Key components to the ISO 11607 procedure. ISO 11607 is the principle guidance for validating terminally sterilized medical device packaging
Stability testing and monitoring in the drug development and manufacturing process. A critical step applicable to Food and Drug Administration (FDA) regulated products.
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 [...]