COMBINATION PRODUCT INCOMING TO LOT RELEASE TESTING
Benefit
We’ve developed and validated custom deterministic CCI methods for client to use to test the integrity of samples for the purposes of lot release.
We developed all test methods used to support their program and authored custom Test method protocols to meet their requirements.
CCI:
- High voltage leak detection
- Helium leak detection
- Dye ingress
- Vacuum decay testing
- Performed feasibility with these methods and chose compatible method
A full suite of syringe functional tests including:
- RNS removal
- Breakloose glide force
- Deliverable volume
- Silicone scanning
- Safety device activation force
- Safety device override force
- And several others
A full suite of AI functional tests including:
- Cap removal force
- Activation force
- Force required to override lockout or other needle safety mechanisms
- Deliverable volume
- Injection time
- Injection depth
- And several others
