Article: Applying Good Engineering Practices To The Design Of Single-Use Systems

By Martyn Botterill and Bruce Rawlings

Significant changes are being incorporated into biopharmaceutical manufacturing processes as a result of drivers such as increasingly strict regulatory demands, reduction of manufacturing costs, and outsourcing to contract manufacturing organizations (CMOs). Historically, many biopharmaceutical processes were designed and built based on cleanable, reusable stainless steel systems and unit operations. Today several industry drivers are shifting some unit operations toward single-use technologies, namely lowered cross-contamination, reduced capital investments, and desired further reduction in manufacturing costs and shortened drug development times .

The general benefits of disposable systems have been described in various case studies and technical articles , but their suitability for each specific process must be assessed individually. One universal requirement, whether a system is single-use or reusable, is the application of good engineering practices and the effective integration of a diverse range of technologies and process operations. This may be easier to achieve for reusable stainless steel systems because of the industry's greater familiarity with established technologies as well as the availability of knowledge on design and operation of existing processes. The task can potentially be more demanding for relatively new technologies, with which users have limited experience. In such cases, success requires close collaboration with system engineering companies, especially those having experience in single-use systems and technologies.

Here we describe a case study in which an integrated single-use system was designed and developed for a CMO (Patheon UK) by a systems supplier (Pall Life Sciences) using appropriate project management tools and good engineering practices.

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