Managing Risk in Single-Use Systems Design and Implementation: A Shared Responsibility

Managing risk in single-use systems design and implementation is a shared responsibility.

The ultimate responsibility for drug processes and products will always remain with manufacturers. However, implementation of single-use systems can shift responsibilities to suppliers within key areas, including design and sterilization, which must be clearly controlled and validated.

This Special Report discusses how suppliers and manufacturers when working together can mitigate the risk of applying single-use systems in biopharmaceutical production from design through validation to point-of-use testing and operator training.

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Hélène Pora, PhD, is vice president of technical communication and regulatory strategy at Pall, where she leads technical training and regulatory support improvements. She has been instrumental in the development of Pall single-use technologies for the past 20 years while heavily involved in manufacturing, quality, and regulatory aspects. Pora has over 30 years of experience working for the biopharmaceutical industry, the past 29 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. Pora is involved in different industry groups, with a strong focus on the BioPhorum Operations Group (BPOG), and she sits on the board of the Bio-Process Systems Alliance (BPSA).