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
25
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
13
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