PT - JOURNAL ARTICLE AU - Roman Mathaes AU - Hanns-Christian Mahler AU - Lothar Vorgrimler AU - Henrik Steinberg AU - Sascha Dreher AU - Yves Roggo AU - Alejandra Nieto-Pena AU - Helen Brown AU - Holger Roehl AU - Michael Adler AU - Joerg Luemkemann AU - Philippe Lam AU - Oliver Stauch AU - Silke Mohl AU - Alexander Streubel TI - The Pharmaceutical Capping Process - Correlation between Residual Seal Force, Torque Moment and Flip-off Removal Force AID - 10.5731/pdajpst.2015.006106 DP - 2016 Jan 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - pdajpst.2015.006106 4099 - http://journal.pda.org/content/early/2016/01/14/pdajpst.2015.006106.short 4100 - http://journal.pda.org/content/early/2016/01/14/pdajpst.2015.006106.full AB - 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&finish operations, as it defines the seal quality of the final product. Different critical capping process parameters can impact rubber stopper defects, rubber stopper compression, CCI but also crimp cap quality. A sufficiently high force to remove the flip-off button prior usage is required to ensure quality of the drug product unit by the flip-off button during storage, transportation until opening and use. Therefore, the final product is 100% visually inspected for lose or defect crimp caps, which is subjective as well as time and labor intensive. In this study, we sealed several container closure system (CCS) configurations with different capping equipment settings (with corresponding residual seal force (RSF) values) to investigate the torque moment required to turn the crimp cap. A correlation between torque moment and RSF 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 lyo) and type of crimp cap (West or Datwyler). In addition, we measured the force required to remove the flip-off button of a sealed CCS. 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 RSF range leads to a tight crimp cap on a sealed CCS and can ensure product quality.