It has become generally accepted that headspace gas ingress methods represent the most robust and flexible approaches for performing container closure integrity (CCI) testing throughout the product life cycle. As one of the deterministic techniques in the USP <1207> chapter on package integrity testing, headspace methods are based on non-destructive analytical measurements and are recommended for use in container closure integrity testing (CCIT) throughout the product life cycle to generate science-based CCI data that, coupled with a risk-based approach, enables informed decisions about a CCIT strategy in commercial manufacturing.

Headspace methods are the only ones to have been validated to detect gross leaks, sub-micron defects down to helium leak sensitivity, and leaks that are temporary. Methods that are developed for lab-based CCIT can be scaled for automated in-line testing in the manufacturing environment. Headspace methods are now regularly being implemented as the “golden tool” for CCIT of all types of sterile pharmaceutical product. The use of headspace methods for recent mRNA therapies as part of a holistic science-based approach to container closure integrity assurance has further demonstrated headspace as the most flexible and reliable deterministic method for CCIT.

This webinar will cover how headspace methods are developed and validated for a variety of product-container configurations including pre-filled syringes. Case studies will be presented that demonstrate the utility of headspace methods for meeting recent specific EU GMP Annex 1 requirements such as transport validation for product needing ultracold storage temperatures.

Speaker:

Derek Duncan, PhD
Director, LIGHTHOUSE Instruments