Page 23 - Microbiology in workplace

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

cGMPs require manufacturers to minimize the numbers of micro-organisms from
entering production areas and products. Typical ways this can be done include
using air pressure differentials so that micro-organisms are precluded and
ensuring that operators are appropriately gowned (e.g., hat, boots, cover-alls).

Micro-organisms, particularly moulds and spores, are transmitted to rooms by

air currents. Positive filtered air pressure in rooms prevents these contaminants
from entering the rooms due to the air barrier.

What do the cGMPs say?

US FDA CFR 211

§ 211.46 Ventilation, air filtration, air heating and cooling.

(a) Adequate ventilation shall be provided.

(b) Equipment for adequate control over air pressure, micro-organisms, dust,
humidity, and temperature shall be provided when appropriate for the
manufacture, processing, packing, or holding of a drug product.

(c) Air filtration systems, including pre-filters and particulate matter air filters,
shall be used when appropriate on air supplies to production areas....

§ 211.113 Control of microbiological contamination.

(a) Appropriate written procedures, designed to prevent objectionable
microorganisms in drug products not required to be sterile, shall be established
and followed.

b) Appropriate written procedures, designed to prevent microbiological
contamination of drug products purporting to be sterile, shall be established and

followed. Such procedures shall include validation of any sterilization process.

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