T/CAV 002-2023 Preventive biological products using pathogenic microorganism strains low temperature preservation technology guidelines

Scope

Main technical content: 1. Basic framework. The group standard includes the preface, scope, normative reference documents, terms and definitions, basic requirements for storage, refrigerated storage, ultra-low temperature storage, deep-freeze storage, freeze-dried storage, and the main parts; as well as two informative appendices on commonly used cryoprotectants and freeze-drying protectants. 2. Main content. In the main body of the group standard, the process and technical requirements for the cryogenic storage of pathogenic microorganisms (toxins) used in preventive biologics are specified. Standardized requirements are proposed for vaccine microorganisms (toxins) storage technology from the key aspects of microorganism (toxin) screening, selection of cryogenic (freeze-dry) protectants, facilities and equipment, storage methods, quality control, programmed cooling, storage, and recovery.

Development Information

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