We regularly work with clients to develop validated test methods which are subsequently used to demonstrate conformance with ISO 11607 and to provide evidence for FDA and EU regulatory submissions.
We can provide testing services for the evaluation of bags, pouches, blisters and rigid blister packs and the materials used in the construction of these sterile barrier systems.
Our laboratory facilities enable us to test not only the strength, structural and chemical methods detailed below, but also make assessments on material properties and simulate transportation. For more information on these services, please see the relevant sections:
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Expert support for ISO 11607-1
- How we can help: We offer a range of tests on materials intended for the construction of sterile barrier packaging systems. Many of these are UKAS, ISO 17025 accredited.
Materials tests are used to evaluate the strength, structure and chemical properties of the materials used in the manufacture of medical packaging. The tests evaluate the properties of the:
- 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, EN868-2, ASTM D737
- Conditioning: ISO 187, ASTM D4332, ISO 2233
- Drape: ISO 9073-9, ISO 2493, DIN 53121
- Flexural durability: ASTM F392
- Chlorides: ISO 9197
- pH: ISO 6588-1, ISO 6588-2
- Sulphates: ISO 9198
Expert support with ISO 11607-2
ISO 11607-2 specifies the requirements for development and validation of processes for packaging medical devices which are terminally sterilized. These processes include forming, sealing and assembly of the sterile barrier packaging system.
- How we can help: We offer a number of services which support this process including test method development and validation, qualification testing and documentation support.
Test Method Development and Validation
Our experts have experience in designing and validating bespoke test methods. We perform validation testing to determine the test methods:
- Sensitivity and detection limits (for integrity tests)
Smithers Pira can perform testing on the product at each qualification stage:
- Instrument Qualification (IQ) - testing to aid critical process parameters to be defined.
- Operations Qualification (OQ) - testing on upper and lower parameter limits to ensure properties meet predefined requirements.
- Protocol Qualification (PQ) - testing to demonstrate consistent acceptable sterile barrier systems
We will work with you to prepare approved documents to provide evidence of conformity for FDA and EU regulatory submissions.
- Test protocols and reports
- Validation protocols and reports
- Supporting documentation – such as calibration records
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