Article
Guidelines For Embracing Single-Use Systems
June 1, 2011
•Article: Guidelines For Embracing Single-Use Systems
By Pall Life Sciences - BioPharmaceuticals
There is now a wealth of experience, case studies and support from suppliers and organizations, such as the Bio-Process Systems Alliance (BPSA), to facilitate the introduction of singleuse processes and to manage the transition with a controlled, low risk approach. It is inevitable that the reasons for adopting single-use technology may differ widely among manufacturing sites. For example, a plant with substantial investment in a validated stainless steel system for a specific product may have a totally different perspective to a Contract Manufacturing Organization (CMO) requiring maximum flexibility and multiproduct capability.
To assist potential users in the decision-making process, in 2009, Pora and Rawlings1 published some general guidelines and checklists on introducing single-use components. Other publications have focused on specific unit operations and, in some cases, quantified the potential savings. In the following section, we have identified and summarized the major factors that can contribute to a well-balanced and objective decision on whether to introduce single-use technology.
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