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New Vaccine Storage Standards: NSF/ANSI 456 – 2021a Just Released

With the rise of COVID-19, those who manufacture, ship, store, and administer vaccines face many pressures. National and international campaigns to vaccinate against the virus continue as a prime strategy to halt the pandemic. These campaigns include safely storing a high volume of vaccines for the required period. Campaigns also include special temperature requirements of the new vaccines, and newly evolving government standards for the temperature ranges in which these vaccines are kept. Emerging technology enables vaccine distributers to achieve these results and safeguard the performance of the vaccines.

COVID-19 is still in the spotlight, now having claimed 4-million lives worldwide. However, the new SARs-CoV-2 vaccines are few compared to the dozens already in use for the prevention of other illnesses. These vaccines are used for annual, periodic, and situational protection against viral and bacterial illness. Many are used for children under the age of 6 for protection prior to enrolling in school.

Like all vaccines, COVID-19 vaccines have storage requirements, shelf-life limits, and delivery device specifications. These requirements ensure that every dose of a vaccine is both safe and maximally effective. In the case of COVID-19 vaccines, these specific formulas must be kept within very low temperature ranges up to the time of injection. Thus, the performance of vaccine refrigerators, freezers, and combination units becomes a top priority.

Defining standards for storage

The COVID-19 vaccination campaign is well underway, with 48.5% of all Americans being fully vaccinated. However, criteria for the performance of vaccine storage units have not been officially defined and standardized. The standards for the design and construction of these units are evolving as well.

The National Sanitation Foundation (NSF¹) just released its Vaccine Storage Standard NSF 456, which defines storage unit performance standards and construction of storage units. (Existing standards are limited to safety in using storage refrigerators, freezers, and combination units as defined by the American National Standards Laboratory (ANSI²) and Underwriter's Laboratory (ULᶟ).

Now, a new voluntary standard, the NSF/ANSI 456, Vaccine Storage, has been made available as an additional resource. The NSF/ANSI 456 was developed as a generalized standard for characterizing performance and construction requirements for vaccine refrigerators and freezers. This new standard is a voluntary standard and not subject to regulatory enforcement.

The standard was developed by the NSF/ANSI Joint Committee on Vaccine Storage, a team with members from public health agencies (including the CDC and NIST), healthcare providers, vaccine suppliers, and equipment manufacturers. The focus, again, is to provide a standard that generalizes construction and performance requirements for vaccine storage.

What does this new NSF 456/ANSI standard mean to me?

The Centers for Disease Control (CDC) is the gold standard for offering guidance to all those distributing and storing COVID-19 vaccines. The CDC reinforces the vital importance of vaccine storage and handling to ensure maximal effectiveness of each dose. The CDC highlights the importance of cold storage. For example, its "Vaccine Storage and Handling Toolkit" recommends systems be designed and built specifically for vaccine storage. This includes utilizing features such as microprocessor-based temperature control and forced-air technology to safeguard vaccines.

Your American Biotech Supply unit

ABS is an active member of the committee that developed the NSF/ANSI 456 standard.  At this time, select ABS units incorporate the state-of-art technology specified by the CDC. These units align with NSF 456/ANSI specifications regarding temperature consistency, unit design and features. The new NSF 456/ANSI standard is a voluntary standard, which seeks to enhance storage requirements but is not subject to regulatory enforcement.

ABS will have units that meet or exceed the newly released NSF 456/ANSI Standard and a growing portfolio of models tested and certified by a 3 rd party lab. In a rapidly changing environment for pharmacy-standard storage, we welcome your comments and requests related to American Biotech Supply products.

1. NSF is a registered trademark of the Nasional Sanitation Foundation

2. ANSI is a registered trademark of the American National Standards Institute

3. UL is a registered trademark of the Underwriters Laboratories

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