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Storage technology for vaccines recognised by WHO

The World Health Organisation (WHO) has given accreditation to UL’s refrigeration laboratory in Gurugram, India to be a designated third-party testing laboratory for refrigeration equipment used for the storage of vaccines.

With an anticipated surge in the need for vaccine storage in preparation for COVID-19 vaccination release, the WHO accredited testing will help refrigeration OEMs ensure refrigeration reliability and temperature consistency impacting overall vaccine efficacy.

This includes cold rooms, freezer rooms, solar-powered refrigerators and freezers, coolant-packs and related equipment. In addition, the WHO accreditation allows UL to carry out full quality assurance testing – on-site installation and commissioning – of cold room, freezer room and related equipment and coolants. 

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The accreditation for UL is part of WHO’s Performance, Quality and Safety (PQS) process. PQS prequalifies products and devices in order that WHO member states and United Nations purchasing agencies help assure of their suitability for use in immunisation programmes.

Before a product or device can be added to the PQS database, it must be tested. Verification testing establishes whether a specific product from a specific manufacturer satisfies the requirements of relevant PQS performance specification.

Storage technology requires rigorous testing

With WHO accreditation, UL will now be carrying out these tests to verify performance, quality and safety. UL received the PQS accreditation for refrigeration equipment and devices after demonstrating to WHO officials the UL Refrigeration Laboratory’s conformity capabilities to appropriate internationally or nationally accepted standards or codes of practice.

The UL accreditation comes at a time when researchers around the world are addressing the development of a COVID-19 vaccine. Producing and deploying enough immunisations to end the pandemic will be one of the biggest medical manufacturing efforts in history.

To accomplish this, pharmaceutical companies, suppliers, governments and non-profit organisations are busy readying the supply chain to handle a high number of needed COVID-19 vaccines.

The vaccine supply chain involves not only manufacturing the vaccine contents, but also temperature-controlled storage to maintain vaccine quality from production to patient. Failing to keep vaccinations at the correct temperatures, including those used for immunisation programmes against children’s diseases, can result in textural degradation, discolouring, bruising and microbial growth.

Todd Denison, vice president and general manager of UL’s Appliances, HVAC and Lighting Division, said: “As billions worldwide eagerly await a COVID-19 vaccine, government agencies, pharmaceutical companies and healthcare organisations globally will be scaling up vaccine cold chain capabilities. 

“Maintaining large quantities in an environment that preserves vaccination efficacy and provides patients with intended benefit will be key to eradicating COVID-19 spread. UL is honoured to be recognised by the World Health Organisation as one of its accredited laboratories and play a key part in the overall protection of public health globally.”

With the WHO accreditation, UL will also test solar-powered refrigeration equipment based on new WHO product standards. Solar-powered refrigeration equipment is seen as critical for vaccine effectiveness in developing countries without a reliable electricity grid.

According to Denison, the World Health Organisation’s approach to refrigeration products prequalification means that selected equipment and devices have to meet specific performance, quality, and safety standards that are appropriate for field conditions.

“As well as cradle-to-grave safety characteristics to help ensure no harm is caused to users, patients or the environment during a product’s life cycle,” said Suresh Sugavanam, vice president and managing director of UL for South Asia and sub-Saharan Africa,” he said.

“UL’s accreditation helps ensure products met these specifications while also strengthening the reliability of the world’s immunisation storage infrastructure,” he concluded.

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