Page 20 - Microbiology in workplace

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

intended usage, and probability of microbial contamination. Suppliers of starting
materials should also be audited, either by extended QC testing or by site
inspections.

GOOD TO KNOW - TYPICAL MICROBIAL LIMITS FOR STARTING MATERIALS

Starting material Microbial limits**
Synthetic, purified, and processed material 100 cfu/g
Processed material of natural origin 1000 cfu/g
Materials of earth origin (mined)
10,000 cfu/g
absence of Clostridia species
Natural products 100,000 cfu/g

** Absence of objectionable organisms depending on intended use.

Control of equipment

Equipment con also be a source of contamination, so there should be controls
in place that ensure equipment is kept dry and sanitary.

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