Detail Engineering, Core Technologies, Quality by Design (GMP)
- Architectural design of the entire facility with respect to GACP/GMP flows: Complete series of layouts, plans and studies. Development of all areas with facilities and equipment incl. equipment arrangement, position of ventilation, design of differential pressures, personnel, materials and waste flows etc.
- Implementation (E/M) study for the detail engineering of the facility: Re-construction of all the E/M facilities required for the remodeled area, i.e. integrated air conditioning system (calculations of the requirements of the clean rooms based on cGMP and all premises requirements), electrical strong and weak, plumbing, fire safety system with full calculations, drawings and technical specifications.
- Room Data Sheets (RDS) for Classified areas (clean rooms) with special conditions and requirements (pressure, temperature, humidity, dimensions, particle control, ISO classification etc.)
- Listing and User Requirement Specifications (URS) of all equipment and technology related to manufacturing and in contact with the product.
- Optimal technologies sourcing based on the state-of-the-art intellectual/industrial property, GMP-compliance as well as on industry standards & project budget. Technical/Financial comparisons of processing technologies in terms of GMP-compliance and Total Cost of ownership vs. Throughput. Tendering, supplier selection and contract negotiation.
- Evaluation on Processing and Quality control systems suppliers. Tendering, supplier selection and contract negotiation.
- Evaluation on Clean Room/HVAC building & commissioning subcontractors. Tendering, supplier selection and contract negotiation.