RT Journal Article SR Electronic T1 An Evaluation of the Glass Vial Hydrolytic Resistance Method JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 212 OP 219 DO 10.5731/pdajpst.2018.008896 VO 73 IS 3 A1 Christopher Sloey A1 Camille Gleason A1 Michael Akers A1 Yasser Nashed-Samuel A1 Joseph Phillips YR 2019 UL http://journal.pda.org/content/73/3/212.abstract AB 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.LAY ABSTRACT: 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.