The production of pharmaceutical products is regulated under the supervision of demanding codes and regulations. Thus the Food and Drug Administration (FDA) demands compliance with different bodies of rules and standards for plants manufacturing pharmaceutical products. Only due to strict compliance can a new pharmaceutical product be authorized for production and subsequent sale. A special focus is aimed at the close out documentation and traceability of the manufacturing process.

What we guarantee with our specially developed pharmaceutical concept:

• GEP compliant Engineering    

• cGMP/ EG-GMP / GAMP compliant Design, Construction, and Installation concept  -  hygienic design
• Detailed and transparent qualification concept with risk analyses included (DQ, IQ, OQ, PQ, RA)
• Innovative fully automated CIP-/SIP-Concepts for demanding cleaning requirements
• Operation and processing concepts for increased process safety and reproducibility
• Ergonomic design concepts for improved accessibility when operating and servicing
• Process controlling concept with FDA compliant user management
• FDA 21 CFR Part 11 compliant electronic processing data recording
• FDA compliant (accepted) Scale-Up-System
• Customer and process specific training and training courses