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Research ArticleResearch Article

Unique Aspects of Steam Sterilization Validation of Disposable Syringe Components

Dominic A. Ventura and George E. Sheaffer
PDA Journal of Pharmaceutical Science and Technology November 1984, 38 (6) 212-215;
Dominic A. Ventura
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George E. Sheaffer
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Abstract

Sterilization Validation of disposable syringe components presents unique process requirements due to component design and required mechanical attributes. These include the requirement of steam penetration through rubber plungers and closures since it is essential to sterilize isolated cavities formed between the rubber and syringe while minimizing thermal effects on the rubber components. Variations in process lethality relative to the sterilization cycle and component type have been observed and investigated. The investigations include determinations of steam penetration rates through various types of rubber closures which include natural, butyl and halobutyl rubber blends. Experimentation includes measurement of steam transmission rates for various rubber stocks and biological inoculations utilizing Bacillus stearothermophilus, ATCC #7953 spores. Differences in steam penetration rates observed between different rubber types and the effect on observed process lethality are discussed. Lag time considerations relative to classical F0 calculations and associated errors are also presented. Methods used to determine rubber closure rheology and the mechanical attributes of the final syringe assembly are also presented. Critical process controls to assure a physically acceptable sterile syringe assembly are defined.

  • Received September 13, 1984.
  • Accepted October 10, 1984.
  • Copyright © Parenteral Drug Association. All rights reserved.

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PDA Journal of Pharmaceutical Science and Technology
Vol. 38, Issue 6
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Unique Aspects of Steam Sterilization Validation of Disposable Syringe Components
Dominic A. Ventura, George E. Sheaffer
PDA Journal of Pharmaceutical Science and Technology Nov 1984, 38 (6) 212-215;
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Unique Aspects of Steam Sterilization Validation of Disposable Syringe Components
Dominic A. Ventura, George E. Sheaffer
PDA Journal of Pharmaceutical Science and Technology Nov 1984, 38 (6) 212-215;

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