Laser EXP – Headspace Gas Analyzer

The Laser EXP is a high-performance, non-invasive headspace gas analyzer designed for 100% deterministic testing of glass pharmaceutical containers (vials from 2R to 100R) containing liquid, powder, or lyophilized products. It leverages Tunable Diode Laser Absorption Spectroscopy (TDLAS) for rapid, accurate, and repeatable gas composition measurements in the headspace.

Key Highlights

  • Accurate CCIT via HGA + TDLAS: Deterministic gas-based container closure integrity testing without compromising sample integrity.

  • Fast Cycle Rates: Offers precise analysis—for 2R vials at up to 150 containers per minute—with typical precision around 0.1% and accuracy ~0.5%.

  • Streamlined Design: Compact, CE-marked, and compliant with IEC and machinery directives for pharmaceutical environments.

Technical Features

  • Testing Technology: TDLAS at 760 nm (Class 1 laser per IEC 60825‑1).

  • Measurement Scope: Capable of measuring oxygen concentrations from 0% to 100%.

  • Sample Compatibility: Designed for glass vials ranging from 2R to 100R with liquid, powder, or lyophilized contents.

  • Performance Specs:

    • Throughput up to approximately 150 cpm for small vials.

    • Precision typically at ~0.1%; accuracy around ~0.5%.

  • Regulatory Design: Fully compliant with CE directives (EMC 2014/30/EU, Machinery 2006/42/EC, Low Voltage 2014/35/EU); IP64-rated chassis to protect against ingress.

Additional Benefits

  • Validation-Ready: Delivered with complete documentation and ISO 9001-certified validation support to facilitate regulatory qualification.

  • User-Friendly Interface: Intuitive HMI displays statistics and raw data in real-time, with advanced alerts to support rapid diagnostics.

  • Remote Connectivity: Ewon-enabled connection allows MES integration, remote support, and troubleshooting via Active Directory and VPN.

  • Low-Maintenance Operation: Designed with minimal moving parts for simpler maintenance and enhanced reliability.

  • Flexible Deployment: Suitable for inline use on production lines or as a standalone post-quarantine inspection station.

Technology & Compliance

  • TDLAS Capability: Measures headspace gases non-destructively, detecting O₂ (and optionally humidity or pressure) by analyzing laser absorption.

  • Regulatory Compliance:

    • EU GMP Annex 1, Section 123 – validated for vacuum-sealed containment verification.

    • USP <1207> – Recognizes laser-based gas analysis (HGA) as a deterministic leak testing method.

    • Software fully supports FDA 21 CFR Part 11 and EU Annex 11 standards, ensuring audit trails, electronic signatures, and data integrity.

Why Choose Laser EXP?

✅ Non-destructive, Deterministic Testing: Ensures every container is tested without sample loss—ideal for sterile pharmaceutical products.

✅ High-Speed, High-Precision Operation: Capable of analyzing a large number of vials quickly—perfect for quality control at scale.

✅ Regulatory Compliance Built-In: Offers validation documentation and software aligned with major pharmaceutical standards.

✅ Ergonomic & Robust: Compact footprint combined with minimal moving parts improves usability and reduces downtime.

✅ Seamless Integration: Remote access and MES-ready connectivity support modern Industry 4.0 workflows.

✅ Low Maintenance & Reliable: Simplified design for consistent performance and fast troubleshooting.

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