Leak-Proof Sterilized Medical Devices Packaging Integrity Tester

Product Description

Product FeaturesNote1

Multiple Test Modes & Intelligent Statistics of Qualified Specimens

• Negative pressure method
• Multiple test modes including standard, multi-grade vacuum and methylthionine chloride mode
• Automatic test with traditional methylthionine chloride
• Vacuum degree, test time and infiltration time can be adjusted and test parameters can be saved automatically so that the tests with same test parameters can be started quickly
• Automatic constant pressure compensation ensures that the tests can be performed under preset vacuum conditions
• Real-time display of test curves, easy to observe the test results
• Automatic statistics of qualified specimens
• Main components and parts are supplied by well-known global manufacturers, with guaranteed performance

Brand New Patented Intelligent Touch Operating System

• Industrial grade touch screen, one-button operation, simplified operating interface, remote upgrade and maintenance
• Chinese and English operating interface
• Measurement unit conversion
• Automatic data storage and power failure memory to prevent data loss
• Storage up to 1200 test records (standard mode)
• Multiple-level user management and login with password
• Micro-printer and USB ports for data transmission (optional)
• The instrument conforms to the requirements of GMP (optional)
• Labthinks unique DataShiledTM System for data management and connecting with information system (optional)

Test Principle

Firstly submerge the specimen in the water in the vacuum chamber, and then evacuate the vacuum chamber to form differential pressure between the inside and outside of specimen. The seal property can be obtained by observing the steady progression of bubbles from the specimen or observing how the specimen expands and restores to its original shape after vacuum release.

Test StandardNote1

ASTM D3078, GB/T 15171

Applications

Basic Applications
Glass Bottles, Pipes, Cans and Boxes
Plastic Bottles, Pipes, Cans and Boxes
Metal Bottles, Pipes, Cans and Boxes
Paper Plastic Composite Bags and Boxes
Extended Applications
Pen Refills
Electronic Components
Medical Instruments

Technical Specifications

Specifications	C660B
Vacuum Degree	0 -90 KPa/ 0 -13 psi
Accuracy	0.25% FS
Resolution	0.1 KPa / 0.01 psi
Vacuum Chamber Effective Sizes	I270 mm x 210 mm (H) (standard)
	I360 mm x 585 mm (H) (optional)
	I460 mm x 330 mm (H) (optional)
	Note: customization is available for other sizes
Gas Supply	Air (outside of supply scope)
Gas Supply Pressure	0.5 MPa 0.7 Mpa (73psi 101psi)
Instrument Dimension	334 mm (L) x 230 mm (W) x 170 mm (H)
Power Supply	220VAC10% 50Hz / 120VAC10% 60Hz
Net Weight	Instrument: 6.5 kg Standard Vacuum Chamber: 9kg

Configurations

Standard Configurations

Instrument, Standard Vacuum Chamber (I270 mm x 210 mm), I6 PU Tubing (1m)

Optional Parts

Micro Printer, Professional Software, Customized Vacuum Chamber, Air Compressor, GMP System, DataShieldTM Note3

Note

1. The gas supply port of the instrument isI6 mm PU Tubing;
2. Customers need to prepare gas supply.

Note 1: The described test standard, applications and product features should be in line with Technical Specifications.
Note 2: The parameters in the table are measured by professional operators in Labthink laboratory under strictly controlled laboratory conditions.
Note 3: DataShieldTM provides safe and reliable data application support. Multiple Labthink instruments can share one single DataShieldTM system which can be configured as required.

Precise Leak Detection for Sterilized Packaging

This integrity tester ensures leak-proof performance of medical device packaging through reliable bubble emission and pressurization test methods. Its accuracy of 1% FS ensures trustworthy measurements, and audible/visual alarm indicators allow prompt leak detection. Advanced calibration, digital controls, and data storage for up to 1000 test results facilitate efficient and reproducible quality control in bench-top laboratory environments.


Easy Operation and Safety-Assured Testing

The tester features a digital touch panel for user-friendly operation and semi-automatic testing routines. Built-in over-pressure protection, operator password lock, and automatic stop functions prioritize user safety. It keeps noise levels under 65 dB(A), making it suitable for laboratory and production settings. Accessories such as test adaptors, tubing, and power cords are included for immediate setup.


Designed for Versatile Packaging Compliance

Compatible with various sterilized non-metallic flexible packaging, this device supports specimen customization up to 300 mm width and 450 mm height. Its compliance with ISO 11607 and ASTM F2096 standards ensures dependable results across diverse sterilization protocols. Digital LCD display, RS232/USB interface, and fast response time enable standardized documentation and seamless integration into existing quality systems.