VHP sterilization

MedDev12

Registered
Hello,

I am seeking insights on the measurement and permissible limits for hydrogen peroxide residue in medical devices sterilized using vaporized hydrogen peroxide (VHP). Based on my review of ISO 22441:2022, Sterilization of healthcare products – Low temperature vaporized hydrogen peroxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices, and the recent 3-part webinar series from NelsonLabs, it seems that the permissible residue levels for hydrogen peroxide have not yet been fully established by the technical committee.

From what I have gathered so far, the primary option appears to involve working with a toxicologist to conduct a toxicological risk assessment (TRA) specific to our device. We have already conducted a TRA for our device, which concluded that it is safe.

However, when it comes to in-house measurement of hydrogen peroxide residue using test kits or peroxide strips, the challenge is the absence of specific comparative values, except those set by the FDA, such as the limit of <0.5 ppm hydrogen peroxide in distilled water under production conditions (2023, Food and Drugs, Chapter I, Subchapter B – Food for Human Consumption, CFR Title 21).

Has anyone in this community faced a similar challenge in establishing residue limits for hydrogen peroxide after VHP sterilization? How do you measure and validate hydrogen peroxide residues for medical devices? Are there any practical insights or standards, protocols you follow when working with in-house hydrogen peroxide measurement kits?

I am particularly interested in learning from those who use VHP sterilization and how they navigate the absence of clear residue limits in standards.

Thank you in advance for your guidance and insights!

Note: I am currently unable to reply to this thread as I have not yet fulfilled the 10 post requirement. I will gladly send a private DM to anyone with insights.

Thank you in advance for your guidance and insights!
 
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