Article: Managing Solid Waste From Single- Use Systems In Biopharmaceutical Manufacturing

By Hélène Pora and Bruce Rawlings

The increasing implementation of single-use systems (SUS) in biopharmaceutical manufacturing has been driven by multiple factors including cost reduction, increased flexibility, improved process development time, and reduced capital investment. But questions are being raised over the disposal of solid waste materials from this alternative technology. Disposal concerns may not be justified on financial considerations because solidwaste disposal costs represent only a small proportion of the total manufacturing costs when using disposable systems . Furthermore, comparative studies have shown that traditional stainless steel systems incur higher costs for their cleaning and rinsing operations, which include disposal of liquid waste .

Perhaps a broader concern today for disposal of single-use processes is their potential environmental impact. Some studies have compared this for disposables with the energy consumption demands of stainless steel systems for sterilization, cleaning, and raw materials, concluding that the total energy consumption for single-use systems is about half that of traditional systems . But another concern to address is the environmental impact of currently available methods of disposal, especially in regards to increasing controls and legislation being introduced to protect the environment and ensure long-term industrial sustainability.

Here we summarize the methods available for management of solid waste and provide working examples of disposal options for many singleuse components. By offering such information, suppliers of components and systems can help users manage waste from disposable systems and also help them establish a responsible approach in their own environmental management programs.

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