To ensure you meet USP regulations regarding testing containers, we provide testing for various classes of pharmaceutical glass. The United States Pharmacopeia outlines specific qualification tests based upon the type of glass used. Glass used for pharmaceutical containers is either a borosilicate (neutral) glass or soda-lime glass. Borosilicate glass contains a significant amount of boric oxide, aluminum oxide and alkali and/or alkaline earth oxides. Borosilicate glass has a high hydrolytic resistance due to the chemical composition of the glass itself and is classified as Type I glass.

Soda-lime glass is a silica glass containing alkali metal oxides. Soda-lime glass has a moderate hydrolytic resistance due to the chemical composition of the glass itself and is classified as Type III glass. The inner surface of glass containers may be treated to improve hydrolytic resistance. The treatment of Type III soda-lime glass containers will raise their hydrolytic resistance from a moderate to high level, changing the classification of the glass to Type II.

The outer surface of glass containers may be treated to reduce friction or protect against abrasion or breakage. Glass may be colored to provide protection from light or may have a coating applied to the outer surface. Such containers must meet the requirements for light transmission under Containers – Performance Testing. The quality of glass containers is defined by measuring their resistance to chemical attack. In addition, Type I containers for aqueous parenteral preparations are tested for arsenic release.

Our USP glass testing procedures include:

  • USP/NF Section <660> Type I Highly Resistant Borosilicate Glass
    • Hydrolytic Resistance – Glass Grains
    • Surface Glass Test
      • Determine Fill Volume
    • Surface Etching
    • USP <211> Arsenic
    • Light Transmission (Amber)
  • USP/NF Section Type II Glass – Treated Soda-Lime
    • Hydrolytic Resistance – Glass Grains
    • Surface Glass Test
      • Determine Fill Volume
    • Surface Etching
    • USP <211> Arsenic
    • Light Transmission (Amber)
  • USP/NF Section <660> Type III Glass
    • Hydrolytic Resistance – Glass Grains
    • Surface Glass Test
      • Determine Fill Volume
    • Light Transmission (Amber)

We also conduct European Pharmacopoeia testing for EP 3.2.1 Glass Containers for Pharmaceutical Use, with a qualified autoclave to meet the current test conditions requirement.

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