PSC Biotech experts were assigned to commission the architectural finish and mechanical completion of the Manufacturing Science and Technology (MSAT) Laboratory. The commissioning took place parallel with the final construction process.
PSC Biotech experts were assigned to commission the architectural finish and mechanical completion of the Manufacturing Science and Technology (MSAT) Laboratory. The commissioning took place parallel with the final construction process. This helped our CQV experts to directly start and complete the project.
The commissioning team successfully completed the modifications to the air handling system according to the client’s specifications and design. They checked the changes to the supply and return ductwork, as well as the new and existing variable air volume boxes.
PSC Biotech consultants drafted the required validation lifecycle documents and provided technical consultation and support for the project. The spreadsheets contained simple to complex calculations and formulae used to generate laboratory results and determine passing or failing criteria that directly impact patient health and product quality.
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 experts supported the client by verifying the installation of all equipment, controls, and programming necessary to provide consistent sterilization of glass and wrapped items. Our experts ensured the system complied with relevant current good manufacturing practices (cGMP).
