CONTAINER CLOSURE INTEGRITY TESTER – DACHTEST

Origin: China

Brand:

Category: Thương hiệu:

The LEAKSCAN series by DACHTEST offers a comprehensive range of Container Closure Integrity Testing (CCIT) solutions using vacuum decay and pressure decay methods in compliance with USP <1207> and ASTM F2338.
This series—spanning from manual (X, XP), semi-automatic (V), to fully automatic (Lab+)—is designed for the pharmaceutical and biopharmaceutical industry, ensuring non-destructive, high-precision leak detection for vials, ampoules, IV bags, prefilled syringes (PFS), and single-use systems.

CONTAINER CLOSURE INTEGRITY TESTER – DACHTEST

Model: LEAKSCAN X/ XP/ V/ MINILAB/ Lab+

Key Features:

  • Dual leak test capability: Vacuum decay + Pressure decay
  • High sensitivity:
  1. Vials: down to 1–2 µm
  2. IV Bags: 5–10 µm
  3. Single-use bags: 100–2000 µm (XP model)
  • 21 CFR Part 11 compliance: Includes audit trail, user control, batch reporting
  • Automatic calculations:
  1. ΔP (pressure drop)
  2. Leak rate (cc/min)
  3. Mean hole size (µm)
  4. Barometric compensation
  • Flexible automation levels:
  1. LEAKSCAN-X / XP: Full manual operation
  2. LEAKSCAN-V: Semi-automatic with chamber open/close control
  3. LEAKSCAN-MINILAB/Lab+: Fully automatic with robotic sampling & vision-based ID

Technical Specifications:

  • Test Method: Vacuum decay, Pressure decay
  • Leak Sensitivity: 1–2 µm (vials), 5–10 µm (IV bags), 100–2000 µm (XP – single-use)
  • Interface: Industrial PC + Touchscreen
  • Compliance: USP <1207>, ASTM F2338, 21 CFR Part 11
  • Reporting: Batch report, audit trail, USB/Ethernet export
  • Automation: Manual (X/XP), Semi-auto (V), Full-auto (MINILAB/Lab+)

Applications

  • Integrity testing for: Vials, ampoules, PFS, IV bags, single-use bioprocess bags
  • R&D and QC laboratories for sterile injectable product lines
  • Ideal for batch testing prior to scale-up or inline implementation

Sản phẩm đã xem

NITROGEN HIGH-TEMPERATURE TEST CHAMBER – TOPECT

This advanced chamber is purpose-built to simulate high-temperature, low-oxygen environments for evaluating material durability and oxidation resistance. Featuring a robust triple-layer insulation design and a direct-drive circulation fan, the system ensures uniform conditions throughout the chamber. Its smart control platform integrates real-time sensors, automated data logging, fault detection with alarms, and remote monitoring capabilities—making it an ideal solution for high-precision thermal and oxidative stress testing.

3D Thermal Properties Analyzer

Based on non-contact infrared thermography and 3D heat transfer inverse analysis, the TCA 3DP-160E directly measures in-plane and through-plane thermal conductivity of pouch lithium-ion batteries without sample destruction.   Test Parameters Thermal conductivity   Applications Pouch lithium-ion batteries  

DARA – LYOLAB+

In non-sterile manufacturing processes, where product quality depends on precision and batch-to-batch control, Dara-Lyo has developed a non-sterile freeze dryer with enhanced capacity, suitable for both vial products and bulk products — the LyoLab+ series.

SMALL VOLUME DISSOLUTION CONVERSION KIT – DISTEK

Dissolution tests for high potency drugs with low concentrations of active pharmaceutical ingredients often surpass the capabilities of standard Apparatus 1 or 2 dissolution baths and common analytical instruments. These challenges extend to the dissolution testing of medical devices, microparticles, beads, and topical formulations like creams, gels, and ointments. Distek's Small Volume Conversion Kit provides an ideal solution to these issues, enhancing the accuracy and sensitivity of dissolution tests for these complex samples.

TRIEPIC – DARA

TriEpic has been developed for flexible use with multiple formats and for unlimited freeze-drying processes, when the equipment is required at different times and for different cycles. TriEpic freeze dryers allow simultaneous processing of different formats, as they can be equipped at the same time with rectangular chambers, circular chambers, or stainless-steel manifolds.

error: Content is protected !!