Moisture and pressure headspace analysis for sealed parenteral containers
Ensuring the integrity of sealed parenteral containers requires precise measurement of both moisture and pressure. Issues like moisture degradation, vacuum leaks, and closure integrity can compromise product quality, demanding a reliable and non-destructive analysis method.
Monitor moisture and pressure simultaneously in sealed containers
The FMS-Moisture/Pressure Headspace Analyzer by Lighthouse Instruments enables simultaneous non-destructive monitoring of both moisture partial pressure and total pressure within sealed parenteral containers. This system is ideal for applications such as vacuum leak detection, moisture determination of lyophilized products, and container closure integrity studies. The analyzer supports a range of configurations, including syringes, ampoules, vials, and bottles, with diameters from 6.85mm to 86mm. It is compliant with 21 CFR Part 11 and Annex 11 regulations, ensuring reliable data integrity. The system’s capabilities include a total pressure measurement range from 0 to 1 atm (0 to 760 torr) and a moisture range of 0 to 25 torr. The FMS-Moisture/Pressure Headspace Analyzer is suitable for clear and amber glass types, tubing, molded, and plastic materials, offering a comprehensive solution for moisture and pressure headspace analysis throughout the product lifecycle.
Benefits
- Non-destructive analysis method
- Simultaneous monitoring of moisture and pressure
- Supports a range of container configurations and sizes
- Compliance with regulatory standards
- Wide measurement ranges for diverse applications