The biopharmaceutical industry gains enormous flexibility in production processes by using sterilized preassembled single-use devices. Gamma irradiation is an established sterilization technology that may be restricted in the future by the availability of ⁶⁰Co as irradiation source and irradiation capacities. X-ray technology is considered an alternative type of radiation for sterilizing SU equipment. In the context of extractables and leachables—one concern connected with the use of single-use process equipment—the effect of X-ray irradiation on the extractables profile of the materials needs to be compared to established gamma irradiation to qualify this alternative technology. An approach is presented to obtain robust and comprehensive extractables data for materials used in SU devices after sterilization either using X-ray or gamma irradiation. A careful selection of the test items and the test design allows a one-to-one comparison of data obtained from a combination of orthogonal analytical techniques. The extractables of a modern SU film material and the copolyester Tritan™ are evaluated. The data presented allow a risk evaluation on the safety of this new sterilization modality for biopharmaceutical applications. It is demonstrated that the extractables profile of a polymer is not affected by the type of irradiation used for sterilization.

中文翻译：

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生物制药制造设备的 X 射线灭菌——薄膜材料和共聚酯 Tritan™ 与伽马射线辐照相比的可提取物特征

生物制药行业通过使用经过消毒的预组装一次性设备在生产过程中获得了巨大的灵活性。伽马辐照是一种成熟的灭菌技术，未来可能会受到⁶⁰Co作为辐照源和辐照能力。X 射线技术被认为是对 SU 设备进行消毒的另一种辐射类型。在可提取物和可浸出物（与使用一次性工艺设备相关的一个问题）的背景下，需要将 X 射线辐照对材料可提取物分布的影响与已建立的伽马辐照进行比较，以证明这种替代技术的资格。提出了一种方法，用于在使用 X 射线或伽马辐照灭菌后获得用于 SU 设备的材料的稳健和全面的可提取物数据。仔细选择测试项目和测试设计可以对从正交分析技术组合中获得的数据进行一对一的比较。评估了现代 SU 薄膜材料和共聚酯 Tritan™ 的可萃取物。所提供的数据允许对这种用于生物制药应用的新灭菌方式的安全性进行风险评估。已证明聚合物的可提取物分布不受用于灭菌的辐照类型的影响。