Process Planning
The company Dr. Franz Köhler Chemie GmbH located in Bensheim is specialised in the production of organ protective dilutions, therapeutics, X-ray contrast agent, vascular protection dilutions and antidotes. The production of liquid drugs is carried out at the Bensheim site. During a reorganization the Alsbach site was restructured into a research centre.
Project challenges
To satisfy the increasing global demand of their products, Dr. Franz Köhler Chemie builts a new facility at their Bensheim site for the production of CUSTODIOL®. In addition an analytical laboratory was built for quality control, on-site testing and release. The focus was on national and international GMP requirements. The new production site with an overall area of 1.750 m² (class C and D cleanrooms) includes the following functional areas: Media supply, weighing area, compounding, filling, terminal sterilization, autoclaving, cooling, packaging and warehousing.
The infusion bags with volumes of 100 to 5.000 ml are filled and sealed in a modern fill/finish system and sterilized by a hot water cascade.
Task:
Process planning for new production facility from concept planning to qualification
Services:
Pharma/Biotech planning
Location:
Bensheim, Germany
