PDA Single-Use Systems Cross-Organizational Workshop-Meeting Summary, May 14, 2014-PDA Global Headquarters, Bethesda,...

The application of single-use systems, or disposables, has increased dramatically in the past 10 years. Although some elements of the pharmaceutical and biotech manufacturing process were single-use and therefore disposable and not reused, the majority of the process equipment and fluid path was cleaned and reused by end users. Today, much more of the manufacturing process is composed of single-use systems, and there are some biotech plants that use single-use systems exclusively. Because of this increasing reliance on suppliers, there is an urgent need for more formal standards specifically for single-use system technology. The objective of this PDA-sponsored workshop held on May 14, 2014 was twofold: (1) to promote a harmonized approach to supporting single-use system activities within the industry and in so doing to minimize duplication of efforts, and (2) to communicate ongoing single-use system initiatives among the group. Representatives of ASME, ASTM, BPOG, BPSA, ELSIE, PDA, PQRI, and USP, as well as representatives of CBER and CDER of FDA, attended.

Today, the majority of pharmaceutical and biotech drug manufacturing equipment is cleaned and reused. However, in the past 10 years, the use of disposable manufacturing systems has increased dramatically; there are even some biotech-derived drugs that are manufactured entirely using single-use technology. This movement toward disposables has placed increased reliance on disposable equipment suppliers, each of which manufactures its products independently to meet customer needs. This fact has led to non-uniformity in design for connectors and similar sub-processes, and has made the need for more formal industry standards. The objective of this PDA-sponsored workshop held on May 14, 2014 was twofold: (1) to promote a harmonized approach to supporting single-use system projects within the industry and in so doing to minimize duplication of efforts, and (2) to communicate ongoing single-use system initiatives among the group. Representatives of industry associations and standard-setting organizations, as well as representatives of the U.S. Food and Drug Administration, attended.