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Microbiological environmental monitoring

Microbiological environmental monitoring describes the microbiological testing undertaken in order to detect changing trends of microbial counts and micro-flora growth in critical or controllled environments areas like cleanrooms, laminar flow hoods, biological safety hoods, isolators, intravenous compounding areas and sterile packaging.

The results obtained provide information about the performance of heating, ventilation, the physical construction, air-conditioning system, gowning practices, equipment, personal cleanliness and cleaning operations.

Bioburden

Environmental monitoring methods

  • Water sampling
  • Active air sampling
  • Passive air sampling
  • Surface monitoring with contact plates (RODAC) or Swabbing method

Sampling locations

The sampling locations shoud be based on risk of microbiological contamination. They also should be clustered around areas where product or components are exposed e.g.

  • Where aseptic connections are made
  • Where there are high levels of operator activity
  • At filling heads on filling lines
  • Stopper bowls

 

Bioburden

Any questions about environmental monitoring ? Please feel free to contact us.