ANNEX 12 USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS 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. irradiation: two different processing modes may be employed: (i) Batch mode: the products 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 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. 1. Treatment by irradiation may be carried out by the pharmaceutical manufacturer or by an operator of a radiation facility under contract (a "contract manufacturer"), both of whom must hold an appropriate manufacturing authorisation. 2. The pharmaceutical manufacturer bears responsibility for the quality of the product including the attainment of the objective of irradiation. The contract operator of the radiation facility bears responsibility for ensuring that the dose of radiation required by the manufacturer is delivered to the irradiation container (i.e. the outermost container in which the products are irradiated). 3. The required dose including justified limits will be stated in the marketing authorisation for the product.
ANNEX 12 USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS 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. irradiation: two different processing modes may be employed: (i) Batch mode: the products 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 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. 1. Treatment by irradiation may be carried out by the pharmaceutical manufacturer or by an operator of a radiation facility under contract (a "contract manufacturer"), both of whom must hold an appropriate manufacturing authorisation. 2. The pharmaceutical manufacturer bears responsibility for the quality of the product including the attainment of the objective of irradiation. The contract operator of the radiation facility bears responsibility for ensuring that the dose of radiation required by the manufacturer is delivered to the irradiation container (i.e. the outermost container in which the products are irradiated). 3. The required dose including justified limits will be stated in the marketing authorisation for the product.
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