Article Information
PubMed
Published By
Print ISSN
Online ISSN
History
- Received June 22, 2016
- Accepted September 18, 2016
- Published online October 27, 2016.
Article Versions
- You are currently viewing a previous version of this article (October 27, 2016 - 16:53).
- View the most recent version of this article
Copyright & Usage
Copyright © 2016, Parenteral Drug Association
Author Information
- Helen Brown1 (helen.brown.hb1{at}roche.com),
- Hanns-Christian Mahler2 (hanns-christian.mahler{at}lonza.com),
- James Mellman3 (james.mellman{at}novartis.com),
- Alejandra Nieto1 (alejandra.nieto-pena{at}roche.com),
- Daniel Wagner4 (daniel.wagner{at}sanofi.com),
- Matthias Schaar3 (matthias.schaar{at}novartis.com),
- Roman Mathaes2 (roman.mathaes{at}lonza.com),
- Juergen Kossinna3 (juergen.kossinna{at}novartis.com),
- Franz Schmitting5 (franz.schmitting{at}abbvie.com),
- Sascha Dreher1 (sascha.dreher{at}roche.com),
- Holger Roehl1 (holger.roehl{at}roche.com),
- Markus Hemminger1 (markus.hemminger{at}roche.com) and
- Klaus Wuchner6,7 (kwuchne1{at}its.jnj.com)
- ↵* Corresponding author; email: kwuchne1{at}its.jnj.com
Cited By...
In This Issue
Jump to section
Related Articles
Cited By...
- Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
- Container closure integrity testing and process validation of closed system transfer devices for aseptic reconstitution of drug vials connected to fluid bags
- A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
- Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
- Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
- Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
- Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
- Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
- Container Closure Integrity Testing--Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis
- Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation
- Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers