Microbiology: Environmental Monitoring
Environmental monitoring of cleanrooms or controlled environments is a critical process. By monitoring the manufacturing environment from a microbial perspective, reduces the risk of possible sterilization failures.
The control of microbial contamination in controlled areas is expected to meet the requirements of ISO 14698. The microbiological monitoring includes passive air monitoring using settle plates, monitoring of the surfaces and garment using contact plates and analysis of water and detergents.
Microbiology: Bioburden Testing
Bioburden testing is performed on medical devices prior to sterilization to determine the number of micro-organisms on the product, according to ISO 11737. A validated method must be performed, setting warning and action limits from where routine monitoring is performed and re-validated.
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