MANUFACTURING PROCESS VALIDATION
Our approach to manufacturing process validation would typically follow the path
summarized below:
- Understand process
- Risk analysis
- Design experiments
- Check process capability
- Explore operating window
- Document and report
- Carry out any remedial action identified
PACKAGING PROCESS VALIDATION
An important requirement for bringing a healthcare product to market is providing
evidence that that pack protects the device and maintains sterility throughout
its shelf life.
Our recommended method for examining pack seals is burst testing. This approach
tests the entire seal as opposed to just a section of it. It also provides electronic
data for analysis and archiving. Combined with visual inspection of seal quality,
this is a very effective route to packaging validation. If packs are not porous,
we use a vacuum pressure decay system capable of detecting pin-size holes in the
pack web material.
- URS compilation
- Machine validation
- Process analysis
- Burst and creep test to ASTM F1140/F2054
- Dye penetration to ASTM F1929
- Gurley porosity to ISO 11607
- Microbial ranking to ASTM F1608
- Vacuum leak test for impermeable packs
STERILISATION PROCESS VALIDATION
- Bioburden measurement
- Sterilisation validation
- Residual gas assessment
- Post-sterilisation materials analysis
For further information and advice, please call us on (0)8454 588924 or E-mail:
