FMS-Carbon Dioxide Headspace Analyzer

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.