Blog

Pending changes effective December 14, 2014 and insights into how industry companies may utilize the procedures to insure they meet the regulatory (FDA) requirements
Stability testing and monitoring in the drug development and manufacturing process. A critical step applicable to Food and Drug Administration (FDA) regulated products.
Pending United States Pharmacopeia (USP) changes for container and package systems.
The USP 661 and USP 671 general chapters are effective in outlining the test requirements for a plastic container and a package system.
USP 661 and USP 671 general chapters. Qualification testing of a closure for a pharmaceutical use container so it meets the USP qualification process
In part three of this series on CCIT, two commonly used methods – Residual Seal Force and Laser Diffraction – will be reviewed.
In part three of this series on CCIT, two commonly used methods – Helium and Mass Extraction – will be reviewed.
In part two of this series on CCIT, two commonly used methods – Vacuum Decay and High Voltage Leak Detection – will be reviewed.
This series of articles will review the present state of Container Closure Integrity Testing, the various methods currently available, the factors for choosing the most optimal method and current regulatory guidelines under development.