HSA Lab

  1. General Details

    Laboratory Headspace Gas Analyzer

    This compact bench top equipment is designed to measure the headspace gas levels of sealed containers filled with parenteral sterile drugs including liquid, dry powder and lyophilized preparations.

    The equipment is configured to accommodate 2 laser sensors in order to provide the user with a maximum flexibility of use.

    This unique feature allows to verify with the same piece of equipment a multiplicity of drug products having various headspace conditions.

    Key Benefits

    • Headspace Gas Analysis system is a proprietary technology of Xepics
    • High level of automation and performance in a small module size
    • Quick inspection time
    • Applicable to vials, ampoules, cartridges, syringes, bottles with different headspace composition
    • Suitable for different glass colors (amber / clear) and types (tubular / molded)
    • HMI and Control System compliant with FDA 21 CFR P11 and EU GMP Annex 11 requirements

     

  2. Applications
    ApplicationsDescription
    Headspace critical gas maintenanceMonitoring the target headspace gas such as Oxygen in a low oxygen/high nitrogen sealed environment arises from the need of ensuring the stability and potency of oxygen-sensitive product.

    The measurement focuses at the detection of an increase of the target gas level in the headspace that could be the result of a breach in the CCI or a purging failure occurred during primary packaging.

    Headspace absolute pressure maintenanceMonitoring the level of partial vacuum under which the container has been sealed is a regulatory requirement over the shelf life of the product (EU Annex 1)
    Container Closure Integrity verificationEstablishing CCI throughout a product life cycle is a function of the detection of permanent and temporary leaks.

    Permanent leaks: ingress of Oxygen through cracks, defective seals, loose caps.

    Temporary leaks: ingress of gases such as Oxygen and Carbon Dioxide due to deep cold storage and transport that determines rubber-glass transition of the elastomeric closures

    Headspace water vapor content monitoringMeasurement of the residual moisture content of a lyophilized pharmaceutical product establish both stability and correct functionality of the packaged drug product.

    Residual moisture content is related to the stability of the formulation over the shelf life of the product.

    Also residual moisture analysis confirms the efficiency, consistency, and robustness of the specific freeze-drying cycle designed for a particular drug formulation

  3. Techical Info
    Specifications
    Containers to be processedAmpoule, Vial, Cartridge, Bottle, Prefilled Syringe
    Container contentLiquid, Freeze Dried, Powder
    Container materialGlass (clear and / or amber)
    Container sizes8 to 52 mm in diameter

    35 to 110 mm in height

    Container typeTubular, Molded
    Fill volume1 to 100ml
    Measurement time:1 second

     

    Equipment Layout

  4. Product Enquiry

    Contact form description text

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  5. Product Video
  6. Documents
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