Sloey Christopher, Gleason Camille, Akers Michael, Nashed-Samuel Yasser, Phillips Joseph
Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320;
Tanvex Biopharma USA, Inc., 10394 Pacific Center Court, San Diego, CA 92121; and.
PDA J Pharm Sci Technol. 2019 May-Jun;73(3):212-219. doi: 10.5731/pdajpst.2018.008896. Epub 2018 Nov 27.
The European Pharmacopoeia (Ph. Eur.) hydrolytic resistance method for glass vials is routinely used to screen pharmaceutical glass vial supply. In an effort to better understand and control the factors affecting method precision and robustness, several potential sources of variability in the Ph. Eur. alkalinity method have been studied for 3 cc glass vials. Method parameters including vial rinsing, vial covering, autoclave cycle execution, sample hold times, and titration procedure were evaluated in this study. The results of this study indicate the method parameters which require stringent control in order to achieve acceptable method precision and robustness. The European Pharmacopoeia (Ph. Eur.) hydrolytic resistance method for glass vials is routinely used to screen biopharmaceutical glass vial supply. The method was studied to assess contributions to its variability and to potentially improve its reliability. The results of this study indicate which method parameters require stringent control in order to generate reliable data using the Ph. Eur. hydrolytic resistance method.
欧洲药典（Ph. Eur.）玻璃小瓶耐水解性方法通常用于筛选药用玻璃小瓶供应。为了更好地理解和控制影响方法精密度和稳健性的因素，已对3毫升玻璃小瓶的欧洲药典碱度法中几个潜在的变异性来源进行了研究。本研究评估了包括小瓶冲洗、小瓶覆盖、高压灭菌周期执行、样品保持时间和滴定程序在内的方法参数。本研究结果表明了为实现可接受的方法精密度和稳健性而需要严格控制的方法参数。欧洲药典（Ph. Eur.）玻璃小瓶耐水解性方法通常用于筛选生物制药玻璃小瓶供应。对该方法进行了研究，以评估其变异性的影响因素，并潜在地提高其可靠性。本研究结果表明，为了使用欧洲药典耐水解性方法生成可靠数据，哪些方法参数需要严格控制。
