Particle Measuring Systems

Complete Contamination Control Solutions

5475 Airport Blvd, Boulder, Colorado 80301, United States of America

5475 Airport Blvd, Boulder, Colorado 80301, United States of America



Particle Measuring Systems (PMS) works with pharmaceutical manufacturers to provide complete contamination control for your clean manufacturing areas. We begin by consulting with our Expert Advisory Services team to perform a risk assessment on your area. We then provide our world-class non viable and viable particle counters, installation, validation and finally, complete data management and reporting; all from one supplier. The PMS team provides you with the expertise to help you meet regulatory requirements including ISO 14644-1:2015, EU GMP Annex 1 and we have complete 21 CFR Part 11 solutions.

As a leader in contamination control and a complete solutions provider, we offer fully integrated and robust monitoring solutions including:

  • Particle Counters and Microbial / Viable Samplers, remote and portable
  • Environmental and Facility Monitoring Systems
  • Data collection and Data Management(DM)

Additionally, our independent Advisory Services team provides an array of services, including:

  • Risk Assessments
  • Sample point location advice
  • Thermal Validations
  • Crisis Handling – 483 management and response
  • Training and education

PMS has broad and global experience with cleanroom environmental monitoring systems consisting of a few to hundreds of measurement points. We’re well versed in integrating data together from sources like differential pressure, temperature, relative humidity, airflow velocity and countless other process control devices. Our experienced team of experts provides trusted thought-leadership and training, including webinars, papers, and training (onsite or fully-remote options).

Facility Monitoring Systems (FMS)

An FMS with industrial control systems assures process automation and data integration with simplicity of use. Our FMS solutions help you maintain and better understand the data from your clean room environmental monitors. Particle Measuring Systems’ family of FMS Processors provide a central hub for a facility monitoring system. The Processor communicates with cleanroom sensors, including particle and microbial monitors, while buffering data and checking tolerances for alarm activation. As a key component of industrial automation architecture, this embedded system offers high reliability as it controls samples and communicates with central software. A complete FMS system includes particle counters, microbial monitors, and various facility EM sensors. Particle Measuring Systems provides you with the equipment, software, installation and industry experts to detect, analyze, and control cleanroom contamination.

Contamination Monitoring Systems for Pharmaceutical Manufacturers

PMS’s equipment is specifically designed and manufactured for pharmaceutical aseptic and cleanroom environmental monitoring. The units have a robust system architecture that ensures critical data is always available when needed for batch release and reporting. This is achieved using Facility Monitoring Systems with fixed and portable particle and microbial counters for air, liquid and gas applications. Including worldwide-compliant, industry-leading data and process management software.

PMS has modular and standalone solutions for cleanroom environmental contamination monitoring for ISO Grades: 5 (Grade A), ISO 5-6 (Grade B), and ISO 7-8 (Grade C-D) cleanrooms. Additionally, we have broad experience in monitoring applications such as loading, filling, capping, lyophilization, sealing, product transfer, operator functions, material transfer, gowning, compounding and packaging applications.

Viable Monitoring Solutions for Pharma & Biopharma Manufacturing

Data from an Environmental Monitoring (EM) program gives you a picture of how well your aseptic and clean areas are maintained. The viable environmental monitoring data is as critical to EM control as the non-viable data.

To achieve compliance with regulatory guidance, a microbial / viable monitoring program includes the following components:

  • Active air monitoring (room or enclosure environment)
  • Passive air monitoring (settle plates)
  • Surface monitoring (contact plates and swabs)
  • Personnel monitoring (gloves and garments)
  • Compressed gases
  • Materials and equipment that could compromise product microbiological quality
  • Understanding the cleaning and sanitization process

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

Helping our customers meet regulatory requirements

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 14644, ISO 14698 and worldwide (c)GMP’s 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, all to worldwide regulatory requirements.

Advisory Services

Particle Measuring Systems’ team of experts is ready and available to support you at every step whether it be non-compliance issues, setting up a new process, GAP Analysis, or training employees. Our Expert Advisory Services offer experienced insight on many topics surrounding:

  • Cleanroom Contamination Control
    • Design & risk analysis
    • Cleaning and disinfection best practices
    • Process risk assessment
    • Aseptic process simulation
    • Audit management
  • Providing equipment and services for monitoring your clean areas from one source
    • Remote & portable viable monitoring equipment
    • Remote & portable non-viable monitoring equipment
    • Compliant data management software
    • FMS designed specifically for Pharmaceutical industry needs
  • Contamination control training
    • Quality Risk Management
    • Aseptic Process Simulation
    • Compliance

Lasair® III Air Particle Counter

The Lasair III particle counter is versatile enough for mobile or remote use for a wide variety of cleanroom monitoring requirements and meets International Standardisation Organisation (ISO) 14644-1:2015 and ISO 21501-4.

APSS-2000 Liquid Particle Counting System

The APSS 2000 liquid particle counting system sizes and counts particles in liquids, including parenterals. This solution meets all US, European and Japanese pharmacopoeia standards, including USP 788.

BioCapt Single Use Microbial Impactor

An improvement and replacement for your old settle plates, the BioCapt® Microbial Impactor essentially eliminates false positives for microbial activity in your cleanroom by removing contamination that occurs during the handling of agar settle plates. This huge decrease in contamination from your sampler means a decrease in investigations while increasing productivity for you.

Airnet® II Particle Sensors

The Airnet II Air Particle Sensor meets the specifications of ISO 21501-4 to measure the size and number of particles suspended in the air for real-time monitoring of defect-causing particles.

Contamination Control Advisory Services

Particle Measuring Systems’ team of experts is ready and available to support you at every step whether it be non-compliance issues, setting up a new process, GAP Analysis, or training employees.

PMS Expanded Solutions

PMS has an ongoing dialogue with different regulatory agencies, which provides a consistent update of regulatory requirements.

20nm Syringe Sampler Release

Particle Measuring Systems is pleased to announce the release of the SLS 20 Syringe Liquid Sampler to be used in conjunction with the Chem 20™ Particle Counter.

Environmental Monitoring Course on 22-23 April

GMP Academy, Environmental Monitoring Course is a two-day course led by industry experts, taking place on 22-23 April at Open Biopharma Research & Training Center Carlsbad, CA.

Particle Measuring Systems Announces Distribution Agreement with BD

Particle Measuring Systems (PMS) recently announced a distribution agreement with BD (Becton, Dickinson and Company) (NYSE: BDX), giving the medical technology company non-exclusive rights to distribute Particle Measuring Systems’ MiniCapt® Mobiles and BioCapt® Stainless Steel Impactors globally.

Particle Measuring Systems

5475 Airport Blvd

Boulder, Colorado 80301

United States of America

+1 303 443 7100 www.pmeasuring.com
Germany Office

Im Tiefen See 45

64293 Darmstadt

Germany

+49 6151 6671 632
Italy Office

Via di Grotte Portella 34

00044 – Frascati

Italy

+39 06 9053 0130
Denmark Office

Korskildelund 6

2670 Greve

Denmark

+45 7070 2855
Switzerland Office

Reinluftweg 1

9630 Wattwil

Switzerland

+41 71 987 01 01
Austria Office
+43 512 390 500