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 …
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 …
Use of a predictive regression model for estimating hold-up volume for biologic drug product presentations
SB Mehta, S Subramanian, R Brown… - PDA Journal of …, 2020 - journal.pda.org
A drug delivery system is designed to administer a therapeutic dose according to its label
claim. Upon delivery of a parenteral drug product, the volume remaining inside the container …
claim. Upon delivery of a parenteral drug product, the volume remaining inside the container …
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 …
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 …
Primary Container Closure System Selection for Lyophilized Drug Products
R Ovadia, P Lam, H Roehl, R Janssen… - Principles and Practices …, 2023 - Springer
For lyophilization applications, the selection of the primary container system (ie vial, stopper,
seal) must be given careful consideration in order to avoid surprises in the later stages of …
seal) must be given careful consideration in order to avoid surprises in the later stages of …
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 …
Quality control of primary packaging in the pharmaceutical industry
TMCN Jerónimo - 2023 - comum.rcaap.pt
This internship was conducted in Hikma, which is a pharmaceutical company located in
Sintra, Portugal responsible for the production of injectables for the Portuguese and …
Sintra, Portugal responsible for the production of injectables for the Portuguese and …