A systematic approach for screening glass containers and elastomeric closures for use with parenteral solutions.
The purpose of this study is to systematically screen different packaging options for a particular pharmaceutical application using a multi-stage strategy. This approach includes initial screening of packaging options with the pharmaceutical formulation testing for critical chemical attributes (Stage 1), assessing compendial compliance of the sterile pharmaceutical product contained within the packaging options identified (Stage 2), testing of the experimental product under accelerated storage conditions (Stage 3), and subsequent confirmation testing through long-term studies designed to evaluate the stability characteristics of the product (Stage 4). Water for injection was evaluated in 19 different Type I glass vial and elastomeric closure configurations. Based on the results for Stage 1, 13 configurations were eliminated for the reason that pH data were at or exceed the United States Pharmacopeia (USP) limits after a single sterilization cycle, or that pH data had markedly variable results. Additional configurations--newly available European Pharmacopoeia (EP) stoppers--were introduced in Stage 2 based on the data available from Stage 1 in regard-to the effect of the glass vials. During Stage 2, four configurations were eliminated because pH data was at the USP limits or failed EP acidity or alkalinity tests. For Stage 3, one configuration was eliminated because pH results exceeded the USP limits after 3 months at 40 degrees C. It was concluded during Stage 4 that a SiO2-coated Type I glass vial configured with a fluropolymer-coated elastomeric closure successfully met USP pH and all EP and Japanese Pharmacopoeia compendia specifications after 12 months at 5- degrees C, 25- degrees C, 30- degrees C, and 40- degrees C storage.
White
Frank
F
Pharmaceutical R&D, BioPharma Solutions, Baxter Healthcare Corporation, Round Lake, IL 60073, USA. frank_white@baxter.com
Koberda
Michael
M
Chilamkurti
Rao
R
D004349:Drug Packaging / Q000592:standards*; D004355:Drug Stability; D004356:Drug Storage; D020724:Elastomers; D005060:Europe; D005898:Glass; D006863:Hydrogen-Ion Concentration; D007564:Japan; D019999:Pharmaceutical Solutions; D010602:Pharmacopoeias as Topic; D012822:Silicon Dioxide / Q000737:chemistry; D013242:Sterilization; D013696:Temperature; D014481:United States
D020724:Elastomers; D019999:Pharmaceutical Solutions; D012822:Silicon Dioxide