Automated method for determining Instron Residual Seal Force of glass vial/rubber closure systems.
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 PURCOAT 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.
Ludwig
J D
JD
Burroughs Wellcome Co., Pharmaceutical Research and Development Laboratories, Greenville, North Carolina.
Nolan
P D
PD
Davis
C W
CW
D017076:Computer-Aided Design; D004349:Drug Packaging / Q000379:methods*; D001330:Electronic Data Processing; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D005612:Freeze Drying; D008962:Models, Theoretical; D013314:Stress, Mechanical