Page 24 - Microbiology in workplace

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

International GMPs

PREMISES
General

3.1. Premises should be situated in an environment which, when considered
together with measures to protect the manufacture, presents minimal risk of
causing contamination of materials or products.

Annex 1 - Sterile Products
29. A filtered air supply should maintain a positive pressure and an air flow
relative to surrounding areas of a lower grade under all operational conditions

and should flush the area effectively. Adjacent rooms of different grades should
have a pressure differential of 10-15 pascals (guidance values).

Control of the environment
When products are exposed to the environment, the environment must be
controlled. Some ways of achieving environmental control include the

implementation of:

Air handling systems

Designated manufacturing zones

Cleaning programs

Air handling systems
Air handling systems include ways to filter the air, for example, with the use of

HEHA (high-efficiency particulate air) filters that trap micro-organisms in the air.
The air handling systems should generally maintain positive air pressure relative
to the outside environment in order to prevent particles and micro-organisms
from entering the facility, and particularly the manufacturing areas.

This is one of the main reasons that all doors should be kept closed.

Designated manufacturing zones

There should be designated manufacturing areas at the facility to keep products

away from the outside, "non-controlled", environment.

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