is linked directly to the solar panel without any intermediary battery, meaning there is no electricity produced while the sun is not directly shining on the panels. Refrigerators/freezers that don’t have built in battery backups will experience power outages during the nighttime.
• Solar Battery Power – Solar battery powered freezers/refrigerators have a regulated battery system in between unit and the solar panels, allowing the batteries to absorb power through the day and slowly disperse it through the night. A properly designed battery backup system will accommodate the full need of the refrigerator/freezer, without any breakages in power, even during emergencies. A battery backup system should still have sufficient safety controls, like any battery system in use. 

Solar Battery Powered Refrigerator Solar Direct Refrigerator

Taken from: WHO - Solar direct-drive vaccine refrigerators and freezers

In the event of persistent power outages/power shortages with no alternative provided for backup power, protocols should be put in place to ensure that goods stored within refrigerators and freezers maintain internal temperature during outages. This might include:

• Instructing staff to not opening the units while power is out.
• The use of temperature dataloggers.
• Using ice and cool packs to augment temperature controls.

Maintaining freezers and refrigerators 

Refrigerators and freezers will degrade over time. Signs of degradation might include:

• Condensation or ice forming on the outside of the refrigerators.
• The compressor motor used to generate cooling runs for noticeably long or frequent periods of time.
• The interior of units never become cool, or reach a given set point.

Suggested maintenance procedures for medical grade refrigerators and freezers include:

• Keep units clean by regularly washing with mild soapy water solution.
• Keep door seals clean, avoiding build-up of material between folds and at corners.
• Remove build-up of ice (use the defrost system or a blunt scraper).
• Keep drains free of debris.
• Clean condenser coil (fins), ensure fins and cooling fan and any grilles are free of dust, fluff and debris.

In any storage location where health items might be stored, there are several general rules that will help avoid loss to stock through damage or unanticipated expiration date.

Item Placement and Visibility:

• Avoid storing boxes, or exposed health items in places that receive direct sunlight. Even short periods of exposure to sunlight can damage some health items, especially those labelled as light sensitive.
• Unless there is an advanced inventory management system in place, stock cards are strongly recommended. Stock cards should contain information on:
  • Batch numbers.
  • Expiration dates.
  • Temperature ranges.
  • Product codes.
  • Programmatic use.
• Avoid mixing the same medication from different batches/expiry dates – if your storage facility is warehousing the same health item but from different batches/expiry dates, those items should be kept separately, and recorded separately. 

If storing health items in cartons: 

• Ensure that cartons with arrows indicating which side should be facing upward are properly followed. 
• Ensure cartons are properly labelled, with contents, expiration dates, batch, and other relevant information visible. If no labels are used, or the boxes come unmarked, write the relevant information on the side. 
• Follow manufacturer’s directions on stacking and handling. 

It is always important to remember that the majority of health items are classified as fragile. Handling personnel and practices should be in place to ensure safe management of goods.

Any storage facility used to store health commodities protect all items from physical damage, moisture, excessive heat or cold, sunlight, dust, dirt, and pests.  Cleanliness in a warehouse used to store medical items is of even more importance than it is for some other categories of commodities.

Colocation with Other Materials – Pharmaceuticals and medical support devices should always be stored separately from chemicals or food. Examples of chemicals commonly found in humanitarian contexts might include:

• Pesticides
• Fertilizers
• Cleaning agents
• Fuel
• Foodstuffs and bulk food items

However, even non typically hazardous materials – such as bags of cement – can impact health items, both in storage and in transport. Wherever possible, health related items should be stored in adequately prepared and separated spaces.

Shelving:

The use of shelving is very common when managing health items. Shelving is useful for easily storing small quantities of a large number of SKUs, enabling storekeepers to withdraw discrete quantities of items while still being able to neatly segregate and track them. 

Frequently shelving is used in the same location as racking; racking is better suited for managing large cartons or pallets and may be used before the cartons are open and the line items are broken down into discrete inventory units, while shelving is better suited for managing individual units that are withdrawn on a case by case basis. Both have their use cases in health facilities.

In addition to the normal practices of using shelves, there are some special considerations when using shelves to store health items:

• Place glass vials on the bottom shelf to minimise risks of damage from falling items.
• Place liquids on the bottom shelf to avoid damaging other items in case of a rupture or leakage.
• Ensure that all items are clearly visible, and when labelled, labels are legible.
• Even if the quantities are small, use stock cards to record transactions. Multiple stock cards can be kept in a single pouch or container to save space.
• In storage areas with temperature zones, temperature sensitive health items should be stored where temperatures are most appropriate for their manufacturer specified requirements, usually on the lower shelves. 

Palletisation:

If health items are stored in pallets, there are some key rules for proper management beyond the regular guidelines for managing pallets and ground stacking:

• All cartons containing health items should be clearly labelled with relevant information, and labels should be outward facing and visible. 
• Medications are frequently light, and sub-packaging may have much empty space – cartons containing health items might be easily crushed or damaged and should not be stacked to excessive heights. Never exceed 2.5 meters as a maximum height of cartons stacked on a pallet, and ideally less height where possible. 
• When storing pallets with multiple types of health items, pallets may need to be physically separated by a minimum of 30 centimetres to allow access to all sides of the pallet for inspection and handling purposes. 
• Where possible, store like-items together, such as health items from the same batch and with the same expiration date. Intermixing different items will make picking specific items more difficult.
• The use of heat treated, or plastic pallets is recommended for storing health items wherever possible.

Damaged and Expired Health Items

Due to the sensitive nature of pharmaceuticals and other medical devices, it is extremely important that managers of health stores monitor, identify and isolate damaged or expired items for proper repair or disposal and prevent accidental release of such items into distribution to avoid harm to end user.

Managers of health items should always track the expiration dates of health items, and routinely conduct inspections and physical inventory counts to ensure any and all instances of expiration or damage are captured. The intervals required for inventory counts of health items may be more frequent that non-medical items, and managers may wish to conduct a physical inventory every three months or even once a month. Based on the number of individual line items in any medical store, a full physical inventory may be prohibitively complex, so managers may also wish to conduct random sampling on an ongoing basis, with intermittent physical inventories through the year.

Health items that have been identified as either damaged or expired should be removed from their regular location in the storage space, and isolated in a specially identified “quarantine area” within the storage facility. A quarantine area doesn’t mean that health items are infectious, but rather they are to be treated separately from the rest of the items on stock.  Quarantine areas should be:

• Clearly marked and labelled as being stock that cannot be issued as regular stock.
• Clearly physically separated from main stock items. This might include painted areas on the floor, or possibly even separate rooms.
• Ideally, quarantine areas should be lockable, and keys should be kept with the warehouse manager. 
• In some contexts, the isolation and management of damaged/expired health items might have specific regulations, including secure monitoring and time limitations. Logistics personnel should consider local laws prior to designing a quarantine strategy.

Items placed in quarantine should:

• Be tracked separately from non-impacted stock items, including their own stock cards and their own record in an electronic inventory system. 
• Be prepped and ready for disposal. 
• Any medication, be it expired or damaged should not be considered fit for human consumption and should be disposed of safely and in a manner in compliance with local regulations. Please reference the section on medical waste management for more information. 

The process for the proper management of health items should follow the general guidelines for all inventory management, including overall demand forecasting and inventory control mechanisms. There are – however – additional concepts that are special to managing health items.

First Expired/First Out (FEFO)

FEFO as a general rule is important for health products because it emphasises expiration dates of products, irrespective of when those items may have entered general storage. In FEFO, products are rotated out of storage based on how close they are to expiration. In health supply chains, there may be multiple products of the exact same type that happen to have different production/expiration dates; FEFO helps reduce product loss by ensuring that wherever possible, the shortest shelf-life items are used first.

In order for FEFO to be effective:

• Expiration dates should be clearly identifiable on products held on shelves and racks. If the expiration date cannot be easily seen on the carton or packaging, then the expiration date may be noted on stickers or pieces of paper on the outside of the cartons/pallets.
• Expiration dates should be recorded on all stock cards and warehouse ledgers/inventory systems. 
• Similar items with different expiration dates should be separated by expiration dates. Where possible the items with the closest expiration dates should be moved to the front of racks or shelves, something that might be more useful in smaller storage facilities with loose items on shelving. 
• Physical inventories should be conducted routinely, with an emphasis on identifying short shelf-life items that may have been ignored or intermixed with other stock items. 
• Persons managing inventory should be told to issue short shelf-life items first wherever possible. 
• Items approaching three to six months prior to expiration dates should be flagged. Any items with less than three months of shelf life should be communicated to project managers immediately so action can be taken as needed. 

Product Inspection

The physical characteristics of health items may change over time and may be clear signs of degradation of product quality. In addition to looking for physical damage to packaging or tracking expiration dates, there are things that logistics managers of health products might look out for to determine if a product has quality problems:

Taken from: JSI - Guidelines for the Storage of Essential Medicines and other Health Commodities

Signs of product defects can be caused by a variety of things and may be sign of a wider problem.

If any product displaying any form of above-mentioned defects is identified, logistics personnel should:

• Separate identified issues from general stock and stop any distribution or use of the items.
• Contact the product distributor and/or manufacturer and/or the organisations quality assurance specialists to see if there is a known cause or if the product may still be usable.
• Contact other storage sites or health facilities with similar products to see if the problem is occurring elsewhere.

Only after a proper course of action is identified should products be either disposed of or returned to general rotation. In the event that the product is damaged, and disposed of, mitigation measures should be implemented to prevent future damages to other items if within the control of the organisation/warehouse.     

Recall Management

Throughout the course of any health-related supply chain, health practitioners may be faced with managing product recalls. A product recall occurs when a manufacturer or a local health authority indicates that one or more health items is considered unfit for human consumption and must not be distributed or used in routine activities. There are multiple reasons why a product may be recalled, including faulty production, product tampering, changes to local regulations, or some other defect that may impact the product’s fitness for human consumption. Manufacturer’s typically reference item batch or lot numbers when identifying recalled items, however entire product lines or even products from specific periods of production may be recalled. The important part is that the manufacturer or local health authority will provide specific criteria for what items should be recalled, and humanitarian actors should endeavour to comply wherever possible. 

Recalled items are occasionally returned to the manufacturer, however in many contexts the owners of the health items will need to actively quarantine all recalled items and manage the destruction/disposal process directly. In most humanitarian contexts, pharmaceuticals and medical devices are frequently imported from outside the country of operation, and the process of collecting and re-exporting recalled items may be prohibitive or even impossible. Any time a recall occurs, logistics planners must assess what is feasible. 

The general steps for recall management include:

• A product manufacturer or local health authority identifies a specific product, or products based on key criteria that should be recalled.
• (If possible) humanitarian organisations should reference all procurement and inventory tracking systems to understand if the recalled items are currently in their supply chains. Note: due to the complex or ad-hoc nature of humanitarian supply chains, this information may not be available. If no records are available, humanitarian organisations should act as if they have recalled items in their possession. 
• Humanitarian organisations should immediately contact all warehouses, storerooms, health facilities, or other locations where recalled products might have been sent. All locations should be informed to do a full inventory to identify any and all recalled items. Identified recalled items should be segregated from the primary inventory items and placed in a secured quarantine area. 
• (If required) humanitarian organisations should contact local communities, ministry of health offices and partner organisations that might have received recalled goods as part of regular programmatic activities and inform each party of which items have been recalled, and what steps they should take to safely secure recalled items. Depending on the context, the humanitarian organisation may be required to retrieve all recalled items directly from each outside party in order to avoid any mismanagement or accidental distribution. 
• (If required) The humanitarian organisation in question may have to organise the pick-up and relocation of all expired items to the capital city or primary distribution facility to enable proper return or disposal of the recalled goods. In many humanitarian contexts, there may be no local infrastructure to support disposal at the local level.
• In every context, there may be different steps required for the proper disposal of recalled items. 
  • Manufacturers may offer or may be obliged to pick up recalled items directly from organisations managing the items themselves. 
  • Local or national health authorities may have dedicated facilities or means to pick up or receive specific recalled items.
  • Local or national regulations may require that recalled health items be disposed of by the product owner in specific way, or that some items be re-exported. In the event items are re-exported, special permits will likely be required. 

Even if there is no specific regulation in place, humanitarian organisations should seek to properly dispose of recalled items using the most ethical and environmentally friendly methods available. Proper disposal methods can be found in the section on managing medical waste. 

While supporting any form of medical intervention, logistics personnel may be asked to manage a variety of medical waste. Medical waste isn’t defined as just the health items that are found as damaged or expired while in storage or transport, but also the biproduct of routine activities that occur in health centres and hospitals as well.

Taken from: WHO - Safe management of wastes from health‑care activities

Medical waste can pose specific threats to humans, animals and the environment, and must be handled appropriately. Infectious waste and pathological waste products in particular are highly sensitive and should only be handled by experts that understand the process, while all of the aforementioned medical waste items are likely subject to some form of regulation or control. 

International conventions such as the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes or the Stockholm Convention on Persistent Organic Pollutants (POPs) in particular define the waste management policies for signatories, however national or local laws may will also outline the procedures. The important thing for logistics personnel to know that that any form of medical waste disposal must be done in a safe and lawful manner. Under no circumstances should medical waste be disposed of with general waste.

Traditionally, the aggregation and storage of medical waste is not the role of logistics personnel and is usually left to healthcare professionals operating in medical facilities. Due to limitations on personnel and resources, logistics staff in humanitarian fields settings may be required to facilitate the handling, storage or transport of medical waste. 

Segregation of Medical Waste

Though local conditions may vary, as a best practice healthcare facility should segregate waste into four categories, each of which should be stored, collected and disposed of separately. The four categories are:

1. Sharps waste (needles and scalpels, etc.), which may or may not be infectious.
2. Non-sharps infectious waste (anatomical waste, pathological waste, dressings, used syringes, and used single-use gloves, etc.).
3. Non-sharps non-infectious waste (paper and packaging, etc.).
4. Hazardous waste (expired drugs, laboratory reagents, radioactive waste and insecticides, etc.).

Almost 85% of medical waste in health centers or hospitals belong to the category of non-sharps non-infectious waste. Any waste item that is cross-contaminated with infections waste should be considered infections waste as well, and proper segregation of non-sharps non-infectious waste from infectious waste can significantly reduce the total amount of infectious waste in a health facility. However, in many humanitarian contexts hazardous and non-hazardous healthcare waste is often not separated. If proper segregation cannot be ensured at source, consider all mixed healthcare waste as hazardous. 

Medical Waste Collection

Collection and storage of medical waste must be done using suitable storage containers. If no suitable containers are available, humanitarian organisations are strongly advised to procure the appropriate storage containers. As hazardous waste is collected, each container should be properly labelled, and collected waste should be placed in a pre-defined, secure location.

WHO has recommended coding and storage for some medical waste storage, including symbols, colour coding and marking. Recommendations for some common medical waste items are:

Type of waste Colour coding  Symbol Type of container Household refuse (non-sharps non-infectious waste) Black None Plastic bag Sharps Yellow and marked with a biohazard symbol: Sharps container Waste entailing a risk of contamination and anatomical waste Yellow and marked with a biohazard symbol: Plastic bag or container Infectious waste Yellow marked “highly infectious” and marked with a biohazard symbol: Plastic bag or container which can be autoclaved Chemical and pharmaceutical waste Brown, marked with a suitable symbol (example) Plastic bag, container

Adapted from: ICRC - Medical Waste Management Guidelines

Common storage container examples and practices include:

• Sharps should be placed immediately after use in yellow puncture-proof, covered safe sharps containers, which are regularly collected for disposal. Containers must not be filled above the line indicated on the label, and they must be sealed using the integrated safety lock prior to disposal.
• Non-sharps infectious waste should be placed in yellow or red infectious waste bags or containers (15–40-litre capacity with lids). Bags should be collected and replaced after each intervention or twice daily. Containers should be emptied, cleaned and disinfected after each intervention or twice daily.
• Non-sharps non-infectious waste should be placed in black waste containers (20–60 litre capacity). The containers should be collected, emptied, cleaned and replaced daily; alternatively, plastic bags may be used as liners inside the containers.

Adapted from: WFP Logistics Cluster - Downstream Logistics in Pandemics

For each of these three waste categories, it is recommended that waste containers are kept no more than five metres from the point of waste generation. Two sets of containers should be provided for each location, for a minimum of three types of waste, or as is required by the activities in the health facility. In hospital wards, at least one set of waste containers should be provided per 20 beds.

Example Sharps Container Example Biohazard Bag

Personal Protective Equipment:

Any persons tasked with collecting and handling medical waste should have the proper and necessary personal protective equipment (PPE). This may include protective eyewear, rubber gloves, aprons, respirators, and the proper body covering. Prior to handling any and all medical waste, personnel should consult with the attending medical staff about the appropriate handling protective equipment. Remember: some health related waste can be extremely hazardous or even lethal if handled incorrectly. If ever logistics personnel are in doubt about the safety of handling medical waste, they should cease activities and consult with a trained professional. 

Medical Waste Storage

The storage of medical waste can and will be regulated by prevailing local and national laws. Humanitarian organisations may also have internal guidelines or regulations on storage of medical waste. As an overall rule, humanitarian responders must check on local regulations before designing storage options.  Medical waste should also be handled by experienced professionals when and wherever possible. Below are general best practices that may be adopted if needed:

Taken from: WHO - Safe management of wastes from health‑care activities

Treatment and Disposal

The process for safe and adequate disposal of pharmaceuticals and health related items in contexts where humanitarians may operate has evolved significantly over the past several decades. Many state and local authorities now have strict regulations on the process of disposing of health waste and may include requirements far beyond the capacities of most individual humanitarian organisations. 

As a primary rule, aid agencies should seek to outsource the destruction of medical waste to licensed and recognised third parties, including private companies, or through state managed entities such as local Ministries of Health. Aid agencies should also seek to understand and respect all local laws wherever applicable. Proper disposal usually has a cost associated with it, and organisations should budget for potential disposal costs.

In any situation where waste is disposed of using a third party, or by the organisation following national protocols or WHO guidelines (subject to regulatory framework), proper documentation must be retained and backed up to prove disposal was undertaken in a lawful manner. Even where disposal is done informally in large scale emergencies, the process must be documented to avoid the suspicion of diversion or health related items, or to avoid the suspicion that expired, damaged, or recalled items were handed out to beneficiaries, or sold illegally. 

The Logistics Capacity Assessments website can provide humanitarian organizations with contact details for licensed waste management companies, overviews on local regulations and procedures in country including medical waste, and lists the existing waste management and recycling facilities in country.

In extraordinary situations, humanitarian organisations might be required to dispose of their own medical waste. Some steps might include: 

• Sharps should be disposed of in a sharps pit. In small health centres or emergency structures, sharps pits may simply be buried drums; in other settings, they might be concrete-lined pits. For safety reasons, it is not advisable to use a decentralized facility to handle collection and off-site treatment and disposal. However, in urban situations this may be unavoidable due to lack of space.
• In small healthcare settings, non-sharps infectious waste should be buried in a pit fitted with a sealed cover and ventilation pipe for on-site treatment. Alternatively, it should be high temperature incinerated or steam sterilized either on-site or off-site. Special arrangements may be needed to dispose of placentas according to local custom. The preferred option for specific infectious waste (such as blood samples, plastic syringes and laboratory tests) is steam sterilization before disposal. This avoids environmental pollution from incineration. One autoclave should be dedicated for waste sterilization. The autoclave used for sterilizing medical devices within the laboratory must not be used for this purpose.
• Non-sharps non-infectious waste should be buried in a pit, a landfill site, or preferably recycled with non-food and non-medical items. If space is limited, non-sharps non-infectious waste should be incinerated. Ashes and residues should be buried in a pit.
• There are several kinds of hazardous waste, and each requires specific treatment and disposal methods. These include encapsulation, sterilization, burial, incineration and long-term storage. Some waste, such as pharmaceutical waste, cannot be disposed of in low-cost settings and should be sent to a large centre for destruction or returned to the supplier. In all cases, national regulations should be followed.

Waste Disposal Zones

In locations where agencies must dispose of their own medical waste there are basic guidelines on the physical locations for disposal.

• The waste disposal zone should be fenced off and should be located at least 30 metres from groundwater sources. 
• It should have a water point with soap or detergent and disinfectant for handwashing or to clean and disinfect containers, and it should have facilities for wastewater disposal into a soakaway system or sewer.
• Where an incinerator is used, it should be located to allow effective operation with minimal local air pollution in the health centre, nearby housing and crops, and it should be large enough for extension if new pits or other facilities have to be built.

WHO has published guidelines on the safe disposal of unwanted pharmaceuticals including strategies for prevention, reusing, returning and safe disposal, in and after emergencies, and the safe management of wastes from health‑care activities.  In the event that agencies must disposed of their own medical waste, they are encouraged to speak with local Ministries of Health or other relevant body and consult with representatives from the local health cluster if available. 

Much like monitoring temperatures in a warehouse, there are a variety of temperature monitoring techniques and devices available for monitoring temperature of health related items while in transit. These devices can come in the form of:

• Electric – Devices that require power and can usually interface with a computer.
• Chemical – Monitors that rely on chemical reactions to produce indications of temperature conditions.
• Passive – Temperature indicators cannot or do not communicate with external servers or alarms.
• Active – A device that has the capacity to send continuous data to a central data point and can be used to see temperatures in real time.

The requirements for duration of shipments, required temperature ranges, reusability needs, access to basic infrastructure, real world conditions on the ground, and other key needs will dictate the types of monitoring devices used.  In modern humanitarian contexts, the last mile delivery of humanitarian supplies usually operates without adequate temperature-controlled transport or monitoring. In the event that adequate temperature monitoring for all items isn’t available, prioritisation of data loggers for the most sensitive and high risk products should be ensured. Continual monitoring of pharmaceutical and health items that should be kept at the +15°C - +25°C range may not be required in all situations, and humanitarian agencies may only wish to enact monitoring upstream or in more stable conditions. At the same time, local or national laws may actually require all temperature-controlled shipments to be monitored at all times, with documented evidence.      

Agencies operating in humanitarian contexts should build a monitoring plan that makes sense based on the requirements on the ground. In the event that there are bottlenecks in end-to-end temperature monitoring, mitigation measures can be implemented, such as random inclusion of a single datalogger for an entire consignment, with collection and analysis by the organisation after supplies arrive to the point of use.       

Additionally, active temperature monitoring devices tend to be too complex, too expensive, or otherwise require training and infrastructure that isn’t available in most humanitarian contexts. Commercial service providers will frequently employ active monitoring in large international shipments, or for entire vehicle loads such as reefer trucks or reefer containers, but individual humanitarian organisations will likely require a variety of monitoring techniques when and where required. Some of the more common passive temperature monitoring devices might include: 

Temperature Dataloggers – Temperature dataloggers have become the most commonly use temperature monitoring devices for most medium to small shipments. Temperature dataloggers are small, electronic and usually passive monitoring devices that can continually monitor temperature for up to weeks at a time, depending on the device. The advantage of a temperature datalogger is that it displays a chronological “history” of the temperature conditions as long as the device was turned on, and shippers can witness fluctuations in temperatures or even see multiple temperature excursions time-stamped against real world events. This will help shippers identify problems and work with transport companies and employees to fix problems. 

There are a variety of datalogger devices available on the market, including dataloggers that can plug directly into USB ports and download data, dataloggers that have electronic displays on the side, dataloggers that have programmable temperature ranges, and dataloggers that can be recharged and reused. The overall type and requirement for the datalogger brand depends on the needs of the shipper.

Once activated, temperature dataloggers can be dropped into a box or package of health items and retrieved on the other end. Temperature dataloggers can therefore be used when shipping single boxes, or when shipping pallets or large volumes of items, and can be used when shipping across multiple carriers or multiple modes of transportation. 

When using temperature dataloggers, humanitarian organisations should:

• Understand what their overall requirements are – what temperature ranges are required, how long will monitoring be required, will the reuse of the device be require?
• Consult the manufacturer guidelines and instruction manuals.
• Ensure that both senders and receivers understand how to use the devices and understand their importance.
• Have a plan for recovering and backing up data from temperature dataloggers at points of reception and have a plan for reviewing data and taking corrective steps in case of any identified problems. 

New advancements in technology are always underway, and newer versions dataloggers are continually being developed. Logistics personnel should conduct a market survey of the latest technology when selecting a product. 

Chemical Indicators - Also called markers or phase-change indicators). They are the most accessible and easy to use, they are based in a chemical impregnated onto a paperboard that changes its appearance under certain temperature. There are two types of chemical indicators:

1. Threshold type.
2. Progressive type.

Threshold Type chemical indicators provide a signal only when exposed to temperatures higher than (ascending indicator) or lower than (descending indicator) a predetermined threshold temperature. They are irreversible (thus, single use) and are suitable for high or low temperatures.

Example of these devices are:

Progressive Type chemical indicators register multiple events in a cumulative way. Whenever the threshold temperature is exceeded, the reaction is activated, and the indicator starts to change. Further temperature violations increase the change process. The indicator for this type of device usually takes the form of a progressive colour change along a paper strip.

Cold Chain Monitor (CCM) Card

Paper-based temperature monitoring device which change colour irreversibly and at a constant rate. Indicator strips are attached to a card on which instructions for use are printed.

CCMs provide a warning when excessive heat exposure occurs during transport. They are used primarily to monitor the international shipment of freeze-dried vaccine consignments where dry ice is used. CCMs may also be appropriate for national vaccine shipments where the delivery takes several days.

Vaccine Vial Monitor (VVM):

Heat-sensitive label that gradually and irreversibly changes colour as the vaccine is exposed to heat. It warns the health worker when a vial should be discarded because the vaccine is likely to have been degraded by exposure to heat. For instructions on how to interpret VVM, refer to WHO How to Monitor Temperatures in the Vaccine Supply Chain.

Electronic Freeze Indicators - used to check if shipments are exposed to freezing temperatures during storage or transport. The alarm indicator is triggered and displayed (changing from a “√” to an “X”) if exposed to temperatures lower than -0.5°C for a continuous period of 60 minutes. To avoid malicious manipulation, once the alert is triggered, the alert is irreversible. If this happens the device is no longer usable and should be discarded. Otherwise, the device can be used until the built-in battery expires. The intermittent “dot” icon confirms active monitoring.

Electronic Shipping Indicators - more sophisticated devices that show if a product has been exposed to temperatures beyond the assigned alarm settings. They record the temperature at regular intervals during a certain period (normally not exceeding 20 days due to memory overflow). They have a digital display that reflects if the item being shipped crossed the alarm thresholds.

Shipping indicators are mounted on a coloured card (yellow or blue) with a data entry section on one side, which the manufacturer fills in at the point of dispatch, and an instruction and interpretation section on the reverse side for the recipient. Yellow indicators are for freeze-sensitive items, and blue indicators are for heat-sensitive items.

These devices are not re-usable once alarm conditions are triggered or the programmed time elapses. In addition, the heat and/or freeze alarm thresholds are product-specific, which means that the device is not reusable with different products than originally intended. Some brands are able to download the temperature data to a computer. This enables recipients to determine whether shipments have been exposed to excessively high or low temperatures; it also helps the procurement agency to determine when, where and to what extent temperature limits have been exceeded. 

Active cold chain transport methods broadly refer to any method of transportation that provides supplemental power, mechanical or chemical processes to maintain temperatures while cold chain items are in transit. Active cold chain can come in a variety of forms – the transport method itself could be completely refrigerated, or supply power to self-contained containers that have a cooling effect on the required cargo. Active cold chain equipment can come in many sizes and form factors but is generally better suited for large volumes of temperature regulated health items, or when local regulations require it. Active cold chain transport items can typically be calibrated to a specific set point, which is adjustable based on the transport needs.  

Refrigerated Road Vehicles 

Refrigerated road vehicles come in a variety of formats, but generally are characterised by:

• Rigid, enclosed structures.
• Active cooling from permanently mounted air conditioner or freezers that draw power either directly from the engine of the vehicle, or specialised independent motors. 
• Insulated interior walls/ceiling/floor.
• A tightly closing, sealable door or doors with proper insulated lining.
• An electronically controlled thermostat with an adjustable set point.
• Some refrigerated vehicles have built in alarm systems in case of a temperature excursion.

Refrigerated vehicles cane come in the form of:

• Vans.
• Single unit box trucks.
• Semi-trailers.

The most common type of refrigerated vehicle used in humanitarian contexts is the single unit refrigerated box truck, usually referred to as a “reefer truck”, however this may vary from context to context.

Example refrigerated box truck, with insulated walls and self-contained freezer unit at the highest point of the container. 

It is highly unlikely that humanitarian organisations will directly own their own reefer trucks or other refrigerated vehicles unless there is a fully dedicated project that would justify the expense. In the event that the vehicle is owned, humanitarian organisations should refer to the fleet management section of this guide consider all regular requirements associated with maintaining their own trucks.

In the highly likely event that humanitarian organisations contract third-party transport services to utilise a refrigerated road vehicle for transport, they should consider the normal procedures associated with contracting any trucking service. Additionally, there are a few additional contractual terms they should consider when soliciting third party refrigerated vehicles.

Contracting Third Party Refrigerated vehicles:

Recommended Terms - Temperature-Controlled Movements / Requirements

In the case of the movement of temperature-controlled goods, the following terms are recommended for contracting and soliciting third party refrigerated vehicles. 

• If required, the contracted trucking company should ensure that the cooling units have been programmed for permanent run prior to loading per instructions.
• Contracted trucking company should ensure a copy of a valid calibration report is present in the truck.
• Contracted trucking company should ensure the driver maintains an activity sheet where temperature readings are recorded at every transition / touch point / stop point.
• Drivers should remain present at the dock area while goods are being loaded at origin and offloaded at destination.
• Drivers should ensure doors are closed immediately after loading. Doors should be barred and locked if required.
• Whenever the trailer doors have to be opened, including but not limited to loading, offloading, they should be closed immediately after-wards to avoid temperature disparities.
• In case of any customs or third-party inspection, the contracted trucking company should inform contracting agency immediately, detailing door opening and closing duration and the temperature readings should be recorded on the activity sheet.
• The contracted trucking company should provide calibrated and proper functioning reefer equipment and ensure the driver checks the temperature and the reefer equipment’s running status at every stop.
• In case of irregularity / temperature variance the contracted trucking company should inform the contracting humanitarian agency immediately.
• The contracted trucking company should make sure the drivers do not remove any temperature monitors / data recorders once they are placed inside the trailer until the truck reaches the point of delivery.
• The contracted trucking company has to ensure temperature monitors / data recorders are to be brought back after delivery.

Temperature Variances / Deviations

• In case of deviations from the terms and conditions contained in this agreement/contract the driver should notify the contracted trucking company, who should communicate this with the contracting humanitarian agency immediately.
• The contracted trucking company should make sure an investigation is done in case of a complaint / temperature variation issue is raised by the contracting humanitarian agency with regards to the temperature variances.
• In any case of claim/complaints the contracted trucking company and contracting humanitarian agency will study the case, should provide the corrective and preventive actions and then proceed with the claim process and procedures.

Maintenance and Calibration

• The contracted trucking company should ensure the reefer system used for transporting temperature-controlled goods should undergo regular preventive maintenance.
• The contracted trucking company should ensure the reefer trucks used are calibrated annually and should be certified.
• Contracted trucking company should provide the contracting humanitarian agency with the records of truck maintenance and calibration certificates upon request.

A general checklist on how to enact road shipments using a refrigerated vehicle can be found below:

Adapted from: WHO - Temperature-controlled transport operations by road and by air

It is very common for refrigerated vehicles to be opened and undergo inspection when crossing borders, or when operating around intense insecurity. Persons sending items using refrigerated vehicles should anticipate situations when enhanced inspection might happen, and how that might impact transported cargo. 

Reefer Containers 

A reefer container is a variation on a standard shipping container used in maritime operations, only with the capacity to maintain a constant temperature. Much like refrigerated trucks, reefer containers have self-contained freezer/refrigerator units, and proper insulation. Reefer containers can be transported on the backs of trucks, mounted onto the decks of sea vessels, or even be used as storage facilities.

Reefer containers usually come with both external power connections and self-contained motors used to power refrigeration equipment. As containers are moved, it’s the responsibility of the transporter to ensure that the reefer produces constant power and will maintain a temperature to the relevant set-point. Reefer containers can be plugged directly into the electrical systems of large sea vessels, trucks or buildings. Where external power isn’t available, reefers – depending on the container – reefers may be able to run an internal motor off of petrol or diesel, however the motors will have to be refuelled and maintained while the items are in transit. 

Reefers and Sea Shipping

When reefer containers are utilised for sea shipping, they are almost always owned by either the shipping line, or an intermediary broker. Typically, the use of the reefer container is negotiated using a freight forwarder, and the overall loading and handling of the container is done outside of the control of the organisation or individual sending refrigerated items via ocean. In many cases, owners of refrigerated cargo won’t even be involved with stuffing containers.

Example reefer container:

All reefer containers used for sea shipping must undergo what is known as a pre-trip inspection (PTI). Unless the reefer container is owned by the sender of the cargo, PTIs are undertaken by the shipping company. PTIs validate the condition of the container, the refrigeration equipment, and the monitoring equipment, and are rated for 30 to 120 days, depending on the needs of the shipping line and policies of the company. 

Humanitarian organisations planning on using reefer containers to transport health supplies should still endeavour to inspect the container wherever possible. 

• Even if a PTI is conducted by the transport company, shippers may request their own inspection if necessary, and include them in their own transport contracts. 
• It is also advisable that organisations shipping cargo via reefer include the obligation of the shipping line to conduct a PTI in the contract – though the failure to fully conduct a PTI may ultimately be the responsibility of the shipping line, having a written agreement outlining the need for a PTI is still advisable. 
• Organisations shipping cargo via reefer may also ask for copies of any monitoring reports that are produced throughout the shipping process. There may even online/real time monitoring capacity available through the transport company. 

Reefers as Permanent Storage

Many organisations in humanitarian settings have opted to use reefer containers as permanent storage structures. The use of reefers as storage facilities can be very useful where no other infrastructure is available, however it is still always advisable to investigate permanent hard sided buildings capable of being retrofitted to maintain the required temperature ranges. 

If a reefer container is to be kept as a permanent storage structure, there are a few things to consider:

• Power - Wherever possible, reefers should be plugged directly into the power grid, or a large enough generator to maintain the power needs of the unit. Though sea shipments might take months to complete, the on-board motor isn’t designed for permanent usage. If the on-board motor is used to maintain a reefer’s set point, the output exhaust cannot be into an enclosed space, like a larger warehouse. 
• Interior set up – Though reefers are used for transport, they are not directly designed for storage. This means that the floors of the container might not be conducive to shelving or rolling handling equipment. Additional flooring may need to be installed to accommodate storage needs. 
• Doors – Reefer containers were designed to be opened infrequently, and using one as a storage facility may lead to excessive heat loss as the large doors may be opened more frequently. Plastic flaps might need to be installed in the interior to reduce heat loss. 
• Temperature monitoring – Organisations using a reefer as a storage facility will still want to conduct a heat mapping exercise and develop some type of monitoring to ensure that products are still properly maintained.
• Foundation Placement - Organisations using reefer containers as storage should ensure that containers are placed on a raised hard surface (usually concrete foundation) or at the very least hard packed soil on raised ground to prevent rain damage.   

Air Transport Containers 

Use of active cooling containers for the transport of temperature-controlled medical items by air requires some additional preplanning. Where air transport using passive cooling containers entails handing self-contained insulated containers directly to air carriers, active cooling air transport containers provide powered temperature regulation directly in the container itself, either powered by direct connection to the electrical system of the air frame, or through a dedicated battery solution.

There are a variety of active cooling air transport containers, usually specified to conform to different types of aircraft. The range of active cooling air transport containers can be from smaller standalone crates to specifically shaped unit load devices (ULDs) use in common commercial air transport. It is highly unlikely that personnel from a humanitarian aid organisation will ever be involved with loading or handling air transport containers – usually temperature-controlled air transport containers are managed by the ground crew and/or load master, and the equipment itself may only be leased from the manufacturer. 

Example temperature-controlled ULD:

Passive cold chain transportation methods broadly refer to any method of transportation of cold chain items that does not involve outside power or maintenance. Passive systems are self-contained and are prepared at the point of origin without continued management by the transporter, other than some basic duty of care.

Passive Cold Chain Containers

Some medical related relief items – such as vaccines and other lifesaving medications – rely heavily on passive cold chain containers for transport in humanitarian field settings. Passive cold chain containers are insulated carries, usually with accompanying ice packs and/or freeze packs, which require no external power or mechanical support and are especially useful in humanitarian contexts where persistent electrical connectivity or advanced infrastructure may not be available or actively working. Passive cold chain containers - either single use disposable or reusable depending on the context - and are only meant to keep cargo items in a pre-defined temperature range for a limited period of time, between 12 hours and 120 hours depending on the container and the external ambient temperature. Please note, the actual duration of passive container will depend on the container and the real-world conditions on the ground. For relatively short transit times, such as single day car rides, or movement via helicopters, passive cold chain containers are ideal for transporting small quantities of items. 

There are two main type of devices - reusable containers (cold boxes and vaccine carriers) and disposable boxes. Note: the term “disposable” does not mean these types of insulated boxes can only be used one, they only refer to the easily disposable nature of the materials. Disposable insulated boxes are frequently reused multiple times in single operation.

Disposable insulated carton boxes are used by manufacturers to ship products with sensitive cold chain needs around the world. Disposable insulated containers must conform to certain standards, and often have a cold life often with a maximum of 4 days. Insulated containers are regulated by WHO prequalification standards.

Three categories of packaging are used for international air freighting (listed below in decreasing order of bulk):

No matter the type of passive insulated carrier used, it is recommended that each insulated carton should weigh less than 50kg to ensure ease of handling during transport as they are frequently loaded and offloaded manually. 

Pallet Shippers

Pallet shippers are passive insulated packaging that is specifically designed to cover or encompass entire pallets of cold chain related items. Pallet shippers can come in the form foam insulation, cardboard, or some form of thermal resistant fabric. Pallet shippers are used mostly by commercial providers shipping bulk volumes of cold chain required medical products. 

Example pallet shippers:

Pallet shippers have a built-in wooden or plastic pallet platform to enable handling and transport by forklift or pallet handling equipment. Pallet shippers will generally accommodate higher volumes per unit. Where used or ordered, It is recommended that external dimensions of pallet shippers should not exceed standard ISO pallet sizes, while also not exceeding not exceed 160 cm in height. Height requirements may vary on the context, but 160 cm is generally the maximum height a pallet can be to fit as a single unit into most aircraft. Shippers should understand the ultimate transport requirements prior to using pallet shippers. Under no circumstance should pallets shippers be depalletized in transport, or double stacked! 

Transporting Passive Cold Chain Containers 

Irrespective of the method, transportation of passive cold chain containers generally should follow a few key steps:

• Wherever possible, passive cold chain containers and boxes should be covered, and kept away from direct sunlight.
• Containers should be kept away from ambient heat sources of excessive heat (such as engines)
• Transportation times should be kept well within the allotted limit of the passive keep cool container. Ideally, maximum transport times should not exceed 2/3 the anticipated duration of the capacity for the container to keep items cool. In many cases, transport times should also be based on the anticipated return journey times, in case cargo items are rejected or may not be able to offload for a variety of reasons. 
• Persons receiving the passive containers should be notified in advance and be waiting at the reception area.
• Depending on the nature of the operation, or the requirements for the cargo items, temperature monitoring devices may be included. For more information on monitoring devices, please reference the section on temperature monitoring in this guide. 

Additionally, a general checklist for transporting passive cold chain containers might include:

Adapted from: WHO - Temperature-controlled Transport Operations by Road and by Air

Planning Passive Keep Cool Container Transport

Use of Portable Passive Keep Cool Containers

Due to infrastructure and logistics constraints in some locations, it is advised to assess the logistics capacity of downstream reception facilities prior to shipping. In case of limited logistics capacity, it is preferable to ship keep cool items using individual insulated cartons.

When choosing means for transport of keep cool items, consider the following factors:

• The heat and freeze sensitivity of every keep cool item being transported, especially vaccines. If available, refer to manufacturer indications for further information on temperature sensitivity of the items. In any other case refer to WHO How to use passive containers and coolant-packs.
• The required cold life to keep transported keep cool items at safe temperatures for an entire transport or outreach session. For vaccination outreach sessions the considered time should include travel to and from the vaccination site, allowing the safe management of non-used vaccines.
• The required capacity based on the volume of keep-cool items to be transported.

When selecting the appropriate container, the time of transport must be considerably less than the cold life of the container. Unexpected events such as vehicle breakdowns, human error or carelessness, often delay the time of transport. When the duration of the journey exceeds the cold life of the container, it is possible to replace the coolant packs if necessary. The back-up coolant packs can be transported in a separated container or swapped in a stop-by storage facility with compatible coolant packs. It is therefore necessary not to compromise on the number of ice packs which may need to be prepared.

Coolant Packs

Once the decision about the type of container is taken, calculate the number of cold boxes required. Subsequently calculate the number of coolant packs and temperature tracking and alert devices required. Each container holds a specific number of coolant packs.

In regular cold chain management, it is recommended that every cold box or vaccine carrier should have at least two sets of coolant packs, allowing one set of the packs to be cooled, while the other set is being used in the cold box or vaccine carrier. Note that one set of coolant packs is normally provided with each procured cold box or vaccine carrier, so that one additional set at least needs to be ordered.

The type of coolant packs must be selected according to the container and the required temperatures. Ideally, they should be compatible with other coolant packs used in the country.

There are several types of coolant packs:

Depending on the urgency of the item, manufacturers of cold chain and keep cool items ship products by air using coolant-packs of various types and sizes containing various fill materials, including water, gel and PCM. It is a common practice to reuse these coolant packs recovered from international shipping containers. WHO discourages this practice as these packs do not necessarily perform in the same way as the water-packs. In addition, they are not designed for repeated use and may not be dimensionally compatible with most of the passive containers used for the in-country supply chain. The recommendation is that these packs are removed from the receiving keep cool items and recycled or disposed of according to the manufacturer’s recommendations and/or national waste management policies.

Conditioning Water-Packs

The temperature of coolant packs must be set according to the temperatures required by the keep cool items to be shipped. There are two main possibilities: 

• The items to be shipped in the cold box may be frozen. Examples: vaccines for Measles, Polio, Yellow fever, Meningitis, etc.
• The items to be shipped in the cold box will be irreversibly damaged when frozen Examples: Oxytocin, vaccines for DTP, DT, Td, TT, Hep A and Hep B, Hib.

To understand if items can be safely frozen or not, consult the manufacturer’s guidelines.  If all items to be shipped in the cold box may be frozen, frozen coolant packs can be directly transferred from the freezer to the cold box.

In the case that items will be damaged when frozen, the coolant packs need to be “conditioned” before being transferred into the cold box. That means bringing its temperature up to 0ºC. The conditioning of coolant packs consists of laying the required number of frozen icepacks on a table or work surface (preferably not under direct sun light) and waiting until they all reach 0ºC.  This may take at least 30 to 45 minutes in hot weather and much longer in cool conditions (from 90 to 120 minutes at +20°C). In order to know when the icepacks are ready to be used, there must be liquid water inside every pack and the ice cores should be able to move freely inside the packs when shaken. To ease the process, place the icepacks in one single layer and separated from each other.

The use of cool water-packs and warm water-packs can be pertinent for some shipments. Warm water-packs are used to protect freeze-sensitive items in countries where temperatures are frequently below 0°C. Warm water-packs are to be prepared at a room temperature between +18°C and a maximum of +24°C. Cool water-packs are to be prepared in a refrigerator at a temperature of no more than +5°.

Packing Keep Cool Containers

The first action during packing is to dry any droplets on the coolant packs surface and placing it in a cold box according to the cold box manufacturer specifications: the correct size and number of coolant-packs must be used. The technical sheet for loading the cold box is often available inside each box.

Place the keep cool items inside the cold box, putting cardboard between thermo-sensitive products and icepacks to prevent them touching. Make sure that any remaining space is filled with packing material to avoid damage during onward transport.

When packing keep cool items without secondary package/carton box (common practice when using vaccine carriers), put the items and diluents in a plastic bag in the middle of the cold box or carrier to protect them from damage due to condensation.

Place the required temperature monitoring devices in the box or carrier. Do not allow monitoring devices to come into contact with coolant packs. If using a thermometer in the container, place it in a visible and easily accessible place to avoid long content handling during temperature checks.

When required, put the top layer of coolant packs and close the container.

Calculating Volumes for Vaccine Shipments using Keep Cool Boxes

To calculate the volume of vaccine to be shipped, it is necessary to know for each vaccine and diluent in the shipment:

• The required storage temperature: 3 ranges of temperature are normally considered for vaccine transportation: -15°C to -25°C, +2°C to +8°C or ambient.
• The number of doses to be transported.
• The packed volume per dose (cm3/dose). The packed volume includes the vaccine vial, the packet containing the vaccine vial and any intermediate packaging (secondary packaging).

 The maximum recommended packed volume per vaccine dose and diluents are:

Be aware that the volume obtained from multiplying the packed volume per dose by the number of doses only takes into consideration the primary and the secondary packages: it doesn’t include the cold box packaging. Estimating the final transport volume (including the cold box) is necessary to correctly plan the transport means. For this purpose, a transport box bulking factor can be used. The bulking factor depends on the type of vaccine. WHO Guideline for establishing or improving primary and intermediate vaccine stores, recommends the following transport box bulking factors:

• BCF, OPV, measles, MMR, MR = 6.0
• Other vaccines = 3.0
• Diluent, droppers = 1.5

Type of Vaccine – The type of vaccine is of key importance because different vaccines have different presentations. The most common are vials (or ampules), however single-dose pre-filled syringes may be used in humanitarian operations. Depending on the vaccine, vials can contain different number of doses, normally 1, 10 or 20 doses. The key variables used to calculate the required volume for vaccine storage and transport are the number of doses to be stored and the estimated volume per dose. The estimated volume per dose (or packed vaccine volume) quantifies the space needed to store or transport vaccines and diluents and will depend on the number of doses per vial, the physical size of the vial or ampule (primary package) and the bulkiness of the external packaging (secondary packages).

Example multi-dose vaccine vial:

Example single-dose pre-filled vaccine syringe:

Some presentations include the diluent in the same packaging as the vaccine. In such cases it is necessary to refrigerate the diluent as well as the vaccine. In all cases, diluents should be refrigerated 24h prior to vaccine preparation. Refrigeration of diluents is normally done in the last step of the vaccine supply chain.

Whenever possible, the packed vaccine volume per dose should be calculated using data from the vaccine manufacturer or supplier. It is also recommended to use the WHO guidance document for vaccine volume calculation: How to calculate vaccine volumes and cold chain capacity requirements.

Humanitarian logistics personnel may be required to organise the transportation of clinical samples from the outbreak location to a reference laboratory may be required, especially during disease outbreaks, such Ebola Haemorrhagic Fever. The transportation of samples is usually handled by either by the local government, or by a WHO representative, or by a specialised agency tasked with the process in the local context. 

Clinical and biological samples are considered "dangerous goods", and transport of these is subject to very strict regulations. Before transporting clinical samples always consult local regulations and international best practice. Commercial air and sea transporters will often have clear guidelines on the transportation of clinical and biological samples – reference the dangerous good section of this guide for more information. In absence of a clear local regulation, humanitarian agencies might refer to WHO’s “Guidance on regulations for the transport of Infectious Substances”.

Biologic samples are separated into two different categories when prepared for shipping:

Adapted from: WHO’s - Guidance on regulations for the transport of Infectious Substances

Packaging

Both Category A and Category B substances have their own forms of approved packaging, and all samples must be transported in their respective approved packaging, usually some form of triple packing. Consider that in some contexts, this type of packaging won’t be available to be purchased locally. Certain health actors or specialised medical agencies may have stock available.

The system for transporting samples consists of three layers:

1. Primary container containing the sample: Tube or bottle tightly closed and labelled.
2. Secondary container intended to protect the primary container: Waterproof box/tube (Category A) or plastic bag (Category B) with enough absorbent material to absorb all the liquid in case of breakage.
3. Outer packaging intended to protect the secondary container: Reinforced cardboard box with UN labelling.

Example Packaging for “Category A” Biological Samples

Example Packaging for “Category B” Biological Samples

The choice of container depends on the classification of the sample to be transported and whether or not it is necessary to transport the sample at controlled temperature; some samples will require +2°C to +8°C temperature. 

Usually, individual transported biological samples will be uniquely identified with information such as the name or patient code number and date/place of collection and will be accompanied by relevant clinical and epidemiological information.  Information to be contained on the on the outer packaging of the box should include:

• Shipper.
• Consignee.
• Emergency contact: mention the name and the phone number of the person to contact in case of emergency (i.e., incidental opening or leakage).
• UN approved marking and product category/class.
• Net capacity of sample only.
• Mandatory marking: "Infectious substance" logo and additional required approval markings.

The shipper is responsible for classifying, declaring, packaging and labelling the samples. Any transporter or service provider involved in the transportation chain, must be informed about the material being sent. If there is any problem during the transport, the shipper must be able to prove that he has strictly followed the regulations. If humanitarian organisations organising the transport of biological samples have any questions on labelling, they may also consult their freight forwarder or transport company. 

The person enacting the shipment be sure to inform the receiving party in advance, specifying the nature of the sample as well as the planned shipping date to ensure readiness to receive the sample. In some cases, biological samples will be delivered to third party laboratories or government offices who may have very little understanding of the humanitarian operation. Shippers should also tell transport companies well in advance as well, as they may have their own protocols for handling and managing these types of shipments. 

Below is a list of UN ID numbers and packing instruction per category that should be included with every shipment.

More information on identifying dangerous goods categories can be found in the dangerous goods section of this guide.