LT‑Pro Leak Tester – Benchtop CCIT System

The LT‑Pro is a non-invasive, non-destructive benchtop system designed for Container Closure Integrity Testing (CCIT). It is ideal for pharmaceutical laboratories and in-process control, providing precise integrity testing for sealed rigid or flexible packaging.

Key Highlights

  • High Flexibility: Interchangeable tooling accommodates a wide variety of container types.

  • Multiple Test Methods: Supports both vacuum decay and pressure decay testing for greater application versatility.

  • Exceptional Accuracy: Available in two configurations – standard accuracy (5 µm) and high accuracy (1 µm).

  • Perfect for Small Batches: Non-destructive, ideal for personalized medicine and low-volume production.

  • Compact & Ergonomic: Lightweight, easy to handle and clean, suitable for limited lab spaces.

  • Advanced Connectivity: Real-time integration via Ewon for seamless connection to OPC UA/DA platforms, allowing remote monitoring and support.

Technical Specifications

  • Supported Container Types:
    Vials, ampoules, Blow-Fill-Seal (BFS), Form-Fill-Seal (FFS), bottles, prefilled syringes, carpoules, cartridges, trays, pouches, sachets, flowpacks, cups, and other sealed formats.

  • Product Media Compatibility:
    Suitable for liquids, powders, pastes, solids, semi-solids, including lyophilized products.

  • Volume Range:
    Containers from 0.1 mL up to 1 liter.

  • Test Duration:
    From a few seconds to approximately one minute, depending on the container size and type.

  • Testing Technology:
    Based on vacuum decay and pressure decay, analyzing pressure changes in a sealed chamber to detect leaks.

  • Detection Capabilities:
    Identifies weak seals, pinholes, micro-cracks, seal imperfections, and container damage.

Additional Benefits

  • Flexible Feasibility Testing:
    Useful in development of new packaging formats or for verifying packaging integrity on a small scale.

  • User-Friendly Interface:
    Customizable touchscreen menus, intuitive layout across test types, latex-glove compatible display.

  • Data Integration:

    • Ethernet and Wi-Fi connectivity for LIS integration

    • OPC UA/DA compatibility

    • Secure data handling and storage

    • Support for electronic signatures and audit trails

    • CFR 21 Part 11 compliance for pharmaceutical environments

  • Contamination Control:
    Designed with smooth, easy-to-clean surfaces to minimize contamination risks.

  • Portability:
    Compact footprint makes it easy to transport and use across different lab or production areas. Includes a calibration kit with guided instructions.

Regulatory Compliance

Fully compliant with:

  • ASTM F2338-09 – Leak detection standards for packaging

  • USP 1207 – Guidelines for container closure integrity testing

  • EU GMP Annex 1 and EMA Annex 11 – Sterile product and computerized system guidelines

  • PDA Technical Report No. 27

  • FDA 21 CFR Part 11 – Electronic records and signature regulations

Model Options

Both versions share identical interfaces, connectivity features, and regulatory compliance.

Applications

  • Personalized medicine production

  • GMP laboratories and QC departments

  • Random integrity testing of production batches

  • Verification of packaging for clinical trials

  • Investigation of rejected containers

  • Early-stage feasibility studies for novel packaging

Why Choose LT‑Pro?

The LT‑Pro Leak Tester stands out as a versatile and cutting-edge solution for container closure integrity testing in pharmaceutical and laboratory environments. Here’s why it’s the optimal choice:

✅ Dual Testing Technology: Combines vacuum and pressure decay methods in one unit for comprehensive, flexible testing.

✅ Exceptional Sensitivity: Detects leaks as small as 1 µm (in HA model), ensuring the highest level of product safety.

✅ Non-Destructive Testing: Preserves samples during inspection, ideal for high-value or limited-quantity batches.

✅ Flexible Format Compatibility: Accommodates a wide range of containers, from vials and syringes to flexible pouches and BFS formats.

✅ Compact & Ergonomic Design: Saves space, supports easy cleaning and mobility across labs or production areas.

✅ Compliant & Connected: Meets all major pharmaceutical standards (USP, GMP, CFR Part 11) and integrates easily into digital environments with OPC UA/DA and secure data management.

✅ Ideal for Modern Pharma Needs: Supports personalized medicine, R&D feasibility studies, small-scale production, and routine quality control.

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