Arktek Awarded Prequalified PQS Status by WHO

THE WORLD HEALTH ORGANIZATION (WHO) AWARDED THE AUCMA ARKTEK PASSIVE VACCINE STORAGE DEVICE “PREQUALIFIED” STATUS UNDER ITS “PERFORMANCE, QUALITY AND SAFETY” PROGRAM. PQS PREQUALIFICATION IS A PREREQUISITE FOR MOST GOVERNMENTS IN THE DEVELOPING WORLD FOR SALE AND IMPLEMENTATION OF A DEVICE. IT IS SEEN AS SEAL OF APPROVAL THAT THE PRODUCT HAS BEEN DESIGNED AND TESTED SUCCESSFULLY FOR THEIR REAL WORLD CONDITIONS.

Recently, the World Health Organization (WHO) awarded the AUCMA Arktek Passive Vaccine Storage Device (PVSD) “prequalified” status under its “Performance, Quality and Safety” (PQS) program. This marks the largest milestone yet of the PVSD program at Intellectual Ventures Laboratory (IV Lab) and Global Good.

PQS prequalification is a prerequisite for most governments in the developing world for sale and implementation of a device. It is seen as seal of approval that the product has been designed and tested successfully for their real world conditions. From theWHO website, “the PQS approach to equipment and device prequalification is based on three key criteria: a selected product must have performance characteristics that meet the relevant specification standards; quality and reliability characteristics that are appropriate for field conditions, and cradle-to-grave safety characteristics that ensure that no harm is caused to users, patients, or to the environment over the course of the product's life cycle.”

IV Lab started working with the WHO approximately three years ago, helping to define the standards under which the PVSD would be tested. We then tested PVSD prototypes to these specifications. One example of a testing standard is in regard to the “hold time”; the PQS defines that hold time is with respect to a 43°C daytime temperature and a 25°C nighttime temperature, with a certain amount of daily access of the vaccines inside. We built a test chamber to meet those requirements in-house, and tested the devices exactly to the letter of the PQS specifications. That’s how we determined we had a “hold time” of 38 to 43 days.

We then educated AUCMA, our commercialization partner, on the PQS specifications, and helped them engage a testing house that was already certified by the WHO PQS team to perform the standard tests for the AUCMA Arktek devices- in our case, CHEARI in Beijing, China. CHEARI formally performed the tests in November and December, and submitted the results to the WHO, who makes the final decision for prequalified status.

This prequalified status will allow AUCMA, with assistance from the partnership team at Global Good, to more readily introduce the Arktek device throughout the developing world.