ASTM D3078 Medical Devices Packaging Compliance Test Instrument

50000 USD ($)/Set

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Product Details:

Max Height 300 mm
Temperature 15C 40C
Display Type Digital LCD
Frequency 50 Hz
Interface Type Touch Screen/Buttons
Automation Grade Automatic
Port Size 6 mm
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ASTM D3078 Medical Devices Packaging Compliance Test Instrument Price And Quantity

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

ASTM D3078 Medical Devices Packaging Compliance Test Instrument Product Specifications

Interface Type Touch Screen/Buttons
Frequency 50 Hz
Display Type Digital LCD
Temperature 15C 40C
Max Height 300 mm
Test Stroke 0 300 mm
Response Time <1 second
Test Range 0100 kPa
Capacity 1 package per test
Usage Sealed flexible package leak testing
Accuracy 1% of full scale
Humidity 20% 80% RH (non-condensing)
Features Microprocessor controlled, automatic pressure compensation, easy specimen mounting
Test Width 300 mm
Machine Weight Approx. 25 kg
Port Size 6 mm
Automation Grade Automatic
Test Speed Adjustable, 0.1 ~ 1.0 atm/min
Specimen Size Up to 300 x 300 mm
Equipment Type Medical Device Packaging Compliance Test Instrument
Resolution 0.1 kPa
Operating Voltage 220V AC
Application Leak integrity testing for medical device packaging as per ASTM D3078
Number of Specimens 1 per cycle
Control Mode Digital/Automatic
Power Supply 220V, 50Hz
Measuring Range 0100 kPa
Mounting Type Bench-top
Gas Pressure 0250 kPa (adjustable)

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 Medical Device Packaging

This instrument is built to rigorously test the seal integrity of flexible medical device packaging in compliance with ASTM D3078. Its advanced pressure measurement and automatic control features allow for repeatable and accurate leak detection, safeguarding the sterility and quality of packaged devices.

User-Friendly Digital Interface and Automation

Equipped with a touch screen LCD and button controls, the instrument offers both continuous and timed testing with automated calibration options. The microprocessor-managed system enables quick mounting of packages and intuitive operation in demanding production and laboratory environments.

Clean Room Compatibility and Reliable Performance

Designed specifically for indoor, clean room use, this benchtop instrument maintains high reliability under strict environmental conditions. Its durable acrylic or polycarbonate vacuum chamber, precise control of gas pressure and humidity, and safety alerts ensure consistent, compliant results for every test cycle.

FAQ's of ASTM D3078 Medical Devices Packaging Compliance Test Instrument:

Q: How does the ASTM D3078 Medical Devices Packaging Compliance Test Instrument perform leak integrity testing?

A: The instrument uses a vacuum chamber to assess the integrity of sealed flexible packaging by detecting potential leaks under negative pressure, consistent with ASTM D3078 requirements. The high-precision pressure sensor monitors changes, providing accurate and responsive results with both automatic and manual calibration.

Q: What types of medical device packaging can be tested with this instrument?

A: This device is suitable for testing sealed flexible packages up to 300 x 300 mm in size. It is specifically designed to evaluate packaging intended for sterile medical devices, ensuring compliance with ASTM D3078 standards.

Q: When should leak integrity tests be performed using this equipment?

A: Leak integrity tests should be conducted during packaging validation, routine quality control, and whenever process changes are made. Regular testing helps ensure ongoing compliance with regulatory and industry standards for medical device packaging.

Q: Where can this test instrument be installed and operated?

A: The instrument is ideal for use in clean room or indoor laboratory environments. Its compact bench-top design ensures easy installation in spaces where sterility and minimal contamination are critical.

Q: What is the typical process for conducting a test?

A: The process involves placing the package inside the vacuum chamber, setting desired test parameters via the digital interface, and initiating either continuous or timed testing. The system automatically records pressure data and alerts operators to leaks or overpressure conditions with visual and audio alarms.

Q: How does the digital interface enhance the usability of the instrument?

A: The touch screen and button controls offer intuitive navigation and precise test setup. Digital LCD display provides real-time monitoring of pressure and status, while data can be output via USB or RS232 ports for documentation and analysis.

Q: What are the main benefits of using this compliance test instrument?

A: Key benefits include high testing accuracy (1% of full scale), fast response (<1 second), automatic/continuous operation, user-friendly digital controls, and assured compliance with the ASTM D3078 standard, all of which contribute to more efficient quality assurance for medical device packaging.

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