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Residual Seal Force
Stability, Medical Device & Unit Dose
The Value of ISO 17025 and cGMP Quality System Standards
Key areas to focus on when qualifying an outsourcing partner are Good Manufacturing Practices (GMP), and ISO 17025 quality standards.
An Overview of ISO 11607 Testing
Key components to the ISO 11607 procedure. ISO 11607 is the principle guidance for validating terminally sterilized medical device packaging
Are You Qualifying Your Dose Cups?
The Proper Approach to Volume Verification Testing of Metered Drug Delivery Devices
USP 671 Permeation – Clarification on Changes Effective December 1, 2014
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 – Overview and Update
Stability testing and monitoring in the drug development and manufacturing process. A critical step applicable to Food and Drug Administration (FDA) regulated products.
Updates on Container & Package Testing
Pending United States Pharmacopeia (USP) changes for container and package systems.
Syringe Qualification Testing
The USP 661 and USP 671 general chapters are effective in outlining the test requirements for a plastic container and a package system.
Container Qualification Testing – The Closure Dilemma
USP 661 and USP 671 general chapters. Qualification testing of a closure for a pharmaceutical use container so it meets the USP qualification process
Container Integrity Testing Part Four – Capping, Residual Seal Force & Laser Diffraction
In part three of this series on CCIT, two commonly used methods – Residual Seal Force and Laser Diffraction – will be reviewed.
Container Integrity Testing Part Three – Helium & Mass Extraction
In part three of this series on CCIT, two commonly used methods – Helium and Mass Extraction – will be reviewed.
Container Integrity Testing Part Two - Vacuum Decay and HVLD
In part two of this series on CCIT, two commonly used methods – Vacuum Decay and High Voltage Leak Detection – will be reviewed.
Part One – Current State of Container Integrity Testing
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.