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SINGLE-USE
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Design and Deployment Strategy for Single-Use Components and Assemblies
Mark A. Petrich, Ph.D.
Associate Director, Engineering Merck & Co., Inc.
How to be Successful with Single-Use Technology
Success with SUS requires a team effort from procurement, planning, supply chain management, logistics, operations, process engineering, quality, and component engineering departments. Recognize that the SUS supplier is an essential part of the team and incorporate them at appropriate times [2, 3, 8]. All team members must understand and address the concerns that limit implementation, and they should be prepared to not deploy single-use technology when it does not make sense for the business.
It is helpful to dedicate engineering staff (component engineering) to assume responsibilities throughout the lifecycle of design, deployment, support, and disposal of SUS. Manufacturing facilities that rely on SUS are continually refreshed with new parts. The team that specifies the parts needs to respond to changing demand, identified design weaknesses, and supplier changes. The best designed assembly will be of no help if it is not available to meet the production schedule. Component engineers need to stay engaged in supply chain management activities to ensure success with SUS.
16 | | November/December 2013
Single-use systems (SUS) promise many benefits to the biopharmaceutical industry including reduced cross-contamination risks, lower capital investment, elimination of cleaning and sterilization operations, reduced turnaround times, and the ability to scale an operation up or down with limited additional investment [1,2]. SUS are provided in a sterile, ready- to-use format, or as non-sterile parts for user processing.
Despite the potential benefits, SUS are sometimes not chosen because of real and perceived obstacles to implementation. System integrity, particulate contamination, and extractables are leading areas of concern that must be addressed by suppliers and end users [3-7]. Although these concerns are familiar in biopharmaceutical manufacturing, they are made more worrisome by the perceived loss of control when converting to single-use technologies. SUS suppliers become operational partners. Core activities such as equipment qualification, cleaning validation, sterilization validation, and sterile assembly manufacture are not handled by the SUS user. Equipment availability, formerly controllable though maintenance and engineering efforts, becomes dependent upon supply chain reliability. Process equipment configuration control transitions to a supplier change management activity [2].
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