Vaccine storage jumped into the spotlight due to COVID-19, with the vaccine storage and packaging market now expected to reach $5.6 billion by 2026. But there’s also been a recent development in vaccine storage guidance with the June 2021 release of the NSF/ANSI 456 Standard for Vaccine Storage. So, what exactly does this standard entail, is it mandatory and what does it mean for you and your lab? Let’s explain.
What are the NSF and ANSI?
The NSF International is a global, independent organization that employs engineers, microbiologists, toxicologists, chemists and public health experts who provide services in 180 countries across the globe. The NSF is “dedicated to protecting and improving global human health since 1944.” The organization develops public health standards and certification programs “that help protect the world’s food, water, consumer products and environment.”
The American National Standards Institute (ANSI) is a private non-profit organization that manages and coordinates voluntary standards. “ANSI is not itself a standards developing organization. Rather, the Institute provides a framework for fair standards development and quality conformity systems and continually works to safeguard their integrity.” ANSI represents the interests of many — more than 270,000 companies and organizations and 30 million professionals around the globe.
So, how do NSF and ANSI work together? NSF is accredited by ANSI and has developed more than 80 voluntary American National Standards related to public health, safety, environment and sustainability. As NSF explains, the processing of developing standards is a public one that involves industry representatives, public health officials and consumer representatives.
Vaccine Storage Standards
Before we explain the NSF/ANSI 456 standard, let’s first discuss vaccine storage guidelines in general. The Centers for Disease Control & Prevention (CDC) is the industry standard for all types of vaccine storage and has issued vaccine storage temperature recommendations that depend on the type of vaccine.
Vaccines that require refrigeration — for example, HepA, HepB, MebN, DTaP, Tdap and HPV — typically have a temperature storage range of 2°C to 8°C (36°F to 46°F). Vaccines that require freezer storage, such as MMRV, typically have a temperature range of -15°C to -50°C (-5°F to -58°F). The exact temperature will, of course, depend on the specific vaccine.
What is the NSF/ANSI 456 Vaccine Storage Standard?
NSF/ANSI 456 is a new vaccine storage standard. It defines the appropriate criteria for the construction and performance of vaccine refrigerators and freezers that are used by those who store or administer the vaccines.
The CDC’s Vaccine Storage and Handling Toolkit is the gold standard for vaccine storage, but when it comes to refrigerators and freezers, they just provide general guidelines that are open to interpretation. There is no official testing or certification performed. This new standard takes it to the next level. They designed testing protocols to simulate worst case storage practices. This includes measuring temperature uniformity throughout the unit, testing performance with the door open and closed and temperature pulldown after door openings.
As explained in the white paper “Emerging Vaccine Cold Storage Standards: NSF/ANSI 456-2021A“, vaccine temperatures are “usually simulated using an appropriate thermal ballast. The CDC recommends a ‘digital data logger’ (DDL) type of temperature monitoring system, which may include a physical ballast, or electronics that provide a virtual thermal ballast to simulate the stored vaccine temperature. The NSF/ANSI 456 standard for vaccine storage defines a specific ballast design called a Vaccine Simulation Device (VSD).”
In other words, when you are monitoring a refrigerator’s temperature, you can have a probe that reads the air. The problem, however, is that the air temperature can fluctuate when you open the refrigerator door. Another way to read the temperature is to mimic the sample (or vaccine) temperature, which is the temperature actually inside the sample (and thus colder than air). In this case, you would use a probe that is typically in something, such as liquid or beads. This protects the temperature probe so that you can read the temperature more accurately.
What Does the NSF/ANSI 456 Standard Mean for Your Lab?
As of now, the standard is not mandatory and is intended to enhance the CDC’s Vaccine Storage and Handling Toolkit, which remains the industry standard for vaccine storage. Also, not all lab equipment is compliant — yet. But anyone looking to buy new lab equipment should be aware of this new standard, which could shift from a recommendation to a requirement. If you buy compliant lab equipment now, it’s something you don’t have to worry about in the future.
Questions About Vaccine Storage? We Can Help!
We have a long history of working with market-leading manufacturers to provide pharmacy-grade refrigerators and freezers for all customers who administer and store vaccines. Whether you’re looking to replace one piece of equipment or you’re outfitting a new lab, we can help. Our factory-trained sales representatives have the specialized knowledge to answer your questions and help you pick out the correct equipment. Contact us today to get started.