PT-LT Leak Test Apparatus
The PT-LT is designed to test the integrity of packaging for strips, blisters, and small sachets containing tablets, granulates, liquids, and similar products. It ensures the quality of the packaging process by detecting small holes and imperfections in the packaging seals, in compliance with USP monograph <1136>.
Test Procedure:
- Application: Used in the pharmaceutical and food industries to check the air-tightness of packaging for items like tablets, capsules, syrups, sweet packets, and ready-to-eat foods.
- Process: Samples are placed in the desiccator, and a vacuum is created. The package should maintain its shape; any deformation indicates a sealing issue. Packages are then immersed in a colored dye solution (e.g., Methylene Blue). Holes in the package will allow the dye to penetrate, revealing leaks.
Operating Principle:
- Setup: Enter parameters such as User ID, Sample ID, Number of Samples, Batch Number, Vacuum Set Level (up to 699mmHg), and Hold Time (up to 99 minutes).
- Operation: The vacuum pump creates and maintains a vacuum in the desiccator, then releases it according to the programmed settings.
Features:
- Integrity Testing: Checks strips, blisters, and bottles for leaks.
- Display: Large LCD for vacuum and countdown timer.
- Data Entry: Function keys for inputting test parameters.
- Vacuum Pump: Built-in, rugged, oil-free pump.
- Printer Port: For parallel dot-matrix printers.
- Automated Print-Out: Provides test reports automatically.
Advantages:
- Ensures packaging quality.
- Easy operation with a microprocessor-controlled system.
- Stainless steel housing suitable for production environments.
- Includes IQ/OQ documents.
Technical Specifications:
- Final Vacuum Level: > 110mmHg (absolute pressure), with a reduction up to 650mmHg.
- Vacuum Dropping: ±10mmHg within 30 seconds (under 400mmHg) or ±5mmHg (above 400mmHg).
- Display: LCD, approx. 100 x 25 mm.
- Timer: Adjustable from 1 to 99 minutes.
- Desiccator Sizes: 380mm, 250mm, 200mm, or 150mm Ø (optional).
- Power Supply: 220 – 240V or 110 – 120V.
- Dimensions: Approx. 360 x 250 x 240 mm.
- Weight: Approx. 14.5 kg.
- Certification: USP/EP requirements, CE/EMC Certification.
Included in Standard Scope:
- PT-LT instrument with built-in vacuum pump.
- Documentation folder with user manual, QC/DQ certificate, IQ/OQ documentation, Conformity Declaration, CE/EMC Declaration, and Instrument logbook.