Automation of a production system for active ingredients
A client wants to establish a new production system for active ingredients, which forms the basis for further processing into pharmaceuticals.
In close coordination with the site management engineering, EXCO creates the concept and takes over the planning of the system automation in collaboration with the system manufacturer.
On the basis of the User Requirements Specification, EXCO creates the requirements specification and evaluates the services of the supplier. Furthermore, the creation of the functional specification (Functional Design Specification and Hardware Design Specification) is supported and then checked.
The EXCO task includes the execution of the
- Concept design
- Basic design
- Detailed design
- IQ, OQ and DQ
- Factory Acceptance Tests (FAT)
- Site Acceptance Tests (SAT)
Automation as per valid GxP guidelines taking into consideration the US-American (FDA) and Japanese (JIS) standards.
We are specialists in concept creation for automation in the pharmaceutical industry.
- Efficient and targeted unburdening of the site management.
- Unburdening due to channeling of information and coordination of suppliers.
Largest global manufacturer of biopharmaceuticals, Mannheim