Tuesday, 26 March 2013

Sterilization by Gamma Radiation for Single-Use Disposable Technologies

Pharmaceutical Technology are hosting a free to read paper by Tim Sandle and Madhu Raju Saghee entitled "Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector".

The introduction to the article reads:

"The primary method for the sterilization of single-use technology is by gamma irradiation. This is because plastics cannot be subjected to heat-based methods of sterilization without damaging the mould (i.e., styrene and other plastics are temperature sensitive). Other alternative methods, such as gaseous sterilization by ethylene oxide, that although used on occasions, can leave unwanted and potentially toxic residuals (e.g., ethylene glycol and ethylene chlorhydrin) post-sterilization (4). Other alternative sterilization methods (e.g., liquid peracetic acid immersion system and plasma sterilization processes) are not sufficiently well established (5). Electronic beam irradiation is an alternative method of radiation to gamma. This is a concentrated, highly-charged stream of electrons generated by the accelera tion and conversion of electricity (6). Electronic beam radiation is not commonly used for single-use disposable systems due to its relatively limited ability to penetrate some types of plastics. Therefore, single-use systems are typically sterilized using gamma rays (i.e., electromagnetic wave radiation). Despite the widespread application of the gamma irradiation, the process remains the only primary sterilization method not described in either the European Pharmacopoeia or United States Pharmacopeia (USP).


This paper outlines the process of gamma radiation and describes the important aspects of validation. The paper is designed to provide a guide to those wishing to understand more about the process and to offer advice for quality assurance personnel who are required to audit the sterility assurance of gamma radiation." 

To read the full paper, go to Pharmaceutical Technology.

Sandle and Saghee are the editors of the new book "Cleanroom Management in Pharmaceuticals and Healthcare".

Posted by Tim Sandle