« SINGLE-USE Summary
The benefi ts of SUS can be realized by developing and implementing good engineering practices and standards. Devise a detailed strategy that works for your manufacturing and supply chain management capabilities. Users are advised to:
• Start with a user-requirements specifi cation.
• Design to meet requirements. •
Source standard supplier products where possible.
• Defi ne and enforce internal best practices and standards for components and assemblies.
Figure 3. Schematic of a high complexity fl ow splitter and fl exible tubing module that can replace the module shown on the right side of Figure 1.
• Adopt a modular design approach: “Design once – use many”.
• •
done to engineer and qualify modules will not need to be repeated for each new process application.
6. Test “fi rst article” shipments from suppliers for all new designs. This goes beyond evaluation of a “prototype” in that it evaluates all aspects of the SUS that will be in the routine supply chain. The whole package – pallets, cartons, packing materials, documentation, labels, and the parts themselves – is the SUS, and the whole thing needs to work for all stakeholders. First articles should be handled by suppliers and end users as planned for normal production. Monitor packaging, paperwork, and the single-use item itself as the fi rst article goes through packaging, shipment and receipt, unpacking, stocking in clean warehouse space, delivery to end user facilities, movement to point of use, use, and disposal.
Change Management
Changes may be requested by the end user, recommended by the supplier, or imposed on both parties by changes made by resin suppliers, regulators, or other diffi cult-to-control sources.
Technical,
quality, regulatory, and business decisions need to be made whenever changes happen. It is a good idea to predetermine how changes of various types will be handled.
A well-constructed component and assembly library will limit the number of internal changes. Users are advised to develop supply and quality agreements that limit the number of supplier-initiated changes. Rules for how to manage changes will facilitate continuous improvement activity both internally and from the SUS manufacturers when necessary. Users need to negotiate with suppliers to ensure that existing product lines continue to be manufactured and supported even as innovative technologies are launched.
The automotive,
pharmaceutical, and software industries provide examples of old designs coexisting with new designs.
Author Biography
Dr. Mark A. Petrich is Associate Director at Merck & Co. and serves on the Bio-Process Systems Alliance (BPSA) board of directors. His work emphasizes single-use technologies in vaccine and biologics manufacturing. holds both his BS and Ph.D. in Chemical Engineering.
Mark
References 1.
2. 3. 4. 5. 6. 7. 8. 9. 10. Recognize suppliers as supply chain partners.
Limit internal changes and work with suppliers to maintain existing product lines.
Eibl, R. and Eibl, D. eds. “Single-Use Technology in Biopharmaceutical Manufacture”, John Wiley & Sons. Inc., Hoboken, New Jersey, 2011.
Vogel, J.D. “The Maturation of Single-Use Applications”, BioProcess International 10(S5), 2012, 10-19.
Craig, J.L. and Jenkins, M., “Toward Flexible Hybrid Facilities of the Future”, BioProcess Int. 10(11) s 2012:34-37
Langille, S.E., “Particulate Matter in Injectable Drug Products”, PDA J Pharm Sci and Tech 2013, 67 186-200.
Riedman, D. and Martin, J., “A Case Study in Qualifi cation of Single-Use Filling Manifolds for Particles and Endotoxins”, BioProcess Int. 9(S2) 2011: 28-35.
Mahajan, E., Ray-Chaudhuri, T., and Vogel, J.D., “Standardization of Single-Use Components’ Extractable Studies for Industry” Pharmaceutical Engineering 32(3) 2012: 54-56.
Jenke, D. Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables. J. Pharm. Sci. 2007, 96 (10), 2566 –2581.
Jenness, E. and Gupta, V. “Implementing a Single-Use Solution for Fill-Finish Manufacturing Operations”, BioProcess Int. 9(S2) 2011: 22-26.
BPSA Guidelines and Standards Committee, “Part 1, Bio-Process Systems Alliance Component Quality Test Matrices”, BioProcess Int. 5 (4) 2007: 52-67 Document also available at www.
bpsalliance.org/guides.html
BPSA Guidelines and Standards Committee, “Bio-Process Systems Alliance Component Quality Test Matrices; Part Two: Tubing and Filters”, BioProcess Int. 5(4S) 2007: 16-23. Document also available at
www.bpsalliance.org/guides.html
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