Methods Used in the Determination of the Alkalinity Imparted to Water by Ampul Glass

Historical Review of Glasses Used for Parenteral Packaging

“…Interestingly, the rationale for this revision (68,69) was harmonization of test methods and limits with the European Pharmacopeia (EP) container on packaging (3.2.1). Differences between the pharmacopeia have existed for decades (25,70), and some differences include which tests used to distinguish glass types, the specific heating and cooling portions of the autoclave cycle, the colorimetric indicator, washing procedures, and the identity of the titrant solution. Each of these differences can measurably affect the result and, ultimately, the inferred performance or identity.…”

“…Figure 2 shows Limousin's sketch of a glass ampoule. Shortly after, French pharmacists were the first to offer injectable medications in such containers (25). The following decades (1880 -1910) saw a surge in injectionrelated research and manufacture, including the use of several animal and human vaccines.…”

“…The glass used in this initial ampoule research and manufacture was of the usual soda-lime type (25). By 1910, the borosilicate glasses intended for laboratory vessels were being used to package these parenteral solutions (26).…”

“…Between 1912 and 1914, other glass manufacturers were pursuing modified quartz glasses (27) for pharmaceutical storage, British labs were exploring borosilicate glass compositions (28), and in 1915 Corning Glass Works intro-duced "Pyrex®" (code 7740) brand borosilicates for lab and consumer applications (29,30). Due to their high fusing points, several of these glasses were not suitable for ampoule applications (25).…”

“…With international trade frozen, alternate suppliers of borosilicate glasses were needed. By the 1930s, the Kimble Glass Company introduced its borosilicate glass (N51A) for lab and pharmaceutical storage applications (25). Corning introduced a similar borosilicate glass for pharmaceutical packaging (code 7800) in 1954.…”