Alarm Rationale For Continuous Particle Counting Systems

By Mark Hallworth, Life Sciences Regional Manager, Particle Measuring Systems

Many of us have grown accustomed to performing routine environmental monitoring with a cart of equipment that takes samples at predetermined cleanroom locations. We collect these particle counts and microbial burdens with portable particle counters, dynamic air-samplers and settle plates, and take surface samples to adhere to gowning protocols. This process occurs regularly based on guidance from industry with frequencies ranging from each shift, every day, once per week, or monthly depending on the associated risk to final product.

However, regulations require continuous particle monitoring in the most critical zones during production and prior to manufacturing, as this reflects a better demonstration of environmental control. This shift to continuous can yield an ocean of data. Rather than using a portable instrument to, for example, collect three one-minute samples at each selected and defined location, data is now a continuous stream flowing from the sensor to a centralized monitoring system. This document is a description of current good manufacturing practices (cGMPs) and how they can be applied to a continuous monitoring system installed within a facility.