prequalification cold chain equipment

1.0 Introduction. This guideline is one of a series which tells you how to make an application to the World Health Organization (WHO) for the pre-qualification of cold chain-related …

PQS Catalogue > Prequalified Devices and Equipment. The following resource documents can be accessed to support cold chain equipment (CCE) management processes, as …

range of cold chain equipment, injection devices and other products needed for safe and effective immunization delivery. The Performance, Quality and Safety (PQS) scheme for the prequalification of equipment and devices for immunization was introduced in 2006 and became functional gradually during a transition

Cold chain equipment: Cold chain equipment, both electrical and non-electrical, is used for storing vaccines and/or transporting them at appropriate temperatures. Figure 4.2 summarizes the cold chain equipment supplied under the UIP. The NCCMIS (National Cold Chain Management Information System) website is the platform where all …

Module 1 : Cold chain, vaccines and safe-injection equipment management ... Module 1 : Cold chain, vaccines and safe-injection equipment management. Global Mid level Management modules (MLM) 31 May 2008 | Training material. Download (804.7 kB) WHO Team. Immunization, Vaccines and Biologicals …

Reinforce and expand WHO prequalification & product risk assessment. 4. ... cold chain equipment, vector control products & in vitro diagnostics •Increase competition to shape the market.

cold chain equipment, vector control products & in vitro diagnostics •Increase competition to shape the market Prequalification WHO Regulatory Activities Ensuring normative and technical excellence drives impact at country level 7 •Strengthen regulatory systems in countries and regions •Promote regulatory cooperation, convergence and

procurement of Cold Chain equipment should be based on national policy, Expanded Programme of Immunization (EPI) strategies and according to planned national asset acquisition and replacement policies. Acquiring refrigeration equipment calls for the involvement of EPI managers and logisticians to determine required storage capacities.

Weak links in the current cold chain in remote areas or in places with intermittent power supply results in large quantities and millions of dollars worth of spoiled vaccines each year. ... The equipment is powered by renewable energy from the sun collected via photovoltaic solar panels. ... The WHO prequalification process allowed the system ...

[E006/DL01.2] Data logger and machine-to-machine interface for Equipment Monitoring Systems -PQS specifications >> :: PQS_E006_DS01_Annex 1_Cold Chain Data Objects >> :: [E006/DS01.2] Data standards for cold chain equipment monitoring - PQS Specifications >> :: [E006/EM01.2]Equipment Monitoring Devices for Equipment …

Cold chain equipment: Equipment used to store and transport temperature-sensitive products at the proper temperature during each stage of the supply chain. Commodities: In the context of this module, the term commodities primarily refers to syringes, safety boxes, and related injection and waste disposal equipment.

Qualification Versus Validation and Good Cold Chain Management Practices. R. Bishara. Published 2005. Medicine, Business. TLDR. While completing qualification studies of controlled temperature shipping packages and systems, it is necessary to utilise temperature profiles that are expected to be typical for the type of package based on a …

"The Kenyan Government is very grateful to the Government of Japan for this cold chain equipment, which will greatly support our COVID-19 vaccination efforts. This equipment will enable appropriate vaccine storage, distribution and continuous temperature monitoring, including storage for vaccines that require 'ultra-cold' temperatures ...

[PQS/E003/BC01.1] Cold Chain Equipment Asset Tag Specification [WHO/PQS/E003/FZ01.2] Vaccine freezer or combined vaccine/icepack freezer (compression cycle): PQS performance specification, [WHO/PQS/E003/FZ02.2] Waterpack freezer (absorption cycle): PQS performance specification

Guideline. Cold Chain maintenance is an essential component of every immunization programme, without which delivery of immunization services is rendered impossible. For the safe storage and transportation of vaccine, cold chain equipment is a mandatory requirement. All equipment must be able to keep vaccines safely whatever …

Guidance to ensure effective and efficient procurement of cold chain equipment, essential for receiving, storing and delivering of vaccines. About Before implementing vaccination programmes, a fully …

E003: Refrigerators and freezers. The products in this category are designed to store vaccines and freeze water-packs. The advantages and disadvantages of each refrigeration technology and energy source are summarized in the PQS Catalogue. A list of prequalified products in this category is provided below. Links to the relevant PQS data sheet ...

E004: Insulated containers. The products in this category relate to cold boxes, vaccine carriers and other insulated containers used in the transport and/or storage of vaccines. Questions to consider when choosing an insulated container are summarized in the PQS Catalogue. A list of prequalified products in this category is provided below.

Safe blood and blood products : manual on the management, maintenance and use of blood cold chain equipment. 30 April 2005 | Manual. Download (5.8 ) Overview . The critical contribution that effective management and use of medical equipment brings to health service delivery is only recently gaining recognition. …

3 WHO PRE-QUALIFICATION ... Cold Chain equipment, but also the running cost, cost of spare parts and consumables. Clear and forward planning is vital …

WHO PREQUALIFICATION TEAM SCOPE AND NUMBER OF PREQUALIFIED PRODUCTS* Diagnostics In vitro diagnostics (IVD) & male circumcision device (MCD) Medicines Finished pharmaceutical product (FPP), active pharm ingredient (API), quality control lab (QCL) Vaccines Vaccines (Vx), Immunization device (ImD) & cold chain …

increased from 2012 after the prequalification and market entry of several innovative solar-powered refrigerators, and Gavi's Health Systems Strengthening (HSS) funding to support ... 3.2 The Gavi Cold Chain Equipment Optimization Platform Gavi's 2016-2020 strategy seeks to ensure an additional 300 million children are immunized with

E007: Cold chain accessories; E008: Injection devices for immunization; E010: Waste management equipment; ... · The "Prequalification of immunization equipment and …

UNICEF procures affordable cold chain equipment (CCE) prequalified by the World Health Organization (WHO) to improve immunization supply chain systems to manage and …

temperature during each stage of the supply chain. Cold chain equipment inventory: A record of the quantities, types and characteristics of the cold chain equipment deployed in a country or other administrative unit. Commissioning: A series of tests and adjustments performed to check whether, and to ensure that, new equipment is

DHAKA, 28 September 2021 – Twenty-six ultra-low temperature freezers delivered by UNICEF through COVAX in August are enabling Bangladesh to receive, store and distribute large quantities of COVID-19 vaccines that require ultra-cold storage. Each of the 26 freezers can hold over 300,000 doses of COVID-19 vaccines, supporting administration …

range of cold chain equipment, injection devices and other products needed for safe and effective immunization delivery. The Performance, Quality and Safety (PQS) scheme for …

E007: Cold chain accessories; E008: Injection devices for immunization; E010: Waste management equipment; ... · The "Prequalification of immunization equipment and devices" pre-submission form should be filled out and submitted for new products seeking PQS prequalification. Product information provided by the manufacturer on this form ...

PQS Devices Catalogue 2020. The PQS on-line catalog includes details of all immunization-related products currently pre-qualified by WHO for procurement by United Nations agencies. The catalog is produced and maintained by the Quality, Safety, and Standards group in the Immunization, Vaccine and Biologicals Department of WHO, …

cold chain equipment, vector control products & in vitro diagnostics •Increase competition to shape the market Prequalification A reminder: WHO Regulatory Activities Ensuring normative and technical excellence drives impact at country level 9 •Strengthen regulatory systems in countries and regions •Promote regulatory cooperation ...

Health (MSH), Partnership for Supply Chain Management (PFSCM), Quality Medicines for All (QUAMED), International Union Against Tuberculosis and ... I.2.2 Equipment 150 I.2.3ehicles and transport V 151 I.2.4inancial systems F 151 ... II.2rinciples for prequalification P 161 II.2.1 WHO Model List of essential medicines 162

E006: Temperature monitoring devices. The products in this category relate to thermometers, freeze indicators, temperature recorders, alarm systems, event loggers and remote communication devices for monitoring temperatures at all levels of the cold chain. A list of prequalified products in this category is provided below.

Delivering vaccines to all corners of the world is a complex undertaking. It takes a chain of precisely coordinated events in temperature-controlled environments to store, manage and transport these life-saving products. This is called a cold chain. Vaccines must be continuously stored in a limited temperature range – from the time they are ...

Overview. This module describes how to calculate vaccine volumes and evaluate the cold chain capacity requirements of a vaccine supply chain. This module also provides guidance on how to calculate cold chain storage needs for coolant-packs and the dry-storage capacity needed for immunization-related commodities.

The overall score for the temperature readings of the ILR space from six sites was 71 percent. Two of the sites had a very low performance score whereas, the other four averaged at 95 percent. Similarly, the Deep Freezer score was also high. The overall performance score from five sites was 81 percent.

prequalification is a requirement for procurement by United Nations agencies or by countries using Gavi, the Vaccine Alliance, funding or Gavi's Cold Chain …

For examples of typical cold chain refrigeration loads and specific product data, see World Health Organization (WHO) prequalified equipment: refrigerators and freezers. Use the …

With the introduction of Performance, Quality and Safety for prequalification of equipment and devices used in immunization services, the Protocol was revised by the Quality, Safety and Standards Team, Department of Immunization, Vaccines and ... Cold-chain staff at each point in the cold chain will direct the monitored shipments

The cold chain is necessary to prevent damage to vaccines caused by heat exposure. However, improper use of cold chain equipment may cause damage to freeze-sensitive vaccines. Studies conducted in several countries with hot and cold climates show frequent occurrences of sub-zero temperatures in the cold chain. 1

Full clinical development, national licensures and WHO prequalification for nOPV2 are also in progresswith an expectation that these can be achieved by 2023. ... Passive Cold Chain Equipment Standard Cold Box and Vaccine Carriers Standard Cold Box and Vaccine Carriers Standard Cold Box and Vaccine Carriers Temperature