- 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.
- 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
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, Prefilled Syringe Container content Liquid, Freeze Dried, Powder Container material Glass (clear and / or amber) Container sizes 8 to 52 mm in diameter
35 to 110 mm in height
Container type Tubular, Molded Fill volume 1 to 100ml Measurement time: 1 second
- Product Enquiry
Contact form description text
- Product Video