Particle Measuring Systems Cleanroom Contamination Management Solutions
Particle Measuring Systems (PMS) provides technologies to detect, analyse and manage cleanroom contamination.
PMS specialises in sterility assurance, offering contamination monitoring solutions ranging from instruments to facility monitoring systems and training. The company’s services maintain data integrity and improve workflow.
With more than 60 patents, PMS’s technology improves process yield and complies with changing regulatory requirements. The company understands the challenges of the industry, as well as the latest technology.
Contamination monitoring systems for pharmaceutical manufacturers
PMS manufactures contamination monitoring systems and equipment, including portable particle counters for air, liquid and gas applications. Its advanced technologies and expertise are suitable for cleanroom manufacturing.
The company has a wide variety of solutions for International Standardisation Organisation (ISO) 5 (Grade A), ISO 5-6 (Grade B), ISO 7-8 (Grade C-D) cleanrooms. It monitors applications such as loading, filling, capping and lyophilisation, as well as sealing, product transfer and operator functions
Cleanroom technology is also suitable for sealing, material transfer, gowning, compounding and packaging applications.
Environmental monitoring solutions for pharmaceutical cleanrooms
PMS’s equipment is specifically designed for pharmaceutical environmental monitoring. The units have a robust system architecture that ensures critical data is always available when needed for batch release and reporting.
Devices are built using the supervisory control and data acquisition (SCADA) version of the GE Proficy® iFix and Historian platform. Redundancy and data buffering are performed throughout the system, which incorporates sensor-based time stamping when recording environmental data.
The system meets the requirements of Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 11.
Bacteria-monitoring software for cleanroom production
PMS’s software is designed to increase the efficiency of collecting and reporting data while reducing the number of errors present in captured data sets. Viable and nonviable information are integrated, and searchable using batch identifiers.
The company’s hardware and software modules make installation more efficient by simplifying upgrades and expansions.
PMS’s comprises standard configurable components, good automated manufacturing practice (GAMP) 5 Category 4 compliant software and a pre-built vacuum and power infrastructure (5010 series). It can easily be integrated with third-party software, offering remote access through client stations, web browsers and tablets.
PMS’ data solutions combine collection and management to create a complete contaminating monitoring solution for pharmaceutical manufacturers. This pre-configured, plug and play system makes connection fast and easy.
The company automates and refines processes to mitigate risk and reduce operator error.
About Particle Measuring Systems
PMS supports pharmaceutical manufacturers to maintain the sterility levels necessary for cleanroom production. Its experts advise clients on aspects such as non-compliance issues, setting up new processes and training employees.
The company’s training materials include application notes for products and equipment, as well as webinars, which highlight specific regulations, events and products. PMS also keeps a knowledge centre blog and holds workshops as part of its Particle College.
PMS has an ongoing dialogue with different regulatory agencies, which provides a consistent update of regulatory requirements.
Its services include data management, calibration, good manufacturing practice (GMP) cleanroom qualification and thermal validation, as well as risk assessment advisory service, validation and project services.
Products and Services
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.
MiniCapt® Mobile Microbial Air Sampler
Particle Measuring Systems' MiniCapt® Mobile is an innovative solution to microbial air sampling.
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.
FacilityPro® Environmental Monitoring Processor
The FacilityPro® Processor provides a central hub for an environmental monitoring system. The Processor communicates with cleanroom sensors, including particle and microbial monitors, while buffering data and checking tolerances for alarm activation.
Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements
Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which ensures the product's quality and public safety.
Sterility Assurance Applied to Stem Cell Therapies
In early 2019, the Centers for Disease Control and Prevention (CDC) reported bacterial infections after use of
stem cell products and are currently investigating the ReGen Series.
Revisions and Impact
The United States Pharmacopeia (USP) is a scientific non-profit organisation that sets standards used worldwide for the identity, quality, purity and strength of medicines, as well as food ingredients and dietary supplements
Efficiently monitoring microbial contamination in the cleanroom has become even more crucial over the recent years, specifically with the impending release of EU GMP Annex 1.Read more
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.Read more
Particle Measuring Systems reveals that the next Particle College will take place in Boulder, CO in September 2019.Read more
5475 Airport Blvd
Boulder, Colorado 80301
United States of America
Im Tiefen See 45
Via di Grotte Portella 34
00044 – Frascati