T/ZAPA 0001-2020 Clean pharmaceutical production facilities operation and maintenance technical specifications
T/ZAPA 0001-2020 Clean pharmaceutical production facilities operation and maintenance technical specifications
Basic Information
Scope
Main Technical Content: Technical Specifications for the Operation and Maintenance of Pharmaceutical Clean Rooms 1 Scope This standard specifies the general requirements, terms and definitions, daily maintenance of production areas, equipment operation and maintenance, and inspection technical requirements for the operation and maintenance of pharmaceutical clean rooms. It applies to the production and operation maintenance of pharmaceutical clean rooms and related enterprises. 2 Normative Reference Documents The following documents are essential for the application of this document. For dated reference documents, only the version dated on the specified date applies to this document. For undated reference documents, the latest version (including all amendment sheets) applies to this document. - GB/T 16292 - Test Methods for Suspended Particles in Pharmaceutical Clean Rooms (Areas) - GB/T 25915.3/ISO 14644-3 - Cleanrooms and Associated Controlled Environments - Part 3: Test Methods - GB/T 25915.9/ISO 14644-9 - Cleanrooms and Associated Controlled Environments - Part 9: Surface Cleanliness Classification by Particle Concentration - GB/T 29469 - Evaluation of Performance and Rationality of Cleanrooms and Related Controlled Environments - GB/T 36066 - Technical Analysis and Application of Body Measurement Technology in Cleanrooms and Related Controlled Environments - GB/T 36306 - Guidelines for Chemical Pollution Control in Cleanrooms and Related Controlled Air Environments - GB/T 36370 - Application Guidelines for Air Filters in Cleanrooms and Related Controlled Environments - GB/T 36372 - General Technical Requirements for Composite Enclosures in Cleanrooms and Related Controlled Environments - GB/T 33555 - Guidelines for Electrostatic Control in Cleanrooms and Related Controlled Environments - GB 50457 - Design Code for Pharmaceutical Industry Plants - GB 50591 - Construction and Acceptance Standards for Cleanrooms - ISO 14644-1 - Clea