[BOOK][B] Pharmaceutical packaging technology
DA Dean, ER Evans, IH Hall - 2005 - books.google.com
Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity
of testing than most other packed products, not to mention a sound knowledge of …
of testing than most other packed products, not to mention a sound knowledge of …
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 …
[BOOK][B] Parenteral quality control: sterility, pyrogen, particulate, and package integrity testing
MK Akers, D Larrimore, D Guazzo - 2002 - taylorfrancis.com
Providing a well-written and easy-to-read review of the subject, this reference describes the
most recent breakthroughs in the validation and execution of testing schemes for parenteral …
most recent breakthroughs in the validation and execution of testing schemes for parenteral …
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 …
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 …
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 …
continue to grow, the need for technologies to enable their efficient storage and delivery are …
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 …
Time-dependent testing evaluation and modeling for rubber stopper seal performance
Q Zeng, X Zhao - PDA Journal of Pharmaceutical Science and …, 2018 - journal.pda.org
Sufficient rubber stopper sealing performance throughout the entire sealed product life cycle
is essential for maintaining container closure integrity in the parenteral packaging industry …
is essential for maintaining container closure integrity in the parenteral packaging industry …
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 …
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 …
using residual seal force (RSF). A correlation between RSF and container closure integrity …