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    • 4. 发明授权
    • Terminal sterilization of injectable collagen products
    • 可注射胶原蛋白产品终端灭菌
    • US07902145B2
    • 2011-03-08
    • US11383845
    • 2006-05-17
    • George ChuC. Randall HarrellHector J. Gomez
    • George ChuC. Randall HarrellHector J. Gomez
    • C12M1/12A61K38/00
    • A61L2/007A61L2/0011A61L2/0035A61L2/0041A61L2/08A61L2202/23
    • Methods of sterilizing dermal fillers and injectable collagen material have been developed which reduce the level of active biological contaminants or pathogens without adversely affecting the material, i.e., wherein the dermal fillers and injectable collagen material retain their same properties before and after its terminal sterilization. In one embodiment the method for sterilizing the dermal filler or injectable collagen material that is sensitive to radiation contains the steps of protecting the filler or material from radiation, and irradiating the filler or material with a suitable dose of radiation for a time and at a rate effective to sterilize the filler or injectable material. In a preferred embodiment the method for sterilizing the dermal filler or injectable collagen material that is sensitive to radiation includes the steps of a) freezing the filler or material at a temperature below its freezing temperature, which is generally below 0° C. and b) irradiating the filler or material with a suitable dose of radiation at an effective rate for a time effective to sterilize the filler or material. The exposure of the radiation differs depending upon the density of the filler or material, but is preferably between 5 kGy and 12 kGy and more preferably between 6 kGy and 8 kGy. These doses result in a sterility assurance level (SAL) of 10−6 SAL for the filler or material.
    • 已经开发了对皮肤填充剂和可注射胶原材料进行灭菌的方法,其降低活性生物污染物或病原体的水平,而不会对材料产生不利影响,即其中真皮填料和可注射胶原材料在其终端灭菌前后保持相同的性质。 在一个实施方案中,对对辐射敏感的真皮填料或可注射胶原材料进行灭菌的方法包括以下步骤:保护填料或材料免受辐射,并且以适当剂量的辐射照射填料或材料一段时间 有效地对填料或可注射材料进行灭菌。 在优选的实施方案中,对对辐射敏感的真皮填料或可注射胶原材料进行灭菌的方法包括以下步骤:a)在低于其冷冻温度的温度下将填料或材料冷冻,其一般低于0℃,和b) 用合适剂量的辐射以有效速率照射填料或材料一段时间以有效地消除填料或材料。 辐射的曝光取决于填料或材料的密度而不同,但优选在5kGy和12kGy之间,更优选在6kGy和8kGy之间。 这些剂量导致填料或材料的10-6 SAL的无菌保证水平(SAL)。