Avenue's significant expertise in validation, Class 100,000 clean room and in-depth knowledge of regulatory requirements have earned us a reputation for excellence among our OEM customer base.
Our capabilities include in-house protocol generation, with validations also carried out to customer supplied protocols. In both instances quality validation procedures are applied, and all validation protocols and reports are sufficiently comprehensive to meet FDA and GHTF validation guidance requirements.
Additional services Avenue provides in this area include:
- Mould validation at customer premises
- Assistance with installation, commissioning and training
- Mould repair and modification
1. Installation qualification
This procedure considers:
- Equipment design features
and installation conditions - Safety features
- Calibration and preventative
maintenance requirements - Software documentation
- Supplier documentation
- Spare parts
2. Operational qualification
- Optimisation
- Taguchi and G&A analysis used
to determine key process variables
in the design of experiments - Process parameter values are established
- Cp determined
- Confirmation - run 1
- Optimised settings ran to confirm part
quality is acceptable - Critical dimensions measured using CMM to compare results with initial trial
- Process capability
- Critical dimensions measured using CMM to determine Cpk and final mould sizing
- Confirmation - run 2
- If mould re-sizing takes place following process capability, further measurements are carried out to confirm the changed dimensions and to ensure the required Cpk is achieved
3. Performance qualification
- Confirms that the process consistently produces a product which meets pre-determined requirements - normally three runs are involved