Balancing container closure integrity and aesthetics for a robust aseptic or sterile vial packaging system
Y Oni, X Song, M Schrader, A Kulshrestha… - PDA Journal of …, 2019 - journal.pda.org
Container closure integrity (CCI) is one of the requirements for a sterile packaging system.
For vial-based systems, the capping process is a critical step in creating and ensuring an …
For vial-based systems, the capping process is a critical step in creating and ensuring an …
Quantifying the vial capping process: residual seal force and container closure integrity
R Ovadia, A Streubel, Y Webb-Vargas… - PDA Journal of …, 2019 - journal.pda.org
Capping completes the closure of parenteral drug products in the final packaging container
and is critical in maintaining an integral seal to ensure product quality. Residual seal force …
and is critical in maintaining an integral seal to ensure product quality. Residual seal force …
The pharmaceutical vial capping process: container closure systems, capping equipment, regulatory framework, and seal quality tests
R Mathaes, HC Mahler, JP Buettiker, H Roehl… - European Journal of …, 2016 - Elsevier
Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration …
environmental factors, including potential microbial contamination during shelf life duration …
The Pharmaceutical Capping Process—Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force
R Mathaes, HC Mahler, L Vorgrimler… - PDA journal of …, 2016 - journal.pda.org
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 …
rubber stopper and a crimp cap. The vial sealing process is a critical process step during fill …
Impact of vial capping on residual seal force and container closure integrity
The vial capping process is a critical unit operation during drug product manufacturing, as it
could possibly generate cosmetic defects or even affect container closure integrity. Yet there …
could possibly generate cosmetic defects or even affect container closure integrity. Yet there …
Holistic considerations in optimizing a sterile product package to ensure container closure integrity
FL Degrazio - PDA Journal of Pharmaceutical Science and …, 2018 - journal.pda.org
A new major chapter dealing with container closure integrity was released by the United
States Pharmacopeial Convention. Chapter< 1207> provides a significant amount of …
States Pharmacopeial Convention. Chapter< 1207> provides a significant amount of …
Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
L Nonis, M Vogt, S Joerg, HC Mahler… - PDA Journal of …, 2020 - journal.pda.org
Sterile pharmaceuticals require they be developed and manufactured using suitable
container closure systems to maintain sterility until product opening. Characterizing …
container closure systems to maintain sterility until product opening. Characterizing …
Influence of different container closure systems and capping process parameters on product quality and container closure integrity (CCI) in GMP drug product …
Capping equipment used in good manufacturing practice manufacturing features different
designs and a variety of adjustable process parameters. The overall capping result is a …
designs and a variety of adjustable process parameters. The overall capping result is a …
Critical Process Parameters of Capping Equipment Used in GMP DP Manufacturing
Capping equipment used in good manufacturing practice (GMP) manufacturing feature
different designs and a variety of adjustable process parameters. The overall capping result …
different designs and a variety of adjustable process parameters. The overall capping result …
A vial container closure system performance optimization case study using comprehensive dimensional stack-up analyses
A Bucci, L Ho, L Orme, Q Zeng - PDA Journal of Pharmaceutical …, 2020 - journal.pda.org
Compatible vial container closure system (CCS) components in combination with a proper
capping process are crucial to ensuring reliable performance, maintaining container closure …
capping process are crucial to ensuring reliable performance, maintaining container closure …