Eudralex – ANNEX 12 – USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS – Free PDF download

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Introduction

Ionising radiation may be used during the manufacturing process for various purposes
including the reduction of bioburden and the sterilisation of starting materials, packaging
components or products and the treatment of blood products.

There are two types of irradiation process: Gamma Irradiation from a radioactive source
and high energy Electron Irradiation (Beta radiation) from an accelerator.

Gamma Irradiation: two different processing modes may be employed:

(i) Batch mode: the product is arranged at fixed locations around the radiation source
and cannot be loaded or unloaded while the radiation source is exposed.

(ii) Continuous mode: an automatic system conveys the products into the radiation cell,
past the exposed radiation source along a defined path and at an appropriate speed,
and out of the cell.

Electron Irradiation: the product is conveyed past a continuous or pulsed beam of high
energy electrons (Beta radiation) which is scanned back and forth across the product
pathway.

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Continue at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/anx12_en.pdf

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