Container Closure Integrity Test Method Development on Vials Stored at− 80° C Using Headspace Carbon Dioxide Analysis
K Victor, AA Caudill, J Veale - PDA Journal of Pharmaceutical …, 2022 - journal.pda.org
Maintaining container closure integrity (CCI) is challenging for vials that are packaged at
room temperature and stored and/or transported at a colder temperature, such as− 80° C …
room temperature and stored and/or transported at a colder temperature, such as− 80° C …
A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
R Mathaes, K Wuchner, D Riesop… - PDA Journal of …, 2022 - journal.pda.org
All products labeled as sterile are required to be free of microbial contamination throughout
their shelf life (obligatory critical quality attribute). Container closure integrity (CCI) needs to …
their shelf life (obligatory critical quality attribute). Container closure integrity (CCI) needs to …