PSC Biotech team supported the client by initially reviewing and providing advice on the design documents, i.e., functional specifications (FS), hardware design specifications (HDS), automation concepts, software design specifications (SDS), and computer specifications (CS).

PSC Biotech supported with the qualification, commissioning, validation, and other Engineering for 50L Reactor. As part of this project, PSC supported the Validation Protocol development, developing Qualification Plan, developing initial qualification documentation, execution, and final reports for different equipment and processes.

The goal of this project was to provide Engineering, Commissioning, Qualification and Validation Services for equipment on the client manufacturing site.

PSC® has been providing engineering and validation services at the San Dimas facility since 2014. When the La Verne facility startup projects began, PSC® has been providing validation support to keep the facility operational. PSC® covers all aspects of facilities, utilities and process equipment qualification and validation across the entire facility.

PSC® provided engineer consulting services for the B1 Exit Program Documentation Support Project. The work for this project entailed performing assessments and modifying 3200 Non-GMP documents and/or drawings, 153 documents that needed addressing before shut down, and 14 documents that needed addressing after shut down. 

PSC® served as the key consultants for the entire facility and covered engineering and validation in various functional areas. After the facility reached the operational phase, PSC® continues to provide Engineering Managed Services to Facility Engineering, PMO and automation groups.