TABLE I

Combinations for Initial Time Study. Stoppers and seals were West Pharmaceutical Services, Inc. products.a Compression targets were low, medium, and high corresponding to approximately 10%–15%, 20%–35%, and 25%–40% for 20 mm stoppers and 20%–30%, 45%–55%, and 50%–60% for 13 mm stoppers, respectively. These corresponded to residual seal force values of 5–18 lbs.

Rubber FormulationStopper Size [mm] (Configuration)Glass Vial Type (Blowback)Glass Vial Size
Serum
4023/50 Gray13 (ART 1104)Straightwall2R
20 (ART 1071)Straightwall6R
20 (ART 1343, F-Tec)bUS6R
4432/50 Gray13 (S2-F451, F-Tec)US2R
13 (V-35)EU2R
20 (S-127)EU6R
Lyophilization
4023/50 Gray13 (ART 1079)Straightwall2R
13 (ART 1356, F-Tec)US2R
20 (ART 1319)Straightwall6R
20 (ART 1346, F-Tec)US6R
4432/50 Gray13 (V2-F451W, F-Tec)EU2R
20 (V10-F597, F-Tec)EU6R
  • a Seals: 13 mm stoppers: 13 FO LQ Long TE (6-B) 3767 Red Matte; 20 mm stoppers: 20 FO LQ TE (6-B) 3767 Red Matte.

  • b F-Tec indicates stoppers were coated with a FluroTec® fluoropolymer laminate.