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  • Applications
    • In-line 100% container closure integrity inspection
    • In process control of headspace oxygen
    • In-line vacuum leak detection
    • In-line moisture determination of lyophilized vials
    • Nitrogen purge optimization and qualification
    • Headspace oxygen stability studies
    • Container closure integrity testing
    • Packaging permeation studies
    • Lyo chamber moisture mapping
    • Lyo cycle optimization
    • Lyo product stability studies
    • Water activity measurements
  • Headspace Systems
    • PULSAR Headspace Inspection System
    • PULSAR Headspace CCI Inspection Lease System
    • FMS-Oxygen Headspace Analyzer
    • FMS-Moisture/Pressure Headspace Analyzer
    • FMS-Carbon Dioxide Headspace Analyzer
    • FMS-Water Activity Analyzer
    • FMS-Flexible Bag Headspace Analyzer
  • Measurement Services
    • Laboratory Measurement Services
    • On-Site Measurement Services
    • Benchtop Equipment Lease
    • Automated Inspection Machine Lease
 

FMS-Water Activity Analyzer

Water Activity Analyzer.


The FMS-Water Activity Analyzer is a non-destructive gas analyzer for making water activity (% RH) measurements of solid dosage drug product samples. This compact analyzer utilizes a patented laser absorption technique developed with funding from the Food and Drug Administration. Light from a near-infrared laser is tuned to match an internal absorption frequency of the water vapor molecule and passed through a glass sample container in the headspace above the product. The amount of laser light absorbed is proportional to the water vapor concentration in the headspace which in turn can be directly related to the water activity of the pharmaceutical solid. The use of a temperature controller for the sample housing enables measurements at defined temperature. The non-destructive nature of the measurement method enables a broad range of moisture activity applications and offers significant advantages over traditional techniques.

Applications.


The water activity analyzer is used for development & QC laboratory applications as well as for at-line in-process control of tabletting processes in production. Systems can be permanently situated in laboratories for product development, release testing, and QC investigations or implemented at-line for in-process monitoring and troubleshooting activities.
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Applications include:
• Water activity determination (% RH) of solid dosage and powder product
• Real-time moisture exchange studies
• Water vapor transmission rate studies
• Replacement of Karl Fischer Titration (KFT), Loss On Drying (LOD) for lyo moisture determination
• Rubber stopper drying studies

Related Information

FMS-Water Activity Analyzer System Specification Note
Validation Protocols
FMS Software Package


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