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