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Sterilant Penetration Studies

Sterilant Penetration Studies

The sterilant penetration test validates that the packaging permits proper penetration of the sterilant.  This ensures that the penetration of the sterilant is sufficient for the packaged contents.  The contents may be medical devices, implants, trays or other sterilizable items. The packaging is critical in allowing proper sterilization and in maintaining a sterile barrier following the sterilization process.    

This test meets the recommended requirements in AMMI in TIR12, ANSI/AAMI/ISO 17665-1, AAMI ST79 and ISO 17664.  Nelson Laboratories has expertise in a wide array of packaging materials.  We will help develop a customized test plan depending on the specific type of packaging.  

Applicable Standards

  • ISO 11607
  • AAMI TIR 12
  • ANSI/AAMI/ISO 17665
  • AAMI ST 79
  • ISO 17664

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
SPV110 Packaging: Sterilant (Steam) Penetration, Thermocouple, test & predicate 0 Add
SPV210 Packaging: Sterilant (Ethylene Oxide) Penetration, test & predicate 0 Add
SPV310 Packaging: Sterilant (STERRAD) Penetration, test & predicate 0 Add
SPV110 - Packaging: Sterilant (Steam) Penetration, Thermocouple, test & predicate
TAT: 0 days
SPV210 - Packaging: Sterilant (Ethylene Oxide) Penetration, test & predicate
TAT: 0 days
SPV310 - Packaging: Sterilant (STERRAD) Penetration, test & predicate
TAT: 0 days

Sample Specifications

SPV110: Single use – 50 test and 50 predicates; Reusable – 5 test and 5 predicates
SPV210: Single use – 50 test and 50 predicates; Reusable – 5 test and 5 predicates
SPV310: Single use – 50 test and 50 predicates; Reusable – 5 test and 5 predicates

Study Outline

The sterilant penetration test evaluates packaging material for sterilant penetration properties.  Testing specifics may include biological and chemical evaluations, adequate drying time and temperature mapping.  For some sterilization methods, the packaging may need to go through aeration and residual testing to ensure proper residual levels are met. Depending on the packaging, a wide array of samples may be appropriate.  Anything from test packs to metal trays may be used in the testing procedure.  Specific sterilization methods and set points will be tested.  

Please contact an FDA reviewer for appropriate sample numbers and configurations.

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