After successful completion of the course, students are able to apply and understand the Basic principles of Pharmaceutical process Technology to a number of unit operations as well as to design a pharmaceutical facility on concept Level.
· Integral pharmaceutical processes and their classification: Biopharm, Fill and Finish, Secondary packaging
· Special Requirements for pharmaceutical facilities
· Regulatory requirements for facility design
· Functions and specification of individual unit operations
· Integration of support functions like CIP, SIP, clean media
· Example: Design of an Facility for an bulk API
· Layout of pharmaceutical facilities, Personnel and Material flow
· Requirements for cleanrooms and cleanroom conditions
GMP Basic requirements, Details of hygienic process design, requirements to unit operations and the production facility