Abstract
This chapter is primarily concerned with facility and equipment features that contribute to protecting the product from contamination from the environment. The concept of “pure culture” is defined and discussed. Prevention of foreign growth (FG) is the most important factor. System and facility design considerations are given. Clean-in-place (CIP) and sanitize-in-place (SIP) designs are discussed. Disposable systems are compared with fixed stainless-steel equipment. The root causes of contamination are explored: design and sterile boundary faults, equipment faults, human error. A checklist is presented for conducting an FG investigation. Risk assessment and validation concepts are introduced.
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