10 Things to include in a sterilization validation protocol

Ship & Print Your FDA eCopy

October 2016

2 min reading time

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.

++++++++++++++++++++++++++++++++++++++++++++++++++++++++

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/.

++++++++++++++++++++++++++++++++++++++++++++++++++++++++

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

Marked as spam

Posted by Rob Packard

Asked on October 31, 2016 8:00 am

2830 views

	Private answer The testers qualification measuring equipment calibration status also have to include and make sure valid status during validation. Marked as spam Report spam
	Private answer Alex Kennedy I am not quite certain what form of sterilization your article is directed at; however no matter whether it is ethylene oxide (EO & EtO) or steam the pressure, temperature and time parameters are all critical to the efficacy of the process. A pre & post in-situ check calibration of the temperature chamber monitoring system must be produced and attached to the protocol. The steam (if used) must have current quality validation. The copies of the calibration certificates for all test and critical process instrument and sensors must be attached to the protocol. The FDA express forbids the use of check lists in validation. Etcetera, etcetera, etcetera. The list produced is seriously flawed. Alex Marked as spam Report spam
	Private answer Rob Packard In response to Alex's comment, the brief announcement I sent out was not intended as a checklist for validation. These are just 10 of the 20+ things I reviewed when I was reviewing and editing an ethylene oxide sterilization validation protocol. The protocol for this type of validation is typically 20-30 pages in length and I was just providing advice on what to look for in a protocol rather than blindly accepting what a vendor provides. BTW...EO and EtO both refer to ethylene oxide. Marked as spam Report spam
	Private answer Sometimes I think you read my mind and know all my doubts. Thank you very much Marked as spam Report spam
	Private answer Alex Kennedy I understand your comments, however, when students come to these forums and read comments; that no one has challenged, they then can only assume that the comments are accurate and represent acceptable practice. It is up to the forum members to ensure that only “best practices” are allowed to pass uncommented. Alex Marked as spam Report spam
	Private answer What would you recommend as minimum requirements for describing the associated bioburden testing in the EO sterilization validation protocol? Marked as spam Report spam

« Back to Previous Page

Meet your next client here. Join our medical devices group community.