White Paper: X-Ray sterilisation

There are several emerging methods of sterilisation which may, in time, become established methods for the sterilisation of pharmaceutical products, medical devices or healthcare materials. Such technologies include: X-rays, ultrasonication, supercritical gases, ultraviolet light, pulsed light, microwaves, infrared radiation, and plasma. This article considers X-rays.

All emerging technologies need to meet a number of criteria in order to be considered as suitable methods for the sterilisation of a product. These criteria are⁽¹⁾:

• The technology can achieve a Sterility Assurance Level of 10^-6 or greater.
• The product can withstand the sterilisation conditions.
• The process can achieve the necessary assurance of sterility.
• Terminal sterilisation of the product can be achieved within the final packaging.
• No chemical residues are created as a by-product of sterilisation.
• Understanding the physical and chemical conditions required to achieve sterilisation.

In addition, novel sterilisation technologies:

• Need to be sufficiently advanced to be used on a practical scale.
• Must be able to be validated, to show microbial kill.
• Must be affordable.
• Must be safe to use.
• Need to have a processing time that meets with production requirements.

To assist with the introduction of new technologies, the international standard ISO 14937 ‘Sterilisation of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilisation process for medical devices’⁽²⁾, provides useful guidance for the development and validation of alternative technologies. The approach is also useful when approaching the sterilisation of other items.

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