BioPharm June eBook: Single-Use Systems

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Page 45 of 46 June 2018 BioPharm International eBook 45 Single-Use Systems Bioreactors exist in hardcopy, digital formats, or both. Some documentation may be lot-based, whereas as others are lot- independent. With analogs in the hardware TOP, lot-independent bio- reactor bag documentation includes validation guides, operating instruc- tions, bag design drawings, and bills of materials. Lot-based documents include material certificates, irradia- tion certificates and, in some cases, documents for integrated sensors. Combined, these documents repre- sent the traceable pedigree of the complete assembly. Without the automated, fixed piping inherent in stainless-steel bioreactors, single-use bioreactors place more and differ- ent responsibility on the operator for installation, set-up, use, and data entry. Installation, set-up, and use of disposable bioreactor bags require necessary, specific user interaction and guidance. In particular, methods for user prompts and acknowledg- ments related to making or breaking connections, confirming execution of manual steps, and performing lot- based data entry are recommended. Concerning disposable bioreactor bags with integral single-use process sensors, calibration data and sensor registration methods may be needed. By automated or manual means, capturing this information correctly and incorporating it within the batch record structure is crucial in satisfying specific functional needs of various stakeholders. CONCLUSION Planning and preparation (7) have been paramount in establishing familiar legacy biomanufacturing paradigms. Both, too, are essential for assessing and implementing single- use technologies and new biomanu- facturing models. Some of the more typical discussion points associated with bioreactor choice include per- formance, contamination risk, utility consumption, facility utilization, cap- ital expenditures, and others. Beyond those points, this article set out to create awareness about other less commonly disc ussed topics that may aid in decision- making: bioreactor lifecycle, design space, and product platforms. As manufacturing capital equip- ment, bioreactors follow a lifecycle, from user requirements to decom- missioning. What makes the sin- gle-use bioreactor unique, not surprisingly, is the disposable biore- actor bag assembly. Similar to other single-use components and assem- blies, bioreactor bags are a lot-based raw material with unique material, document, and data considerations and have a unique lifecycle. For the platform to perform as a bioreactor, hardware and bag design spaces must work in unison. A defined design space supports standardization and f lexibility. Standardization pro- motes sustained supplier investment in supply chain, product develop- ment, manufacturing, and quality processes. The growing adoption of single- use technology in general, and biore- actors specifically, makes it critically important for buyers and other members of the mature supply chain to understand the expanse of the design space and the modularity of commercially available single-use products and bioreactors. Similarly, suppliers must be aware of applicable user requirements. By understanding interrelationships between design space, user requirements, and prod- uct platforms, buyer and supplier stakeholders can appropriately align their requirements and deliverables. Figure 3. A comparison of turnover documentation for the two bioreactor types and the bioreactor bag assembly. Different colored "folders" reflect specific, corresponding content. Folder sizes are indicative of document quantity. The mixed color single-use bioreactor folders represent level of similarity to stainless-steel.

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