EMA: Q&A on Use of X-Ray Sterilisation

On 9 November 2023, the EMA published a 5-page document with three Q&As on the extended interpretation of Annex 12 of the EU GMP Guideline "Manufacture of medicinal products using ionising radiation" for X-ray sterilisation processes. The questions relate to the use of X-ray sterilisation for single-use systems (SUS) in pharmaceutical manufacturing. These processes are becoming increasingly established.

So far, the two mainly industrial irradiation technologies used are:

• Based on radioactive cobalt-60, Gamma sterilization has around 80 % of the irradiation capacity installed worldwide.
• Electron beams account for around 20 % of the total installed irradiation capacity.

X-ray sterilisation is currently gaining importance:
Due to the increasing demand for pre-sterilised single-use materials, it is evident that gamma-ray sterilisation capacity at sterilisation companies is limited, not least due to a supply shortage of cobalt-60 and its disposal. An evaluation of alternative technologies such as X-ray radiation as an option for the sterilisation of components for single-use systems is evident: X-ray sterilisation techniques show a penetration depth of photon radiation comparable to gamma-ray sterilisation techniques and could be considered a suitable alternative to replace gamma sterilisation.

The EMA's detailed answers to the questions

1. What quality and GMP standards are relevant/applicable to support the use of an X-ray sterilisation process for Single Use Systems (SUS)?
2. What studies are expected to be performed to support a switch from an established gamma irradiation sterilisation process to an X-ray irradiation sterilisation process for Single Use Systems (SUS)?
3. When would such a switch in sterilisation process trigger the submission of a variation?

explain to manufacturers of sterile products how X-ray procedures can be used in compliance with GMP. As Annex 12 of the EU GMP guideline "Manufacture of medicinal products using ionising radiation" refers exclusively to gamma- and electron radiation, the Q&A closes a gap. Among other things, the responsibilities of the manufacturer, the risk assessment process, the implementation of qualification and validation activities, or when changes to the authorisation dossier become appropriate are clarified for the GMP area.

Source:

EMA: Q&A on the use of X-ray sterilisation processes for Single Use Systems (SUS) used in pharmaceutical manufacturing