100L Perfusion Fermentation System

including Inactivation and CIP System

Basic and detail engineering, production, automation, installation and commissioning of a cGMP and FDA compliant 100L perfusion fermenter with inactivation and CIP system. The process with continuous sampling and parallel refeeding required a highly complex engineering solution to fulfil the special requirements. Both static and dynamic FAT were performed before the system was shipped.

  • Product/service category: Bioreactors and Fermentation Systems

  • The continuous process with long incubation times  required a special sterile design in order to maintain sterility over long periods. The maintenance of long-term sterility was verified using bioindicator tests.

  • The strict isolation of areas contaminated with activated ingredient  reduces the risks to personnel and environment and the risk of cross-contamination.

  • The customised system design enables the cleaning of both BSL and non-BSL sections.

  • Scope of supply: basic engineering, detail engineering, production, installation, automation, commissioning, qualification

  • Main equipment: one 100L fermenter, one 250L preparation vessel, pumps, agitators, filters

  • Application: mAb Production

  • Project country: Germany

  • Completion time: 14 months
 
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