Continuous & Effective Microbiological Air Monitoring in Critical Environments
A Comparison of Microbial Analytical Methodologies
Manufacture of sterile products must strictly follow carefully established and validated analytical methods of manufacture and control. Based on this consideration, we evaluated scientific literature describing settle plates and active air sampler monitoring effectiveness. A contamination control strategy should be implemented by pharma manufacturers, especially for aseptic productions, to assess the effectiveness of environmental monitoring and demonstrate that the process is under statistical control. It is of key importance for microbiological monitoring data to correlate as best as possible with total particle monitoring data so that each batch release is reliably supported.
The full paper is published in the
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RELEVANT CONTENT
Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1
Thoughts on 2021 and Beyond from a Global Service Provider (Part 2 of 2)
Microbiological Plate Incubation and Pharmaceutical Risk Assessment
Potential Cleanroom Sampling Points per Annex 1 Draft (Part 4 of 5)
Three Core Events to Establish Environmental Contamination Control – Per EU GMP Annex 1
