Oxygen headspace analyzer for container closure integrity testing
Ensure the integrity of oxygen-sensitive products with precise headspace analysis, providing essential leak detection and validation throughout the product lifecycle, from research development to quality control in production.
Monitors Headspace Oxygen for Quality Control
The FMS-Oxygen Headspace Analyzer from Lighthouse Instruments offers a precise solution for monitoring oxygen levels in pharmaceutical and biotech applications. This benchtop device facilitates non-destructive examination of oxygen-sensitive environments in sealed parenteral containers, crucial for maintaining product integrity. Its specialized role includes leak detection and real-time in-process control during filling operations. With a measurement range up to 25% oxygen, customizable to 100%, it addresses diverse product types, from liquids to lyo powders, and accommodates various container configurations, such as syringes and vials. The analyzer enhances process efficiency by optimizing purging systems, validating production settings, and adhering to 21 CFR Part 11 compliance, ensuring data integrity and traceability. Suitable for R&D and quality control labs, it integrates seamlessly into existing production lines, supporting stability testing and shelf-life studies. Available glass and plastic options provide compatibility across medical and packaging industries, making it an essential tool for maintaining product efficacy and compliance with industry standards.
Benefits
- Ensures product quality by precisely monitoring oxygen-sensitive environments non-destructively.
- Supports regulatory compliance with data integrity through 21 CFR Part 11 compliance.
- Optimizes production efficiency by validating and controlling purging systems in real time.
- Minimizes production errors and contamination risks with automated leak detection and IPC monitoring.
- Enhances versatility with compatibility across various container types and product forms.
- Applications
- Liquid formulations,Medical devices,Biopharmaceuticals,Oxygen-sensitive products,Parenteral solutions,Pharmaceuticals
- End products
- Lyo powders,Biologics,Liquid vials,Oxygen-sensitive pharmaceuticals,Iv solutions,Medical-grade inhalers,Ampoules,Pre-filled syringes,Injectable drugs,Autoinjectors
- Steps before
- Gas purging,Filling line setup,Container filling
- Steps after
- Container closure integrity testing,Stability testing,Packaging,Shelf life studies
- Input ingredients
- oxygen-sensitive products,sealed parenteral containers,liquid,powders,lyophilized products,syringes,autoinjectors,ampoules,vials,bottles
- Output ingredients
- headspace oxygen levels,oxygen level measurements,integrity testing results,purging system optimization data,stability trends,packaging permeation studies results,oxygen degradation studies outcomes
- Market info
- Lighthouse Instruments is known for its expertise in providing high-precision laser-based inspection and measurement systems, primarily for the pharmaceutical industry, specializing in non-destructive testing solutions for ensuring container integrity and product quality.
- Required Headspace
- 3mm
- Measurement Range
- 0 – 25% Oxygen (customizable up to 100% at the time of build)
- Configuration Sizes
- 6.85mm to 86mm outer diameter of the configuration
- Software Compliance
- 21 CFR Part 11 and Annex 11 compliant
- Operation type
- Non-destructive analysis
- Monitoring capability
- At-line,in-process control
- Oxygen measurement range
- 0 – 25% Oxygen (customizable up to 100%)
- Container compatibility
- Syringes,Autoinjectors,Ampoules,Vials,Bottles
- Automation level
- Manual / Automated (FMS Automation Module)
- Software compliance
- 21 CFR Part 11 and Annex 11 compliant
- Density/particle size
- 0.5–2.5 g/cm³
- Glass Types
- Tubing,molded and plastics
- Color Types
- Clear and amber
- Product Types
- Liquid,powders,lyo
- FDA materials
- 21 CFR Part 11
- Required Headspace
- 3mm
- Configuration Types
- Syringes,Autoinjectors,Ampoules,Vials and Bottles
- Configuration Types
- Syringes,Autoinjectors,Ampoules,Vials,Bottles
- Configuration Sizes
- 6.85mm to 86mm outer diameter
- Color Types
- Clear,Amber