Page 31 - Cleaning and sanitation in GMP

GMP Training – Cleaning and Sanitation in GMP Areas by www.gmpsop.com

required contact times on equipment

the targeted microbial population

Disinfectants must be used in strict accordance with instructions. They should
never be topped up, used, or stored without labels and expiry dates.

GOOD TO KNOW - DISINFECTANTS

Disinfectants are tested for their bactericidal activity against four standard

cultures of micro-organisms, namely:

Pseudomonas aeruginosa

Pr. Vulgaris

E. coli

Staphylococcus aureus

The disinfectant is tested at the manufacturer's recommended dilution as
stated on the product label. The disinfectant dilution is passed or failed
according to the extent of growth shown by the challenge bacteria. This is the
reason it is very important to make dilutions correctly during use.

A common practice in the industry is to rotate between different sanitizing
agents on a regular basis (for example, monthly). The intent of this is to prevent

the possible build up of organisms with resistance to the sanitizing agent being
used.

GOOD TO KNOW - POTENTIAL RESIDUES

Some potential residues can include:

cleaning agents

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