T/CAB 0389-2024 Biological aerosol monitoring and disposal system application technical procedures - Part 3: Cleanroom in pharmaceutical industry

Scope

Scope: This document specifies the general requirements for the biological aerosol monitoring and disposal system in pharmaceutical industry cleanrooms, including the requirements for monitoring, sampling, disinfection and disposal, as well as operation and maintenance and management requirements. It also describes the system's operation and application process. This document is applicable to the monitoring, alarming, and disposal of biological aerosols in pharmaceutical industry cleanrooms. The monitoring and disposal of biological aerosols in sterile rooms and centralized medication preparation centers can be implemented with reference to this document. Main technical content: This standard, based on the current and future development needs of biological aerosol monitoring technology and focusing on the key aspects of pharmaceutical industry cleanrooms, highlights the new monitoring technologies adopted by the biological aerosol monitoring and disposal system, such as laser-induced fluorescence-based monitors, which enable real-time monitoring and rapid response. It clarifies the operation process of the monitoring and disposal system to ensure that the monitoring of biological aerosols in pharmaceutical industry cleanrooms can be standardized and unified. Chapter 1: Scope. Specifies the scope of application of the standard. Chapter 2: Normative references. Compiles the main standards referenced in the preparation of the standard, providing a list of referenced standards to fully ensure the enforceability and feasibility of the standard provisions. Chapter 3: Terms and definitions. Explains important terms in the standard to enhance understanding, defining cleanrooms, pharmaceutical industry cleanrooms, microorganisms, biological aerosols, and spores. Chapter 4: General requirements. Specifies personnel requirements, equipment requirements, and monitoring and disposal project requirements, clearly defining the system and its components and specifying the monito

Development Information

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