Module 14: Design Development and Certification of Medical Devices

17/11/2023

CHLORINE DIOXIDE STERILISATION

● Same basic stages as ETO – Acts as an oxidizing agent - reacts with several cellular constituents, including the cell membrane of microbes.

– By "stealing" electrons from them (oxidation), CD breaks their molecular bonds, resulting in the death of the organism by the break up of the cell.

– The potency of CD is attributable to the simultaneous, oxidative attack on many proteins, thereby preventing the cells from mutating to a resistant form.

– Because of the lower reactivity of CD, its antimicrobial action is retained longer in the presence of organic matter.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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CHLORINE DIOXIDE STERILISATION

SUITABLE FOR: – Items that cannot be sterilised at high temperature and under moist conditions – Due to its low (15° to 40°C) temperature conditions, CD sterilisation is well suited for medical devices with embedded electronics. – CD gas is NON-FLAMMABLE at concentrations used and is NOT CARCINOGENIC – It does not require high concentrations to achieve sporicidal effects

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

26

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