[HTML][HTML] Air, helium and water leakage in rubber O-ring seals with application to syringes

C Huon, A Tiwari, C Rotella, P Mangiagalli… - Tribology letters, 2022 - Springer
We study the leakage of fluids (liquids or gases) in syringes with glass barrel, steel plunger
and rubber O-ring stopper. The leakrate depends on the interfacial surface roughness and …

Leakage Dynamics of Glass Bottles on Container Closure Integrity Testing: Influence of Different Laser-Drilled Microhole Geometries

W Han, X Duan, J Wu, L Jiang, H Wu, Z Chen - Journal of Pharmaceutical …, 2023 - Elsevier
Container closure integrity testing (CCIT) is a critical step in ensuring package integrity and
providing feedback on package designs. In practical applications, CCIT methods, namely …

[HTML][HTML] Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage Conditions

J Baseggio, A Zverev, O Pinato, A Vico… - Journal of …, 2023 - Elsevier
Abstract Development of novel pharmaceutical drug modalities has created a need for
frozen storage and transportation. Accurate and easy assessment of container closure …

[HTML][HTML] Defect Detection Sensitivity of Bubble-Point-Type Tests for Sterilizing-Grade Membrane Cartridge Filters

S Giglia, A Alembath, J Hersey - Membranes, 2023 - mdpi.com
Bubble point tests are widely used for assessing the integrity of sterilizing-grade membrane
cartridge filters. While many authors have considered the limitations of bubble point tests as …

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 …

Container closure integrity test using frequency modulation spectroscopy headspace analysis with carbon dioxide as a tracer gas

AA Caudill, K Victor, M Timmins… - PDA Journal of …, 2021 - journal.pda.org
As described in USP< 1207>, the container closure integrity (CCI) of a pharmaceutical
package must be maintained throughout the product lifecycle to ensure sterility and stability …

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 …

[HTML][HTML] An Evaluation Study of Leak Testing Technologies for Watertight Plate Heat Exchangers: Fast and sustainable leak testing technology for high energy …

F Nilsson, Y Peng - 2023 - diva-portal.org
Background: One part of manufacturing a Plate Heat Exchanger (PHE) is to leak test them
before delivery. Today, helium is used extensively in leak testing. How-ever, it is …

[PDF][PDF] Design of Remote Helium Mass-Spectrometer Leak-Detector

HY He, JM Liu, RH Liu, H Song… - Chinese Journal of …, 2020 - accelconf.web.cern.ch
Leak detection is the key to get a good vacuum system. For the dangerous areas, or facility
with complicit structure required to be detect online, it is a hard mask to seek for the …

[PDF][PDF] Study of Remote Helium Mass Spectrometer Leak Detection in Accelerator

HY He, DH Zhu, JM Liu - … '21), Campinas, SP, Brazil, 24-28 …, 2021 - accelconf.web.cern.ch
In order to solve the problem that the vacuum system of the accelerator cannot be close to
the operation for a long time, a long-distance helium mass spectrometer leak detection …