1. INTRODUCTION
Packaging systems, also referred to as container–closure systems, are defined in Packaging and Storage Requirements 〈659〉; these systems are the sum of components that together contain, protect, and in certain cases, deliver the drug product. Glass packaging components are used in packaging and delivery systems for various parenteral preparations (as defined in Injections and Implanted Drug Products 〈1〉), and in non-parenteral preparations such as liquid oral and anesthetic drugs.
2. SCOPE
Glass containers for pharmaceutical use intended to come into direct contact with pharmaceutical products include, but are not limited to, ampules, bottles, cartridges, syringes, and vials in both flint (clear) and colored (amber) glass.
3. DESCRIPTION
Glass containers for pharmaceutical use are identified by the bulk or base glass composition, description of treatment, coating or processing, and designated by type, by the inner surface composition, and by glass performance criteria. The container is defined by identity and classified by performance. Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical products on the interior surface. The determination of elemental composition of glass containers (see 4.1 Elemental Composition by Wavelength Dispersive X-Ray Fluorescence) and the inner surface hydrolytic resistance (see 4.2 Determination of Inner Surface Hydrolytic Resistance) determine glass performance.
Glass containers for pharmaceutical use shall comply with the performance testing requirements of this chapter. Type I glass is a silicate glass that exhibits a high surface hydrolytic resistance and low extraction profiles due to the chemical composition and processing of the glass. Traditionally, Type I glass is a highly resistant borosilicate glass that contains significant amounts of boric acid, aluminum oxide, alkali, and/or alkaline earth oxides in the glass network. Other highly resistant glass compositions that could meet Type I performance testing requirements are aluminosilicate glass, which contains the same oxides as various borosilicate glasses without boron oxide, and quartz glass, which is silica without any inorganic additives.
Type III glass, traditionally soda–lime–silica glass, contains alkaline metal oxides and alkaline earth oxides. It has a moderate hydrolytic resistance due to its chemical composition and processing. Suitable treatment of the inner surface of soda–lime–silica glass will raise the hydrolytic resistance from moderate (Type III) to a high (Type II) level of performance (see 4.3 Surface Treatments). The general composition and physical properties of the four glass compositional families are summarized in Table 1.
Source from USP and Please refer to USP for details:
28mm child resistant cap for glass bottle liquid
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