Evolution and Future Directions in Glass Packaging：A Comprehensive Revision of USP 660 -Desmond G. Hunt. Ph.D.pdf

1、1 2021 USPContainersGlass:UpdateDesmond G.Hunt,Ph.D.Sr.Principal ScientistSuzhou,ChinaAugust,20242 2021 USPGlass Containers:Glass Container standard has a long history in the USPGlass Types I,II,and III was described in USP(1940)Type I(Borosilicate)Type II(Treated soda-lime)Type III(Soda-lime)The Co

2、ntainers Glass(2023)is very similar to the glass chapter published in USP(1965)Chapter is currently aligned with Pharm.Eur.Chapter 3.2.1.Glass Containers for Pharmaceutical UseRevision of was initiated in 2016 with the formation of the current Expert Panel The purpose of the Expert Panel is to revis

3、e to delineate the tests,testing procedures,technology requirements,and specifications for the different glass quality attributes3 2021 USP3 2021 USPUSP Glass Chapter:Expert PanelCurrent ChapterNomenclature:Type I Borosilicate;Type II Treated Soda-Lime-Silica;Type III Soda-Lime-SilicaGlass Grains Te

4、st(Identity Test to distinguish Type I from Types II and III)Inner Surface Hydrolytic Resistance Test(distinguishes Types I and II from Type III)Surface Etching Test(distinguishes high hydrolytic resistance is due to either the inner surface treatment or to the chemical composition of the glass cont

5、ainers)Extractable Arsenic Test(USP;Colorimetric Test)Spectral Transmission for Colored Glass ContainersPotential RevisionsNomenclature:Add treated aluminosilicate glass and quartz glassGlass Grains Test:Replace with a new test based on Wavelength Dispersive X-Ray Fluorescence(WDXRF)Inner Surface Hy

6、drolytic Resistance Test:Retain test but provide guidance on the application of the autoclave instructions in from a new studySurface Etching Test:Consider replacing test(uses Hydrogen fluoride)Extractable Arsenic Test:Develop a new test based on ICP Spectral Transmission for Colored Glass Container