CATEGORIES OF THERMOSENSITIVITY

Vaccines as well as most drugs and diagnostic products are very sensitive products (light and temperature). Exposure to heat and / or freezing can have a negative impact on the quality, safety and efficacy

In 2020 the Thermosensitive Classification Codes changed. The previous codes *0(F), *A(F), *B(F), *C(F)… represented a mixture of temperature storage requirements and excursion management thresholds. The EU, WHO GDP (guidelines for good distribution practices) for pharmaceutical products, as well as the different national regulations, requires a focus on ensuring proper environmental conditions (as per manufacturer label claim) during storage and transportation.

The new thermosensitive codes are defined for storage and transport temperature requirements only. They are aligned with general (or targeted) storage facilities in the field (freezers, fridges, pharmacies, medical warehouses or transport vehicles) and their targeted temperature ranges. A wider application of temperature sensitivity codes for medical devices and therapeutic food will bring more clarity for the field in terms of (additional) storage needs from a quality perspective.

In the medical catalogues and ordering tools, all thermosensitive products are associated to a thermosensitive code listed in the table below.

The products that do not require a temperature control have no thermosensitive code associated.

In any case, IT IS ALWAYS CRUCIAL TO RESPECT THE STORAGE INDICATIONS REQUIRED BY THE MANUFACTURER (stated on the packaging or on the leaflet).

A pharmaceutical product, if not stored according to manufacturer’s specifications, might become ineffective or dangerous for the patient.

Controlled Temperature: 2°C-30°C

The storage and transportation of medical items falling into this thermosensitive classification needs to be done in compliance to the Good Storage and Distribution Practices.

In the medical storage facilities, the temperature should be monitored recorded twice a day in a dedicated sheet.

Example of items stored between 2°-30°C: Specialised Food items (NFOS), medical devices of class I and IIa.

Controlled Temperature: 2°C-25°C

The storage and transportation of medical items falling into this thermosensitive classification needs to be done in compliance to the Good Storage and Distribution Practices.

In the medical storage facilities, the temperature should be monitored recorded twice a day in a dedicated sheet.

Example of items stored between 2°-25°C: some Specialised Food items (NFOS), dressings (SDRE), sampling and transport mediums and containers (STSS), medical devices of class IIb and III.

Controlled Room Temperature 15°C-25°C

The storage and transportation of medical items falling into this thermosensitive classification needs to be done in compliance to the Good Storage and Distribution Practices, following the requirements expressed by the World Health Organization and the national drug regulatory authorities (NRAs). The premises and vehicles used for storing or transporting medical products, should be of a suitable size and of a standard that allows for a secure, clean and temperature-controlled storage with a relative humidity below 65 % and no direct sunlight affecting the products.

Temperature and relative humidity should be monitored recorded twice a day in a dedicated sheet, the tool recommended for this purpose is the following: PCOLMONIHLU THERMO-HYGROMETER recorder (Log Tag Uhado-16) display.

Example of items stored between 15°-25°C: medicines (DORA, DINJ, DINF, DEXT, DEXO), some dressings (SDRE), laboratory reagents (SLAS).

Cold Chain / Refrigerated 2°C-8°C

The transport of items falling in this thermosensitive classification needs to be done in isothermal containers, while the storage requires ice-lined refrigerators (see storage and transportation equipment)

Temperature should be monitored and recorded twice a day in a dedicated sheet, with monitoring by FreezeTag and LogTag (see cold chain management).

Example of items stored between 2°-8°C: most of the vaccines (DVAC), some rapid diagnostic tests (SDDT), laboratory tests and controls (ELAE)

Frozen -20°C

The transport of items falling in this thermosensitive classification needs to be done in isothermal containers with dry ice. The storage requires qualified freezers.

Temperature should be monitored and recorded twice a day in a dedicated sheet, with monitoring by the PCOLTHER35A THERMOMETER alcohol (Moëller 104614) -30°C-+50C° (to be kept vertically).

Example of items stored at -20°C: a few laboratory tests and controls (ELAE), a couple of laboratory reagents (SLAS) and antibiotic powder for antibiotic susceptibility testing (SAST)

DEFINITIONS

See Cold Chain Management guideline, MSF, 2022

• Cold Chain: A system intended to keep thermosensitive medical products, within a specific temperature range from the manufacturer until its final use. In MSF settings, the “cold chain” means keeping medical products between +2°C and + 8°C (inclusive)

• Active Cold Chain: includes all devices that require electricity to produce and maintain the cold. This kind of equipment is mainly used for medical item storage or icepack production. Examples include fridges, freezers, cold rooms.

• Passive Cold Chain: includes the equipment which, in order to maintain the cold, does not require electricity, however requires pre-conditioned ice-packs. Examples include isothermal/cold boxes, vaccine carriers

• Storage volume: For fridges, freezers and cold rooms, the net volume (expressed in litres) indicates the maximum quantity of medical items that the appliance may contain using the storage baskets (or shelves in the case of a cold room). The gross value is the overall volume without the baskets or the shelves. For isothermal/cold boxes and vaccines carriers the storage capacity indicated is normally always the net one (excluding the space occupied by icepacks).
• Freezing capacity: Specific for the freezer equipment, it is the capacity of a specific appliance to produce a certain volume of ice in a specific interval of time. The units of measure are indicated in Kg/24 hours).
• Holdover time: The standard MSF active cold chain equipment has the characteristic of guaranteeing, in the absence of its energy source, that the temperature is kept within range for a period of time (thanks to thermal insulation, Ice-Lining, etc). This cold time extending characteristic is called “holdover time”, and is measured in hours. The holdover time changes according to the equipment brand and model. The holdover time is always specified within an environmental temperature range (e.g. 02-08°C maintained for 48 hours if external temperature is between 15°C and 43°C).
• Cold life: Refers to passive cold chain equipment. Is intended as the time (in hours) that the equipment can keep the medical products between a specific range (e.g. between +2°C and +8°C). The cold life parameter is also only reliable within a specific external temperature range for which the equipment has been qualified.)
• Cold Chain Breakdown: Refers to passive cold chain equipment. Is intended as the time (in hours) that the equipment can keep the medical products between a specific range (e.g. between +2°C and +8°C). The cold life parameter is also only reliable within a specific external temperature range for which the equipment has been qualified.)

TEMPERATURE MONITORING DEVICES

Thermosensitive items require continuous temperature monitoring throughout their lifecycle using standard articles included in the PCOL catalogue such as:

• Alcohol thermometer
• Freezing Indicator ( FreezeTag®)
• Historical Data Logger (LogTag®)
• Remote monitoring and Alerts (BluLog®)

Refer to the OC Specific guidance and protocols for more information regarding their usage and configuration.

COLD CHAIN STORAGE AND TRANSPORTATION EQUIPMENT

MSF supplies mainly equipment pre-qualified by WHO (PQS). Consult your Technical Department before ordering cold chain equipment as an incorrect choice may result in substantial losses of vaccines/medicines/rapid diagnostic tests, delays in the program, or worse, in the use of ineffective products.
Maintenance is important for all equipment and should be carried out regularly to keep the equipment in good condition. Details of these tasks can be found in technical documentation and guidelines.

Cold chain equipment is divided into two main groups:

The active cold chain category includes all equipment that require energy to produce and maintain the cold. This kind of equipment is mainly used for the items storage or icepacks production. This category contains:

• Ice Lined Refrigerators
• Freezers: used for ice pack production or F-20 item storage.
• Cold rooms

The passive cold chain category includes the equipment which, in order to maintain the cold, requires pre-conditioned ice-packs. This category contains:

• Isothermal/cold boxes
• Vaccine’s carriers.
• Icepacks

The choice of PCOL equipment is determined by: vaccine storage capacity needed, the cold life needed, weight and volume of the box (depends of mode of transport) and number of ice-packs needed. Refer to PCOL family in the logistic catalogue for manufacturer specification and item details.

TRANSPORTATION RECOMMENDATIONS FOR COLD CHAIN ITEMS

• The shipment receiver has to check their storage capacity before green lighting an order of cold chain items. Preclearance or any possible administrative paperwork is completed in advance to avoid transit delays (that are linked to packing cold life).
• The first choice of transport between central and periphery stocks for cold chain items should be by air freight when available.
• In case of road transportation, choose the fastest option, match packing cold life with anticipated delivery times and avoid open vehicles.
• The packaging container should be chosen depending on the type of transport, the lead-time and the means of transport.
• Prior to any shipment, the sender should confirm the volume, date and time of arrival of a cold chain shipment (to ensure adequate storage space upon arrival).

IN CASE OF COLD CHAIN BREAKDOWN

Follow your MSF section specific cold chain protocol. In general take following steps:
dentify the product clearly and keep it separate in a refrigerator (between 2ºC and 8ºC).

• Keep the temperature recorder as evidence after stopping the recording.
• Contact your OC or Supply Centre focal point to find out what action to take.
• Information to be given:
• Product: name, code, batch number, expiry date
• Temperatures: temperature ranges, duration of exposure, temperature monitor readings.
  

GENERAL RECOMMENDATIONS FOR TEMPERATURE-SENSITIVE PRODUCTS

• Pay attention that storage and transportation conditions complies to the IFU of the manufacturer.
• Prevent the risk of cold chain item freezing by following ice pack conditioning procedures.
• Implement a cold chain contingency plan and provide continuous training per OC recommendations.
• Keep all vaccines in their original packaging during storage as this is printed with the expiry dates and batch numbers and protects the vaccine from light and damage.
• Diluents should be at the same temperature as the vaccines (between 2º C and 8º C) at the time of reconstitution. It is not necessary to store them in the refrigerator, but the required quantity of diluent should be placed in the refrigerator or in some cool box 24 hours before use. Diluents must never be frozen. Only the specific diluent recommended for the vaccine can be used. Replacement diluents can be ordered using the specific diluent code mentioned in MSF catalogue and specifying the manufacturer required.
• Do not store food, drinks or biological samples in medical refrigerators or freezers.