Vaccines have been one of the strongest lines of defense in the fight against the spread of infectious diseases. From development to transport and storage, and ultimately administration, the goal of vaccine manufacturers and clinicians is to deliver safe, effective prevention and treatment measures through vaccinations.
To meet that goal, proper vaccine storage conditions are critical. Improper temperature storage can reduce the potency of a vaccine – or in the case of freezing, destroy it altogether.
An example of this was brought to light in a 2011 audit of 45 Vaccines For Children (VFC) providers across four states and New York City. Inspectors discovered vaccines at 76 percent of the audited facilities were exposed to improper temperatures for at least 5 cumulative hours over two weeks. While this audit did not result in the need for parents to re-vaccinate their children, incidents like this may erode public trust and increase vaccine hesitancy.
While the CDC and other governing bodies regularly issue and update guidance on proper storage and management of vaccine inventory to help ensure vaccines remain in range throughout the cold chain, there has not been a good standard in North America that could be referenced for the performance of a refrigerator or freezer for the storage of vaccines or refrigerated medications. Until now.
Recently, NSF International (NSF) and the American National Standards Institute (ANSI) released NSF/ANSI 456 – 2021a – a certification standard for refrigerators and freezers specifically designed for vaccine storage.
Choosing vaccine refrigerators and freezers that meet NSF/ANSI 456 is the gold standard for ensuring consistent and appropriate vaccine storage.
Here are five reasons why:
1) Third-Party Development and Validation
a. The standard was developed by NSF and ANSI based on input and insight from vaccine manufacturers, equipment manufacturers, national health organizations, NIST, and clinicians. This level of inclusion helped ensure complete understanding and support along every step in the vaccine manufacturing and storage process.
b. NSF/ANSI 456-certified units must be validated by a third-party certifying body.
2) Calibration Certificates
a. To be considered NSF/ANSI 456 compliant, vaccine refrigerators and freezers must include calibration certificates for the temperature display probe(s) included with the units.
b. Calibration certificates must be maintained by the manufacturer and made available if replacement certificates are needed.
c. Manufacturers have developed calibration and service schedules for NSF/ANSI 456-compliant units to ensure they continue to meet the standard requirements for as long as they are in service.
3) Real-World Conditions
a. Ambient temperatures – All units are tested at an ambient temperature of 22°C. This ensures units are exposed to real-world ambient temperatures during door opening tests.
b. Door opening tests – Units are subjected to short and long door opening tests to mimic real-world scenarios. Short door opening tests represent vaccines being removed for administration, and long door opening tests represent the time it takes to reload a unit or manage an inventory process.
c. Empty/loaded testing – Certified units are tested twice – once while empty and once loaded to 35 percent capacity. This ensures units can meet real-world temperature management demands including delivery of vaccine shipment and low-inventory periods.
4) Tight Temperature Control
a. Reaching and maintaining appropriate temperature quickly is a key component in ensuring a unit meets NSF/ANSI 456 standards. There are temperature thresholds that units cannot cross at any time during testing, which ensures a tight range of temperature control, reducing the risk of temperature excursions.
b. For refrigerators, at no time during testing can the temperature drop below 1°C. This avoids the risk of freezing.
5) Fail-safes and Monitoring
a. Temperature displays – Certified units must include a digital temperature display. Units must also allow for the introduction of a third-party temperature monitoring device without breaking the seal of the door.
b. High/low alarms – Certified units must include audible AND visual alarms for temperature excursions. The NSF/ANSI 456 vaccine storage standard is a big step in the right direction to ensuring consistent standardized storage of vaccines.
Other Blogs You Might Be Interested In...
- Importance of Temperature Uniformity for Vaccine Storage
- Explaining the NSF / ANSI 456 Vaccine Storage Standard
- Supporting Safe Vaccine Storage with CDC Recommendations, NSF Standard
- Helmer Scientific’s GX Solutions Refrigerators, Freezers Certified to New NSF/ANSI Vaccine Storage Safety Standard
Not only will adherence to this standard help ensure the administration of safe and effective vaccines, but it may also reduce waste and cost associated with vaccine loss due to improper storage.
Our eBook provides guidance on safely storing vaccines so they remain potent and viable.
