TABLE IV

Evaluation of Rubber Stopper Temperature Limits in Lyo Stoppers with 20 mm Vial Neck Size

Container Closure Integrity
Vial#Leak Rate (mbar × L/s)T (°C)Leak Rate (mbar × L/s)T (°C)Leak Rate (mbar × L/s)T (°C)Leak Rate (mbar × L/s)T (°C)Leak Rate (mbar × L/s)T (°C)
1Tight22.9Tight−20.2Tight−31.2Tight−41.0Tight−60.3
2Tight23.2Tight−21.6Tight−31.6Tight−41.7Tight−60.0
3Tight22.4Tight−22.5Tight−31.0Tight−42.7Un-tight−60.5
4Tight22.2Tight−21.7Tight−31.4Tight−41.3Tight−59.8
5Tight24.8Tight−22.5Tight−32.4Tight−41.5Un-tight−60.3
  • Shaded cells show 1%–100% leaking vials (leak).