Description
LIGHTHOUSE continues to innovate the use of rapid, non-destructive headspace gas analysis.
LIGHTHOUSE’s FMS-Carbon Dioxide (CO2) Headspace Analyzer measures CO2 concentration in sealed parenteral containers for a variety of applications.
The benchtop headspace carbon dioxide analyzer can be used throughout the entire product lifecycle, from development to QC laboratory applications to at-line, in-process control of headspace CO2 levels in production.
Applications include:
- Container closure integrity testing of frozen product stored on dry ice for transport
- General container closure integrity testing when the test method involves using carbon dioxide as a tracer gas
- IPC monitoring of carbon dioxide levels during the filling of product purged with carbon dioxide in the headspace
- Microbial growth detection in media vials
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
- Measurement Range: 0 – 760 torr
- Measurement Time: 5 seconds
- Container Sizes: 1 to 100 mL
- Container Capability: Tubing or molded; amber or clear
Physical and Electrical
- Dimensions (WxDxH): 30.5 x 30.5 x 29.2 cm (12” x 12” x 11.5”)
- Weight: 13.6 kg (30 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.
