Maintaining the integrity of a sterile barrier system is essential to protect the sterile contents until the point of use. Smithers provides independent laboratory testing to evaluate package and seal integrity, identify potential failures and assess package strength.
Testing can support packaging development, validation and stability programmes for terminally sterilised medical device packaging.
- Integrity testing evaluates the continuity of the package and seals and can identify leaks, channels or other potential failure points.
- Strength testing evaluates the mechanical performance of the package and seals, including the force required to separate seals and resistance to burst or creep failure.
Sterile barrier system testing capabilities
Our testing capabilities include:
- Packaging system performance
- Stability testing
- Gross leak detection
- Dye penetration
- Seal strength
- Bubble emission leak testing
- Visual inspection
Standards and test methods
Testing can support requirements within ISO 11607-1, including packaging system performance and stability testing, with applicable test methods including:
- ASTM F2096 – gross leak detection
- ASTM F1929 – dye penetration testing
- ASTM F88 – seal strength testing
- ASTM D3078 – leak detection by bubble emission
- ASTM F1886 – visual inspection
Talk to our experts about your sterile barrier system, packaging validation
- ISO 11607-1 Testing for Medical Device Packaging
- Medical Device and Pharmaceutical Shipment Studies
- Shelf Life Studies
- Sterile Barrier System Integrity Testing
- Tamper-Evident Packaging Testing
- Temperature-Controlled Vibration Testing for Healthcare Packaging
- Temperature-Controlled Vibration with Pressure Testing for Drug Product Stability