Comparison of radiation methods for the sterilisation of cleanroom items

 

Many items entering cleanrooms, especially aseptic processing facilities, are required to be sterile. Sterilisation by an ionising radiation source is the most common way of achieving sterility and is used for cleanroom garments as well as for plastic items intended for single use, such as sampling containers, aseptic connectors, biocontainer bags, and mixers. For several decades, Gamma radiation was the standard method for the irradiation of cleanroom consumables. In more recent years, both electron beam and X-rays have been added as ionising radiation methods for the processing of cleanroom items.

 

 

The increase in use of these latter technologies is evidenced by change control notifications from cleanroom product companies indicating a move away from Gamma radiation to these alternative radiation sterilisation methods (primarily electron beam but sometimes X-rays). The shift away from Gamma is because the process of radioactive decay utilises costly isotopes which require periodic replacement (typically five years) and because international transport for radioactive materials has become far more difficult.

 

This article looks at the similarities and differences between the three types of irradiation sterilisation technologies commonly used to irradiate items going into the cleanroom: Gamma, E-beam, and X-ray.

 

Sandle, T. (2022) Comparison of radiation methods for the sterilisation of cleanroom items, Clean Air and Containment Review, Issue 47, pp20-23

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)