Biological indicator with resistance properties adjusted

The bio-sterilization indicator, designed with a non-porous hydrophobic substrate and a fragile container, solves the problem of insufficient resistance of traditional indicators in monitoring extended sterilization cycles, and achieves effective monitoring and reliable sterilization of complex medical devices.

CN117500532BActive Publication Date: 2026-07-073M INNOVATIVE PROPERTIES CO
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
3M INNOVATIVE PROPERTIES CO
Filing Date
2022-05-24
Publication Date
2026-07-07

AI Technical Summary

Technical Problem

Traditional bio-sterilization indicators are not resistant enough to monitor extended sterilization cycles, cannot effectively monitor the sterilization effect of complex designs or large medical devices, and have variability issues when placed in the equipment.

Method used

The biosterilization indicator is designed with a non-porous hydrophobic substrate and includes a shell and a container. The container can change its state before and after sterilization. The compartment design and substrate control fluid flow, increase resistance and provide a moisture barrier. The fragile container and fluid path promote contact between the sterilizing agent and the bioactive source.

Benefits of technology

It improves the monitoring capability of biological sterilization indicators during extended sterilization cycles, ensures the reliability of sterilization effects, reduces variability when equipment is placed in the system, and enhances the moisture barrier effect.

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Abstract

A biological sterilization indicator (BI) is provided. The BI can include a housing and a container disposed in the housing. The BI can also include a first chamber and a second chamber having a source of biological activity disposed therein. The BI can also include a substrate disposed in the housing between the first chamber and the second chamber. The substrate can be disposed in fluid communication with the first chamber and the second chamber, and the substrate can also be disposed such that the substrate does not directly contact the source of biological activity. The substrate can include a hydrophobic non-porous membrane having an orifice. The substrate and the orifice can be sized to control fluid flow between the first compartment and the second compartment. The substrate can extend substantially around an entire inner perimeter of the housing between the first compartment and the second compartment.
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Citation Information

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