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Methodology for Assessing Product Inactivation During Cleaning Part II: Setting Acceptance Limits of Biopharmaceutical Product Carryover for Equipment Cleaning

When multiple products are manufactured using the same equipment, it is important to ensure that potential product or process residues from the previously manufactured batch are removed to an acceptable level to ensure the subsequently manufactured product will not be impacted. The acceptable level of carryover has often been based on the active, intact API. However, for biopharmaceutical products, the API typically degrades and becomes pharmacologically inactive during cleaning, and therefore the cleaning acceptance criteria do not need to be based on the concept of intact and active product. Rather, the cleaning acceptance limit should be based on potential process residues that have a greater carryover potential founded on phenomenological aspects of the cleaning process. The scope of this paper targets biopharmaceutical APIs; nonetheless, the under- lying concepts may be useful in setting acceptance limits for other types of pharmaceutical products where inactivation during the cleaning process can be demonstrated. This paper will include a review of product inactivation, information on product detection using total organic carbon (TOC), and alternative approaches for setting acceptance limits for equipment cleaning. The intention of this paper is to propose acceptable approaches for setting cleaning limits for biopharmaceutical process equipment that may be considered. However, it should not be considered prescriptive for what approach is most appropriate or should be used since every production facility, processes, and products manufactured are unique. Read more at this link

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