阅读说明：本技术 用电子束辐射对柔性袋灭菌的改进装置和对其灭菌的方法 (Improved apparatus for sterilizing flexible bags with electron beam radiation and method for sterilizing same ) 是由 乔迪·博伊拉邦霍拉 丹尼尔·弗莱塔科伊特 卡洛斯·罗拉萨赖尔蒂 于 2020-03-31 设计创作，主要内容包括：本申请涉及用电子束辐射对柔性袋灭菌的改进装置和对其灭菌的方法。本发明涉及制药领域,具体地说,涉及一种用于柔性袋的电子束辐射灭菌的改进装置,该柔性袋特别是可容纳用于治疗用途的人血浆蛋白溶液的柔性袋的类型。该装置包括两个电子加速器:第一个加速器发射能量在400keV和500keV之间的电子束,第二个加速器发射能量至少为4MeV的电子束。此外,本发明涉及通过电子束辐射对这种柔性袋进行灭菌的方法,以及使用本发明的灭菌装置和方法的柔性袋的连续填充流程。(The present application relates to an improved apparatus for sterilizing flexible bags with electron beam radiation and a method of sterilizing the same. The present invention relates to the field of pharmacy and, in particular, to an improved device for electron beam radiation sterilization of flexible bags, particularly of the type that can contain solutions of human plasma proteins for therapeutic use. The apparatus comprises two electron accelerators, a first accelerator emitting an electron beam having an energy between 400keV and 500keV and a second accelerator emitting an electron beam having an energy of at least 4 MeV. Furthermore, the present invention relates to a method for sterilizing such flexible bags by electron beam radiation, and a continuous filling process of flexible bags using the sterilization apparatus and method of the present invention.)

1. An apparatus for sterilizing flexible bags, characterized in that the apparatus comprises a sterilization zone comprising a first accelerator emitting an electron beam with an energy between 400keV and 500keV and a second accelerator emitting an electron beam with an energy of at least 4 MeV.

2. The apparatus for sterilizing flexible bags according to claim 1, wherein said second accelerator emits an electron beam having an energy between 4MeV and 5 MeV.

3. The apparatus for sterilizing flexible bags according to claim 2, wherein said second accelerator emits an electron beam with an energy of 4 MeV.

4. An apparatus for sterilizing flexible bags according to any of claims 1 or 3, characterised in that said accelerators are arranged parallel at the top of the apparatus and in such a way that they emit an electron beam downwards in a direction perpendicular to the ground.

5. An apparatus for sterilizing flexible bags according to any of claims 1 to 4, characterised in that it is arranged in a radiation-proof area where measures have been taken to control the radiation emitted by the electron accelerator.

6. An apparatus for sterilizing flexible bags according to claim 5, characterised in that said control means are walls and/or floors at least 65cm thick.

7. An apparatus for sterilizing flexible bags according to claim 6, characterised in that said walls and/or bottom plate are made of lead.

8. A method of sterilizing a flexible pouch containing a human plasma protein solution using an electron beam using the apparatus according to any one of claims 1 to 7, comprising the steps of:

a) emitting at least one electron beam having an energy between 400keV and 500 keV;

b) after about 10 nanoseconds to 1.5 seconds, at least one second electron beam pulse having an energy of at least 4MeV is emitted.

9. The method of claim 8, wherein the second accelerator emits an electron beam having an energy between 4MeV and 5 MeV.

10. The method of claim 9, wherein the second accelerator emits an electron beam having an energy of 4 MeV.

11. The method according to any one of claims 8 to 10, wherein the distance from the flexible bag to be sterilized to the radiation source is between 1.5cm and 7 cm.

12. The method of claim 11, wherein the distance from the flexible bag to be sterilized to the radiation source is 4 cm.

13. The method according to any one of claims 8 to 12, wherein the bag to be sterilized may comprise a volume of 50mL to 500 mL.

14. A method according to any of claims 8 to 13, wherein the method is performed before or after bag filling.

15. The method according to any one of claims 8 to 14, wherein the accelerators are arranged in parallel at the top of the device and are arranged to emit electron beams downwards in a direction perpendicular to the ground.

16. The method according to any one of claims 8 to 15, wherein the solution contained in the flexible bag is a pharmaceutical solution of biological origin, such as blood or a blood product, such as plasma, serum, red blood cells, albumin, alpha 1-antitrypsin, von willebrand factor, coagulation factors including factor VII, factor VIII and factor IX, immunoglobulins, plasminogen, plasmin, antithrombin III, fibrinogen, fibrin, thrombin or combinations thereof.

17. A continuous filling method for flexible bags, characterized in that it comprises the following steps

a) Bag formation and thermal printing;

b) sterilizing the pouch by electron beam with the method of claims 8 to 14;

c) filling the pouch with a human plasma protein solution in a sterile environment; and

d) the bag is sealed.