Reference project

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.


Implementation

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

  • Pre-engineering
  • Concept design
  • Basic design
  • Detailed design
  • IQ, OQ and DQ

and monitoring

  • Factory Acceptance Tests (FAT)
  • PQ
  • Site Acceptance Tests (SAT)

Methods used

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.

Andreas Saddey, EXCO PCC GmbH

Customer benefits
  • Efficient and targeted unburdening of the site management.
  • Unburdening due to channeling of information and coordination of suppliers.

Client

Largest global manufacturer of biopharmaceuticals, Mannheim

Your contact

Andreas Saddey

T+49 6233 73778-520