Leveraging the ASME-BPE Standard for Compliance and Continuous Improvement

The regulated life sciences industry is under increasing pressure to improve process reliability, control manufacturing costs, and manage risk. The ASME-BPE provides a consensus standard for hygienic design of bioprocess equipment, developed by industry subject matter experts, that can be leveraged to achieve compliance and process improvement. This presentation provides strategies for leveraging the ASME BioProcessing Equipment (BPE) standard to manage risk, and control the cost compliant manufacturing. The BPE standard provides industry best practices for protecting product quality. Case studies will be used to illustrate how the BPE standard can be applied to enhance reliability, cost control and risk management in biopharmaceutical processes. The presentation will also preview content anticipated for 2014. Participants will understand the breadth and depth of the BPE standard, learn how to leverage the BPE standard to manage risk, and preview new content for the 2014 BPE.