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Application Note

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 PDA Journal of Pharmaceutical Science and Technology, July/August 2020.

Download the full paper here.

Looking for an effective continuous microbial air monitoring solution? Check out the BioCapt® Single-Use Microbial Impactor, the innovative replacement for settle plates. Full specifications and a testimonial from our experts are available by filling out the form on this page.

 

 

Fill out the form on the right to learn about the BioCapt Single Use Microbiological Impactor for a continuous and effective monitoring solution

RELEVANT CONTENT

Data Trending Requirements Annex 1, Rev 12

Virtual Demo: Antibacterial MiniCapt® Mobile Microbial Active Air Sampler from Particle Measuring Systems

Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1

The New Normal & Data Integrity eSignatures

 

Single Use in Pharmaceutical Manufacturing

Thoughts on 2021 and Beyond from a Global Service Provider (Part 2 of 2)

Continuous Viable Air Monitoring per Annex 1 Draft, Rev 12

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

 

 

Learn about the BioCapt Single Use Impactor

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Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Industrial Manufacturing

Applications

  • ISO 21501-4
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates

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  • Customer Service

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About Us

  • Contact Us
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  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility, Sustainability, Health & Safety
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems- DK

Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

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