ISO 11607-1 Testing for Medical Device Packaging

ISO 11607-1 specifies requirements for materials, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilised medical devices until the point of use.

Smithers can support packaging programmes through testing of materials, sterile barrier integrity, packaging performance, stability and distribution performance.

Testing can support a range of sterile barrier packaging formats, including bags, pouches, blisters and rigid blister packs.

Materials testing for ISO 11607-1

Smithers provides physical and chemical testing to characterise materials used in sterile barrier and packaging systems. Many of these methods are available as UKAS ISO 17025 accredited testing.

Sterile barrier system and packaging performance

Our healthcare packaging and materials specialists can provide testing to evaluate:

• Sterile barrier system integrity – including seal integrity, leak detection and visual inspection
• Package and seal strength – including peel, burst and creep performance
• Shelf life and stability – including real-time and accelerated ageing studies
• Distribution performance – including vibration, shock, compression and climatic conditioning
• Post-distribution integrity – assessing sterile barrier integrity following simulated shipment and environmental exposure

Testing is available using recognised international methods, with UKAS ISO 17025 accredited testing available for a range of relevant methods.

Where required, our specialists can also draw on wider Smithers expertise in Packaging Materials Testing and Distribution Testing to support more complex programmes.

Talk to our experts about your sterile barrier system, ISO 11607-1 requirements and the testing needed for your packaging programme.