The FMS-Water Activity Headspace Analyzer enables robust and accurate determination of water activity of drug product samples. Applications include water activity determination of dry sterile product, oral solid dosage forms, and API material.
Specifications
Required Headspace
3mm
Measurement Range
0 to 1.0 (0 to 100% relative humidity)
Configuration Sizes
10.5 to 52mm outer diameter of the container closure system
Temperature Controller Range
19 to 45°C
Prodcut Types
dry sterile product, oral solid dosage, API bulk material
Container Closure Systems
Ampoules, Vials and Bottles
Glass types
tubing and molded
Software
21 CFR Part 11 and Annex 11 compliant
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
Water activity determination (% RH) of solid dosage, lyo, and powder product
Real-time moisture exchange studies
Water vapor transmission rate studies
Replacement of Karl Fischer Titration (KFT), Loss On Drying (LOD) for moisture determination
