Detailed scope of services plant design and engineering

Our engineers work both in The Netherlands and abroad. Detailed information on engineering services is given below:

• Conceptual design:
  We assist in writing the User Requirement Specifications. In good communication with your specialists (user group) we develop Process Flow Diagrams, facility layouts, personnel and material flow diagrams, equipment lists and utility requirements. We set-up the project planning and estimate the project budget.
• Basic engineering:
  The conceptual design is translated into contract packages for vendors and builders. Impact Assessments are performed and the Project Validation Plan is developed. Functional Design specifications are written. For example P&ID’s, equipment specifications, clean room specifications are set-up. HAZOP, GMP risk assessments and Design Qualifications are part of the quality tools in this project stage.
• Procurement and construction:
  We assist in purchasing equipment and services, we review and approve vendor documents, expedite deliveries and manage and inspect construction activities.
• Commissioning, qualification and validation:
  From the early project phases qualification and validation is an integral part of the project. We apply an effective approach by leveraging testing (FAT and SAT) and commissioning results into Qualification. We perform IQ, OQ and PQ protocol writing, execution and reporting.
• Areas of expertise:
  o Bioprocess engineering
  o Fermentation
  o Down stream processing
  o Pharmaceutical manufacturing technology:
     - Oral dosage forms (solids and liquids)
     - Formulation
     - Aseptic filling
     - Freeze drying
     - Labeling and packaging
     - Medical Devices
  o Hospital pharmacies
  o Radio pharmaceutical facilities
  o Facility engineering (Clean room and HVAC)
  o Process control and visualisation
  o Building management systems
  o Clean Utility Systems (WFI, Clean Steam, CIP etc.).