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Particle Measuring Systems
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Microbial Monitors

Active Air Samplers, Impactors: Remote & Mobile; Single Use Option

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Microbial Contamination Monitors

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Particle Measuring Systems (PMS) has been the global leader in cleanroom contamination monitoring for over 45 years.

We are the only provider giving you complete monitoring instruments and services to meet pharmaceutical industry requirements. Our microbial monitoring instruments help you effectively meet regulations including ISO 14698 and (c)GMP, such as EU GMP Annex 1. We provide a complete line of remote and portable solutions, including single-use devices, to help you monitor air and surfaces in Grade A/ ISO 5, B/ISO 5-6, and C-D/ISO 7-8 environments.

Microbiological active air samplers are an essential component for compliance with  ISO 14698.   When choosing an active air sampler, the ISO 14698 Section 5.3.2.2 lists all factors that should be considered for the optimal instrument.  PMS’ active air samplers meet ALL ISO 14698 recommendation factors including:

  1. Type of viable particles for which to sample
  2. Sensitivity of the viable particles to the sampling procedure **
  3. Expected concentration of the viable particles
  4. Indigenous microbial flora
  5. Accessibility of the risk zones
  6. Ability to detect low levels off biocontamination
  7. Ambient conditions in the risk zone being sampled
  8. Time and duration of sampling
  9. Sampling method, material, and properties of the sampling medium
  10. Effect of the sampling device on the process or environment to be monitored **
  11. Collection accuracy and efficiency
  12. Incubation and viable particle detection and evaluation method
  13. Type of information to be obtained (e.g.: qualitative or quantitative aspects)

** The only solution that meets all of the regulatory guidelines.

What Are the Benefits of our Active  Air Samplers?

Active air samplers are beneficial because they allow a user to sample a quantitative amount of air and determine the risk for contamination. When active air sampling is performed continuously during the entirety of a process, a manufacturer will have more confidence in the surrounding environment:

  • settling plates in critical environment results are not validatable and will not give reliable results
  • Active air samplers can be used to understand what contaminants (microbial flora) may be in the surrounding atmosphere and impose a risk to your sterile product.
  • With the results of continuous active air sampling, the customer can understand the total risk of culturable microorganisms in the in released product.

Active Air Sampler Applications

Get the results you need to meet regulatory requirements in a wide variety of applications and environments including:

Applications

  • Cleanroom qualification
  • Cleanroom Monitoring

Areas of interest

  • (Aseptic) preparation
  • (Aseptic) Filling
  • Capping
  • Lyophilization
  • Sealing
  • Product Transfer
  • Material Transfer
  • Gowning
  • Compounding
  • Packaging
  • Sterility testing

Industry standards are addressing a lack of microbial monitoring and increasing guidelines to ensure better environmental monitoring. Get your  solutions developed by industry experts to ensure you are positioned for increased production with fewer excursions and positive audit results.

Contact us today for more information on how we can help you with your application.

Remote Microbial Air Sampler: MiniCapt® Pro

Annex 1 compliant, self-contained, remote microbial air sampler
Sensitivity: 1 CFU

Annex 1 compliant, remote Microbial Air Sampler with installation flexibility and easy integration into Environmental Monitoring Systems

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Remote microbial air sampler

Microbial Air Sampler: MiniCapt® Mobile

Sensitivity: 1 cfu

This active air cleanroom microbial air sampler is EU GMP Annex 1 and ISO 14698:2003 compliant.

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Microbial Monitor: BioCapt® Single-Use

Sensitivity range: 1 cfu

This cleanroom microbial monitor is an innovative replacement for settle plates. In combination with an active air sampler, it provides Annex 1 compliant 2-hour sampling, and minimizes false positives, resulting in a decrease in investigations.

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Remote Air Sampler: MiniCapt®

Sensitivity range: 1 cfu

Annex 1 compliant, remote microbial air sampler uses a unique HEPA-filtered exhaust to reduce contaminate introduction to your cleanroom.

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Viable Cleanroom Monitor: BioCapt® Impactor

Sensitivity range: 1 cfu

Viable cleanroom monitor enables the capture of viable particles on a suitable media surface for later incubation and enumeration.

Take a closer look

BioCapt® viable cleanroom monitor

Compressed Gas Kit

Compressed Gas Kit for Viable Particulate Monitoring

The Compressed Gas Kit works with the Minicap Mobile instrument to provide reliable viable contamination monitoring for process gases.

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Products

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  • Software / Data Management

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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:

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 Environmental Monitoring Solutions for Your Contamination Control
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • PMS™ Knowledge Center
  • Particle College
  • 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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