Clean rooms are designated a class number based on their method of monitoring and tight control. As the product progresses in its development, the type of Class room utilized increases with maintenance measures and strict control. Bioreactors are considered to operate in an internally closed system (class 100,000 type room), where the risk of contamination is avoided at all costs. Working in a closed system, contamination risk is heavily reduced. Purification and seed train operations are examples of open systems (class 10,000 type room), because the potential for contamination is increased due to transfer between bioreactors, and exposure to possible airborne or surface environment contaminants.

Principles Of Radiographic Imaging: An Art And A Science
6th Edition
ISBN:9781337711067
Author:Richard R. Carlton, Arlene M. Adler, Vesna Balac
Publisher:Richard R. Carlton, Arlene M. Adler, Vesna Balac
Chapter41: Radiation Therapy
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Clean rooms are designated a class number based on their method of monitoring and tight control. As the product progresses in its development, the type of Class room utilized increases with maintenance measures and strict control. Bioreactors are considered to operate in an internally closed system (class 100,000 type room), where the risk of contamination is avoided at all costs. Working in a closed system, contamination risk is heavily reduced. Purification and seed train operations are examples of open systems (class 10,000 type room), because the potential for contamination is increased due to transfer between bioreactors, and exposure to possible airborne or surface environment contaminants.

 

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