Automated headspace inspection for parenteral containers
Consistency and safety are critical when ensuring that parenteral containers maintain their integrity over time. Challenges include preventing contamination and ensuring proper pressure and gas levels within each sealed container.
Ensure 100% inspection of headspace integrity
The PULSAR Headspace Inspection System by Lighthouse Instruments is designed for automated, comprehensive inspection of headspace oxygen, pressure, and carbon dioxide levels in sealed parenteral containers. The system supports container sizes ranging from 2R to 100R (or 16.0 mm to 47.0 mm in diameter) and handles both tubing and molded types, whether amber or clear. It can inspect up to 9000 containers per hour, ensuring high throughput and reliability. The system’s software is compliant with 21 CFR Part 11, making it suitable for regulatory environments. Installation and qualification support, including system qualification (IQ/OQ), user training, and performance testing, are provided by Lighthouse Instruments. This technology is particularly useful for applications such as 100% CCI (Container Closure Integrity) inspection of both freeze-dried products with vacuum or modified headspace and liquid and powder products.
Benefits
- Automated 100% inspection of headspace integrity
- Supports various container sizes and types
- High throughput: up to 9000 containers per hour
- 21 CFR Part 11 compliant for regulatory use
- Comprehensive installation and qualification support