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Product categories & general introduction

Product categories & general introduction


WHO IMD-PQS prequalifies a wide range of immunization devices and equipment of the following categories.

Information available for these product categories includes:

  • category information - the performance specifications and verification protocols
  • guidelines for applicants - including the requirements a manufacturer or licensed reseller must meet, in order to obtain the prequalification of a product
  • supporting information for users - guidance on the procurement, operation and/or maintenance of products included in that category.

Note: Categories E009, E011 and E012 are currently not in use.

    This section provides general information on:

    • vaccine storage temperatures
    • vaccine distribution guidelines
    • transporting vaccines without vaccine vial monitors (VVMs)
    • appropriate refrigerants and foaming agents.

    Vaccine storage temperatures

    The following table summarizes the current WHO guidance on vaccine storage temperatures. Use these recommendations when calculating refrigeration needs for the procurement of PQS prequalified refrigerators.

    WHO vaccine storage recommendations

    Refer to: Immunization in Practice: a practical guide for health staff - 2015 update. Module 2: The vaccine cold chain (https://www.who.int/immunization/documents/IIP2015_Module2.pdf)

    Vaccine distribution guidelines

    For comprehensive information see: WHO/IVB/15.03: How to use passive containers and coolant-packs for vaccine transport and outreach operations (July 2015)

    Use WHO PQS prequalified freeze-preventive vaccine carriers or cold boxes, which are designed to protect vaccines from freezing temperatures. With freeze-preventive vaccine carriers, frozen icepacks can be taken directly from the freezer and placed in the vaccine carrier, without conditioning. This eliminates subjectivity in judging when an icepack is properly conditioned and saves time previously required to condition icepacks. Freeze-preventive vaccine carriers are certified to work between +15°C to +43°C ambient temperatures and meet all the requirements of traditional vaccine carriers, including holdover. For more information, see Freeze-preventive passive containers – technical resources. (Refer to Freeze-preventive passive containers – technical resources on TechNet-21.org (https://www.technet-21.org/en/topics/freeze-prevention). The following coolant-packs can be used in passive containers if freeze-preventive vaccine carriers or cold boxes are unavailable.

    Frozen water-packs

    Frozen water packs can be used to transport all lyophilized vaccines, or any liquid vaccine that is NOT freeze sensitive, such as OPV. Frozen icepacks must NEVER be used to transport a freeze-sensitive vaccine or a lyophilized vaccine that is packaged (bundled) with its diluent.

    Use passive containers with a published cold life at least as long as that required for the longest planned transport leg, measured from the time of packing the container in the supplying store to the time of unpacking in the receiving store. It is important to provide a good safety margin to cover unexpected events such as transport delays.

    Conditioned icepacks

    Conditioned icepacks can be used to transport any vaccine, including lyophilized vaccines with bundled diluent. However, the icepacks MUST be conditioned correctly. For more details refer to EVM-SOP-E7-04.1: Conditioning frozen icepacks, and EVM-SOP-E7-02.1: Packing vaccines and diluents for transport using cold boxes.

    Use passive containers with a published cold life which is at least as long as the longest planned transport leg, measured from the time of packing the container in the supplying store to the time of unpacking in the receiving store. Some cold life is always lost during the conditioning process so it is important to allow a good safety margin when estimating the required cold life, to cover eventualities such as transport delays and variations in the extent to which conditioned icepacks have melted at the time of packing.

    Cool water-packs

    If the vaccine has a vaccine vial monitor (VVM), cool water-packs can be used for transport between the primary store and the health facility for any vaccine EXCEPT those with a VVM 2 or VVM 7. This includes the oral poliovirus vaccine (OPV), some brands of inactivated poliovirus vaccine (IPV) and varicella vaccine. When transporting vaccines for outreach purposes, cool water-packs can be used for ALL vaccines that carry a VVM.

    For short journeys in sub-zero temperatures, cool water-packs will protect both liquid freeze-sensitive vaccines and vaccine diluents against the risk of freezing. They can safely be used for this purpose even when the vaccine does not have a VVM.

    Use passive containers with a published cool life at least as long as the longest planned transport leg, measured from the time of packing the container in the supplying store to the time of unpacking in the receiving store. It is important to allow a good safety margin to cover unexpected events such as transport delays and variations in cool water-pack temperature.

    Warm water-packs

    For long journeys in sub-zero temperatures, warm water-packs are needed to prevent most liquid freeze-sensitive vaccines and vaccine diluents from freezing, provided the vaccines have VVMs. However, warm water-packs should NEVER be used to transport OPV, IPV with VVM 7, varicella or any other highly heat-sensitive vaccine. They should also NEVER be used for any vaccine without a VVM because there is no way to monitor the effect of exposure to temperatures above the labelled storage range of +2°C to +8°C.

    Passive containers should have a rated warm life at least as long as that required for the longest planned transport leg, measured from the time of packing the container in the supplying store to the time of unpacking in the receiving store. Once again, it is important to ensure a good safety margin to cover eventualities such as transport delays and variations in warm water-pack temperature at the time of packing.

    Transporting vaccines without VVMs

    For vaccines that are NOT supplied with VVMs, the following principles for choosing coolant-packs apply:

           In warm and hot climates, cool water-packs should NOT be used for routine vaccine transport because cumulative heat exposure to temperatures above +8°C cannot be monitored adequately.

         In cold climates, use cool water-packs to protect freeze-sensitive vaccines or lyophilized vaccines bundled with diluent from exposure to sub-zero conditions. Warm water-packs should NEVER be used for this purpose because of the risk of prolonged exposure to temperatures above +8°C.

           RotaTeq® should only be transported using conditioned icepacks; its freeze-sensitivity status is not fully established and a suitable VVM is currently not available for this vaccine. In addition, its maximum allowable exposure time at temperatures above +8°C is only 48 hours at +9°C to +25°C. It is highly likely that temperatures above +8°C will occur when cool water-packs are used in hot climates. Since there are usually two or three transport legs between the national store and the health facility, it is possible that this 48-hour exposure period could be exceeded, unless all the journey times are very short.

    Outreach recommendations are the same as for vaccines with VVMs (see previous section “Vaccine distribution guidelines”) because of the relatively short transport times involved.

    Refrigerants and foaming agents

    Refrigerants

    Refrigerants made with chlorofluorocarbon (CFC) or hydrochlorofluorocarbon (HCFC) are potent ozone depleting substances with extremely high global warming potential (GWP) ratings. Due to their ozone depleting impact they were scheduled to be phased out under the regulatory regime of the Montreal Protocol. CFCs were phased out in 1996 in industrialized countries and 2010 in low and middle-income countries (LMICs). HCFCs are to be 100% phased-out in industrialized countries by 2020, and in LMICs by 2030.

    Hydrofluorocarbon (HFC) has been used as a substitute for CFCs and HCFCs. HFCs do not impact the ozone layer but have far greater GWP than the basic standard carbon dioxide (CO) with GWP of 1.

    Natural refrigerants, such as hydrocarbons, CO and ammonia are increasingly used in domestic and commercial refrigeration. They are low GWP substances with a GWP of less than 3 for hydrocarbons, 1 for CO and 0 for ammonia.

    R12, a CFC, was commonly replaced with HFC (e.g. R134a). An increasing number of manufacturers are now using the hydrocarbon R600a (isobutene). Cold room and freezer room manufactures may use a variety of other refrigerants. Until 2010, developing country manufacturers were still allowed to use CFC refrigerants, but many of them had already made the change to more environmentally-benign gases.

    PQS performance specifications permit the use of hydrocarbon (e.g. R600a) and are phasing out HFC refrigerants in refrigerators and freezers. Existing appliances with HFC refrigerants including R134a will be phased out in 2020. Hydrocarbons are still not permitted for cold rooms and freezer rooms.

    The table below gives the Ozone Depletion Potential (ODP) and Global Warming Potential (GWP) figures for the gases described above and in the next section. Equipment which uses cyclopentane foamed insulation and the refrigerant R600 is currently the best environmental choice. However, it is flammable and must be handled with care.

    ODP and GWP figures for some key gases

    Refer to: Environmental management of refrigeration equipment: Technical supplement to WHO Technical Report Series, No. 961, 2011: May 2015 Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, Table 1, page 14.


    Gas

    Use

    Ozone Depletion Potential (ODP)

    Global Warming potential (GWP)a

    R11

    Refrigerant & foaming agent

    1.0

    4,750

    R12

    Refrigerant & foaming agent

    1.0

    10,900

    R134a

    Refrigerant

    0.0

    1,430

    R600a

    Refrigerant

    0.0

    3

    Cyclopentane

    Foaming agent

    0.0

    11

    R404a

    Refrigerant

    0.0

    3922

    R452

    Refrigerant

    0.0

    2141

    R141b

    Foaming agent (HCFC)

    0.12

    725

    a. The basis for GWP is CO2 = 1.0

    As per the Montreal Protocol and Kigali Amendment, refrigerants which have GWP potential values of >2500 will be phased out. One of the widely used refrigerants in cooling units for cold rooms is R404A, a HFC blend with a GWP value of 3922. Phasing out of this gas will start in 2020 in EU and other countries will follow as per their national phase-out plans. To comply with this transition plan, this gas will be replaced with alternative gases with lower GWP values (<2500 GWP) such as R134A or R452A for cold and freezer room cooling units.

    Foaming agents

    R11 is no longer used as a foaming agent by any of the industrialized country manufacturers listed in the PQS catalogue. It is now replaced by cyclopentane in European countries and by R141b in the USA (the use of R141b was banned in Europe as of 1st January 2004 and it will eventually be phased out in 2020 in LMICs and worldwide in 2030). R141b has a much higher Global Warming Potential (GWP) than Cyclopentane, which is therefore less damaging to the environment when it is released into the atmosphere. Other gases are under investigation as replacements for R141b, including HPC-245fa, HFC-365mfc, HFC-234a, isopentane and n-pentane and various blends.

    Managing existing equipment containing CFCs

    CFCs have now been phased out worldwide. For this reason, programme managers should ensure that remaining CFC equipment is responsibly managed, specifically by:

    1.     Checking that tools for the repair of CFC equipment is locally available and that cold chain technicians are trained.

    2.     Keeping an inventory of CFC equipment and where it is installed.

    3.     Ensuring that CFC equipment is decommissioned in a responsible manner at the end of its service life and that the refrigerant is recovered and destroyed.