As global vaccine demand soars, proper storage has become vital. The necessity for developing and distributing effective vaccines gained unprecedented significance during the COVID-19 pandemic. As scientists persist in creating new preventative treatments for various diseases, the healthcare cold storage industry has likewise innovated in manufacturing and design to ensure the proper storage of these vital materials.
This blog delves into how these standards are transforming vaccine preservation, ensuring efficacy and safety from production to administration. Whether you're in healthcare, pharmaceuticals, or interested in vaccine logistics, this guide will illuminate the significance of optimal storage solutions. Let’s explore how these standards are influencing the future of public health!
What is NSF/ANSI 456 and what does it mean for vaccine storage?
The NSF/ANSI 456 Standard for Vaccine Storage establishes the essential criteria for the design and performance of storage units used by those who administer vaccines. This standard pertains to vaccine storage refrigerators, freezers, and combination units. The Centers for Disease Control (CDC) Toolkit continues to be the benchmark for the safe storage and handling of vaccines. The new standard does not replace the CDC's Vaccine Storage and Handling Toolkit guidelines, which provide best practices for vaccine storage. Instead, it outlines design protocols and performance criteria specifically for the cold storage equipment referenced in the CDC's Toolkit, and the NSF 456 certification remains a voluntary standard, as no regulatory body currently mandates NSF 456 units for vaccine storage.
The standard was established by the NSF/ANSI Joint Committee on Vaccine Storage, comprising members from public health agencies such as the CDC and NIST, healthcare providers, vaccine suppliers, and equipment manufacturers. This standard sets forth comprehensive construction and performance guidelines for vaccine cold storage equipment.
Proper storage and handling begin with an effective vaccine cold chain.
What are the NSF/ANSI 456 Standard testing protocols?
NSF/ANSI 456 certification testing utilizes aluminum thermal ballasts, known as vaccine simulation devices (VSDs), strategically positioned inside the cabinet. These defined positions ensure temperature uniformity is met throughout the entire refrigerator or freezer regardless of where the vaccine(s) are stored. The testing protocol employs a data acquisition rate that captures temperatures 30-90 times faster than standard data loggers, to ensure accurate data. The assessment includes evaluating temperature performance in both empty and fully loaded units, during sequential 8-second door openings, as well as analyzing pulldown time following extended 3-minute door openings.
Vaccine Simulation Device (VSD). 1
A VSD simulates a small vial of vaccine that was taken out of its original packaging and placed at an extreme position within the chamber to simulate the 15 worst case storage practices.
Performance Requirements.
Refrigerators:
During the door opening test, no probe shall go below 2°C or above 8°C. After a 3-minute opening test, temperature must recover to 5°C +/- 3°C in 15 minutes and cannot go below 1°C.
Freezers:
During the door opening test, no probe shall go below -50°C or above -15°C. After the 3-minute opening test, the temperature of the probes Must recover to -15°C in 15 minutes and cannot go above 0°C.
Compliance criteria for certification.
The following criteria are essential for compliance with the NSF / ANSI 456 standard and certification through third-party testing:
- Temperature performance under steady-state and door-opening conditions.
- Temperature performance with minimal volume stored in the unit and when fully loaded; units must display internal temperature.
- Doors must be self-closing.
- Internal barriers to prevent vaccine storage in areas that do not meet temperature requirements.
- Audible and visual alarms for temperature excursions and door openings.
- Capability to pass cables into the unit without compromising the door seal.
23 CU. FT. CAPACITY STANDARD CERTIFIED TO NSF/ANSI 456 PHARMACY SOLID DOOR REFRIGERATOR.
Key Questions to Consider Before Purchasing a Vaccine Refrigerator.
- Is the unit certified according to NSF/ANSI 456 standards?
Ensure you review actual certification documentation rather than relying solely on claims. Certification indicates that the unit has been tested and meets the standard's requirements.
- What are the testing protocols?
Verify that the unit has been tested under the stringent conditions outlined by the NSF/ANSI456 standard, including temperature probes and load conditions.
- Could the manufacturer supply performance data?
Request comprehensive performance data that illustrates the unit's capacity to maintain uniform temperature, stability, and recovery. Ensure that this data adheres to the NSF/ANSI 456 Standard.
- How is the unit equipped to manage defrost cycles?
Units must maintain consistent temperatures throughout defrost cycles. Ensure the design incorporates a defrosting method that does not compromise temperature stability.
Certified products will display a certification mark on the serial tag.
When purchasing a refrigerator or freezer for vaccine storage it is important to inquire whether products have been certified to the NSF/ANSI 456 standard by an independent testing agency. In order to achieve NSF 456 certification, cold storage units are tested by a certified 3rd party laboratory, such as UL, ETL, or NSF. Certified products will display a certification mark on the serial tag. Exercise caution with unspecified claims such as "complies with emerging CDC and NSF standards" as some manufacturers assert these without adequate independent testing or certification.
References:
- https://www.labrepco.com/2021/11/17/what-is-an-nsf-certified-vaccine-storage-refrigerator-or-freezer/
- https://indd.adobe.com/view/1b3ae12c-eca7-4bc8-bb48-93c2f618aaeb
