Water activity headspace analyzer for drug product samples
In pharmaceutical manufacturing, ensuring the precise determination of water activity in drug product samples is vital. Controlling moisture levels is crucial for product stability and efficacy, impacting every stage from development to production.
Determine water activity of solid and powder products
The FMS-Water Activity Headspace Analyzer by Lighthouse Instruments provides accurate water activity determination for various drug product forms, including dry sterile products, oral solid dosage forms, and API materials. It offers real-time moisture exchange studies and water vapor transmission rate analyses, making it an essential tool throughout the product lifecycle. The analyzer can replace traditional methods like Karl Fischer Titration and Loss On Drying for moisture determination. It features a measurement range of 0 to 100% relative humidity and is compatible with ampoules, vials, and bottles ranging from 10.5 to 52mm in outer diameter. Additionally, the system is compliant with 21 CFR Part 11 and Annex 11 software standards.
Benefits
- Accurate water activity measurement from 0 to 100% RH
- Applicable to various drug forms: dry sterile, oral solid dosage, API
- Replaces traditional moisture determination methods
- Supports real-time moisture exchange and vapor transmission studies
- 21 CFR Part 11 and Annex 11 compliant software