A company specialising in medical gas solutions and their means of delivery approached Sovrin to develop and manufacture a novel device for the administration of a special mixture of medical grade helium and oxygen.
Project:
- Design and development support for moulding, assembly and testing
- Consideration of critical failsafe features
- Support of polymer selection with Moldflow
- Integration of crucial bought-in components
- Validation of mould tooling, components and device assembly
- Support in the preparation of FDA compliant Drug Master Files
- 100% Functional Testing
- Application of labels and point-of-use packaging
Outcome:
- Protocols for mould tool validation compiled and objectives achieved
- Tooling validated by use of IQ, OQ, & PQ.
- FDA compliant Drug Master Files prepared
- Product taken to clinical and user trials as programmed