Ensure Sterile Products with Non-Destructive Headspace Analysis
Verify container closure integrity with a single method throughout your product life-cycle
- Use carbon dioxide as a high-sensitivity tracer gas, with samples conditioned in a pressurized CCI Test Vessel prior to measurement.
- The only technique that can detect a loss in CCI occuring during dry ice storage and shipment
- Non-destructive and quantitative headspace measurement — no product is sacrificed to confirm integrity
- Suitable for syringes, autoinjectors, ampoules, vials, and bottles from 6mm to 86mm outer diameter
- Works across clear and amber, glass and plastic containers, and liquid, powder, or freeze-dried products
- Delivers results in seconds, supporting testing from development through routine QC
From CCIT to automated media fill inspection, use headspace analysis to detect microbial growth
- Apply the same non-destructive measurement to detect microbial growth in media-filled vials
- Supports bi-annual APS inspection with objective, instrument-based data
- Calibrated against NIST-certified carbon dioxide standards for verified accuracy
- 21 CFR Part 11 and Annex 11 compliant software, with a full validation package included
Why choose LIGHTHOUSE?
- Supports CCIT strategies aligned with USP <1207> & EU GMP Annex 1
- Patented laser absorption technology, originally developed with funding from the FDA
- Custom change parts hold each sample in a consistent position for repeatable measurement across container types and sizes
- Compact benchtop footprint (30.5 x 30.5 x 29.2 cm) fits directly into existing lab or at-line workflows
- Easy-to-use hardware and software require minimal operator training
- LIGHTHOUSE is the industry leader in laser-based headspace analysis
FMS-Carbon Dioxide Headspace Analyzer
FMS-Carbon Dioxide Headspace Analyzer
FMS-Carbon Dioxide
SPECIFICATIONS
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
Our other benchtop instruments
FMS-Moisture/Pressure
Lost vacuum and moisture ingress after freeze drying threaten product stability, yet many methods can't measure these headspace conditions directly. The FMS-Moisture/Pressure Headspace Analyzer measures moisture and total pressure simultaneously and non-destructively, straight through the container wall.
FMS-Oxygen
The FMS-Oxygen Analyzer enables precise, non-invasive oxygen analysis in sealed containers — ideal for pharma QC, process validation, and container closure integrity testing (CCIT).
FMS-Water Activity
Reactive moisture drives degradation, caking, and stability failures in solid dosage and lyophilized product, yet Karl Fischer titration and loss on drying destroy the very samples you need to monitor over time. The FMS-Water Activity Analyzer measures water activity non-destructively, straight through the container.
Learn more about...
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Get in touch with Steven
Do you have questions about our services or need expert advice for your project? Our dedicated team is here to help. Contact us today to learn how we can support your specific needs.
