Microbial environmental monitoring programs are used by pharmaceutical and medical device manufacturers in the evaluation of cleaning and disinfection procedures and to assess the microbial cleanliness of a manufacturing environment. The programs are used to control microorganism levels in the manufacturing environment to minimize the bioburden on the item that is manufactured. Environmental monitoring programs are implemented in cleanrooms, manufacturing plants, packaging facilities, testing laboratories, and other areas where microbial and particulate control are critical to the quality of operations and production, such as medical device manufacturing and packaging, sterile and aseptic production and fill environments, and sterile and aseptic product primary and secondary packaging areas.
Air and surface samples are taken during production to obtain a microbiological profile of the manufacturing environment. Additional observations of work practices are also made during the survey. The data are evaluated to determine any actions that might be taken to reduce or stabilize the bioburden of the medical product or production area.
Programs may include viable and nonviable air monitoring, cleaning effectiveness, equipment monitoring, surface monitoring, disinfectant efficacy, gowning and personnel monitoring, compressed air testing, compressed gas testing, water system validation, and water system monitoring.
New facilities, new programs, construction areas, adjacent areas, post-construction areas, and/or change control, typically warrant a risk assessment and program design which may include evaluation of:
- baseline bioburden and particulates (often including seasonal trending)
- identification of organisms across the baseline sample
- process, procedure, and practice
Once a comprehensive evaluation is conducted, a program is typically implemented with a defined frequency and specifications established either by regulatory requirement or trending data.
USP <1116> – Microbiological Evaluation of Clean Rooms and other Controlled Environments
PDA TR 13 – Fundamentals of a Microbiological Environmental Monitoring Program.