Contamination Control: Cleanrooms and Clean Air Devices

Authored by: Tim Sandle

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v1-47

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Abstract

Pharmaceutical processing, for both sterile and non-sterile processing, requires that products are developed and manufactured in areas that minimize the potential for contamination through the control of environmental cleanliness and minimize the possibility of personnel introducing contamination into the process. The FDA states in its 21 CFR Part 820.70 Production and process controls, section ‘c’ (1) that

Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions.Environmental control system(s) shall be periodically inspected to verify that the system, including necessary equipment, is adequate and functioning properly. These activities shall be documented and reviewed.

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