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.

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Particle Measuring Systems

5475 Airport Blvd

Boulder, Colorado 80301

United States of America

+1 303 443 7100 www.pmeasuring.com

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Particle Measuring Systems

5475 Airport Blvd

Boulder, Colorado 80301

United States of America

+1 303 443 7100 www.pmeasuring.com

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