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Article: Environmental Impact of Single-Use And Reusable Bioprocess Systems

Pall Life Sciences - BioPharmaceuticals
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By Bruce Rawlings and Hélène Pora

Bioprocess manufacturing systems have incorporated single-use/disposable components for more than 50 years and have demonstrated welldefined process benefits from their use (1–6). The environmental impact of single-use technologies, however, has been a major focus of attention only in recent years. This evolving interest has been driven by many factors including concerns over environmental change, emissions, and energy supplies; rapidly increasing costs and restrictions on waste disposal; greater recognition of the role of disposables in bioprocessing; and availability of a wider range of disposable options.

For those reasons, today's process designers and users must be in a position to assess and provide data on the environmental impact and sustainability of their manufacturing systems. This task can be very difficult and challenging, especially for complex multistage processes, whether involving traditional stainless steel equipment or disposables. Local factors such as restrictions on waste disposal or water resources, energy costs, and so on will also play a vital role in any assessment. Fortunately, there are many sources of information (7–10) that can facilitate an environmental assessment including guidelines from industrial organizations (e.g., BioProcess Systems Alliance, BPSA); regulatory guidelines and directives; data from suppliers and manufacturers; and published articles, reviews, and case studies.

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