The need for this document arises from field testing and reports that have identified adverse conditions in vaccine refrigerators due to excess humidity and condensation. High relative humidity levels can lead to mold growth on compartment surfaces and vaccine containers, posing potential health risks. One solution to address humidity issues is to change vial labeling and container materials to moisture-resistant materials. However, the preferred approach is to control humidity directly in vaccine refrigerators.
The World Health Organization's Performance, Quality, and Safety (WHO PQS) intends to introduce requirements for maximum operating compartment relative humidity levels. A refrigerator that meets these humidity levels will be recognized as having "humidity control" in its WHO PQS catalog data page. The document also provides definitions related to humidity conditions, such as ambient humidity, compartment humidity, and humidity control.
The specifications section outlines the criteria for a refrigerator to be tested and rated for humidity control. For instance, in a hot ambient temperature of +43°C with 45-75% ambient humidity, the acceptable compartment humidity should be 55% or lower at +2-8°C. The document also provides a laboratory verification protocol, which includes guidelines for testing the humidity control capabilities of refrigerators.
Furthermore, the document discusses the design of humidity mitigating controls. It emphasizes that manufacturers should aim to meet humidity control specifications with minimal device design modifications and additional components. The reason for these changes is to address instances where vaccine containers in refrigerators have been damaged due to excessive moisture.
Lastly, the annexes provide a draft protocol for verifying refrigerator humidity control and consolidate feedback from the industry along with WHO PQS responses. The feedback section addresses various concerns and suggestions from manufacturers regarding the proposed humidity control requirements and testing protocols.
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