Abstract
Instron Residual Seal Force (IRSF) of glass vial/rubber closure systems was determined using an Instron 4501 Materials Testing System. Computer programs were written to process raw data and calculate IRSF values. Preliminary experiments indicated both the appearance of the stress-deformation curves and precision of the derived IRSF values were dependent on the internal dimensions and top surface geometry of the cap anvil. Therefore, a series of five cap anvils varying in shape and dimensions were machined to optimize performance and precision. Vials capped with West 4416/50 PURCOA T® button closures or Helvoet compound 6207 lyophilization closures were tested with each cap anvil. Cap anvils with spherical top surfaces and narrow internal dimensions produced more precise results and more uniform stress-deformation curves than cap anvils with flat top surfaces and wider internal dimensions.
- Received December 1, 1992.
- Accepted March 2, 1993.
- Copyright © Parenteral Drug Association. All rights reserved.
In This Issue
Jump to section
Related Articles
Cited By...
- Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
- Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
- The Pharmaceutical Capping Process--Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force
- Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
- Impact of Vial Capping on Residual Seal Force and Container Closure Integrity