CONTAINER CLOSURE INTEGRITY TESTER – DACHTEST

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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

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