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.
Particle Measuring Systems
5475 Airport Blvd.
Boulder, CO 80301
Contact: Nina Morton
Environmental monitoring should be performed using suitable techniques that meet the needs of the risk assessment. Learn about environmental monitoring requirements, features typically included in instrumentation, and more.
Explore the fundamentals of particle counting and cleanroom designs, standards applicable to production areas, expectations of regulatory bodies governing release to market, required instrumentation and techniques, and more.
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.
Discover how an effective approach to risk management can further ensure delivery of a high quality drug or medicine to the patient.
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.
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.
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.
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.
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.
In our recent webinar many thoughtful questions were asked that concern how compliance with the latest regulation changes can be met, the requirements for passive monitoring, and the industry applications affected. Here we answer questions submitted after the webinar regarding active air and settle plates, rapid micro methods, and specific applications.
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.
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.
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.
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.
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.
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.
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.
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.
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.
- Pharma 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