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.