The new vaccine storage standard, NSF456, was designed in concert with the U.S. Centers for Disease Control and Prevention (CDC) and NSF International, formerly known as the National Sanitation Foundation, a product testing, inspection, and certification organization based in Ann Arbor, Michigan. In addition to the two organizations mentioned, vaccine manufacturers and equipment suppliers themselves were involved in the development of NSF456, the purpose of which is to create a universal criterion through which to judge the performance and construction of vaccine storage units. Applying to refrigerators, freezers and combination units, vaccine storage standard NSF 456 establishes comprehensive temperature control requirements to maintain the cold chain throughout the vaccine distribution process, from production and delivery to final administration.
The CDC defines the cold chain as
“A temperature-controlled supply chain that includes all vaccine-related equipment and procedures. The cold chain begins with the cold storage unit at the manufacturing plant, extends to the transport and delivery of the vaccine and correct storage at the provider facility, and ends with administration of the vaccine to the patient1.” According to a December 2021 report from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), worldwide, manufacturers of the numerous COVID-19 vaccines were able to scale production from zero to 11.2 billion doses within the calendar year 2021
2. As the COVID-19 vaccine supply continues to rapidly scale worldwide, it is more important than ever to increase our efforts in reducing the number of doses that need to be discarded because of lost potency due to improper temperature regulation. The CDC highlights 3 main contributors in maintaining proper cold chain adherence, “a well-trained staff, reliable storage and temperature monitoring equipment and accurate vaccine inventory management
1”. Globally,
the World Health Organization (WHO) estimates that over 50% of vaccines distributed worldwide are wasted each year4, with the primary cause of such high waste number being
“Bad management …of unopened vials being discarded because of expiry and heat exposure and freezing in the cold chain”.