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Online Catalogue

Online Catalogue


In this section of the website, the IMD-PQS Catalogue is "browsable" by category.

 

Product categories

 

   The "product categories" page provides access to all 10 IMD-PQS categories and the category-specific guidance.

    

 

Search & compare

 

Users can also search and compare products.

 

 

 

General information

 

    The catalogue includes a Preface, General Introduction and End Notes available in the drop down sections below.

 

 

The WHO PQS Catalogue includes details of all immunization-related products and devices currently prequalified by WHO for procurement by United Nations agencies. The catalogue is produced and maintained by the World Health Organization (WHO) Performance, Quality, and Safety (PQS) Secretariat in the Access to Medicines and Health Products (MPH) Division of WHO in Geneva, Switzerland. The PQS Catalogue replaces the old WHO/UNICEF Product Information Sheets (PIS), of which the last edition was published in 2000.

Only products that are included in the IMD-PQS Catalogue are recommended for purchase by UN agencies.

Products that successfully meet WHO standards for immunization products and devices are “prequalified” for use in any national Expanded Programme on Immunization (EPI) to which they are relevant. Prequalified products are listed in the IMD-PQS Catalogue and accompanied by information sheets to help buyers select the most appropriate products for their specific needs. 

The IMD-PQS Catalogue and individual product data sheets are available and accessible as an online version on the IMD-PQS website under Key resources/Prequalified products1. Each edition of the catalogue is date-stamped and updated regularly to ensure that the information it contains remains current.


Navigation

The PQS Catalogue is organized into the following sections:

 

E001: Cold rooms, freezer rooms and related equipment 

E002: Refrigerated vehicles

E003: Refrigerators and freezers 

E004: Cold boxes and vaccine carriers

E005: Coolant-packs

E006: Temperature monitoring devices

E007: Cold chain accessories 

E008: Single-use injection devices 

E010: Waste management equipment 

E013: Injection devices for therapeutic purposes

 

Categories E009 and E012 are currently not in use.

 

Coding

Each catalogue section includes a brief presentation of the equipment category, details of currently prequalified products and links to relevant supporting documents, including equipment selection.

 

Every product has a unique reference: the IMD-PQS product code. The code comprises the category reference (e.g. E003) followed by a number that is exclusive to the product. A unique reference is never reassigned to another product, therefore breaks in the numerical sequence will appear when an item is dropped from the catalogue.

 

Feedback

User feedback is an essential component of the regulatory value chain for cold chain equipment. Information on how equipment performs in the field operating context informs WHO IMD-PQS equipment standards. It also provides valuable information for product manufacturers and EPI programmes to take actions that result in improved CCE performance. 

 

IMD-PQS actively encourages product users to provide feedback on:

product performance or any defects encountered, and

your evolving operational needs.

 

The IMD-PQS Feedback Form2 can be used to share information on equipment performance issues, or an email can be sent to [email protected] for general comments and queries. 

 

Conditions of use

Information presented in the WHO IMD-PQS Devices Catalogue does not reflect the views or policies of the World Health Organization (WHO) and the mention of specific companies and products does not imply any endorsement or recommendation by the WHO. 

 

The IMD-PQS Catalogue may be reproduced and translated in whole or in part for educational or non-profit purposes without special permission. However, no use may be made for resale or for any other commercial purpose whatsoever.

 

Web-accessible links to sites external to the WHO are provided as additional resources in the catalogue. However, no endorsement is implied and WHO is not responsible for the accuracy of information provided by external sites. 

 

Abbreviations

The following symbols and abbreviations may occur in the section guidelines and in the product data sheets:

--

information not applicable or not available

<

less than or equal to

>

greater than or equal to

°C

degrees celsius (centigrade)

A

ampere

AC

alternating current

BCG

bacille Calmette-Guérin vaccine (for tuberculosis) 

cc

cubic centimetre

CFC

chloro-fluoro-carbon

cm

centimetre

DC

direct current

DT

diphtheria and tetanus toxoid vaccine

DTP

diphtheria-tetanus-pertussis vaccine

g

grams

G

gauge

GWP

global warming potential (CO2 = 1.0) 

H x W x L

height by width by length (or depth) 

HC

hydrocarbon

HDPE

high-density polyethylene

HepB

hepatitis B vaccine

HFC

hydro fluorocarbon

Hib

Haemophilus influenzae type b vaccine

HIPS

high impact polystyrene

hrs

hours

Hz

hertz (cycles per second)

id

internal diameter

IPV

inactivated polio vaccine

kg

kilograms

km

kilometre

kVA

kilovolt-ampere

kWh

kilowatt-hours

L

litres

m

metre

m3

cubic metre

max

maximum

min

minimum

ml

millilitre

mm

millimetre

MMR

measles-mumps-rubella vaccine

MR

measles-rubella vaccine

No.

number

od

outer diameter

ODP

ozone depletion potential

OPV

oral polio vaccine

PoA

price on application

psi

pounds per square inch

PVC

polyvinyl chloride plastic

RPM

revolutions per minute

TT

tetanus toxoid vaccine

V

volt

VAC

voltage alternating current

VDC

voltage direct current

W

watt

YF

yellow fever vaccine

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product prequalification under IMD-PQS

Every item listed in the catalogue has been shown to comply with the relevant IMD-PQS performance specifications and has been independently assessed against the companion verification protocols. IMD-PQS performance specifications and verification protocols can be downloaded from the IMD-PQS website3.

 

A performance specification defines the functional requirements of a product and describes the environment within which it must operate. It also describes any interface and inter-changeability requirements. 

 

A product verification protocol describes in detail how the performance of a class of immunization-related products will be tested or otherwise evaluated as part of the IMD-PQS product prequalification procedure. Products that satisfy performance specification standards are deemed to be prequalified and will be included on the IMD-PQS database. 

 

Following initial prequalification, all listed products must pass an annual review in order to maintain WHO-prequalified status. This process will take account of feedback from manufacturers, purchasing agencies and end-users. Adverse reports may lead to product modifications, suspension of prequalified status or, in serious cases, loss of prequalified status and withdrawal from the IMD-PQS Catalogue.


How to order products

Procurement of IMD-PQS-prequalified products can be done through various mechanisms such as government public procurement service providers, UN agencies, NGOs and others. 

 

An overview of the procurement process via UN agencies can be found in the UN ‘Procurement Practitioner's Handbook’4 (PPH), a reference document that provides guidance in best procurement practices, processes and procedures. 

 

Procurement practices will vary and are governed by established regulations and rules of each procurement agency. For procurement via UNICEF Supply Division, detailed procurement instructions can be accessed in the UNICEF Supply Division ‘General Procurement Guideline’5 on the UNICEF Cold Chain Support Package website6.

 

When you order a product, whether from a UN procurement agency or direct from the manufacturer, you will be requested to provide the:

  • full IMD-PQS product code

  • manufacturer’s product code as shown on the product data sheet, and the

  • product options required (if any), including spare parts.

 

Guide prices: Where prices are given, they are shown in US dollars and are generally given as indicative Ex-Works (EXW) prices. Where possible these guide-prices will be updated annually. However, before purchasing, you will need to obtain a firm quotation, either from a UN procurement agency or by direct negotiation with the manufacturer.

 

Shipping: Shipping costs vary considerably according to destination and are not included within the guide prices. Purchasers should always confirm freight charges with the supplier before placing an order. Estimated freight charges should be included in budgets and shipping lead times should be included in project plans. Manufacturers and suppliers offer delivery arrangements based on international standard definitions known as Incoterms. The UNICEF pricing data7 website provides up-to-date information on Incoterms. 

 

Where to order products

Orders can be placed directly with the manufacturer at the address provided on each product data sheet.

 

Most items can also be purchased through the WHO Contracting and Procurement Service 8, the PAHO Revolving Fund9 or from UNICEF Supply Division in Copenhagen, Denmark via the UNICEF Supply Division Catalogue10.

 

Vehicles, motorbikes and power products can be purchased through the Inter-agency Procurement Services Office (UNDP/IAPSO)11. UNICEF Supply Division also supplies vehicles.

 

Other equipment suppliers include: International Dispensary Association (IDA)12 in the Netherlands and Médicins Sans Frontières Logistique (MSFL)13 in France.

 

Authorization is needed to gain full access to most of these websites.

 

Footnotes

1 PQS Catalogue, PQS website Key resources/Prequalified products: https://extranet.who.int/prequal/immunization-devices/online-catalogue

2 PQS Product Feedback Form: https://extranet.who.int/prequal/form/imd-feedback-form

3 WHO Prequalification of Immunization Devices (PQS) website: https://extranet.who.int/prequal/immunization-devices

4 UN Procurement Practitioners Handbook : https://www.ungm.org/Shared/KnowledgeCenter/Pages/PPH2

5 UNICEF Supply Division General Procurement Guideline: https://www.unicef.org/supply/documents/general-procurement-guidelines-cold-chain-equipment

6 UNICEF Cold Chain Support Package: https://www.unicef.org/supply/index_68367.html

7 UNICEF Pricing Data : https://www.unicef.org/supply/pricing-data

8 WHO Contracting and Procurement Servicehttp://www.who.int/3by5/who_procurement/en/index.html

9 WHO PAHO Revolving Fund: https://www.paho.org/hq/index.php?option=com_topics&view=article&id=396&Itemid=42192&lang=en

10 UNICEF Supply Division Catalogue : https://supply.unicef.org/

11 Inter-agency Procurement Services Office (UNDP/IAPSO): http://www.unwebbuy.org/

12 International Dispensary Association : http://www.idafoundation.org/ 

13 Médecins sans Frontières Logistique http://www.msflogistique.org/


 

 

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.

 

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.

IMD-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.

The IMD-PQS Devices Catalogue, which includes the product data sheets, is updated regularly. The product data sheets are individually accessible on the IMD-PQS website in the section “Key resources/Prequalified products”1.

 

Products are added to the IMD-PQS Catalogue only if and when they are found, by the process of WHO independent verification, to comply with the applicable performance, quality and safety standards current at the time of submission. Those products found to successfully comply will be granted IMD-PQS prequalified status which indicates that the product may be procured by United Nations agencies for use in immunization programmes.

 

WHO may suspend or withdraw products from the IMD-PQS Catalogue according to the IMD-PQS Standard Operating Procedures (SOP)2. Reasons for suspension or withdrawal are listed in the SOP 011 “How to remove a prequalified product from the IMD-PQS database”.

 

WHO operates a policy of “grandfathering” for previously IMD-PQS prequalified products that no longer meet current PQS standards. PQS will define a period of a specific duration, following the introduction of a new or revised product specification, during which previously prequalified equipment are exempt from compliance with the new requirements. The IMD-PQS Secretariat will identify any specification clause that requires eventual compliance by previously prequalified equipment including the duration of the Grandfathering period.

 

The IMD-PQS Catalogue does not provide an exhaustive overview of products for use in immunization programmes. The IMD-PQS Catalogue includes only those products which have been independently assessed in accordance with IMD-PQS verification procedures and found to meet the requirements of the relevant IMD-PQS performance specifications.

 

The fact that certain products and manufacturers are not included in the IMD-PQS Catalogue does not mean that, if independently tested, they would not be found to comply with the relevant IMD-PQS performance specifications. WHO IMD-PQS therefore encourages a wide range of manufacturers to apply for prequalification to support the development of a competitive marketplace.

 

The IMD-PQS Catalogue may not be used by manufacturers and suppliers for commercial or promotional purposes.

Disclaimer

 

The inclusion of a product in the IMD-PQS Catalogue does not constitute a WHO endorsement of the product and/or its manufacturer (beyond compliance with IMD-PQS specifications). 

 

WHO does not guarantee that IMD-PQS Catalogue is complete or error free.

Furthermore, by including products in the IMD-PQS Catalogue, WHO does not imply that:

the products which have been found to meet the relevant PQS performance specifications will continue to do so, nor that the products included in the PQS Catalogue have obtained marketing authorization for their specified use or any other use in any country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws.

 

WHO wishes to alert procuring agencies that the improper handling and transportation of products may affect their quality, safety and/or effectiveness. WHO disclaims any and all liability and responsibility for any injury, death, loss, or damage of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the IMD-PQS Catalogue.

 

Procurement suggestions

Any Member State and UN organization intending to use the IMD-PQS Catalogue for procurement purposes should ensure that only products from the manufacturers mentioned in the IMD-PQS Catalogue are supplied to it. However, inclusion of a product in the IMD-PQS Catalogue does not constitute any guarantee for the procurement of this product.

 

Procurement agencies using the IMD-PQS Catalogue for procurement purposes remain solely responsible for ensuring the quality of the products to be delivered to them. Procurement agencies are also responsible for ensuring the financial stability and standing of the supplier, their ability to supply the required quantities and that the products have obtained the required marketing authorizations.

 

Guideline revision history

Date

Change summary

Reason for change

Approved

15 April 2011

First publication

 

IG

25 August 2019

Substantial technical revisions all sections; editing / proofing and streamlining contents.

Updates in line with technical product changes and the PQT Immunization Devices website review.

IG

17 September 2024

Substantial technical revisions all sections; editing / proofing and streamlining contents.

Updates in line with technical product changes and the PQT Immunization Devices website review.

IG

© World Health Organization

This electronic document is not a formal publication of the World Health Organization (WH O) and all rights are reserved by the organization. The document may, however, be freely re viewed, abstracted reproduced and translated, in part or in whole, but not for sale nor for use in conjunction with commercial purposes.

The views expressed in documents by named authors are solely the responsibility of those authors.


Footnotes

1 IMD-PQS Catalogue, IMD-PQS website Key resources/Prequalified products: https://extranet.who.int/prequal/immunization-devices/online-catalogue   

2 WHO Performance, Quality, and Safety Standard Operating Procedures https://extranet.who.int/prequal/immunization-devices/standard-operating-procedures

[1] IMD-PQS Catalogue, IMD-PQS website Key resources/Prequalified productshttps://extranet.who.int/prequal/immunization-devices/online-catalogue 

[2] WHO Performance, Quality, and Safety Standard Operating Procedures (https://extranet.who.int/prequal/immunization-devices/standard-operating-procedures