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Page 10 of 26 June 2019 BioPharm International eBook 11 Single-Use Systems Supply Chain First, SUS manufacturers or inte- grators may be relying on the same supplier or suppliers for critical subcomponents, undermining the redundancy strategy if that supplier runs into production issues. There is also a growing number of com- ponents (e.g., tubing, bags, filters, and gaskets) that may have limited sources of material supply. In many cases, the component specifica- tion may require a particular brand name for a material, rather than the key specifications or regulatory cri- teria the given material needs to fulfill. This specification introduces more risk if the brand-name mate- rial provider runs into a shortage or cannot produce the material. A better practice would be to specify material properties to a known spec- ification instead of a brand name, allowing for the possibility of true alternate sourcing to limit risk. In addition, although companies may want to standardize designs to be used across multiple global facilities, SUS often require some level of customization for a given application or region, which adds to the complexity. For a high level of customization, for example, a single-use manufacturing facility could handle as many as 2000 new drawings and 3600 revised draw- ings in one year while managing 50 critical raw material suppliers, coordinating dozens of customer and supplier audits, and compiling more than 500 unique documenta- tion packages. All of these factors indicate that the traditional approach of select- ing two supplier sources to fulfill SUS component production may not be appropriate. It ignores the complex it y, interdependencies, and volatility of the market for any building block subcomponents and materials. As a result, bio - pharma manufacturers may find themselves in sit uations where their production is at risk because the availability of a seemingly sim- ple component, such as a gasket or connector, becomes the weak link in their supply chain. Biopharma manufacturers should implement a comprehensive sup- ply-chain strategy as early as pos- sible in their SUS development cycle to prevent the possibility of future negative outcomes. As a first step, collaborating with the SUS man- ufacturer or integrator, as well as focusing on good industrial design principles and system requirements for the application at hand, can help identify possible manufactur- ing problem areas, bottlenecks, or potential sourcing and supply issues before components are selected and drawings are made. COMPLYING WITH REGULATIONS AND QUALITY STANDARDS The SUS manufacturer's supply- cha in e xper t ise a nd abilit y to c omply w it h r eg u l at ion s a nd quality standards can ensure that the drug manufacturer successfully migrates a SUS from pilot scale to GMP production. Manufacturers can reduce the number of issues they face by thinking ahead and understanding the scale-up chal- lenges they anticipate. The goal is to design the system for full GMP production even at the pilot scale to eliminate a potential hurdle later. The following criteria for reg- ulatory and quality compliance are worth considering when choosing a supplier for single-use products and technology. Cleanroom management The manufacturing area where sin- gle-use equipment and materials are being produced (see Figures 1 and 2 ) should be checked to ensure proper controls are in place to monitor and track environmental conditions. Typically, SUS will be manufactured in an International Organization for Standardization ( I S O) C l a s s 7 (C l a s s 10 , 0 0 0 ) Figures are courtesy of the authors. Figure 1. A team of individuals builds custom single-use assemblies in an ISO Class 7 cleanroom.

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