Author Archives: Mark A. Petrich

Integrity of Single-Use Systems: Practical Applications and Deployment

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Single-use (SU) technology plays an important role in modern vaccine and biologics manufacturing. System integrity, managed by critical process controls, ensures sterility and is a prerequisite for successful leak-free processing. Nonintegral systems cause loss of product, quality, and time; increase costs through investigations; and lead to potential safety problems. The BioProcess Systems Alliance (BPSA) issued a white paper in 2017, Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance (1), that describes in detail the strategies for design and…

September 30, 2021

The Green Imperative: Part Two — Engineering for Sustainability in Single-Use Technologies

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In BPI’s June 2020 issue, the first installment of this series introduces the study and implementation of single-use (SU) technology to provide a more sustainable manufacturing environment (1). We presented evidence showing that the economic and social benefits of SU systems currently outweigh the residual environmental risks. Not only is SU technology often a better environmental choice than traditional biomanufacturing options, it also is sometimes the only choice for rapid process design and facility start-up. In situations such as the…

February 4, 2021

The Green Imperative: Part One — Life-Cycle Assessment and Sustainability for Single-Use Technologies in the Biopharmaceutical Industry

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Much has changed since large-scale single-use biomanufacturing equipment was introduced some 15 years ago. Since then, these materials have become accepted and established in production and downstream bioprocessing. Concerns about the environmental impact of single-use (SU) biomanufacturing equipment have become more prevalent as our environmental awareness has increased and related concerns have become more urgent (1). For example, many recommendations and even laws have emerged regarding plastic convenience packaging and products (2, 3). People have become more sophisticated in appreciating…

June 11, 2020

eBook: SUStainability — Concerning Single-Use Systems and the Environment

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Disposable materials have been used in many aspects of biomanufacturing since muromonab was first launched in 1986. Single-use stirred-tank bioreactors first became commercially available from HyClone in 2004 (1). Despite their demonstrated value to bioprocessing, disposable materials remain the subject of wide-ranging differences of opinion. Discussions of any technology are healthy and important for identifying areas for improvement, but some hearsay and bold propositions made regarding single-use components and the environment are not always helpful. Sustainability is an important and…

June 7, 2018