Monitoring the environment for non-viable particulates and microorganisms is an important control function in achieving product compendial requirements for 1) Foreign and Particulate Matter; and 2) Sterility. 1

Particle Monitoring to Meet USP 797 Compliance (Non-Viable) The Parenteral Drug Association (PDA) issued a recommendation 1 for routine monitoring for all Aseptic Grade areas using portable particle counting devices.

Regulatory Guidance and Limits for Monitoring (NVPC) Non-Viable Particle Counts: USFDA and EUGMP Standards. Regulatory authorities such as the US Food and Drug Administration (USFDA) and the European Union Good Manufacturing Practice (EUGMP) provide guidelines and limits for non-viable particle monitoring in the pharmaceutical industry.

We recommend using a particle counter that is backed by manufacturer support, sets industry standards, and leads innovation. For air samplers, that’s the ActiveCount100H. This air sampler has a HEPA filtered exhaust and a d50 collection efficiency of 1 micron.

Increased regulatory focus on reducing use of portable, human-operated, particle counters in favor of permanently installed, online, computer-controlled particle counters. Reduces need for operator presence in Grade A to place probes and take samples.

The MET ONE 7000 provide high accuracy non-viable particle monitoring for cGMP/FDA compliance. Stainless steel wash-down resistant enclosure and VHP tolerant optics protect the instrument while ISO 21501 certified calibration assures accurate continuous monitoring in aseptic and sterile pharmaceutical production environments.

By detecting and counting particles of varying sizes, non-viable aerosol particle counters help monitor and manage the concentration of particulate matter in a clean room, ensuring that it remains within the specified limits to prevent contamination and ensure product quality and safety.

Monitoring can now be controlled remotely from outside the aseptic area, or it can be accomplished by Production staff using a simple, error-free, single-button process that controls the particle counters and defines the workflow.

“With modern laser-based portable particle counters, real-time analysis of daily non-viable particle counting at a variety of critical locations is simple and inexpensive. Viable particle counts, although similarly automated, use costly culture media and …

Jun 3, 2023 · A non-viable particle counter is a device used to measure and monitor the concentration of airborne particles that are not capable of reproducing or growing, typically referred to as non-viable particles.