Carbon dioxide headspace analyzer for parenteral containers
Ensure accurate headspace gas analysis to maintain container integrity and detect microbial growth in sealed pharmaceutical products.
Analyzes Carbon Dioxide in Sealed Containers
The FMS-Carbon Dioxide Headspace Analyzer by Lighthouse Instruments is a pivotal tool for ensuring container closure integrity in the pharmaceutical and biopharmaceutical sectors. This benchtop analyzer is designed for non-destructive analysis of headspace carbon dioxide within sealed parenteral containers, facilitating critical tests and inspections across various stages of product development. Utilizing a precise detection system, it measures carbon dioxide levels to monitor microbial growth, verify container closure, and perform in-process control during production. Suitable for a range of product types, including liquids and powders, it efficiently tests configurations such as syringes, vials, and bottles. The analyzer supports integration into both laboratory settings and automated production lines, equipped with 21 CFR Part 11 and Annex 11 compliant software for secure data management. The device accommodates different glass types and sizes, ensuring versatility and compliance with industry standards.
Benefits
- Enhances product safety by ensuring container closure integrity, reducing contamination risks.
- Increases efficiency in quality control processes with non-destructive testing capabilities.
- Provides versatility across various container types and sizes, supporting diverse packaging needs.
- Facilitates regulatory compliance with software aligned to industry standards.
- Boosts operational reliability with precise carbon dioxide measurement and monitoring.
- Applications
- Biopharmaceuticals,Liquid formulations,Nutraceuticals,Pharmaceutical tablets
- End products
- Insulin vials,Freeze-dried vaccines,Powdered antibiotics,Parenteral solutions,Omega-3 capsules,Effervescent vitamin tablets
- Steps before
- Container filling,Sealing,Headspace purging
- Steps after
- Quality control,Microbial growth assessment,Storage,Transport
- Input ingredients
- carbon dioxide,sealed parenteral containers,liquid,powders,lyophilized products,configuration types (syringes,autoinjectors,ampoules,vials,bottles),frozen product,dry ice
- Output ingredients
- carbon dioxide level data,CCI test results,microbial growth detection results,IPC monitoring data,integrity test results
- 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.
- Measurement Range
- 0 to 1 atm (0 to 760 torr)
- Required Headspace
- 3mm
- Configuration Size
- 6.85mm to 86mm outer diameter
- Software Compliance
- 21 CFR Part 11 and Annex 11 compliant
- Product Type
- Liquid,powders,lyo ea
- Configuration Type
- Syringes,Autoinjectors,Ampoules,Vials and Bottles
- Glass Type
- Tubing,molded and plastics
- Color Type
- Clear and amber
- Detection Method
- Non-destructive Headspace Gas Analysis
- Product Life Cycle Application
- Development to QC and In-process Control
- Monitoring Type
- At-line,In-process Monitoring
- Container Compatibility
- Syringes,Autoinjectors,Ampoules,Vials,Bottles
- Configuration Range
- 6.85mm to 86mm Outer Diameter
- Headspace Requirements
- 3mm Minimum Headspace
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Container type
- Syringes,Autoinjectors,Ampoules,Vials,and Bottles
- Product Types
- Liquid,Powders,Lyophilized
- Required Headspace
- 3mm
- Measurement Range
- 0 to 1 atm (0 to 760 torr)
- Configuration Types
- Syringes,Autoinjectors,Ampoules,Vials and Bottles
- Configuration Sizes
- 6.85mm to 86mm outer diameter
- Glass Types
- tubing,molded and plastics
- Color Types
- clear and amber
- Configuration Types
- Syringes,Autoinjectors,Ampoules,Vials and Bottles
- Configuration Sizes
- 6.85mm to 86mm outer diameter
- Glass Types
- Tubing,Molded and Plastics
- Color Types
- Clear and Amber