On Demand Webinar

The New EU GMP Annex 1 Revision 2017: Review, Insights, and Feedback

Learn more or

Download Now

Microbial Viable Contamination Monitors

TYPE:

SAMPLING ENVIROMENT:

APPLICATION:

METHOD:

FLOW RATE:

Particle Measuring Systems (PMS) has been the global leader in cleanroom contamination monitoring for over 40 years. We are the only provider giving you complete monitoring instruments and services to meet pharmaceutical industry requirements. Our microbial 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
  • Growning
  • 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. 

MiniCapt® Mobile Microbial Air Sampler

Sensitivity: 1 cfu

The innovative solution to microbial air sampling. ISO 14698:2003 compliant

Take a closer look

MiniCapt® Mobile Microbial Air Sampler

BioCapt® Single-Use Microbial Impactor

Sensitivity range: 1 cfu

 

This innovative approach provides 24 hr sampling, and minimizes false positives, resulting in a decrease in investigations.

Take a closer look

BioCapt® Single-Use Microbial Impactor

BioCapt® Microbial Impactor

Sensitivity range: 1 cfu

Enables the capture of microbiologically viable particulates on a suitable media surface for later incubation and enumeration.

Take a closer look

BioCapt® Microbial Impactor

MiniCapt® Remote Microbial Air Sampler

Sensitivity range: 1 cfu

HEPA-filtered exhaust =no cleanroom contamination

Uses a unique HEPA-filtered exhaust so it doesn’t contaminate the cleanroom.

Take a closer look

MiniCapt® Remote Microbial Air Sampler

BioLaz® Real-Time Microbial Monitor

Sensitivity range: 0.5 - 50 µm

Provides real-time detection of biological organisms in controlled environments used for the manufacture of sterile products.

Take a closer look

BioLaz® Real-Time Microbial Monitor

SurCapt™ Microbial Surface Detection

Sensitivity range: 1 cfu

An all-inclusive, ready-to-use rapid microbial surface detection system. Reduces the likelihood of sample contamination and mishandling.

Take a closer look

SurCapt™ Microbial Surface Detection

No Products Found.

loading