Micheal Marino
Program Manager, Global Facilities Operations
The products that we manufacture in our plant require very stringent quality control and controlled environment. RH, temperature and differential pressure controls are critical to the cleanroom and are required to ensure that they are always within design specification and monitored by our validated CMS which is FDA 21 CFR 11 compliance. The main control system is using Schneider SmartStruxure Platform. The main automated control system platform is built and verified in accordance to GAMP5 standards as part of Boston Scientific’s procedures to ensure quality controls.
All the automation system commissioning phases are completed in time with documented pre-functional and functional system commissioning reports delivered for approval. They also supported cleanroom & IHT validation phases; IQ, OQ and PQ to ensure that the system meet our stringent requirements. The entire team have worked extra hours in this fast track project to meet the tight project deadlines.