ABSTRACT
Practical, achievable and verifiable cleaning validation acceptance criteria for biotechnology processes are typically established using a combination of rational approaches and combining these with an analysis of one or more critical, process related factors. Biotechnology processes used to produce biopharmaceuticals differ from traditional biochemical or chemically synthesized pharmaceuticals and manufacturing methods. The biotechnology processes used to produce biopharmaceuticals involve significant sequential purification of the protein or polypeptide product in most cases. Most biotechnology processes have distinct steps grouped as upstream and downstream processing. A method for calculating cleaning validation acceptance limits for the final stages of processing has been presented by Mullen and Forman. Acceptance criteria can be based upon one or more of several different process criteria. Acceptance criteria for steps in the upstream stages of the manufacturing process should be workable from the process perspective. When establishing acceptance criteria for cleaning processes, it is often the product itself that is of most interest.
