The level of microbial contamination inside a cleanroom must comply with the requirements of the Good Manufacturing Practice. Annex 1: Production of sterile medicinal products. The results determine the level of microbiological purity of the air, buildings, equipment, surfaces, clothes and personnel which define sampling points and the frequency of checks.

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Microbial Environmental Monitoring Of Clean Manufacturing Areas/Cleanrooms

Standard:

Good Manufacturing Practice,
EN PN ISO 14644-1
EN ISO 14698-1
PN ISO 18593

Method:

Active Air Sampling – volumetric method
Passive Air Sampling – gravimetric method (Settle Plates)
Contact Plates
Swabs
Testing time 10 days

If necessary we can perform Identifications of Microorganisms.

Analysis of trends
If required the laboratory may perform an analysis of trends and present the results yearly / half-yearly / quarterly in the form of Trend Analysis Report of Microbiological Monitoring.

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Microbial Environmental Monitoring Of Clean Manufacturing Areas/Cleanrooms

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