One platform for CCIT across the product life cycle meeting current regulatory expectations
Dye ingress and other probabilistic CCI tests leave leak detection to chance and destroy product in the process. The LIGHTHOUSE CCI Tester combines a pressurized CCI Test Vessel, automated conditioning control, and carbon dioxide headspace analysis into one deterministic, non-destructive system that can detect defects down to 0.1 micron.
Catch Microleaks Before They Become Recalls
- Automated purging, pressurization, and venting eliminate manual gas handling
- Detects defects ranging from 0.1 micron to gross, using carbon dioxide as a high-sensitivity tracer gas
- Conditions samples inside a pressurized CCI Test Vessel, at pressures up to 20 psig (1.38 barg), to accelerate gas ingress through any open defect
- Deterministic, non-destructive result: elevated headspace carbon dioxide after conditioning indicates a leak pathway, without sacrificing the container
- Versatile across container types, from 1 mL syringes to 500 mL bottles
- Compatible with clear, amber, molded glass and plastic containers
Build a unified CCIT strategy from development through commercial QC
- Supports method development and validation for CCIT protocols, backed by mathematical gas ingress modeling that defines the most sensitive test for each product’s critical leak size
- Scales from development sample sets to full production batches with 8 L, 40 L, or 50 L test vessel options
- Fully automated, reproducible conditioning cycles remove operator-to-operator variability
- Easy selection of pre-validated methods for range of container sizes and specific leak size sensitivity
- Integrates with the LIGHTHOUSE GxP Database for 21 CFR Part 11-compliant data storage, batch review, and audit trail documentation
- Robust stainless-steel vessel construction, rated to ASME “UM” and CE Pressure Directive standards, for durability and cleanliness
Why choose LIGHTHOUSE?
- LIGHTHOUSE has developed equipment and methods resulting in a platform approach for CCIT
- One platform for product life cycle CCI data generation and testing to meet current regulatory expectations
- Standard methods can be defined as recipes for ‘push button’ CCIT, from inherent package integrity to routine QC testing
- LIGHTHOUSE offers a holistic approach to CCIT covering most needs & requirement
- Compliant with FDA guidance, USP <382> and <1207>, and EU GMP Annex 1
- Greater sensitivity than dye or other liquid ingress tests, validated to detect the smallest defects
- Patented laser-based headspace analysis, originally developed with funding from the FDA
CCI Tester
SPECIFICATIONS
Typical Measurement Time
5 seconds
Container Closure Systems
Syringes, autoinjectors, ampoules, vials, bottles
Recipe Management
User-defined test sample conditioning recipes
User Interface of control module
Built-in touchscreen display
Test Vessel Options
8 L, 40 L or 50 L
Software
21 CFR Part 11 and Annex 11 compliant
Power Requirements
110–240 VAC, 50/60 Hz, 60W
Data Management
Integration with LIGHTHOUSE GxP Database
More information on the CCI Tester can be found in our product note
Trusted by the Pharmaceutical Industry
More than 30 years of experience in laser-based headspace analysis
Used by all of the top 10 global pharmaceutical companies
GMP certified services aligned with global regulatory expectations
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