Page 4 - Microbiology in workplace

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

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

Annex 1 Sterile products – General

3. Clean areas for the manufacture of sterile products are classified according to
the required characteristics of the environment. Each manufacturing operation
requires an appropriate environmental cleanliness level in the operational state

in order to minimize the risks of particulate or microbial contamination of the
product or materials being handled.

Overview:

In the pharmaceutical industry, the major types of micro-organisms of concern
are bacteria and fungi. Manufacturers of biological products are also concerned
with the presence of viruses in their products.

Some species of bacteria are very hardy. They can live in extremely harsh
environments, such as in high salt concentration, acids, or high temperatures.
Manufacturers need to control these micro-organisms to ensure that they stay
at acceptable levels. Micro-organisms higher than acceptable levels may harm

the products or consumers.

GOOD TO KNOW – VIRUSES

Viruses are much smaller than bacteria and readily pass through bacteria-
retaining filters.

In manufacturing environments where living cells are involved in the

manufacturing process, viruses are of concern. For this reason, manufacturers
of biological products generally include a virus reduction step in their
processes. This may be by chemical means or application of heat.

Because of the difficulty in removing viruses, they need to be excluded from
"at risk" products. Typically, materials are screened for undesirable viruses.

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