The following provides information on why changes to current USP chapters <660> and <1660> are beneficial to the industry. Review and submit comments to the USP: 1) To redefine Type I glass as a ‘neutral’ material that meets or exceeds testing requirements including aluminosilicate glass, and 2) To recommend a new testing method that will assess a glass container’s heterogeneity such as Chemical Durability Ratio method. 

The scope of USP’s proposed standard encompassed in Chapter <660> of PF 43(3))  is narrowly focused on borosilicate glass and does not allow for innovation in this critical area in ways that could significantly enhance the quality of pharmaceutical packaging.  Type 1 glass exhibiting hydrolytic performance and a low extraction profile, such as aluminosilicate and quartz, also should be included in the revised standard.  Below is suggested language which goes beyond the status quo to enable opportunities for innovation.

"Glass containers for pharmaceutical use are intended to come into direct contact with Pharmaceutical products. Glass used for pharmaceutical containers shall comply with testing requirements of glass Type I and Type III of this monograph. Type I glass (Neutral glass) exhibits a high hydrolytic and thermal shock resistance due to the chemical composition of the glass itself. Type I glass is typically a borosilicate glass that contains significant amounts of boric acid, aluminium oxide, alkali and/or alkaline earth oxides in the glass network and has both a high hydrolytic and thermal shock resistance.  Aluminosilicate and Quartz are other examples of Type I glass exhibiting excellent hydrolytic performance and a low extraction profile.”

Carol Rea Flynn

(856)-207-8066
FlynnC2@corning.com

Robert Schaut

(607) 974-3199
SchautRA@corning.com

Allison Matusick

(607) 974-3072
matusickag@corning.com

Benjamin Amsler

(607) 974-4913
amslerba@corning.com

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