BioPharm June eBook: Single-Use Systems

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44 BioPharm International eBook June 2018 Single-Use Systems Bioreactors piping, valves, and numerous other components of a custom stainless- steel bioreactor. Without process piping, fewer design drawings are produced. The quantity and type of fabrication documents change substantially. Without valves, fittings, and steam traps, no such component docu- ments are needed. Bioreactor bag documentation has particular con- tent (see Figure 3) and requires spe- cific management practices. Within the bioreactor lifecycle, delivering the TOP is a one-time, dis- crete event. The scope, content, and quantity of documentation in the TOP differs by bioreactor type. These differences are based on the custom nature of stainless-steel bioreactors, reflecting the influence of scale and facility integration needs. Because the majority of single-use bioreactor systems are based on product plat- forms with well-established design spaces, suppliers have compiled TOP documentation that represents the modularity of the mechanical, elec- trical, and automation attributes of the system. Consistency facilitates the assembly into a ready-to-use TOP. SINGLE-USE MATERIAL AND INFORMATION MANAGEMENT The disposable bioreactor bag is what differentiates the two biore- actor types most. The impact on the bioreactor hardware and cor- responding (TOP) documentation was discussed in the previous sec- tion. The material handling, doc- u me nt at ion, a nd d at a a sp e c t s associated with disposable bioreac- tor bags have varied and significant impact on the flow of material and waste, personnel workf low, and data management in the biomanu- facturing process and organization. Managing these aspects and their impact on the drug maker's func- tional groups or stakeholders based on a single-use lifecycle is recom- mended. Effective lifecycle man- agement helps achieve the greatest value from single-use technology. As a physical material, the quan- tity and complexity of the disposable bioreactor bag has no equivalent in manufacturing operations based on stainless-steel bioreactors. As such, planning for sufficient warehouse space, managing just-in-time deliver- ies, staging for use, and controlling disposal are critical to manufactur- ing efficiency. Captured in standard operating procedures (SOPs) and reinforced with training should be examination methods that prevent use of defective or damaged dispos- able assemblies in manufacturing. Also, SOPs should include contingen- cies for bioreactor bag replacement and substitution. Support for this level of flexibility will be reliant on an appropriate definition of the manufacturing bills of materials and batch records. P e r h ap s l e s s o b v io u s t h a n handling the physical material, handling documentation and data is no less important. Information technology and process automation software applications may be appro- priate tools to address the needs of various stakeholders and effectively manage the single-use lifecycle. Like the hardware, documentation may Figure 2. The interrelationships between user requirements and design space. Scenario 1 is a single-use bioreactor; Scenario 2 is a stainless-steel bioreactor.

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