Since the introduction of single-use technologies (SUTs) more than 20 years ago, their benefits have been well recognized, and their adoption has been swift. The ability to customize a solution for every operation, every scale, and every product is an attractive proposition when compared with the fixed, stainless-steel facilities SUTs have replaced. But now customization has gone too far. Custom assemblies are being used when there is no need or benefit, and excessive customization is becoming a key challenge of implementing SUTs in biomanufacturing.
Consequences of Excessive Customization
Too much customization creates complexity. One challenge is the need to stock and control many low-volume items, including managing and writing off expired stock. Lead times for products are increased due to low-volume production runs and the changeover processes between products. The potential for loss in quality increases in smaller production runs because of the complex assemblies and customized parts. Finally, costs are higher because of the time required for the design, testing, and management of single-use systems.
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