Jd. Ludwig et al., AUTOMATED-METHOD FOR DETERMINING INSTRON RESIDUAL SEAL FORCE OF GLASSVIAL RUBBER CLOSURE SYSTEMS, Journal of parenteral science and technology, 47(5), 1993, pp. 211-232
Instron Residual Seal Force (IRSF) of glass vial rubber closure system
s was determined using an Instron 4501 Materials Testing System. Compu
ter programs were written to process raw data and calculate IRSF value
s. Preliminary experiments indicated both the appearance of the stress
-deformation curves and precision of the derived IRSF values were depe
ndent on the internal dimensions and top surface geometry of the cap a
nvil. Therefore, a series of five cap anvils varying in shape and dime
nsions were machined to optimize performance and precision. Vials capp
ed with West 4416150 PURCOAT(R) button closures or Helvoet compound 62
07 lyophilization closures were tested with each cap anvil. Cap anvils
with spherical top surfaces and narrow internal dimensions produced m
ore precise results and more uniform stress-deformation curves than ca
p anvils with flat top surfaces and wider internal dimensions.