Ensure Sterile Products with Automated Non-Destructive Headspace Analysis
Statistical sampling can miss the one defective vial in a lot of thousands, and manual CCI testing can't keep pace with a fill-finish line. The PULSAR Headspace Inspection System delivers automated, 100% inline inspection of headspace oxygen and pressure, rejecting non-conforming containers in real time.
Move from statistical sampling to 100% inspection
- Automated, non-destructive inspection of every container in the batch, not just a statistical sample
- Measures headspace oxygen and pressure to identify containers out of specification
- Detects CCI failures in freeze-dried product with a vacuum or partial nitrogen headspace, and in modified-headspace liquid and powder products
- Automatically sorts non-conforming containers into a dedicated reject lane, separate from unmeasured containers
- Runs at up to 300 containers per minute, matching fill-finish line speeds
- Suitable for tubing or molded vials, amber or clear
Automate media fill inspection with laser-based headspace analysis
- Extends the same 100% headspace inspection to automate media fill inspections
- Four permanently mounted Standard Calibration Vials continuously verify sensor calibration during operation
- Runs on single-phase power and standard plant compressed air and nitrogen supplies — no specialized utilities required
- Compact, wheeled platform moves into place without modifying doorways or plant layout
- 21 CFR Part 11 compliant database logs every measurement, alarm, and settings change, with exportable Batch, Measurement, Alarm, and Audit Trail reports
- Available as a per-project lease for CCI inspection campaigns that don’t require a permanent installation
Why choose LIGHTHOUSE?
- Automated, deterministic 100% inspection
- Patented laser absorption technology, originally developed with funding from the FDA
- LIGHTHOUSE introduced laser headspace technology to the pharmaceutical industry more than 30 years ago and holds the largest installed base of laser-based headspace systems worldwide
- Continuous, in-process calibration verification via permanently mounted Standard Calibration Vials
- Installation by LIGHTHOUSE engineers, including IQ/OQ qualification, user training, and performance testing
- Flexible acquisition — purchase a permanent line installation or lease a system per project
PULSAR Headspace Inspection System
PULSAR Headspace Inspection System
PULSAR
SPECIFICATIONS
Container Sizes
Vials ranging in size from 2R to 100R, or 16.0 mm to 47.0 mm
Container Capability
Tubing or molded; amber or clear
Maximum Throughput
300 containers per minute
Software
21 CFR Part 11 compliant database
Dimensions
330 cm x 130 cm
Compressed Nitrogen
25 slpm @ >3.5 barg
Electrical Power:
200 – 240 VAC 1-phase, 15 amp 50/60 Hz
Compressed Air:
35 scfm @ >5.5 barg
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 automation systems
FMS Automation Module
Manual sample handling can slow headspace testing, limiting how large a sample set you can realistically test. The FMS Automation Module pairs a robotic handler with your FMS Headspace Analyzer to test hundreds of vials unattended, at up to 300 samples per hour.
Illuminator
The Illuminator Headspace Inspection System delivers automated, 100% inspection of headspace oxygen, moisture, and carbon dioxide concentrations for process development, filling line and freeze dryer qualification, vacuum maintenance and automated media fill inspection.
Learn more about...
-
100% Container Closure Inspection of Freeze Dried Product in Quarantine
— Read more -
Equipment Lease
Our flexible lease option allows clients to plan for short… — Read more -
Automated Media Fill Inspection
Manual inspection of media-filled vials for contamination is tedious, time-consuming,… — Read more
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.
