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.
 
Strength
Structure
Chemical
  • Burst strength: ISO 2758
  • Puncture: ASTM D1709, ASTM F1306, ASTM D3420
  • Tear resistance: ASTM D1922, ASTM D1938, ISO 1974
  • Tensile properties: ISO 1924-2, ASTM D882
  • Wet burst: ISO 3689
  • Wet tensile properties: ISO 3781
  • Basis weight: ISO 536, ASTM D4321, ASTM D3776
  • Thickness and density: ISO 534, ASTM D645, ASTM F2251
  • Coat weight: ASTM F 2217
  • Air permeance: ISO 5636-2, ISO 5636-3, ISO 5636-5, ASTM D737
  • Conditioning: ISO 187, ASTM D4332, ISO 2233
  • Flexural durability: ASTM F392
  • Chlorides: ISO 9197
  • pH: ISO 6588-1, ISO 6588-2
  • Sulphates: ISO 9198
 

Sterile barrier system and packaging performance

Our healthcare packaging specialists can also 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 packaging programmes.

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

 

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