Carbon dioxide headspace analyzer for parenteral containers
Ensuring the integrity of sealed parenteral containers is crucial in pharmaceutical manufacturing. Contaminants or leaks can compromise sterility, affecting product safety and efficacy. Swift detection of carbon dioxide levels in container headspaces offers a non-destructive means to verify closure integrity and identify potential microbial growth.
Analyze carbon dioxide headspace non-destructively
The FMS-Carbon Dioxide Headspace Analyzer by Lighthouse Instruments is designed for the rapid, non-destructive analysis of carbon dioxide in the headspace of sealed parenteral containers. It supports a range of applications including container closure integrity testing, inspection of media fill containers, and detection of microbial growth. The analyzer can be used throughout the product life cycle, from development to quality control and in-process control during production. Notable features include a 3mm required headspace, a measurement range from 0 to 1 atm (0 to 760 torr), and compatibility with various container types such as syringes, autoinjectors, ampoules, vials, and bottles. The system complies with 21 CFR Part 11 and Annex 11, ensuring data integrity in regulated environments. It accommodates liquid, powder, and lyophilized products, making it ideal for diverse pharmaceutical applications.
Benefits
- Non-destructive testing preserves sample integrity
- Supports various container and glass types
- Applicable throughout the product life cycle
- Compliant with regulatory data integrity requirements
- Detects microbial growth and closure integrity efficiently