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Dan Brigden reacted to this post about 5 years ago
Isaac Gobina replied to a discussion, Why is there no discussion on the equipment needed to distribute Covid-19 vaccines.Hi Larry,
For vaccines requiring ultra-low storage temperatures (i.e. ≤60°C), WHO PQS is in the process of developing a range of performance specifications and testing protocols to ensure the performance, quality and safety of ultra-low temperature (ULT) CCE. Building on lessons learned from the Ebola vaccine, WHO PQS wants to make sure that ULT CCE takes into account the needs and challenges immunization programs face when it comes to transportation, storage, management and handling of ULT vaccines.
Right now, WHO PQS performance specifications for both active (freezers) and passive (cold boxes) ULT appliances are under development with the support of industry and non-industry partners. Dedicated specifications for ULT power systems are also being developed to ensure a continuous power supply to ULT appliances. The same goes for ULT accumulators for use in passive ULT devices. Our objective is to publish these ULT performance specifications and testing protocols in December...Hi Larry,More
For vaccines requiring ultra-low storage temperatures (i.e. ≤60°C), WHO PQS is in the process of developing a range of performance specifications and testing protocols to ensure the performance, quality and safety of ultra-low temperature (ULT) CCE. Building on lessons learned from the Ebola vaccine, WHO PQS wants to make sure that ULT CCE takes into account the needs and challenges immunization programs face when it comes to transportation, storage, management and handling of ULT vaccines.
Right now, WHO PQS performance specifications for both active (freezers) and passive (cold boxes) ULT appliances are under development with the support of industry and non-industry partners. Dedicated specifications for ULT power systems are also being developed to ensure a continuous power supply to ULT appliances. The same goes for ULT accumulators for use in passive ULT devices. Our objective is to publish these ULT performance specifications and testing protocols in December 2020. Specifications for ULT temperature monitoring devices will follow in the new year.
In addition to ULT CCE availability, a discussion is also needed on how we will prepare our health care professionals to safely manage and handle ULT CCE. EPI Standard Operating Procedures and guidelines need to developed concurrently to ensure the safe distribution of ULT vaccines.
Isaac GOBINA, WHO PQS Secretariat
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Isaac Gobina started a new discussion, WHO Guidelines on the international packaging and shipping of vaccineDear Sir/Madam, Kindly be informed that the revised Guidelines on the international packaging and shipping of vaccines has been published on the WHO website for public consultation. https://www.who.int/immunization_standards/vaccine_quality/vaccines_packaging_guidelines2019/en/ We would appreciate your comments not later than 30 September 2019. Thank you and best regards,
...Post is under moderationStream item published successfully. Item will now be visible on your stream.Moderator reacted to this post about 7 years ago
Isaac Gobina started a new discussion, Together, developing quality, reliable immunization products that meet every needThe WHO PQS product feedback cycle
Did you know that at the heart of WHO Performance, Quality & Safety (PQS) is a crucial performance monitoring and feedback mechanism? This mechanism makes it possible for PQS to enforce and improve product standards and make sure that products and devices procured for use in immunization programmes are suitable, quality and reliable. This cycle of feedback and improvement is powered by the input of EPI programmes and product manufacturers. In-field insights - such as reports of product life cycle performance or defects and faults - help WHO PQS develop new or review existing product specifications to maintain a robust prequalification process and, ultimately, help EPI programmes safeguard and deliver precious potent and safe vaccines.
Envisioning the future
WHO PQS also gathers up-to-date insights about the evolving requirements of product users’ operating environments, with which PQS can help shape the design of novel product features....
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