ABOUT PARTICLE MEASURING SYSTEMS
Particle Measuring Systems (PMS) provides Pharmaceutical aseptic and controlled manufacturing customers with the superior knowledge, technology, quality, and service you need to successfully meet global regulatory requirements and manufacture your product to the highest quality possible. Partnering with our customers, we provide a complete contamination monitoring solution. Starting with our Advisory Services team to assess risk, then collecting data with our world-class viable and non viable particle counters, through to compliant data management, analysis and reporting. We have the expertise to help you meet global regulatory requirements and get your product to market. As one of the world’s leading clean room contamination control experts and complete solutions provider, we offer fully integrated and robust monitoring solutions including:
- Particle Counters and Microbial Samplers, portable and remote
- Environmental and Facility Monitoring Systems (FMS)
- Data collection and fully compliant data management
Additionally, we offer a wide variety of expert Advisory Services including:
- Sampling locations
- Risk Assessments – avoiding 483’s
- Thermal Validations
- Crisis Handling – 483 management and response
Founded 50 years ago, PMS is a trusted thought-leader in the Pharmaceutical clean manufacturing and other Life Science industries. Our team provides multiple webinars, papers, and training throughout the year to support professionals and cleanroom manufacturers with reliable guidance on the application of and compliance to global regulations.
FEATURED PRODUCTS
The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).
Innovative new portable particle counter meeting all regulatory requirements.
The MiniCapt® Mobile Microbial Air Sampler from Particle Measuring Systems (PMS) is an innovative, light and mobile viable sampler. It simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data.
Facility Monitoring System with industrial control systems assures data integrity, process automation, simplicity of use, and data integration.
The APSS-2000 Liquid Particle Counter for USP 788 sizes and counts suspended particulate matter in a wide range of liquids, including parenterals, to meet all current U.S., European and Japanese Pharmacopoeia standards. When it comes to particle monitoring quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste.
Viable, Non Viable and Environmental Monitoring Software.
The BioCapt® Single-Use Impactor secures the process, product, and ultimately the patient by avoiding contamination risks.
A compact, user-friendly variable channel remote particle counter. Designed for minimum downtime and multiple option flexibility.
Monitor your viable and non-viable particles according to the most recent regulatory requirements. Count, report, document and manage your pharmaceutical environmental monitoring data meeting 21 CFR Part 11 data integrity requirements.
The MiniCapt® Remote Air Sampler features modern, easy to use data and sample configuration management by integration with a FacilityPro® system.
A simple and cost-effective way to monitor your cleanroom, the Airnet II Air Particle Sensor provides unparalleled performance with data transmission capabilities for remote monitoring.
The top Data Collection and leading Data Management companies combined to create a complete contamination monitoring solution for pharmaceutical manufacturers.
FacilityPro® Cleanroom Software by Particle Measuring Systems provides the interface, data management, and reporting for an environmental monitoring system. FacilityPro’s ability to manage viable, nonviable, and environmental data through a common system improves the efficiency of production operations and quality investigations.
Particle Measuring Systems partners with companies in the Pharmaceutical industry as a complete contamination monitoring solutions provider. Starting with our Advisory Services team, then collecting data with our viable and non-viable, particle counters, through to complete validation, data management and reporting. We have the expertise to help you meet regulatory requirements including ISO 14644-1:2015 and EU GMP Annex 1 to get your product to market.
The Lasair® III Aerosol Mobile Particle Counter minimizes operator errors with intuitive recipe configuration and meets ISO 14644-1/2:2015, ISO 21501-4, EU-GMP.
The BioCapt® Microbial Impactor meets regulatory requirements - remote sampling and ISO 14698-1/2 compliance.
The Airnet® II Particle Sensor is part of an automated monitoring system reducing manpower that provides consistent location monitoring.
A compact, VHP resistant remote particle counter.
As part of a facility monitoring solution, the IsoAir® Pro-E Remote Particle Counter from Particle Measuring Systems (PMS) is an effective piece of a Contamination Control Strategy using the latest technologies to streamline cleanroom monitoring while meeting global regulations including EU GMP Annex 1, ISO 14644-2, and part of a 21CFR Part 11 solution. This remote particle counter has all the features you need for reliable particle monitoring in your clean area are built into a simple but powerful package.
The Lasair® III 110 Airborne Particle Counter is a laser diode-based true 0.1 micron (μm) particle counter with 1.00 CFM flow rate. It provides real-time measurement of yield-impacting particles with three configurations to meet your unique application needs. Part of the series of cleanroom particle counters from Particle Measuring Systems.
The Lasair® III Cleanroom Particle Counter is designed with your unique needs in mind. It sets the standard for portable aerosol particle counters in highly regulated environments, so you can make sure your environment is clean.
CONTACT INFORMATION
Particle Measuring Systems
5475 Airport Blvd.
Boulder, CO 80301
UNITED STATES
Phone: 303-443-7100
Contact: Nina Morton
FEATURED ARTICLES
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![Cleanroom GettyImages-184293451]( "ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments")
Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.
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![Scientists In Cleanroom GettyImages-1341292033]( "Designing An Environmental Monitoring Solution For cGMP Manufacturing")
Environmental monitoring in cleanrooms should be performed using suitable techniques that meet the needs of the risk assessment. Learn about the requirements, typical instrumentation features, and more.
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![Environmental Monitoring GettyImages-1134998410]( "Environmental Monitoring Handbook For Pharmaceutical Manufacturers")
Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting and cleanroom designs, regulatory expectations regarding market release, and more.
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![Pharma Manufacturing GettyImages-487201181]( "Review Of Annex 1 2022: Environmental Monitoring Changes")
We highlight the changes to the new revision of the EU GMP Annex 1 regulatory standard for sterile drug products that was released in August 2022.
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![Risk GettyImages-519706040]( "Risk Assessment As A Process Quality Assurance Tool")
Discover how an effective approach to risk management can further ensure the delivery of a high-quality drug or medicine to the patient.
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![Data Artificial Intelligence Algorithm iStock-1295900106]( "A New Challenge For Quality Experts – The Data Quality Concept")
Quality experts are facing the challenge of rethinking their roles and redesigning the quality systems of their pharmaceutical companies to be based on the concepts of data quality.
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![Laboratory scientist ipad GettyImages-1293773576]( "USP <1788> Methods For Determination Of Subvisible Particulate Matter Revision Overview FAQs")
Thoughtful questions regarding how the USP <1788> revision expands the scope of testing requirements to include newly viable technologies such as flow imaging and new therapeutic protein solutions.
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![Staphylococcus microbes GettyImages-502707109]( "Study Of Single Use Device Media Dehydration And Biological Recovery Efficiency")
In this study, we review the performance of collecting contamination from continuous three-hour samplings using the BioCapt® Single-Use under unidirectional airflow, at 22 °C with 48% relative humidity.
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![iStock-1219894348-cleanroom-PPE-lab-team]( "An Analysis Of Acceptable Particle Losses In Tubing")
This paper addresses the various forces, the losses, and what are the acceptable results to allow for a better understanding what is acceptable particle loss in tubing.
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![magnifying glass w pills 450x300]( "A Review Of USP <1788> Methods For Determination Of Subvisible Particulate Matter")
A recent revision to the USP 1788 Methods for Determination of Subvisible Particulate Matter was published to aid in clarification and support of the information given in various chapters. With the advent of flow imaging technologies and new therapeutic protein solutions, the scope of the document was widened. Here we explore the applicability methods, particle count limits, test method influences and more.
WEBINARS
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![Compliance GettyImages-1212446127]( "Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques")
Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.
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![ISOEN]( "ISO EN 17141 & ISO 14698 Overview")
This webinar provides insight to the new standard for microbiological monitoring and control, ISO/EN 17141, and how it harmonizes with ISO 14698 parts one and two.
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![USP17882022 Revision Summary]( "USP<1788>2022 Revision Summary")
Review the latest revisions to the USP<1788>, which has expanded to support a holistic view of finished product contaminants, how they should be investigated, and added flow imaging technologies.
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![Understanding ISO]( "Understanding ISO 21501-4 – Particle Counter Calibration")
In this webinar we review how to be compliant with the most recent particle counter calibration requirements, particle counter terminology, and how a particle counter works in theory.
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![Validation Of 4-Hour Active Sampling Using BioCapt Single Use]( "Validation Of 4-Hour Active Sampling Using BioCapt Single Use")
Learn how the BioCapt® Single Use microbial impactor for cleanroom monitoring satisfies the requirements of new EU GMP Annex 1 and is an efficient device under stress conditions.
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![Intelligent Automation AI]( "Leveraging Microbial Contamination Monitoring Data For Actionable Insights To Meet And Exceed The Auditor’s Expectations")
Modern pharmaceutical manufacturers are already generating and managing big data from environmental monitoring; the next step is to create actionable insights and ensure 21CFR11 compliance. This webinar discusses data collection, 21CFR11 data management and the generation of actionable insights.
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![Particle Measuring Systems 5]( "Viable Monitoring Solutions: Prepare Your Contamination Control Strategy (CCS) For EU GMP ANNEX 1")
The New Annex 1 has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems (PMS) experts focuses on the Viable/Microbial Air Monitoring aspects.
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![Particle Measuring 3]( "Data Quality - The Journey Of The Data Management Life Cycle")
Sometimes we focus on data while forgetting how poor practices, bad decisions, incorrect definitions, and lack of evaluations effect the outcome. In this webinar, we analyze how to go from “data” to “data quality” to improve your overall contamination control strategy.
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![Particle Measuring 2]( "Replacing Settle Plates With Active Air Sampling")
Settle plates are a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We discuss the using active air sampling versus passive air settle plate monitoring in routine environmental monitoring.
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![Particle Measuring 1]( "Considerations & Steps For Building A Contamination Control Strategy (CCS)")
Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy.
PODCASTS
- Manufacturing Contamination Control Strategy And Risk Assessment
- Environmental Risk Assessment: PQ Systems And Tools
- Facility Monitoring Systems (FMS) vs. Building Management Systems (BMS)
- Tackling Viable And Non Viable Isolator Manufacturing
- Continuous Viable Air Monitoring For EU GMP Annex 1
- Risk Assessment When Setting Microbiological Monitoring Conditions
- Working Towards NetZero Emissions In Pharma Manufacturing