Single –Use Systems for Flexible Operations in Biopharmaceutical Production

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

The Road Ahead – A Look at the Future of Biopharmaceutical Production

Risk analysis conducted for conventional production facilities has to be reassessed in the light of single-use technology because of the increased deployment of SUS that represent closed process environments. These systems can be combined with and connected to one another using various connection procedures to maintain an extended closed process environment. This closed process operation mode calls for critical examination of clean room requirements that are already in place.

Local laminar flow units used in a pharma-controlled environment (CNC) and closed processing in a controlled, but nonclassified environment, are approaches that are discussed while considering the operation of single-use systems.

Single Use Bioreactors

Successful Cell–Cultivation in Single Use Bioreactors

Scientifically verified studies are the need of the hour to examine new conceptual approaches for compliance with clean room requirements when SUS facilities are used. Further, concepts for the flow of personnel and materials taking single-use technology into special account are important aspects in designing single-use production facilities. Transfer over clean room barriers requires technical solutions for tubing ports, which are already available on the market, to some extent, but still have considerable room for development, particularly in view of multiple ports.

* The author is Vice President - Integrated Solutions at Sartorius Stedim Biotech

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