Clean Room Biocontamination Tests

In clean rooms designed for the production of health products, the number of viable particles or microorganisms is allowed in the filtered air and on the surfaces within the scope of certain acceptance criteria. The number of viable particles suspended in the air in these environments should be determined by measuring passive and active air.

In addition, the microbiological load should be checked for contamination on clean room and equipment surfaces and contamination from personnel. Operations are carried out based on EN 17141 and ISO 14698 standards.

Although the clean room classification is made according to the amount of solid particles, the number of microorganisms is also taken into account as a GMP requirement. In the production of medical products, especially product biological load limits are closely related to clean room microbiological acceptance criteria.