06/03/2026
With USP now in effect, pharma manufacturers must move beyond component testing and evaluate the entire packaging system for “fitness-for-intended-use.” This is especially critical for multi-dose systems, where stoppers must reliably reseal after repeated needle punctures.
The old USP blue dye test is no longer enough. Modern regulations demand deterministic, quantitative methods aligned with USP .
In our latest study, LIGHTHOUSE demonstrated how non-destructive laser-based headspace analysis provides a robust solution for evaluating stopper resealing performance.
Study highlights:
· Real-time monitoring of resealing dynamics after needle withdrawal
· Reliable detection of permanent leaks after repeated punctures
· Sensitivity down to micron sized defects using a CO₂ tracer gas method
· Fully non-destructive CCI test method that is suitable throughout the product life-cycle
Read the full article below for detailed study data and methodology https://lighthouseinstruments.com/knowledge-center/implementing-usp-evaluating-elastomer-resealing-capacity-with-non-destructive-headspace-analysis/
Ready to modernize your multi-dose vial testing strategy? Let’s connect.
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