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Pharmaceutical Manufacturing and Packing Sourcer

Particle Monitoring and Control

The control of airborne, non-viable particles is fundamental to the design and operation of a cleanroom. Cleanrooms are defined (whether by ISO14644, EU GMP, USP <1116> or the former FS209E) by their ability to control a defined level of particles in different occupancy states. Controlling the level of particles in the air is arguably the most challenging aspect of contamination control.

This article examines some approaches to the monitoring of particles, including techniques and monitoring regimes, and examines some of the areas associated with particle control. The emphasis of this article is upon aseptic filling, but many aspects are also applicable to other cleanroom operations.

Why Monitor?

The measurement of particles is indicative of the cleanliness of a cleanroom. A cleanroom is a room with a specially designed heating, ventilation and air-conditioning (HVAC) system that is designed to control the level of contamination. Although it is the totality of the different physical checks that go towards contamination control, it is the measurement of particles that provides the best indicator of the level of control.


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By Tim Sandle, BPL Microbiologist at Bio Products Laboratory

Tim Sandle BSc (Hons) MA MIScT MIBiol Cbiol is BPL Microbiologist at Bio Products Laboratory (BPL). BPL is the manufacturing unit of the National Blood Authority, a special health authority within the NHS.

Prior to his current role, Tim worked on a number of different microbiological projects within the blood service including: developments in the testing of endotoxins and pyrogens for protein-based products; establishing the environmental monitoring regime in the pharmaceutical factory; and validating a sterility testing isolator system.

Prior to BPL, Tim worked in an MRC parasitology laboratory. He has written several articles relating to pharmaceutical microbiology, including LAL testing and pharmaceutical microbiological testing.

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Tim Sandle
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