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Related Experiment Videos

Particulate contamination from siliconized rubber stoppers--a statistical evaluation

L C Li1, J Parasrampuria, Y Tian

  • 1Hospital Products Division, Abbott Laboratories, Abbott Park, Illinois.

Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|September 1, 1993
PubMed
Summary

Siliconized stoppers can introduce particulate contamination into parenteral drugs. Solution pH significantly impacts this contamination, with alkaline conditions (pH 8) causing higher particle levels than acidic conditions (pH 4).

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Area of Science:

  • Pharmaceutical Science
  • Drug Delivery Systems
  • Material Science

Background:

  • Siliconized stoppers are critical components in parenteral drug packaging.
  • These stoppers have been identified as a potential source of particulate contamination in injectable drug products.
  • Controlling particulate matter is essential for parenteral drug safety and efficacy.

Purpose of the Study:

  • To investigate the impact of various factors on particulate contamination from siliconized stoppers.
  • To identify key variables influencing particle generation in parenteral drug packaging.

Main Methods:

  • An eight-run Plackett-Burman experimental design was employed.
  • Evaluated variables included solution pH, buffer concentration, Teflon coating, autoclaving cycle (F0), and siliconization lot variation.

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  • Particulate levels were quantified to assess the impact of each variable.

    • Main Results:

    • Solution pH was found to be a statistically significant factor affecting particulate contamination (p < 0.05).
    • Alkaline solutions (pH 8) resulted in significantly higher particulate loads compared to acidic solutions (pH 4).
    • Buffer concentration, Teflon coating, autoclaving, and lot variation showed no significant impact on particulate levels (p > 0.15).

    Conclusions:

    • Solution pH is a critical parameter to control to minimize particulate contamination from siliconized stoppers.
    • Optimizing pH conditions can enhance the quality and safety of parenteral drug products.
    • Further research may explore the mechanisms behind pH-dependent particle release.