Validation protocol of ethylene oxide sterilization process
Ethylene Oxide Sterilization validation protocol.doc (229.0 KB)
Thanks for posting this. Very timely for me, as a matter of fact!
Welcome.
Selv-Tak
Thanks for the help.
but still i have one querry can u pl help me.
I wanted to know the resiudal level of ETO after the completion of cycle and the procedure for the detecting the level of the same, which is not avaialble in ur protocol, however the test is mentioned but not the limit and the procedure for verification.
ANSI/AAMI/ISO guidance 10993-7:1995, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals and in AAMI TIR-19.
[COLOR=“blue”]Since ethylene oxide is neurotoxic, in addition to measuring the EtO residue levels, additional testing should be performed on the finished EtO sterilized device using intracranial implantation to assess irritation. Evidence should be provided demonstrating that the level of sterilant residues remaining in the device do not raise concerns over the safe use of the product.
In general, a SAL of 10-6 is important for dura substitutes, unless there is scientific justification for not being able to achieve this level and that it does not create a safety concern. The processing methods and sterilization techniques should be demonstrated to be sufficient to reduce the amount of virus in the final product by at least 106 fold. Such data can be obtained by determining the viral inactivation properties of scaled down versions of specific production techniques and sterilization methods using appropriate model viruses.
Review of the International Conference on Harmonisation’s “Q5A Viral Safety Evaluation of Biotechnology Products from Cell Lines of Human or Animal Origin” is recommended with regard to the design of such studies and the selection of model viruses. The final results of these studies should demonstrate that the sum of the log clearance of virus from the selected process steps and sterilization processes are at least six logs greater than the concentration of virus anticipated in the unprocessed source material.[/color]
A quick note to all readers, ISO 10993-7:1995 is no longer active as it has been replace with the 2008 release. This version has significantly reduced the acceptable residuals limits from EtO sterilization.
If there are any questions, please feel free to contact me.
Robert J. Bard, JD, CQE, RAC
Managing Director, HealthCare Technologies Consultants
Yes. I gave reference in another post and uploaded the old guidance right here.I do not want to infringe on the legal disclosure of these ISO documents.
Thanks for your comments.