Container leak tester HTY-LT100P

for packagingfor bottlesfor the pharmaceutical industry

Product Introduction
The vacuum/pressure decay leak tester HTY-LT100P — CCIT is a laboratory device designed to assess container closure integrity of pharmaceutical packaging. By reproducing transport and storage conditions, it identifies minute leaks in rigid and flexible containers to support sterility and product safety requirements.

Compliance
Complies with ASTM F2338-09 (vacuum decay), USP <1207>, FDA 21 CFR Part 11, EMA Annex 11

Features

• Detection sensitivity: Detects leaks down to 1 μm for rigid containers and 5–10 μm for flexible packaging.
• Operation: 10.1-inch capacitive touchscreen and intuitive user interface for automated testing workflows.
• Data management: Detailed test reports, data logging and 4-level user management for traceability.
• Versatility: Suitable for ampoules, vials, cartridges, bottles, bags and other rigid/flexible packaging.
• Modular design: Quick exchange of components to adapt test functions.
• Remote storage: Test results can be uploaded, stored and analyzed remotely.
• Non-destructive testing: Non-invasive method suitable for laboratory and controlled-process CCI applications.

Applications

• Small-batch quality control
• Non-bacterial ingress assessment
• Non-destructive leak testing
• R&D of new packaging and products
• Detection of suspected leaking units on production lines
• Applicable to pharmaceutical liquid preparations, radiopharmaceutical production, disposable filtration (PUPSIT) and other packaging integrity workflows

Specifications

• Detection method: Vacuum/pressure decay
• Detected packaging types: Ampoules, vials, cartridges, plastic bottles, bags and other rigid/flexible containers
• Detection accuracy: Rigid: 1–2 μm; Flexible: 5–10 μm
• Display: 10.1-inch capacitive touchscreen
• User management: 4-level authority
• Operating conditions: Use 0–40 ℃; Storage -5–45 ℃; Humidity <85% RH (no condensation)
• Power supply: 100–240 VAC, 50/60 Hz, ≤200 W
• Dimensions (mainframe): 55 cm × 32 cm × 32 cm
• Weight: 25.5 kg