Sustaining and preserving vaccines is becoming increasingly significant in our everyday life. Furthermore, maintaining critical refrigeration and freezer temperatures for vaccines, such as SARS-CoV-2, has created a unique class of storage devices compared to traditional residential and commercial refrigeration units. As vaccine providers and manufacturers navigate to find temperature-effective storage units, Keystone Compliance realizes the importance of ANSI refrigerator and freezer unit testing and guides companies through the process.
Keystone Package partners with customers to achieve package compliance. Our pricing is competitive and we offer volume discounts. Keystone creates an accurate test plan to eliminate expensive over-testing. Additionally, when packages do not meet the requirements, we assist with finding solutions.
Request a quote to see why so many companies partner with Keystone Package Testing. Have a question about our vaccine sustainability testing lab? Contact us and we will determine the best course of action.
Summary of NSF/ANSI 456 Standard Testing of Storage Units
This NSF certification defines criteria for units used to store vaccines. ANSI equipment in this type of testing consists of refrigerators, freezers, and combination units. Combination units consist of both refrigeration and freezer units.
The NSF/ANSI standard test method is conducted at the ambient temperature of 22 to 1.5 Celsius. The relative humidity is tested within 20% and 60%. Other conditions carried out prior to the test procedure include:
- Time measurements with an accuracy of 0.5%.
- Air velocity measured with an instrument having an accuracy of 10%.
- The unit is set to the manufacturer’s recommended temperature set point and factory settings.
Vaccine Simulation Device (VSD): A VSD is described as a weighted temperature probe used to simulate the temperature response performance of an individual vial.
Temperature Measurement Device (TMD): A TMD device measures temperature through direct contact with a sensor. The device provides a digital output or display of the determined value.
NSF/ANSI Regulatory Compliance of Refrigeration Units
Design and Construction
Doors, lids, and closure devices are sized per the manufacturer’s intent. Units can have a sliding door or multiple doors. Furthermore, opaque or transparent doors are permissible.
Some vaccines are sensitive to light. However, light protection is not addressed in this conformance test. Generally, vaccines such as the COVID vaccine are stored in their original packaging until use. It is recommended that loose vials or syringes be stored in their original packaging.
If the medical packaged product is exposed to unnecessary light, the medical device may lose potency. The exposed product may also be more difficult to track expiration dates.
Refrigerators are urged to have automatic controls. These controls must be capable of maintaining temperatures where the product is to be stored. The equipment designed for the storage of vaccine products such as COVID-19 vaccines requires a digital display. Additionally, the device requires an audible and visual alarm. The alarm will indicate temperature deviations that fall below 2 C or rises above 8 C.
Compliance Testing
For closed door and portal operating methods, the medical unit under test is monitored for 30 minutes. A vaccine simulation device is used and turned on to its coldest setting. If the unit has an automatic defrost, the temperatures of the VSDs must recover within 15 minutes of defrost operation. The data is collected during or immediately after the closed-door test.
During opened door operating testing, the method is run twice. One time with an empty unit. The second time with the unit’s usable space. VSDs are positioned in specific locations during both tests.
For doorless units, the proves are used as the temperature measurement device for testing after the performance is validated. If weighted probes are used, they must conform to a specified ANSI VSD setup.
Lastly, for long portal openings, the portal is closed for at least 15 minutes. After 15 minutes, the portal is opened for 3. If the unit features an automatic portal closure mechanism, the portal is open until it automatically closes on its own.
NSF/ANSI Regulatory Compliance of Freezer Units
Design and Construction
This portion of the NSF/ANSI 456 standard test addressed freezers intended to store vaccines requiring storage temperatures at -15 C to -50 C.
Doors, lids, and closures are sized to fit their openings. The devices will close and seal as per the manufacturer’s intent. Like refrigeration units, closure devices, lids, and doors can be opaque or transparent.
Units equipped with doors are required to include a method for automatically closing the door. This is only necessary if the door is left ajar less than 20 degrees. For units with sliding doors, the door is required to automatically close if left ajar 2.5 cm or less.
Freezers without a forced-air cycle must have indicators affixed to the interior. These are necessary to inform users when defrosting is required. Indicators are placed where frost commonly occurs.
Compliance Testing
Closed door and portal operating test methods for freezer package integrity are similar to the refrigeration compliance portion of this standard. The ANSI 456 unit under test is monitored and the doors are kept closed for 30 minutes.
Opened door operating test methods are also similar to the refrigeration standard. This method runs twice. Once with an empty unit, and again with the unit’s usable space filled.
For doorless freezer units, probes are used as the temperature measurement device for the testing after the performance is validated. For an empty unit under test, the portal is opened every 30 minutes for a total of two times every hour. After short portal testing, the freezer is tested for long portal openings.
NSF/ANSI Regulatory Compliance of Combination Units
The NSF/ANSI vaccine storage refrigerator section is required to be capable of maintaining specific air temperatures of 5 to 3 C. The vaccine storage freezer section must be capable of maintaining an air temperature of -50 C to -15 C. This is maintained in all parts of the cabinet where the product is stored.
If the ANSI 456 standard tests for the refrigerator and freezer are run separately, the portion not being tested must have the temperature monitored. If the temperature does not stay within specified ranges, the entire unit will fail.
Expert NSF/ANSI Vaccine Storage Unit Testing
Keystone has a full lab of test equipment which permits us to provide short lead times on scheduling. Our team strives to give our customers more time and energy on product development instead of testing. We can accommodate flexible and rigid packages of all sizes, including large pallets.
Contact us to learn first-hand why so many companies partner with Keystone to achieve their ANSI storage unit certification needs.