Page 21 - Microbiology in workplace

GMP Training – Microbiology in the Workplace by www.gmpsop.com

GOOD TO KNOW - MICROBIAL MONITORING

Focus microbial monitoring on "at-risk" equipment, such as on topicals and
liquids lines, as well as product contact surfaces.

Monitor after cleaning or before re-use.

Periodically identify the bioload to check for objectionable organisms, and build
up a profile of them.

Control of pharmaceutical water

Water is a key ingredient of many pharmaceutical products, however, it is an
essential ingredient in promoting microbial growth.

Therefore, its microbial "'cleanliness'" is critical within pharmaceutical
companies.

Pharmaceutical water is used in two main ways: as part of product formulation,
and as a cleaning agent for equipment.

Purified water

This water is intended for the formulation of non-sterile products and final
rinsing of equipment after cleaning. Purified water is used extensively in the

plant. It is monitored by Quality Control and has specified limits for bio burden.

These limits are not failure limits but rather indicate when action should be
taken to correct the system.
Action limit 100 cfu/mL
Warning limit 10 cfu/mL
Target limit 1 cfu/mL

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