Blogs

Categories

Select a sub-category to view results

Icon
Films and Coatings
vail 4ml
Pharmaceutical Packaging Components
Icon
Prefillable Systems
Icon
Self Injection Devices
Icon
Vial Containment Solutions
Icon
Washing and Sterilization
Icon
Reconstitution and Transfer Devices

Select a sub-category to view results

Icon
Analytical Lab Services
Icon
Contract Manufacturing
Icon
Fill-Finish
Icon
Regulatory Support

Select a sub-category to view results

Icon
Cell and Gene Therapy Packaging
Icon
Drug Development Process
Icon
Regulatory Challenges
Icon
Transitioning to Combination Products

Select a sub-category to view results

Icon
Corporate Development
Icon
ESG/Sustainability
Icon
One West Team (Employee Culture)
Icon
Our Culture of Giving (Philanthropy)
Icon
Research and Development

Previous Blogs

Capped Vials
USP <1207> residual seal force container system RSF
Evaluation of Container Systems with Residual Seal Force (RSF)

By Mary Tan

December 09, 2019

Parenteral drug products must be stored in a container system that provides good container closure integrity (CCI) over shelf life for the purpose of preventing environmental contamination. This system typically comprises a glass vial, elastomer stopper, and an aluminum seal. USP Chapter <1207> Packaging Integrity Evaluation – Sterile Products discusses in detail methods to measure CCI to determine if the system can meet the maximum allowable leak limit (MALL) for its specific drug product (i.e., the smallest gap, or leak rate, that places quality at risk). Critical to achieving good CCI is proper capping of the vial with the stopper and seal, making sure that the compression level of the stopper is appropriate.

Read More