Will just Heat and Humidity be Adequate to Simulate EtO Sterilization?

D

dxchang

My company makes single use disposable catheters that are supplied to customers sterilized by EtO. We are testing a new product and want to simulate the sterilization effect (to save time from having to send the products for regular sterilization, which takes at least 2 weeks back and forth). To describe loosely, the simulated sterilization is achieved with high heat and high humidity.

My understanding of EtO sterilization is the combination of heat, humidity, pressure and the gas itself. Assuming we are 100% certain that the EtO gas does not react with our products, will just heat and humidity adequate to simulate sterilization? Looking forward to some feedback.
 
M

MIREGMGR

Not from a regulatory validation perspective.

If you're just doing a technical investigation for your own non-regulatory purposes, such a technique would simulate the effect of heat and humidity, which perhaps could be useful. It would be a stretch to claim that it simulated anything more.

When you say your product has no reaction with EtO, are you including chemical interactions with, and residuals of, EtO-H2O reaction products?
 
D

dxchang

Dear MIREGMGR, thank you for your feedback. I would like to take a step back to understand a bit more about sterilization validation. When validating the functional properties of a product post sterilization, what sterilization parameters should be considered? Heat, humidity, EtO gas, pressure, what are the other parameters? What would you propose to simulate sterilization? Or can it be done at all? Also, at the end of the reply, you asked me if I have inlcuded "chemical interactions with, and residuals of, EtO-H2O reaction products?" Could you elaborate what these interactions are? I appreciate your input. Thanks!
 
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