Microbiological Monitoring

Microbial Environmental Monitoring of Clean-room

Non- accredited methods

The level of microbial contamination inside cleanroom must comply with the requirements appropriate for cleanliness class in acc. with Good Manufacturing Practice. Annex 1: Production of sterile medicinal products.

The obtained results allow determining the level of microbiological purity of the air, buildings, equipment, surfaces, clothes and personnel to define sampling points and determining the frequency of checks.

Standard:

  • Good Manufacturing Practice,
  • ISO 14644-1
  • ISO 14698-1

 

Method:

  • Active Air Sampling – volumetric method
  • Passive Air Sampling – gravimetric method (Settle Plates)
  • Contact Plates
  • Swab

If is necessary we can perform Identifications of Microorganism.

 

Analysis of trends

At the customer’s request, 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.