1660 EVALUATION OF THE INNER SURFACE …（1660年评估内表面u2026）.pdfVIP

Page 1 of 9 BRIEFING 1660 Evaluation of the Inner Surface Durability of Glass Containers. In response to the recent product recalls that have further increased the pharmaceutical industry’s heightened awareness of glass quality and glass delamination (i.e., the formation of glass flakes in a vial), USP proposes a new general information chapter to recommend approaches to predict potential formation of glass particles and delamination. (PSD: D. Hunt.) Correspondence Number—C115672 Add the following: ▪ 1660 EVALUATION OF THE INNER SURFACE DURABILITY OF GLASS CONTAINERS PURPOSE This general information chapter provides information about factors that affect the durability of the inner surface of glass containers and recommends approaches to predict the potential of a drug product to cause formation of glass particles and delamination and to detect their occurrence. Useful procedures are listed and can be applied for both characterization and control tests. SCOPE This chapter addresses molded bottles and vials manufactured by molding; or ampules, cartridges, vials, and prefillable syringes manufactured from tubing glass. Glass for pharmaceutical packaging is classified as Type I borosilicate glass, Type II treated soda-lime- silica glass, or Type III soda-lime-silica glass on the basis of the hydrolytic resistance of the glass, as defined in Containers— Glass 660 . Type I glass containers are suitable for most products for parenteral and nonparenteral use. Type II glass containers are suitable for most acidic and neutral aqueous products for parenteral and nonparenteral uses, and can be used for alkaline par