A refrigerator or freezer that is NSF certified for vaccine storage means the units have been tested and certified to meet the NSF/ANSI 456 storage standards. The NSF/ANSI 456 certification defines the appropriate criteria for construction and performance of vaccine refrigerators & medical freezers used by personnel who administer vaccines. These standards were developed through a collaboration with the NSF, CDC, healthcare providers, public health agencies, equipment manufacturers and vaccine manufacturers. The NSF 456 certification is currently a voluntary standard only. Currently there is no regulatory body requiring NSF 456 units for vaccine storage.
What is included in the NSF/ANSI 456 testing protocol?
Testing for the NSF/ANSI 456 certification is performed with aluminum thermal ballasts. These are referred to as a Vaccine Simulation Device (VSD), that are placed in defined positions 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 data acquisition rate for the testing protocol records temperatures 30-90 times faster than typical data loggers to ensure accurate data. Testing also includes measuring temperature performance in empty and fully loaded units, during consecutive 8 second door openings as well as pulldown time after extended 3 minute door openings.
Do current CliniCool brand units meet the NSF certified vaccine storage standard?
Due to very specific requirements, most existing refrigerators and freezers in the industry will not fully meet the standard. Rest assured, your pharmacy-grade CliniCool models from LabRepCo continue to meet the existing CDC Guidelines for vaccine storage.
How will customers know if a product is certified to NSF/ANSI 456?
Customers should ask manufacturers if products have been certified to the NSF/ANSI 456 standard by an independent testing agency such as Intertek (ETL). Approved products will have a certification mark on the serial tag. Beware of vague statements such as “complies with emerging CDC and NSF standards”. Some manufacturers are making these statements without proper independent testing or certification.
Key Takeaways:
- NSF/ANSI 456 is currently a voluntary standard. There is no forced change from any regulatory agency at this time.
- LabRepCo is one of first in the vaccine storage industry to release refrigerators and freezers which are certified to the NSF 456 standard.
- Existing LabRepCo CliniCool Pharmacy/Vaccine storage units still meet the CDC recommendations for safe vaccine storage.
- What is LabRepCo’s stance on the standard? LabRepCo view’s this new standard as a positive development for the pharmacy and clinical industry to provide even safer vaccine storage solutions and improve patient care.