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 …

Impact of vial capping on residual seal force and container closure integrity

R Mathaes, HC Mahler, Y Roggo, R Ovadia… - PDA journal of …, 2016 - journal.pda.org
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 …

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 …

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 …

Influence of different container closure systems and capping process parameters on product quality and container closure integrity (CCI) in GMP drug product …

R Mathaes, HC Mahler, Y Roggo, J Huwyler… - PDA journal of …, 2016 - journal.pda.org
Capping equipment used in good manufacturing practice manufacturing features different
designs and a variety of adjustable process parameters. The overall capping result is a …

Quantifying the vial-capping process: reexamination using micro-computed tomography

R Ovadia, P Lam, V Tegoulia, YF Maa - PDA Journal of …, 2020 - journal.pda.org
A vial-capping process for lyophilization stopper configurations was previously quantified
using residual seal force (RSF). A correlation between RSF and container closure integrity …

Container closure integrity testing—practical aspects and approaches in the pharmaceutical industry

H Brown, HC Mahler, J Mellman, A Nieto… - PDA journal of …, 2017 - journal.pda.org
The assurance of sterility of a parenteral drug product, prior to any human use, is a
regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must …

Container closure integrity testing of prefilled syringes

SS Peláez, HC Mahler, A Matter, A Koulov… - Journal of …, 2018 - Elsevier
Prefilled syringes (PFSs) are increasingly preferred over vials as container closure systems
(CCSs) for injectable drug products when facilitated or self-administration is required …

Container closure integrity of vial primary packaging systems under frozen storage conditions: a case study

YO Oni, J Franck, C Evans, D Paniagua… - PDA Journal of …, 2023 - journal.pda.org
As the complexities of the pharmaceuticals needed to prevail over serious diseases
continue to grow, the need for technologies to enable their efficient storage and delivery are …

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 …