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Application Note

Compressed Gas Microbial Monitoring in Aseptic Manufacturing

Microbial Survival in Compressed Gases Under Fast Decompression to Normal Atmospheric Conditions

Compressed gas microbial monitoring in aseptic manufacturing presents particular challenges. The FDA guideline for the manufacturing of sterile products using aseptic processes specifically mentions that a compressed gas should be of appropriate purity (e.g., free from oil) and its microbiological and particle quality after filtration should be equal to or better than that of the air in the environment into which the gas is introduced.

Compressed Gas Microbial monitoring in aseptic manufacturing from Particle Measuring Systems (PMS)

Additional guidance on cleanroom or clean air monitoring and limits of particulate and microbial contaminants in the pharmaceutical industry is provided in EU GMP Annex 1 20082 , and the USP chapter 11163 . A more specific reference is ISO 8573, a group of international standards relating to the quality (or purity) of compressed air. The standard consists of nine separate parts, with part 1 specifying the quality requirements of the compressed air4 and parts 2 – 9 specifying the methods of testing for a range of contaminants. The test method for microbial monitoring of compressed gases is provided in ISO 8573-75 .

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Looking for a microbial monitoring solution? Particle Measuring Systems (PMS) has a wide range of portable and remote microbial viable samplers including:

  • MiniCapt Active Air Samplers available in a variety of portable or remote models
    • use with the compressed gas kit
  • BioCapt Impactors available as a single use solution or stainless steel

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T: +41 79 261 67 41
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Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt®Certificates of Analysis
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

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  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing

Service & Support

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About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems- EN/CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

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