LEAK-M Micro Leak Tester

Product catalog summary

Overview: The LEAK-M Micro Leak Tester by Pubtester Instruments Co., Ltd. is designed to test the sealing integrity of various pharmaceutical packaging using the vacuum decay method, compliant with ASTM F2338-09 standards.

Product Features:

Equipped with a 10.1” colorful touch screen for intuitive operation.
Utilizes vacuum and differential pressure dual sensor method for detecting pressure and time changes.
Features trace pressure sensors for detecting small pressure changes.
Includes imported pneumatic components and pressure sensors for stable performance.
Allows presetting of multi-level vacuum degrees for gradient testing.
Automatically determines test completion and qualification status.
Supports multiple test units (kPa, psi, mbar, mmHg) for flexibility.
Stores vacuum degree, test, and infiltration time in a database for consistent test conditions.
Displays real-time test curves and provides intelligent data statistics for quick result viewing.
Offers historical data viewing and printing capabilities.
Includes a micro printer and USB data interface for data output and transmission.
Can store up to 50,000 test records and supports GMP functions like user management and data audit trails.

Test Principle: The tester connects to a vacuum decay chamber where the sample is placed and vacuumed. A pressure difference is created, and gas enters through any leak holes. The host monitors vacuum degree changes to determine sample qualification.

Applications:

Flexible, non-porous packages like bags and pouches with solids.
Sealed cups or trays with solids.
Non-lidded, empty cups or trays.
Rigid, non-porous containers such as plastic screw-capped bottles, glass or plastic vials, ampoules, pre-filled syringes, ophthalmic dropper bottles, and Blow Fill Seal bottles or strips.

Technical Specifications:

Absolute Vacuum Degree: 10Pa (0.1mbar).
Sensitivity: Detects leak rates of 0.05ccm.
Authority Management: 4 levels.
Opening Method: Pneumatic.
Gas Supply Pressure: 0.7 MPa.
Port Size: Φ6 mm PU Tubing.
Display Mode: 10.1” colorful touch screen.
Instrument Dimensions: 380mm(L)×260mm(W)×210mm(H).
Power Supply: AC 220V 50Hz / AC 120V 60HZ.

Standards: ASTM F2338, USP1207, YY/T0681.18-2018.

Configuration: Standard configuration includes the instrument, vacuum chamber, and vacuum pump.

Catalog excerpts

Pubtester Instruments Co., Ltd. ^t^Pubtester LEAK-M Micro Leak Tester is designed based on the vacuum decay method and conforms to the requirements of ASTM F2338-09. It is applicable to test the sealing integrity for different volume injection and lyophilized pharmaceuticals such as vials, ampoule bottles, infusion bottles, eye drops bottles, liquid filled packaging, non-porous flexible packages, rigid and semi-rigid packaging. It is also suitable for the detection of minimum leakage points and pinholes in blister packaging, semi-rigid or rigid packaging such as glass vials. > 10.1” colorful touch screen with intelligent data processing function provides a comfortable and smooth operation experience > Using the principle of vacuum and differential pressure dual sensor method, can detect pressure and time changes > Using trace pressure sensor to detect small pressure changes > Imported pneumatic components and pressure sensors with stable and reliable performance > Multi-level vacuum degree can be preset for gradient test > Automatic design, the instrument determine the end of the test and whether it is qualified automatically > Multiple test units kPa, psi, mbar, mmHg , which can be switched easily > Vacuum degree, test and infiltration time can be setup and stored in the database to ensure the consistency of test conditions

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Pubtester Instruments Co., Ltd. ^t^Pubtester > Display test curve in real time, intelligent date statistics, convenient for viewing test results quickly > Historical test data can be viewed and printed > Micro printer and USB data interface, convenient for data output and transmission > With powerful data storage function, which can up to 50,000 test records > Satisfies GMP functions such as user management, authority management, and data audit trail. The host is connected to a vacuum decay chamber, the sample is put into it and vacuumed, there is a pressure difference between the inside and...

Open the catalog to page 2