Expertise and organizational set-up in Process Engineering & Validation

Sterile Process Engineering & Validation Biotechnology & Bioanalytical Services

for small, medium, and large scale microorganism fermentation and cell culture. Manufacturing and packaging processes for production of small volume parenterals.

  • Fermentation, separation, and downstream processing,
  • in-place cleaning & sterilization (CIP / SIP / DIP),
  • one to multi chamber washing equipment and autoclaves,
  • weighing & compounding equipment for preparation of nutrients, buffers, and sterile drug formulations,
  • machinery for fill & finish, inspection, and packaging for the production of small volume parenterals,
  • in-process and QC equipment and devices.

[.-ING] is set up to provide the complete range of life cycle services based on current EU- and FDA GMP considering latest inspectoral recommendations.

  • Process engineering services,
  • qualification planning for new and renovated facilities,
  • proven and trained customizable set of test protocols DQ, IQ, OQ, and PQ,
  • validation of sterilization / depyrogenization processes incl. heat distribution, microbiological / endotoxine starts,
  • process and cleaning validation incl. laboratory work bench.

Closely connected with our fellow disciplines, two branches and a network of more than 100 specialists,
[.-ING] is able to support customer’s projects effectively by using state of the art QbD methods and risk based approach experience.