This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It sets out the requirements for establishing and demonstrating a state of microbiological control in clean controlled environments, using both engineering controls and operational controls in a holistic manner.
This document is limited to viable microbiological contamination and excludes any considerations of endotoxin or prion contamination.
This document provides guidance for the determination of impact and need for microbiological control in common applications in cleanrooms and associated environments, including pharma/biopharma, medical devices, hospitals and food.
Recognizing that cleanrooms and associated environments can be used for many purposes, this document provides guidance regarding the following:
• performing an impact assessment regarding the potential detrimental effects of micro-organisms or types of micro-organisms on a product, process or service performed in a cleanroom and associated environment;
• considering sources of micro-organisms in cleanrooms and associated controlled environments including personnel, water, air, surfaces, raw materials, components, consumables, equipment, manufacturing processes and utilities;
• understanding the processes and routes of transfer as micro-organisms can originate from a number of sources and have different routes of transfer to locations where adverse impact can occur;
• identifying preventative actions to establish a state of control using facility design and engineering controls as well as operational controls such as personnel gowning, behaviour and cleaning and disinfection, to reduce the release of micro-organisms into the cleanroom and associate controlled environment and prevent their proliferation;
• development of a monitoring program as can be needed, and commensurate with the specific use and results of the impact assessment. The monitoring program can be applicable to engineering and process control features or biological assessments.
• documentation.
This document does not provide the following:
• requirements for prescriptive limits or levels of viable and culturable micro-organisms in a cleanroom and associated controlled environment;
• prescriptive requirements for an environmental monitoring program.
• requirements for alignment of microbial limits or levels associated with airborne particle classifications as described in EN ISO 14644-1;
• requirements on the possible presence of prions or microbiological the by-products of bacterial growth such as endotoxins/exotoxins.
