The current demands in today’s pharmaceutical industry for quality control and quality assurance have been driven by the aspiration to deliver consistently high quality and safe products to the consumer. The standards that are set to meet this goal are exorbitant and tightly controlled both internally and externally.

Cleanroom environments are a crucial area for the process and manufacture of pharmaceutical products. Cleanrooms are controlled and maintainedusing very stringent protocols and guidelines outlined by organizationssuch as the FDA [1] and ISO [2]. Quality control and assurance withinthe cleanroom has become a science in itself; part of this relatesto monitoring particulate matter in the cleanroom. This monitoring verifies that the cleanroom is operating within the required classificationsand that the level of particulate matter is at such a level that it will not have an adverse effect on the sterility of the product, which further down the line could possibly be a matter of life or death. Let us take a closer look at the way the cleanroom environment is monitored to verify the existence or nonexistence of particles both viable and non-viable.

What is a Viable Particle?

A viable particle is a particle that contains one or more livingmicroorganisms. These can affect the sterility of the pharmaceuticalproduct and generally range from ~0.2µm to ~30µm in size[3].