Elastomer Change Out-Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility.

Abstract

The primary objective of any Biopharmaceutical Product Changeover (PCO) program is to employ control strategies before, during, and after the manufacturing process, as well as from the beginning of the lifecycle approach for the equipment and validation, 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. Lifecycle systems (e.g. Preventive Maintenance (PM), Cleanability Coupon Testing, Good Engineering Practices, etc.) and procedures should be in place and data should be generated demonstrating the soft parts do not harbor residues from the previous product campaign(s). The determination of whether or not to replace elastomers/soft parts should be made in the context of all of these systems along with the proper assessment of Risk. 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.