Novel, Low Temperature Sterilizer
Developing novel life sciences technology is challenging, exacting and time intensive because of the rigorous performance and documentation standards required by the FDA.
For a start-up life sciences company introducing a novel, low temperature gas sterilizer to the medical industry, Primaira worked as the company’s research and engineering department, creating sterilization equipment to establish the sterilization process, prove the feasibility of the sterilizer, and provide the engineering support for an FDA submittal.
Senior Primaira staff served as VP of Engineering for the company through the initial critical development milestones. Primaira utilized its codified product development process to meet Good Manufacturing Practice requirements for the medical device development.
The engineering challenges included: safely delivering, metering, containing and scrubbing a highly toxic gas; developing a medical device for FDA approval; translating requirements from life sciences companies and hospitals into engineering specifications.