AM Technical Solutions has been chosen for a new CQV (Commissioning Qualification Verification) project for a leading biotechnology company that develops gene therapies for patients with rare conditions.
The biotech company is looking to grow its capabilities by launching a new Life Science facility that will support advanced research.
AM was awarded significant project scope for the startup, commissioning, and qualification of the company's facility, utilities, and fixed process equipment to facilitate fit-out and startup.
Project scope for CQV
The scope for this project is to provide the biotech company with a technical team of qualified personnel to plan, lead, and execute the startup, commissioning, and qualification for the following key systems in the new facility:
- MEP Systems - Non-Hygienic
- MEP Systems - Hygienic
- Autoclave & Pure Clean Steam Generator
- Cold Room(s)
AM's team will employ several advanced Life Science methods and tools to successfully and safely complete the project on time and within budget.
To achieve this goal, the company will be prepared to bring in a turnkey team for implementation or supplement the client's team throughout the project. Through a collaborative approach, AM is confident that its team will deliver the right solution during each phase of the project so that we remain focused on successful project delivery.
Using early quality integration (EQI)
Specific to providing startup and CQV services, AM will utilise its proven approach of EQI. This approach brings a superior method for the design-build-qualify process by ensuring a First Time Right approach at each stage.
EQI starts with integrating the startup, commissioning, and qualification programme elements at the beginning of the engineering lifecycle. This ensures success by delivering on schedule with the right functionality and inherent quality, which results in reduced cost.
We are eager to implement our EQI approach to deliver on all aspects of the projects for our client
The EQI approach requires a comprehensive and hands-on understanding of starting up and operating Life Science facilities and processes. We possess expert knowledge of quality, regulatory, and process controls that informs the integrated requirements for all phases of the lifecycle, which drives project efficiency and effectiveness.
"We are eager to implement our EQI approach to deliver on all aspects of the projects for our client," said Brian Williams, SVP for AM Life Science. "We have the ideal experience, approach, expertise to provide our client with a world-class facility. Our team is committed to the mission of supporting our client's need for advanced research capabilities that will enable them to continue their life-changing work."
