Commissioning and qualification of manufacturing clean rooms

In 2014-2015 BEPC ensured the Commissioning and Qualification of a large Medical Device Manufacturing Facility part of a Fortune 500 company; two cleanrooms for a new facility were qualified as per defined in ISO14644-1, 2 for ISO Class 8 Cleanrooms. Implemented and qualified a versatile integration between Environmental Monitoring System and the Building Management System allowing these system to control and monitor Particulate, temperature, pressure and humidity data and process it to control the Cleanroom environment minute after minute. In Charge of the Commissioning and Qualification effort BEPC successfully commissioned all the ancillary systems for the startup building as well as participated with the Software development team to ensure the User Requirements Specifications were met with the EMS-BMS integration. BEPC also utilized Computer System Validation Methodology to qualify any computerized system as per the customer procedures, Industry best practices and FDA Regulations. BEPC also served as the temporary staffing agency for the Microbiology scientists, Quality Assurance engineering and project Management involved in the Development, execution, testing and data reporting activities related to commissioning, Installation Qualification and Operational qualification activities. BEPC has an extensive experience with several Document Management Systems and with the archiving, filing of any Validation documentation through the Documentation Control Vault.

BEPC Commissioning and Qualification Team ensured the customer’s facility, utilities and equipment perform as intended, and using a risk based approach. All activities and document development from User Requirement Specification to Factory and Site Acceptance tests were part of the Commissioning and Qualification activity.