These two related papers help those involved with the design and organization of product changeover drug substance operations to justify the elimination of elastomer change-outs and reduce other changeovers. Using a science-based risk management approach the guides show how to ensure that value-added work is the sole focus of changeovers and how unnecessary changeover activity can be eliminated, reduced or removed from the facility down time.
Abstract
Product changeover is a process that prepares and configures the facility and equipment for the next manufacturing process, and includes actions taken to protect the subsequent process against contamination from the previous process. Historically, the change-over between two products within a multi-product facility has created a great deal of operational inefficiency. This paper shows how with the use of risk-based tools and supporting data, the changeover activities of multi-product facilities can be significantly reduced and, under well-controlled and characterized operations, concurrent manufacturing may be achieved. Specifically, the change-out of small parts and elastomers as well as the collection of changeover cleaning samples may be significantly reduced or eliminated. This article is primarily intended for the manufacture of bulk biologic drug substance; however, the principles may be applied to finished drug product as well.
Abstract
The primary objective of any biopharmaceutical product changeover (PCO) program is to employ control strategies before, during, and after the manufacturing process which will minimize the opportunity for cross- contamination when switching between products. Evaluation of the need for an elastomer change out (ECO) should be considered as a segment of an overall changeover assessment. By understanding the actual value of ECO in terms of the overall PCO program, and the other systems and procedures that are in place that protect against cross contamination, the need for ECO for every product changeover is not necessary. The purpose of this paper is to review the practice of ECO at product changeover, evaluate the need for an ECO using a risk based approach, and provide rationale for justifying the reduction or elimination of ECO at product changeover. Based on the experience in six companies and the use of elastomers in over 10 manufacturing sites. It outlines that using a risk-based approach to outline the rationale for reducing elastomer change-out at the biopharmaceutical change over.
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