Answered: Clean rooms are designated a class…

Human Anatomy & Physiology (11th Edition)

11th Edition

ISBN:9780134580999

Author:Elaine N. Marieb, Katja N. Hoehn

Publisher:Elaine N. Marieb, Katja N. Hoehn

Chapter1: The Human Body: An Orientation

Section: Chapter Questions

Problem 1RQ: The correct sequence of levels forming the structural hierarchy is A. (a) organ, organ system,...

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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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