- General Details
100% Online Headspace Gas Analyzer
This equipment allows a fully automated 100% measurement of the headspace gas levels of sealed containers filled with parenteral sterile drugs including liquid, dry powder and lyophilized preparations.
The equipment can accommodate up to 8 laser sensors in order ensure that user requirements in terms of performance, accuracy and resolution of the measurement are fulfilled.
The equipment max operating speed is 400 pieces per minute.
- Headspace Gas Analysis system is a proprietary technology of Xepics
- Flexible in/outfeeding: Off-line (Tray-in and Tray-out) or Online (conveyors)
- Applicable to vials, ampoules, cartridges and bottles with different headspace composition
- Suitable for different glass colors (amber / clear) and types (tubular / molded)
- Easy configuration, fast changeover, short retooling time
Applications Description Headspace critical gas maintenance Monitoring 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 maintenance Monitoring 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 verification Establishing 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 monitoring Measurement 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
- Techical Info
Specifications Containers to be processed Ampoule, Vial, Cartridge, Bottle Container content Liquid, Freeze Dried, Powder Container material Glass (clear and / or amber) Container sizes 8 to 50 mm in diameter, 35 to 100 mm in height Container type Tubular, Molded Fill volume 1 to 50ml Production speed 400 containers per minute (24000 containers per hour)
Equipment Layout – HSA 400
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