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Performance of Qualification of Ethylene Oxide Gas Sterilization Process Hideharu Shintani* Chuo University, Tokyo, Japan *Corresponding author: Hideharu Shintani, Faculty of Science and Engineering, Chuo University, 1-13-27, Kasuga, Bunkyo, 112-8551, Tokyo, Japan, Tel: +8142592233; Fax: +81425922336; E-mail: shintani@mail.hinocatv.ne.jp Received March 25, 2015; Accepted March 26, 2015; Published April 02, 2015 Citation: Shintani H (2015) Gas Plasma Exposure to Bacterial Spore, Endotoxin and Prion. Pharmaceut Reg Affairs 4: e152. doi:10.4172/2167-7689.1000e152 Copyright: © 2015 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. There are several different methods for performance qualification of an ethylene oxide gas (EOG) process for sterilization of a medical device or component. They are half cycle method, overkill method, combined BI (biological indicator)/bioburden method and absolute bioburden method. The most popular procedure is overkill method as described in ISO 14161. This is the most popular and cost-effective method utilized in the industry today. ISO14161 and ISO 11135 describe the qualification process for an overkill method as follows: This method involves determination of the minimum time of exposure to EOG, with all other process parameters held constant, at which there are no survivors of BIs. A short duration from which survivors can be recovered should also be run to demonstrate the adequacy of the recovery technique. Initial population is 106 CFU (colony forming unit)/carrier and SAL (sterility assurance level) of 10-6, so as a whole 12 log reduction exposure time is the overkill method. The qualification method described above is very similar to a half cycle method. In overkill method, one half of the gas exposure times were conducted in which a 106 CFU/carrier BI is reduced to SAL of 100 spores when it is placed in the most difficult to sterilize location within the medical device and within the sterilizer load and this 6 log reduction doubled and as a whole 12 log reduction (Figure 1). The BI used for EOG sterilization is Bacillus atrophaeus ATCC 9372, which is defined in ISO 11138-2. Also as a benefit, the fractional cycle may be utilized to establish a relationship between a BI placed on the outside surface (external) of a pallet and the BI placed in the most difficult to sterilize location (internal). This data may allow routine monitoring using only external BIs, thus preventing internal BI monitoring. This is a great advantage since the cartons do not have to be opened which prevents potential operator exposure to elevated levels of ethylene oxide. Monitoring of internal load temperatures and relative humidity is also a requirement of performing qualification process which complies with the guidelines established in ISO11135. The total number of sensors required is load size dependent. The actual number can be calculated using the formulas and procedures identified in the respective documents. The parts of a simple EOG validation, assuming qualification of a single device of simple design, are presented below. AAMI TIR No. 14-19975, titled “Contract Sterilization for Ethylene Oxide” recommends that all qualifications be performed using a written action plan in the form of a protocol.

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