Non-Destructive Leak Testing for Packaging Seal Integrity

Product Description

Featuresnote1

Batch Testing

• Equipped with fully-automatic gravity fed sample feeder, which is Labthinks latest scientific and technological achievement that can facilitate continuous testing of 20 to 120 samples.
• A & B dual-channel design can test samples of two different specifications simultaneously.
• The target vacuum degree can be set by the operator to meet testing requirements of different samples.
• Dual methods of vacuum decay and pressure decay provide the flexibility to accommodate various types of package samples.

Precise Data

• Advanced pressure detection technology, using world renowned components for data stability which is not affected by ambient environment.
• Advanced microflow automatic flow control technology that can accurately simulate different sizes of leakage holes without manual adjustment.
• Both the differential pressure transducer and flow meter are traceable to NIST.
• The system can achieve a higher test repeatability of 1um.

Intelligent Control

• 15.6" embedded touch tablet computer with Windows OS.
• New longitudinal interface layout, and easy to use graphic user interface.
• Automatic alarm, automatic capture, automatic collection of unqualified samples.
• The pressure curve is displayed in real time, and the test results are counted automatically.
• Leakage rates are calculated automatically.
• The system is equipped with various sensors as intelligent reminders for safer operation and control.
• Universal printer can be connected for test results output.
• The system features embedded with USB and network ports to facilitate the external access and data transmission of the system, which can be upgraded remotely

Security Compliance

• Verified by compensation and calibration methods.
• The leak tester meets GMP requirements for data traceability and meets the needs of the pharmaceutical industry.
• User operation permission is managed at multiple levels, and the permission content can be configured on demand.
• Electronic signature is designed according to the standard requirements of 21 CFR Part11.

Test Principle

The sample is placed in the sample feeder and automatically delivered into the test cell. The leak rate and other results can be calculated and obtained by analyzing pressure changes measured by the sensor.

Reference Standards

ASTM F2338, YY-T 0681.18, and USP<1207>

Applications

Basic Applications	Vials	Various vial sealing test.
Extended Applications	Ampoule	Various ampoule bottle sealing tests.
	Cartridge Bottles	Various cartridge bottle sealing tests.
	Injection bottles	Various injection bottles sealing test.

Technical Parameters

Table 1: Test Parameters Note2

ParameterModel		C690H
Testing Range	um(Reference aperture size USP1207)	3i8igreat leakage
Detection Lower Limit	um	3
Resolution	um	0.1
Repeatability	um	1
Pressure Range	kPa	-100i0ii14100
Extended Functions	21 CFR Part11	Optional
	GMP computer system requirements	Optional

Table 2: Technical Specifications

Testing Cell	1 set for A group and 1 set for B group
Sample Feeder	1 set for A group and 1 set for B group
Sample Size	I45 mm80mmNote3
Sample Quantity	20120 pieces
Gas Specifications	Compressed Air (Gas source is provided by the user)
Gas Source Pressure	40.6 PSI / 500 kPa
Port Size	I6 mm Polyurethane tube
Dimensions	33.4 H x 19.6 W x 28.7 D (85cm 50cm 73cm)
Power	120VAC10% 60Hz / 220VAC10% 50Hzi14select one from the twoi14
Net weight	209Lbs (95kg)

Product Configuration

Standard Configuration	Mainframe, embedded tablet computer, software, flow meter, European vacuum pump, I6 mm polyurethane tube
Customization	Test cell and sample feeder of group A, test cell and sample feeder of group B, negative standard reference sample and positive standard reference sample designed according to sample specifications
Optional Parts	GMP computer system requirements, 21 CFR Part11, air compressor, IQ/OQ/PQ documents

Note 1: The described product characteristics are subject to the specific annotation of the "Technical Parameters" table.
Note 2: The parameters in the table are measured in the Labthink laboratory by professional operators according to the requirements and conditions of the relevant laboratory environmental standards.
Note 3: Group C test cell can be customized for samples beyond the "Sample Size", but the lower detection limit and test range will change according to the sample size, and the actual delivery shall prevail.

Reliable, Non-Destructive Packaging Integrity Tests

Engineered for maximum precision, this tester ensures your package seals remain uncompromised. Utilizing vacuum decay, pressure decay, and differential pressure methods, it enables non-invasive, repeatable leak detection suitable for food, pharmaceutical, and industrial applications. Programmable cycles and multi-language support streamline your workflow, increasing productivity and confidence in results.


Safe and User-Friendly Operation

Ease of use is prioritized through a digital LCD touchscreen, semi-automatic control, and intuitive manual options. The robust stainless steel chamber is equipped with protection against over-pressure and power surges, guaranteeing both operator and equipment safety. Adaptable to diverse environments, it efficiently tests up to 120 samples per hour with reliable accuracy.


Unparalleled Data Management and Compliance

Benefit from comprehensive test record storage and export capabilities via RS232/USB interfaces. Designed for traceability and regulatory compliance, it meets leading standards including ASTM F2338, ISO 11607, and USP 1207. Reliable performance, calibration customization, and real-time alarms ensure seamless integration into GMP and QC processes.