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Application Note

Microbial Monitoring Solutions for Aseptic Processing Cleanrooms

Aseptic processing cleanrooms and associated controlled environments provide the control of contamination (particle and microbial) to levels appropriate for accomplishing contamination-sensitive activities.

Microbial monitoring, including all Environmental Monitoring (EM), particularly in Pharmaceutical manufacturing facilities, includes both particle counters and microbiological test methods. It is a common assumption that if fewer total particles are present in a cleanroom, it is less likely that airborne microorganisms will be present. However, it is not possible to clearly distinguish between background total particulate contamination generated largely by mechanical operations and the total particulates contributed by personnel. Thus, it is routine for cleanroom environmental monitoring programs to consist of both particle counting and microbial monitoring components.

molecular contamination monitoring

The data originated from these cleanroom monitoring components provide critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.

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Looking for a an environmental monitoring solution? Only Particle Measuring Systems (PMS) has a wide range of solutions to meet all your needs:

  • Particle counters, portable and remote
  • MiniCapt Active Air Samplers available in a variety of portable or remote models
  • BioCapt Impactors available as a single use solution or stainless steel
  • Environmental motoring software
  • Data management solutions
  • Advisory services

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.

RELEVANT CONTENT

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

The Antibacterial MiniCapt® Mobile – For Best-in-Class Microbial Contamination Monitoring

Compressed Gas Microbial Contamination Monitoring & Contamination Control Strategy

Microbial Environmental Monitoring: Managing Auditor Expectations

Electronic Data in Pharmaceutical Manufacturing: Real-Time Microbial Monitoring (Series Part 6 of 6)

USP and Its Implications for Measuring Microbial Recovery Rates

Table of statistical corrections according to Feller for the BioCapt® Microbial Impactor in microbial air sampling

Statistical Corrections Microbial Monitoring in Grade C/D Cleanrooms

 

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5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
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Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • BioCapt® Certificate of Analysis (CofA)
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP<788> Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates
  • 21CFR 11

Service & Support

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Education and Training

  • PMS™ Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility, Sustainability, Health & Safety
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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