TABLE I

Comparison of the Influence of Capping Force on the CCI of 2 mL and 20 mL Vial Neck Size Using Serum (Liquid) and Lyo (Lyophilization) Stoppers

Pressure Block Height (mm)Pre-Compression Force—Target (lbs)RSFa (N)Helium-Leak @ RTb (Number of Leaking Vials/Total Vials)Helium-Leak @ −20°C (Number of Leaking Vials/Total Vials)Helium-Leak @ −60°C (Number of Leaking Vials/Total Vials)
2 mL, serum
0.1701012 ± 30/50/55/5
0.1822334 ± 40/50/55/5
0.1872242 ± 50/50/55/5
0.21060112 ± 20/50/55/5
2 mL, lyo
0.1701014 ± 30/50/55/5
0.1822327 ± 40/50/55/5
0.1872241 ± 50/50/55/5
0.21060112 ± 70/50/55/5
20 mL, serum
0.1051018 ± 32/52/55/5
0.1252448 ± 50/50/55/5
0.17560125 ± 100/50/55/5
20 mL, lyo
0.1051024 ± 50/50/55/5
0.1252450 ± 120/50/55/5
0.17560120 ± 90/50/55/5

  • ↵a RSF: residual seal force.

  • ↵b RT: room temperature. Shaded cells show 1%–100% leaking vials (leak).