From 2D- and 3D-CAD design drawings to Project Quality Plans
Process and facility requirements are key business drivers and their consideration forms an integral part of overall project execution. The layout design of a single-use facility is achieved by using specific design principles which focus on the process technology. Process closure (open vs. closed), as well as different segregation principles (physical, timely or procedural segregation), also have to be considered.
For example, closed processing represents the lowest risk option in terms of mitigating the risk of contamination from the environment for both aseptic and low bioburden operations and it also enables the realization of “ballroom” environments. Detailed risk assessment for process closure and environmental background for process unit operations are typical exercises performed during this detailed engineering phase. Within this phase all relevant documents are prepared gaining the status AFC “Approved for Construction”, as the basis for assembling and manufacturing of the individual process units or skids.
Typical tasks and deliverables during Detailed Engineering:
• Process Equipment Specification
• Detailed P&IDs
• 2D-CAD and 3D-CAD design drawings
• Electrical design
• Project Quality Plan
Discover our Project Phases:
Our Integrated Solutions Team develops and implements rapid and cost-effective biomanufacturing solutions from early phase development through scale-up to commercial manufacturing.