Lighthouse

As described in the chapter subsection USP <1207.3> Package Seal Quality Test Methods, the measurement of residual seal force (RSF) indicates the quality of the vial package seal, giving insight into the quality of the sealing process. Correlating RSF to CCI data enables optimization and validation of the vial sealing process with parameters that give assurance of good CCI. This Case Study describes how science-based statistically valid RSF data was generated on the vial sealing process and combined with CCI data to ensure good CCI of sterile product needing deep cold storage

Download this Case Study to learn how a purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

This new case study demonstrates how a non-destructive container closure integrity test method can be developed for autoinjectors with an optically transparent window.

Webinar Date/Time: Thu, Mar 27, 2025 10:00 AM EDT

Webinar Date/Time: Wed, Mar 13, 2024 11:00 AM EDT

Webinar Date/Time: Tuesday, April 4th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Thursday, October 21, 2021 at 4pm CEST |10am EDT| 7am PDT| 3pm BST Protect not only your valuable product but also public health by ensuring correct storage choices. Gain insight into the effects of deep cold storage and a holistic approach to ensure Container Closure Integrity of sterile pharmaceuticals.

• Container closure integrity testing is vital for sterile injectable products. • The Headspace Gas Ingress method is a robust detection method of critical leaks. • This method is an upgrade to the blue dye test and can be scientifically validated.