Product Description
The Laser-Pro Next-Gen Headspace Gas Analyzer is a non-destructive laboratory solution designed to measure specific gas concentrations in the headspace of sterile, transparent pharmaceutical packaging, including ampoules, vials, and plastic containers. This advanced system is suitable for a wide range of product types, including liquids, lyophilized (lyo) products, powders, pastes, solids, and semi-solids.
The Laser-Pro utilizes Headspace Gas Analysis (HGA) based on Tunable Diode Laser Absorption Spectroscopy (TDLAS) to accurately measure gaseous concentrations. A diode laser beam is transmitted through the container’s headspace and reflected back to the receiver, where laser beam absorption is analyzed to determine gas concentration levels.
The Laser-Pro is designed to meet stringent regulatory requirements, ensuring compliance with EU GMP Annex 1, Section 123, which mandates testing for vacuum maintenance in vacuum-sealed containers. It also adheres to USP General Chapter <1207>, which recognizes laser-based gas analysis as a deterministic method for leak detection in sterile pharmaceutical packaging. Additionally, the software is fully compliant with FDA 21 CFR Part 11 and EU Annex 11, meeting all electronic records and data integrity requirements.
The system includes a pre-verified tooling format, and its advanced protocols and documentation make validation and qualification processes easy to implement. The Laser-Pro Next-Gen Headspace Gas Analyzer is the ideal solution for ensuring the highest standards of container closure integrity testing (CCIT) in pharmaceutical manufacturing, delivering precision, efficiency, and regulatory compliance in every analysis.
