I recently reviewed a sterilization validation protocol for a client and I thought some of you might be interested in the things that needed to be modified:

1. Make sure you specify the revision of all standards referenced and make sure the version is the most current version.
2. Be sure to plan for flexibility, such as the possibility of needing to perform two fractional cycles during EO sterilization instead of one.
3. Identify all the equipment, including the model of test sensors, that will be used during sterilization.
4. Explain the selection of worst-case product samples in detail–pictures are extremely helpful to demonstrate differences in configuration too.
5. Make sure you identify the genus, species and strain of the biological indicators used–and the supplier’s catalogue number for re-order of the biological indicators. There should also be a place to write the lot number, expiration date and D-value for the biological indicators in the data collection forms.
6. Include photos for your product, packaging and the biological indicator in the protocol. Reviewers need a clear picture of what the internal and external process challenge devices (PCDs) will look like, all the specifications and details.
7. Specify both the minimum and maximum loading conditions. Both need to be evaluated in your validation or you will need to use dunnage regularly.
8. Clearly define acceptance criteria for both the testing and the operating parameters. If written as a checklist, you can reuse the checklist later for review of sterilization documentation for each lot.
9. Specify how many samples will be taken. The number of samples must match the recognized standard or you must provide a statistical justification for the sample quantity.
10. If dunnage is used, specify what it is and how it compares to worst-case samples.

Note: Dunnage is a filler made of similar materials to your product. Dunnage is used to take up the space and should have approximately the same density as your packaged product during sterilization validation.

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I am teaching a live webinar on Sterilization and Shelf-Life Requirements this Thursday, November 3. The cost is $49: http://medicaldeviceacademy.com/sterilization-shelf-life-webinar/.

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I’m recruiting for a full-time consultant to help me with 510(k) submissions and I have a client in San Francisco that is hiring for a full-time QA/RA person. If you or someone you know is interested, please contact me at rob@13485cert.com or visit my website: http://medicaldeviceacademy.com/career/.

source: https://www.linkedin.com/groups/2070960/2070960-6198925349116477442