Medical Gas Delivery Device
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