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Is Sterad<sup>R</sup> from Jandamp;J is Truly Plasma Gas Sterilizer? | OMICS International
ISSN: 2167-7689
Pharmaceutical Regulatory Affairs: Open Access
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Is SteradR from J&J is Truly Plasma Gas Sterilizer?

Hideharu Shintani*

Chuo University, School of Science, Tokyo, Japan

*Corresponding Author:
Hideharu Shintani
Chuo University, School of Science, 1-13-27
Kasuga Bunkyo 112-0003, Tokyo, Japan
Tel: +81425922336
E-mail: [email protected]

Received date: December 13, 2013; Accepted date: December 16, 2013; Published date: December 18, 2013

Citation: Shintani H (2013) Is SteradR from J&J is Truly Plasma Gas Sterilizer? Pharmaceut Reg Affairs 3:e124. doi:10.4172/2167-7689.1000e124

Copyright: © 2013 Shintani H. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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SteradR from Johnson & Johnson (J&J) is provided as a hydrogen peroxide (H2O2) gas plasma sterilizer in the market. Several papers published as SteradR is not H2O2 gas plasma sterilizer, but H2O2 gas sterilizer because SteradR can skip plasma exposure procedure to attain sterilization and the sterilization result is identical between with skipping and without skipping from the result of SAL (sterility assurance level) (Figure 1). In addition, from SteradR it produces OH radical for sterilization and OH radical has a greater oxidationreduction potential among active oxygen species (Table 1), but the life period of OH radical is too short (10-6 to 10-9 second), indicating it is hard to sterilize too large capacity like SteradR 100.

Name chemical sytructure Eh (V)
Hydroxy radical OH 2.05
Atomic Oxygen O1 1.78
Ozone O3 1.52
Hydrogen Peroxide H2O2 1.30
Hypochlorous Acid KOCl 1.10
Oxygen O2 0.94

Table 1: Oxidation reduction potential (Eh) of active oxygen.

pharmaceutical-regulatory-affairs-sterilization-cycles

Figure 1: The Sterad 100S sterilization cycles. The exposure time, for this particular cycle is about 55 min. Pressure changes during the cycle are shown in a log10 scale. During the cycle, exposures to hydrogen peroxide gas (injection of gas indicated by arrows) and times of plasma generation are shown (black bars). Note that atmospheric pressure is 760 mmHg.

Most of the gas plasma sterilizer has much smaller capacity to sterilize the items. These gases are nitrogen, oxygen, argon or xenon which are inert gases. On the contrary H2O2 gas itself has a sterilization capacity and lifer time is so and so. It means H2O2 gas plasma has no or little contribution to sterilization in SteradR. The main contribution of gas plasma is radical. Radical is too short life time and flight distance is also too short, therefore sterilizer capacity cannot large. Most of the gas plasma sterilizer capacity is around 10 cm distance between electrodes and the gases used are inert, so gas itself has no capability to sterilize bioburden (viable microorganisms on/in the products). SteradR can sterilize buiburden without any help of gas plasma, therefore the sterilizer capacity can be large, too large as a gas plasma sterilizer, therefore the serious gas plasma sterilizer researcher has a curiosity that SteradR is truly H2O2 gas plasma sterilizer.

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