Laser-Pro Next-Gen Headspace Gas Analyzer

Pharmaceuticals

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.

Ampoules

Cartridges

Prefilled Syringes

Vials

Tech specifications

Highlights

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

Technology

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