Commissioning

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
  • Commissioning

Project Details

Key Features:

  • 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

Project Size:
5,000 sq.ft

Project Value:
Confidential

Client Reference:
Available Upon Request

 

 

 

 

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