Use of Enzyme Indicators, Enhanced and accelerated validation of Hydrogen Peroxyde sanitization cycles

Franck PAVAN1, Phillip GODDEN2 1. EUROCOM SARL 6 Chemin des Garennes, 31260 TOUILLE France
2. PROTAK SCIENTIFIC, England

In the evolution of the sanitization systems used for generation of Vaporised Hydrogen Peroxyde dedicated to isolators for pharmaceutical preparation and cleanrooms, main bottleneck is the method used for validation and control activities. Validation methods are using Biological Indicators to insure a correct qualification of sterilization cycles.

These Indicators have to be incubated for 7 days in order to clearly demonstrate cycle validation.

Public Health England investigated alternatives for years in order to prevent to wait for so long and to replace Biological Indicators in order to minimize this incubation period in order to control quickly the killing effect of the sterilization cycles performed with VHP (Vaporised Hydrogen Peroxyde)

After 15 years of Research & Development, a special protein discovered in a highly resistant to oxydative agents micro-organism led to a tremendous breakthrough and released a new alternative to Biological Indicators.

Protak Scientific acquired the worldwide exclusive rights on this molecule and EUROCOM became the french distributor of Protak Scientific product line.

This protein called « thermostable Adenylate Kynase (tAK) » will be introduced in the
presentation, this poster will introduce the work done and the several dedicated products developed specifically to serve the hospital and pharmaceutical market to reduce the incubation period from 7 days to 1 minute.

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