The FMS-Oxygen Headspace Analyzer measures headspace oxygen levels in sealed drug product containers. This data can be used to monitor headspace conditions for oxygen-sensitive products, test container closure integrity, and monitor.
Specifications
Required Headspace
3mm
Measurement Range
0 – 25% Oxygen (customizable up to 100% at the time of build)
Configuration Sizes
6.85mm to 86mm outer diameter of container closure system
Software
21 CFR Part 11 and Annex 11 compliant
Prodcut Types
liquid, powders, freeze-dried
Container Closure Systems
Syringes, Autoinjectors, Ampoules, Vials and Bottles
Container closure system material
tubing, molded and plastics
Color Types
clear and amber
Key Features
Rapid non-destructive measurement allows for 100% inspection
High-sensitivity signal analysis delivers an accurate measurement in seconds
Custom change parts provide consistent positioning of sample for optimal measurement across a wide range of container types and sizes
NIST-certified standards for calibration and verification ensure accurate results
Applications Include
Leak detection
Container closure integrity studies
IPC monitoring of oxygen levels during the filling of oxygen-sensitive product
Optimization and validation of purging systems on filling lines
