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

FLOW THROUGH CELL SYSTEM (USP4)- LABINDIA

F7 Smart is an advanced flow-through drug dissolution system (USP Apparatus IV) developed by Labindia, fully compliant with 21 CFR Part 11 regulations. This system enables high-precision drug dissolution testing for research, quality control, and analytical applications. F7 Smart is compatible with international pharmacopeial standards including USP, EP, JP, and ChP, and supports both closed loop and open loop testing modes.

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.

error: Content is protected !!