Pharmaceutical Concept

The manufacturing of pharmaceutical products is subject to especially strict rules and regulations. Thus the Food and Drug Administration (FDA) requires the compliance with a specific body of rules for plants producing pharmaceutical products. Only due to strict compliance are new pharmaceutical products approved and launched on the market. A special focus is put on the complete chain of documentation and traceability of the vessel manufacturing process and all its components. In addition, plants have to be able to consistently reproduce every process.

 

What we guarantee with our specially developed pharmaceutical concept:

 

– GEP compliant engineering

– cGMP/ EG-GMP / GAMP compliant design, construction, and installation concepts (sanitary designs)Explicit and transparent qualification concepts including risk analysis (DQ, IQ, OQ, PQ, and RA)

– Innovative and fully automated CIP-/SIP-concept for challenging cleaning demand

– Operation and process concepts for higher process safety and reproducibility

– Ergonomic design concepts for excellent access to all components during production and service

– Process control concept with FDA compliant user management

– FDA 21 CFR Part 11 compliant electronic process data recording

– FDA compliant (accepted) Scale-Up-System

– Customer and process specific training and instruction program