RT Journal Article
SR Electronic
T1 The Pharmaceutical Capping Process - Correlation between Residual Seal Force, Torque Moment and Flip-off Removal Force
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2015.006106
DO 10.5731/pdajpst.2015.006106
A1 Roman Mathaes
A1 Hanns-Christian Mahler
A1 Lothar Vorgrimler
A1 Henrik Steinberg
A1 Sascha Dreher
A1 Yves Roggo
A1 Alejandra Nieto-Pena
A1 Helen Brown
A1 Holger Roehl
A1 Michael Adler
A1 Joerg Luemkemann
A1 Philippe Lam
A1 Oliver Stauch
A1 Silke Mohl
A1 Alexander Streubel
YR 2016
UL http://journal.pda.org/content/early/2016/01/14/pdajpst.2015.006106.abstract
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.