Product/Service

Pharmaceutical Water Activity Analyzer: FMS

Lighthouse Headspace Analyzer

LIGHTHOUSE’s FMS-Water Activity Analyzer measures the water activity (% RH) of drug product samples.

The water activity analyzer can be used throughout the entire product lifecycle from development to QC laboratory applications to at-line, in-process control of tableting processes in production.

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
  • Rubber stopper drying studies
  • Microbial studies

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

Specifications

Nominal Specifications

  • Moisture Measurement Linearity Range: 0 to 100% RH
  • Temperature Control Range: 20 to 45oC
  • Measurement Time: 10 seconds (default)
  • Initial Warm-up Period: 30 minutes
  • Sample Container Sizes: 1 to 50 mL

Physical and Electrical

  • Dimensions (WxDxH): 19.1 x 43.2 x 33.0 cm (7.5” x 17” x 13”)
  • Weight: 9.1 kg (20 lbs)
  • Power Requirements: 110-240 VAC, 50/60 Hz, 60 W
  • Controller: PC

FMS Software Package

Data Integrity and Compliance

To meet the current regulatory requirements on data integrity, the FMS Software Package includes a GxP mode to support the collection of compliant analytical data while limiting the need for procedural controls.
Software Features

All FMS systems are provided with the basic software package. This includes different operating modes allowing the performance of measurements that do and do not require strict compliance.

For enhanced compliance features and centralized data management, the additional GxP Database Package is available. Some main features:

  • Password protected software access
  • Data is stored in a secure database
  • Results are logged at the time of measurement
  • Access to raw data & searchable for easy retrieval of data or user events
  • Electronic signatures for review & approval
  • Complete system audit trail

Install Options

The FMS benchtop headspace analyzers are installed by a LIGHTHOUSE Application Engineer with the following support:

  • System qualification (IQ/OQ)
  • User training and system start-up support
  • Performance testing

Validation Protocols

LIGHTHOUSE offers a complete set of validation protocols, as well as on-site validation services designed to assist customers in their validation efforts of LIGHTHOUSE systems. The validation documentation can be modified to fit a customer’s particular document format standard.