Preventing Pharmaceutical Packaging Failures with NDT Leak Testing

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

Parameter\Model		C690H
Testing Range	um(Reference aperture size USP1207)	38great leakage
Detection Lower Limit	um	3
Resolution	um	0.1
Repeatability	um	1
Pressure Range	kPa	-1000100
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	45 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	6 mm Polyurethane tube
Dimensions	33.4 H x 19.6 W x 28.7 D (85cm 50cm 73cm)
Power	120VAC10% 60Hz / 220VAC10% 50Hzselect one from the two
Net weight	209Lbs (95kg)

Product Configuration

Standard Configuration	Mainframe, embedded tablet computer, software, flow meter, European vacuum pump, 6 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.

Innovative Leak Detection Technology

Utilizing non-destructive Vacuum Decay and Pressure Decay methods, this solution provides pharmaceutical manufacturers with rapid and reliable detection of packaging leaks, ensuring product quality and patient safety. The automated microprocessor-based controls streamline testing processes, supporting both single and multiple pack configurations, while maintaining high accuracy and quick response times.


Effortless Data Management and Compliance

Onboard data storage with both internal memory and USB export capabilities facilitates efficient recordkeeping and compliance with global industry regulations such as USP <1207> and ASTM F2338. Visual and audible alarms, digital LCD display, and multilingual support enhance user experience and ensure consistent, accurate test documentation.


Designed for Operational Excellence

The equipment is engineered for ease of use with tool-free chamber access, low maintenance requirements, and a robust IP54 protection class. Its tabletop mounting and customizable test parameters accommodate a wide range of packaging types and sizes, making it ideal for product development, quality control, and batch release environments in pharmaceutical manufacturing.