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 …
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 …
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 …
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 …
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 …
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 …
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 …
Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
JW Buecheler, J Luemkemann, H Gieseler… - PDA Journal of …, 2019 - journal.pda.org
Vial capping plays a critical role in the drug product manufacturing process owing to the
complex interplay of several adjustable process steps. Seal quality and integrity and …
complex interplay of several adjustable process steps. Seal quality and integrity and …
Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation
A Nieto, H Roehl, M Adler, S Mohl - PDA journal of pharmaceutical …, 2018 - journal.pda.org
Frozen-state storage and cold-chain transport are key operations in the development and
commercialization of biopharmaceuticals. Today, several marketed drug products are stored …
commercialization of biopharmaceuticals. Today, several marketed drug products are stored …
Time temperature superposition evaluation and modeling for container closure system's seal performance at low temperatures
Q Zeng, A Bucci, L Ho - PDA J. Pharm. Sci. Technol, 2020 - journal.pda.org
There has been a growing interest in the assessment of container closure systems (CCS) for
cold storage and shipment. Prior publications have lacked systematic considerations for the …
cold storage and shipment. Prior publications have lacked systematic considerations for the …