Larka

Contamination

Customer Experience - Biotech company identified the contamination of a fermentor used in the manufacture of a therapeutic protein generated by a bacterial host.

 
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Solving Quality Issues.

Context

Biotech company identified the contamination - Enterobacter cloacae - of a fermentor used in the manufacture of a therapeutic protein generated by a bacterial host. They requested Larka to help them solve this major quality issue.

Company Profile

  • Western European company
  • 50+ employees
  • Above 15mn EUR of revenue

Larka's Scope Of Intervention

Larka's project management team covered the following tasks:

  • Investigation
    • Identification of the root cause, point of entry – media simulation
    • Manufacture of engineering batches
    • Conclusion – incorrected fitted components, air filter deformation, missing O-rings
  • Corrective actions
    • Replacement of membrane valves
    • Replacement of O-rings
    • Improvement of fermentor sterilization and cleaning process
  • Preventive actions
    • Development of a preventative maintenance plan – fermentor, tank agitators, probes, gaskets, diaphragms, O-rings, valves, and filters
    • SOP update
    • Employees training

Conclusion

Preventative maintenance plans and understanding of microbial control at certain process steps were implemented. In order to ensure the good implementation of maintenance plans and microbial control, the biotech requested Larka to support its team.

Contamination was erased. Cleaning and sterilisation process was effectively implemented, still supported by Larka. Fermentor has not met any new contaminations untill now.