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Related Experiment Videos

Glass for parenteral products: a surface view using the scanning electron microscope.

T J Roseman, J A Brown, W W Scothorn

    Journal of Pharmaceutical Sciences
    |January 1, 1976
    PubMed
    Summary

    Scanning electron microscopy revealed distinct surface changes in glass containers after chemical treatments. These findings are crucial for the pharmaceutical industry to minimize particulate matter in parenteral products.

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    Area of Science:

    • Materials Science
    • Analytical Chemistry
    • Pharmaceutical Technology

    Background:

    • Parenteral products require high-quality glass containers to prevent contamination.
    • Surface characteristics of glass packaging can impact product integrity and safety.
    • Understanding glass-treatment interactions is vital for quality control in pharmaceutical manufacturing.

    Purpose of the Study:

    • To investigate the internal surface topography of USP Type I borosilicate glass ampuls and vials.
    • To analyze surface alterations following exposure to sulfur, ammonium bifluoride, and sulfuric acid treatments.
    • To assess the utility of scanning electron microscopy (SEM) in evaluating glass quality for parenteral applications.

    Main Methods:

    • Utilized scanning electron microscopy (SEM) to examine the internal surfaces of treated glass ampuls and vials.

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  • Employed electron microprobe analysis to identify the composition of glass flakes.
  • Compared surface topography changes resulting from different chemical treatments (sulfur, ammonium bifluoride, sulfuric acid).

    • Main Results:

    • SEM revealed significant differences in surface topography based on treatment type and container (ampul vs. vial).
    • "Sulfur treatment" induced surface pitting and sodium sulfate crystals in ampuls, with distinct alterations in vials.
    • Vitreous flakes, identified as delaminated glass layers, were observed, indicating surface instability under certain conditions.

    Conclusions:

    • SEM is a valuable tool for assessing the quality of glass used in parenteral products.
    • Chemical treatments can significantly alter glass surface topography, potentially generating particulate matter.
    • These analytical techniques are important for the pharmaceutical industry's efforts to reduce particulate levels in parenteral dosage forms.