Laser‑Pro Next‑Gen Headspace Gas Analyzer

The Laser‑Pro is a non‑destructive laboratory headspace gas analyzer engineered to measure oxygen concentration in the headspace of sterile, transparent pharmaceutical packaging such as vials, ampoules, and clear plastic containers. It supports a range of product forms including liquids, lyophilized powders, pastes, solids, and semi‑solids.

Key Highlights

  • Fast, Accurate Analysis: Provides highly repeatable results in as little as 1 second per container.

  • Long-Term Calibration Stability: Eliminates the need for batch-by-batch calibration for consistent reliability.

  • Built for Minimal Interference: Sample housing and magnetic coupling tooling minimize external influences.

  • Tooling Recognition System: Automatically confirms correct vial/tooling pairing for error-free operation.

  • Magnetic Tooling Mechanism: Safe, intuitive format placement without direct contact.

  • No Nitrogen Purging Required: Simplifies workflow and reduces operational complexity.

Technical Specifications

  • Container Format: Compatible with transparent cylindrical containers – tubular vials (2–100 R), molded vials (16–49 mm), and ampoules (1–30 mL). Custom tooling available for plastic containers.

  • Compatible Products: Works with lyophilized (lyo), liquid, powder, pastes, solids, and semi‑solids.

  • Measurement Time: Accurate oxygen readings in approximately 1 second per sample.

  • Technology: Tunable Diode Laser Absorption Spectroscopy (TDLAS) at 760 nm (Class 1 per IEC 60825‑1), for high‑precision O₂ detection.

  • Inspection Capability: Non‑invasive headspace gas analysis recognized by USP 1207; under some conditions can serve as CCIT (Container Closure Integrity Testing).

Additional Benefits

  • Immediate Start-Up: No need for calibration before each batch.

  • Self‑Verify Tooling Format: Ensures loaded format matches configuration, reducing setup errors.

  • Single Tooling Part: Compatible with clear and amber containers using the same format piece.

  • Compact Laser Design: Precise, reliable, and space-efficient.

  • Intuitive Interface: Customizable HMI displays real-time data and raw statistics; includes advanced alerting and diagnostics.

  • Remote Connectivity: Ewon-enabled for OPC UA/DA connectivity, Active Directory integration, and VPN access for troubleshooting and support.

Regulatory Compliance & Validation

  • Complies with EU GMP Annex 1 (vacuum-sealed container testing), section 123.

  • Recognized under USP <1207> as a deterministic headspace gas analysis method.

  • Software adheres to FDA 21 CFR Part 11 and EU Annex 11, supporting electronic records, audit trails, and secure validation.

  • Includes pre-verified tooling format and comprehensive documentation for simple validation and qualification.

Why Choose Laser‑Pro?

✅ Ultra-Fast, High Sensitivity: Get oxygen concentration readings in about 1 second, ideal for high-throughput or small-batch environments.

✅ Deterministic Accuracy: Uses TDLAS laser technology to detect even minor deviations in headspace composition.

✅ Non‑Destructive & Clean: Leaves samples intact — essential for high-value or limited-quantity pharmaceutical products.

✅ Regulatory-Ready: Designed to support full compliance with EU Annex 1, USP 1207, CFR Part 11, and Annex 11 requirements.

✅ Operational Efficiency: No purging or calibration delays; automated tooling checks and magnetic setup make workflows faster and less error-prone.

✅ Smart & Connected: Remote access, real-time diagnostics, and customizable interface with advanced alerts simplify operation and maintenance.

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