Page 15 - Microbiology in workplace

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

pre-cleaning to remove most of the chemical residues and bio burden

the length of time the heat and sanitizing agents are applied for: too short an
exposure time will be less effective.

What do the cGMPs say?

US FDA CFR 211

§ 211.67 Equipment cleaning and maintenance.

(a) Equipment and utensils shall be cleaned, maintained, and sanitized at
appropriate intervals to prevent malfunctions or contamination that would alter

the safety, identity, strength, quality, or purity of the drug product beyond the
official or other established requirements.

§ 211.84 Testing and approval or rejection of components, drug product
containers, and closures

6) Each lot of a component, drug product container, or closure that is liable to
microbiological contamination that is objectionable in view of its intended use

shall be subjected to microbiological tests before use.

International GMPs

3.36 Manufacturing equipment should be designed so that it can be easily and
thoroughly cleaned. It should be cleaned according to detailed and written

procedures and stored only in a clean and dry condition.

5.10 At every stage of processing, products and materials should be protected
from microbial and other contamination.

5.19 Cross-contamination should be avoided by appropriate technical or
organizational measures, for example:

…
e) using cleaning and decontamination procedures of known effectiveness, as
ineffective cleaning of equipment is a common source of cross-contamination;

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