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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LASERCUBE – Benchtop Headspace Gas Analyzer

The LASERCUBE is a benchtop device designed for fully automated headspace gas analysis (HGA) of sterile pharmaceutical containers such as ampoules, vials, cartridges and pre‑filled syringes. It supports manual loading and unloading within an automated test cycle.

Key Highlights

• Double‑path system enhances signal strength for improved accuracy

• Nitrogen purging is not required, streamlining operations

• Automatic height adjustment ensures optimal measurement position

• Interactive HMI display shows real‑time statistics and raw data

Technical Specifications

• Container types supported: Ampoules, vials (up to ≈250 mL), cartridges, pre‑filled syringes

• Product media: Lyophilized powders, liquids, powders

• Container dimensions: Diameter approximately 10–69 mm

• Throughput: Up to ~4 containers per minute

• Technology: Tunable Diode Laser Absorption Spectroscopy (TDLAS) in the near‑infrared range

• Measured parameters: Oxygen concentration, carbon dioxide level, moisture content, and absolute pressure

• Testing method: Non-intrusive, non-destructive, laser-based inspection

Additional Benefits

• No need for a reference container during testing

• Negligible etalon effect for stable measurements

• Automatic spinning plate rotates each container for full-volume sampling

• Lightweight and compact (approx. 22 kg, footprint ~36 × 37 × 40 cm)

• Fast, reliable, repeatable results with low power consumption

• Cost‑efficient design

Technology & Compliance

• Based on TDLAS (Tunable Diode Laser Absorption Spectroscopy), delivering high-precision measurements

• Accuracy and stability maintained even with containers having minimal headspace

• Software and validation features comply with FDA 21 CFR Part 11, EU Annex 11, and USP <1207>, supporting audit trails, electronic records, and qualification documentation

Why Choose LASERCUBE?

✅ Rapid Multigas Measurement: Simultaneously monitors O₂, CO₂, moisture, and pressure in one test cycle

✅ Fully Automated Workflow: Manual loading/unloading with automatic sequencing ensures efficient operation

✅ Highly Accurate & Stable: Double-path laser optics and sampling rotation guarantee reliable headspace analysis—even in challenging overfilled containers

✅ Compact & Flexible: Designed for benchtop use, easy to configure and adapt to different container formats

✅ Regulatory-Ready: Built-in validation package and compliance with global pharma quality standards

✅ Operational Simplicity: No need for gas purging, reference containers, or complex setup—ideal for routine QC or feasibility testing

LASERCUBE delivers fast, non-destructive, highly accurate gas analysis in a compact footprint—making it the ideal solution for pharmaceutical labs focused on compliance, speed, and flexibility.

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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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SAIL – Smart Automated Inspection Laboratory

SAIL is a fully automated inspection system that integrates three advanced testing technologies—CCIT, AVI, and HGA—into a single platform. It is designed for seamless in-process, clinical trial, and laboratory use across various container types and formats.

Key Highlights

• Integrated All‑in‑One System: Combines Container Closure Integrity Testing (CCIT), Automated Visual Inspection (AVI), and Headspace Gas Analysis (HGA) in one Industry 4.0 compliant station.

• High Throughput: Capable of inspecting 50–500 containers per hour depending on configuration.

• Ergonomic Design: User-friendly workstation with automated container handling and minimal operator effort.

• Full Traceability and Objective Inspection: Ensures 100 % auditability with real-time evaluation via HD display.

Technical Specifications

• Supported Containers: Blow‑Fill‑Seal units (BFS), vials, ampoules, pre-filled syringes, cartridges, and carpoules.

• Product Types: Lyophilized powders, liquids, and powders.

• Container Size Range: Diameters from approximately 10 to 69 mm.

• Speed: 50–500 units per hour (configurable).

• Technologies Incorporated:

  • CCIT via vacuum decay for detecting leaks,

  • AVI with high-resolution cameras under controlled lighting to identify cosmetic, foreign matter, or cap defects,

  • HGA using Tunable Diode Laser Absorption Spectroscopy (TDLAS) for gas-level analysis.

• Inspection Capabilities: Detects seal integrity issues, particulate contamination, surface defects, and measures headspace conditions including O₂, CO₂, moisture and pressure.

Additional Benefits

• Single Operator Workflow: Fully automated loading, inspection, and ejection.

• Tool‑less Format Changes: Automatic mechanical adjustments without manual format tooling.

• Unified Validation & Qualification: One standardized protocol covers all inspection modalities.

• Intuitive Touchscreen HMI: Android‑style interface on an adjustable 22″ HD panel with dynamic data display.

• Real-Time Feedback: Instant evaluation with advanced alerting and optimized decision-making.

Technology & Compliance

• Built to perform CCIT + AVI + HGA in one streamlined module.

• AVI method supports standardized visual defect detection and traceability.

• CCIT employs industry-standard Vacuum Decay testing for container integrity.

• HGA is based on precision laser absorption spectroscopy for accurate gas quantification.

• Software includes full compliance with FDA 21 CFR Part 11, EU Annex 11, and EU Annex 15 qualification protocols.

• Supports pharmacopeia-aligned validation standards such as USP <790> (AVI), ASTM F2338 (CCIT), and USP <1207> (HGA).

Why Choose SAIL?

✅ Comprehensive Inspection in One Unit: Eliminates the need for separate CCIT, AVI, and HGA systems—simplifying workflow and footprint.

✅ High-Speed, High-Precision Testing: Suitable for production lines needing rapid and reliable multi-point quality control.

✅ Minimal Operator Input: Automated handling and intuitive interface reduce manual intervention.

✅ Consistent Compliance: Built-in validation frameworks and audit-ready documentation streamline regulatory alignment.

✅ Flexible & Adaptable: Supports multiple containers, formats, and test methods with tool‑less changeover and modular design.

✅ Audit-Ready Traceability: Real-time HD display and traceable results ensure full batch control and quality assurance.

SAIL delivers an unparalleled combination of leak testing, visual inspection, and headspace analysis in one compact, connected, and compliant system—ideal for modern pharmaceutical QC, R&D labs, and clinical trial workflows.

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