BioPharm June eBook: Single-Use Systems

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Page 43 of 46 June 2018 BioPharm International eBook 43 Single-Use Systems Bioreactors ALL FIGURES ARE COURTESY OF THE AUTHORS supplier. There have been sizable investments in product develop- ment, supply-chain management, manufacturing processes, scientific/ regulatory support, and quality sys- tems to build, supply, and support these product platforms. HARDWARE DOCUMENTATION AND INFORMATION MANAGEMENT Documentation and data represent essential information elements that require management within a biomanufact ur ing operation. Proper documentation with suffi- cient detail contributes to the trace- abilit y of user requirements to the finished, qualifiable bioreac- tor system. Documentation also supports on-going use and main- tenance. Documents may exist in hardcopy (paper), digital formats, or both. Data may originate from within particular documents, be generated from process sensors, and result from user interaction with the bioreactor. For use in GMP bioman- ufacturing, any bioreactor is only as good as the documentation pro- vided to support it and the integrity of the data it generates. Information management will involve enterprise resource planning (ERP) tools and process automation systems. Documentation that captures the form, fit, and function of bioreac- tor's design space is routinely cate- gorized as follows: installation and maintenance; vessel, piping, and mechanical design; calculations and components; electrical and controls; automation; fabrication; and testing. Collected commonly in a turnover package (TOP), the documentation provides a record of traceability from user requirements to the finished, qualified bioreactor system. Despite common documentation categories and intended uses, content differ- ences exist between bioreactor types (see Figure 3). Differences originate from the fundamental element that makes the two bioreactors types dif- ferent: the disposable bioreactor bag. The bioreactor bag, with its attached filters, t ubing, and connectors replaces the sterilize-in-place vessel, Figure 1. Stages of a bioreactor capital equipment lifecycle are listed along the left side of the figure. Black represents buyer-specific stages; blue represents supplier-specific stages; and gray represents stages involving both parties. The top bullet of each describes the lifecycle stage, and the bottom bullet explains how a single-use (S-U) bioreactor disrupts or improves the lifecycle compared to a stainless-steel bioreactor.

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