Mathaes Roman, Mahler Hanns-Christian, Vorgrimler Lothar, Steinberg Henrik, Dreher Sascha, Roggo Yves, Nieto Alejandra, Brown Helen, Roehl Holger, Adler Michael, Luemkemann Joerg, Huwyler Joerg, Lam Philippe, Stauch Oliver, Mohl Silke, Streubel Alexander
Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
Device Development, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
PDA J Pharm Sci Technol. 2016 May-Jun;70(3):218-29. doi: 10.5731/pdajpst.2015.006106. Epub 2016 Jan 21.
The majority of parenteral drug products are manufactured in glass vials with an elastomeric rubber stopper and a crimp cap. The vial sealing process is a critical process step during fill-and-finish operations, as it defines the seal quality of the final product. Different critical capping process parameters can affect rubber stopper defects, rubber stopper compression, container closure integrity, and also crimp cap quality. A sufficiently high force to remove the flip-off button prior to usage is required to ensure quality of the drug product unit by the flip-off button during storage, transportation, and until opening and use. Therefore, the final product is 100% visually inspected for lose or defective crimp caps, which is subjective as well as time- and labor-intensive. In this study, we sealed several container closure system configurations with different capping equipment settings (with corresponding residual seal force values) to investigate the torque moment required to turn the crimp cap. A correlation between torque moment and residual seal force has been established. The torque moment was found to be influenced by several parameters, including diameter of the vial head, type of rubber stopper (serum or lyophilized) and type of crimp cap (West(®) or Datwyler(®)). In addition, we measured the force required to remove the flip-off button of a sealed container closure system. The capping process had no influence on measured forces; however, it was possible to detect partially crimped vials. In conclusion, a controlled capping process with a defined target residual seal force range leads to a tight crimp cap on a sealed container closure system and can ensure product quality.
The majority of parenteral drug products are manufactured in a glass vials with an elastomeric rubber stopper and a crimp cap. The vial sealing process is a critical process step during fill-and-finish operations, as it defines the seal quality of the final product. An adequate force to remove the flip-off button prior to usage is required to ensure product quality during storage and transportation until use. In addition, the complete crimp cap needs to be fixed in a tight position on the vial. In this study, we investigated the torque moment required to turn the crimp cap and the force required to remove the flip-off button of container closure system sealed with different capping equipment process parameters (having different residual seal force values).
大多数注射用药品是在带有弹性橡胶塞和压接帽的玻璃瓶中生产的。小瓶密封工艺是灌装和成品操作中的关键工艺步骤，因为它决定了最终产品的密封质量。不同的关键封盖工艺参数会影响橡胶塞缺陷、橡胶塞压缩、容器密封完整性以及压接帽质量。在使用前需要足够高的力来移除翻盖按钮，以确保药品在储存、运输以及直至打开使用期间的质量。因此，对最终产品进行100%的目视检查，查看压接帽是否松动或有缺陷，这既主观又耗时费力。在本研究中，我们用不同的封盖设备设置（具有相应的残余密封力值）密封了几种容器密封系统配置，以研究转动压接帽所需的扭矩。已建立扭矩与残余密封力之间的相关性。发现扭矩受几个参数影响，包括瓶口直径、橡胶塞类型（血清瓶或冻干瓶）以及压接帽类型（韦斯特（®）或德特威勒（®））。此外，我们测量了移除密封容器密封系统翻盖按钮所需的力。封盖工艺对测量的力没有影响；然而，可以检测到部分压接不良的小瓶。总之，具有确定的目标残余密封力范围的受控封盖工艺会使密封容器密封系统上的压接帽紧密，并可确保产品质量。
大多数注射用药品是在带有弹性橡胶塞和压接帽的玻璃瓶中生产的。小瓶密封工艺是灌装和成品操作中的关键工艺步骤,因为它决定了最终产品的密封质量。在使用前需要足够的力来移除翻盖按钮，以确保药品在储存和运输直至使用期间的质量。此外，完整的压接帽需要牢固地固定在小瓶上。在本研究中，我们研究了转动压接帽所需的扭矩以及移除用不同封盖设备工艺参数（具有不同残余密封力值）密封的容器密封系统翻盖按钮所需的力。
