Leak Detection Test Devices for Safeguarding Sterility of Medical Device Packaging

50000 USD ($)/Set

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Product Details:

Application Sterility assurance of medical device packaging
Frequency 50 Hz
Automation Grade Automatic
Number of Specimens 1 to 4
Max Height 400 mm
Accuracy 1 mbar
Operating Voltage 220 VAC
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Leak Detection Test Devices for Safeguarding Sterility of Medical Device Packaging Price And Quantity

Minimum Order Quantity 1 Set
Price Range 50000.00 - 100000.00 USD ($)/Set
Price 50000 USD ($)/Set

Leak Detection Test Devices for Safeguarding Sterility of Medical Device Packaging Product Specifications

Resolution 1 mbar
Test Speed 30 test/min
Response Time Less than 5 seconds
Humidity 20% to 80% RH
Gas Pressure 0.6 MPa
Control Mode Digital touch screen
Usage Medical device packaging leak detection
Features User programmable test cycles, data logging, energy efficient
Power Supply AC 220V, 50Hz
Measuring Range 0 to 999 mbar
Mounting Type Benchtop
Interface Type USB, Ethernet
Temperature 5C to 40C
Equipment Type Leak Detection Test Device
Machine Weight 27 kg
Port Size 1/4 BSP
Display Type 7 TFT LCD digital
Specimen Size Up to 250 mm
Test Range 0-999 mbar
Capacity Single and batch mode
Operating Voltage 220 VAC
Accuracy 1 mbar
Test Width 250 mm
Max Height 400 mm
Test Stroke 100 mm
Automation Grade Automatic
Number of Specimens 1 to 4
Frequency 50 Hz
Application Sterility assurance of medical device packaging

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.

Comprehensive Sterility Compliance

Designed to meet international standards ISO 11607-1 and ASTM F2096, this leak detection device provides reliable assessment for medical device packaging. Its high accuracy (1 mbar) and fast response ensure sterility assurance, making it essential for regulatory compliance and patient safety in medical environments.

User-Friendly Digital Operation

Featuring a 7-inch TFT LCD touchscreen and user-programmable test cycles, operation is intuitive and efficient. The instrument offers both manual and automatic modes, visual and audible leakage alarms, tool-free maintenance, and rapid data logging. This makes the process smooth for lab technicians and quality control staff.

Advanced Connectivity and Data Management

Equipped with Wi-Fi, LAN, USB, and Ethernet interfaces, the device enables seamless data transfer and easy integration into digital record-keeping systems. With storage capacity for up to 10,000 test records, it simplifies documentation and reporting for quality assurance teams.

FAQ's of Leak Detection Test Devices for Safeguarding Sterility of Medical Device Packaging:

Q: How does the Leak Detection Test Device ensure the sterility of medical device packaging?

A: The device utilizes a sensitive pressure transducer to detect leaks in packaging, in accordance with ISO 11607-1 and ASTM F2096 standards. Its visual and audible alarms alert users instantly when leakage is detected, ensuring only sterile, intact packaging proceeds to use.

Q: What is the typical process for performing a leak test using this device?

A: Place 1 to 4 packaging specimens into the sample tray (up to 250 mm width), connect the tray, and select the desired test mode (manual or automatic) via the digital touchscreen. The device then conducts pressurization, monitors for leaks, and records results-all within seconds.

Q: When should I perform calibration and maintenance on this unit?

A: Thanks to automatic calibration, the device keeps itself accurate before each test cycle. Maintenance is straightforward and tool-free, recommended as per the user manual's schedule or when prompted by the unit's status indicators.

Q: Where can the data from the tests be stored or accessed?

A: The device features onboard storage of up to 10,000 test records. Data can be accessed or exported through USB, Wi-Fi, LAN, or Ethernet connections, facilitating easy transfer to laboratory management systems or external drives.

Q: What benefits does this device offer over manual leak testing methods?

A: Compared to manual methods, this device delivers greater consistency, accuracy (1 mbar), faster throughput (30 tests/min), automatic documentation, and enhanced safety with features like overpressure protection and emergency stop, boosting productivity and compliance.

Q: How energy efficient is this leak detection device?

A: Engineered for energy efficiency with an AC 220V, 50Hz power supply and smart automation, the device minimizes energy use during operation without compromising test reliability or speed.

Q: Can this device be used for various specimen sizes and testing volumes?

A: Yes, it accommodates packs up to 250 mm wide and specimen heights up to 400 mm, handling single and batch test modes, making it suitable for different packaging sizes and batch quantities in medical facilities.

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