Laser-Pro Next-Gen Headspace Gas Analyzer


Non-Destructive laboratory headspace gas analyzer measuring specific gas concentration in the headspace of sterile transparent pharmaceutical packaging such as ampoules, vials, cartridges, pre-filled syringes and plastic containers. Suitable for the following types: liquids, lyo, powder, pastes, solids, or semi-solid content.



Prefilled Syringes




  • Flexible, accurate, and easy-to-use solution
  • Fast, reliable and repeatable results
  • Stable calibration for long-lasting reliability
  • Sample-housing unit that minimizes outside influences
  • Simple and safe tooling format placement (based on magnetic couplings)
  • Nitrogen purging not required

Technical Features

  • Container Application: Transparent cylindrical containers such as: ampoules, vials, cartridges and pre-filled syringes with a required headspace of 5 mm minimum (in ampoules intended as headspace with overturned ampoule). Plastic containers are subject to feasibility study and custom tooling format.
  • Products: Lyo, liquid, powder, pastes, solid, semi-solids
  • Container Dimensions: From 2 R to 100 R ISO vials (tubular), 16 to 49 mm (molded) and ampoules from 1 to 50 ml. Plastic containers (both clear and frosted plastic)  - all require custom tooling format.
  • Testing time: Application dependent, accurate results can be obtained in just 1 second.
  • Technology: HGA by Tunable Diode Laser Absorption Spectroscopy (TDLAS)
  • Inspection Feature: Non-destructive and non-invasive CCIT and QC, laser-based inspection method
  • Inspection Capabilities: In-process quality control ensuring the correct composition of the protective atmosphere; under specific conditions can also be used as CCIT.

Additional Benefits

  • No calibration required before starting a batch
  • Tooling format automatic identification system to check the loaded format matches the attached one
  • Selected testing parameters receipt matches the tooling features
  • Single tooling format part for clear and amber containers
  • Precise and compact next generation laser
  • Customizable and intuitive HMI with real-time display of statistics and raw data
  • Troubleshooting advanced alerts
  • Ewon connection makes the troubleshooting easy to quickly find the right solution
  • Connections to Active Directory and VPN router for machine remote access


  • Headspace Gas Analysis (HGA) inspection process based on Tunable Diode Laser Absorption Spectroscopy (TDLAS) method to accurately quantify gaseous concentration levels.

  • Diode laser beam transmitted through headspace region of the container and reflected back towards the receiver. 

  • Laser-Pro sensors measure the laser beam absorption related to target gas concentration.

Quality Assurance

Equipment test method refers to:
    • EU GMP Annex 1 Manufacture of Sterile Medicinal Products, section 123: “Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period”
    • Testing method in conformity with provisions of USP- United States Pharmacopeia - General Chapter <1207> “Package Integrity Evaluation – Sterile Products” (USP 39-NF34): Laser-Based Gas Analysis is listed among the Deterministic Leak Test Technologies
    • Software designed to comply with FDA 21 CFR Part 11 and EU Annex 11
    • First tooling format supplied for verification
    • Easy to perform validations and qualifications thanks to advanced protocols and documentation


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