KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, 3000 Leuven, Belgium.
Sterigenics NV, a Sotera Health division, 2015 Spring Road 650, Oak Brook, IL 60523, United States.
J Pharm Sci. 2022 Jul;111(7):2011-2017. doi: 10.1016/j.xphs.2022.01.020. Epub 2022 Jan 31.
Ensuring the sterility of life science products plays a pivotal role in the healthcare sector. Gamma irradiation and ethylene oxide sterilization are two commonly applied methods for the sterilization of medical devices, packaging components and Active Pharmaceutical Ingredients (API) for medicinal products. Focussed studies on the effects of sterilization processes on APIs remain limited. In this research study, five APIs, frequently used in sterile ophthalmic preparations were subjected to both gamma irradiation and ethylene oxide under different process conditions. The following APIs of GMP quality were selected: dexamethasone, aciclovir, tetracycline hydrochloride, triamcinolone and methylprednisolone. Analyses were performed using High Performance Liquid Chromatography equipped with UV detection and the effect of sterilization conditions on the APIs was evaluated by the assay and related substances test prescribed by the European Pharmacopoeia (Ph. Eur.). It was concluded that exposure to ethylene oxide resulted in compliance with Ph. Eur. for all APIs. While dexamethasone and methylprednisolone did not meet the requirement for the Ph. Eur. after exposure to gamma irradiation, the other three APIs did meet the requirement under the specified irradiation conditions. Subsequent optimization of sterilization parameters positively influenced the compliance to the Ph. Eur. requirements.
确保生命科学产品的无菌性在医疗保健领域起着关键作用。伽马射线辐照和环氧乙烷灭菌是医疗器械、包装部件和药品的活性药物成分（API）灭菌的两种常用方法。聚焦于灭菌工艺对 API 影响的研究仍然有限。在这项研究中，五种常用于无菌眼科制剂的 API 分别在不同的工艺条件下接受了伽马射线辐照和环氧乙烷灭菌。选择了以下符合 GMP 质量标准的 API：地塞米松、阿昔洛韦、盐酸四环素、曲安奈德和甲泼尼龙。使用配备紫外检测的高效液相色谱法进行分析，并通过欧洲药典（Ph. Eur.）规定的含量测定和有关物质试验评估灭菌条件对 API 的影响。结果表明，所有 API 经环氧乙烷处理后均符合 Ph. Eur. 的要求。虽然地塞米松和甲泼尼龙经伽马射线辐照后不符合 Ph. Eur. 的要求，但其他三种 API 在规定的辐照条件下符合要求。随后对灭菌参数进行优化，对符合 Ph. Eur. 要求产生了积极影响。
