Commissioning of a New Sterility Assurance Microbiology Laboratory
CIBA Vision Canada, Mississauga, ON, Canada
SAGE Engineering Services Inc. was selected as the Engineering Services provider throughout the Start-Up and Commissioning phases of the Sterility Assurance Microbiology Laboratory construction.
Upon completion of the newly designed Sterility Assurance Microbiology Laboratory, SAGE was the recipient of a client’s award which formally recognized their commitment, approach and overall project dedication.
SAGE was responsible for commissioning new equipment/systems that included an ISO Class 10,000 HVAC system, an ISO Class 100 sterility testing isolator, clinical fridges, incubators, bio-safety cabinets, laminar flow hoods, a laboratory water system, and a decontamination autoclave. Existing equipment that was modified and commissioned included a sterilizing autoclave, incubators, laminar flow hoods, clinical fridges and a cryofreezer.
SAGE Engineering dedicated a team which integrated with the client team from the installation of the equipment/systems to the release of the Sterility Assurance Microbiology Laboratory for use by the Microbiology department. The SAGE team provided Project Management, Vendor Management, and Commissioning support for the following:
- Installation coordination for new microbiology equipment and supporting systems
- Modification and installation coordination of existing equipment
- Commissioning protocol development and execution
- Management of cross-functional teams representing different departments and vendors
- Facility and equipment execution against GMP/GLP requirements
- 5,000 sq.ft state of the art microbiology laboratory
- Designed for sterility assurance sample testing
- Laboratory designed for an ISO Class 10,000 environment containing an ISO
- lass 100 Sterility Testing Isolator
- Commissioning of laboratory equipment and supporting systems
Available Upon Request