Single –Use Systems for Flexible Operations in Biopharmaceutical Production

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

Conflict Situation: Standardization vs. customization

Although both manufacturers and buyers of systems and products endeavor to use as many standardized products as possible, in reality this is unfortunately quite difficult. The monoclonal antibodies (mAb) process, which has been sufficiently described according to its essential steps, is an example. Despite being considered a generic process, it always requires slight customizations when it comes to actually defining and implementing the user requirement specifications (URS). Such customization makes it necessary to deviate from existing standard products and engineer customized adaptations.

For qualification of single-use systems, both the SUS equipment and corresponding plastic consumables have to be defined and specified, and their basic functions tested and verified as part of FAT and SAT. Based on the flexible design of SUS, there are also frequently builton platforms with rollers for mobile use. For some customers, this flexibility in transportation to a different location is absolutely desirable and indispensable in the choice and sequence of individual process steps. For others however, such flexibility can entail a certain degree of difficulty in specifying a particular design of the matching single-use products, including the tubing assemblies to be connected.

Requirements for the Design of Single Use Bioreactors

Therefore, it is quite conceivable that the design of such SUS components may need to be changed as dictated by the allotted space available inside a specific manufacturing facility or by process modifications required during on-site testing. Even though such modifications to single-use products usually do not entail any changes to their functionality, these must be taken into account during the entire design concept.

NIR Spectroscopy in Bioprocessing

Real–Time Data on Manufacturing Bio–Processes with NIR spectroscopy

In individual cases, such considerations may not only affect the design but also the number and cost of single-use components at a later stage. Although changes to single-use consumables are technically easier to implement than those related to reusable stainless steel systems, the time and labor involved for documentation and testing of these modified consumables should not be underestimated.

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