Medical Packaging Seal Integrity Testing Instrument

50000 USD ($)/Set

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Product Details:

Measuring Range 0-1000 N
Interface Type RS232/USB
Gas Pressure 0.4-0.7 MPa
Operating Voltage 220V/50Hz
Features Intelligent operation, Overload protection, Data storage
Humidity 20% - 80% RH
Max Height 400 mm
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Medical Packaging Seal Integrity Testing Instrument Price And Quantity

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

Medical Packaging Seal Integrity Testing Instrument Product Specifications

Resolution 0.01 N
Max Height 400 mm
Display Type Digital LED/LCD Display
Capacity Single and multiple testing
Humidity 20% - 80% RH
Test Speed 10-200 mm/min (adjustable)
Test Stroke 0-400 mm
Interface Type RS232/USB
Measuring Range 0-1000 N
Features Intelligent operation, Overload protection, Data storage
Operating Voltage 220V/50Hz
Gas Pressure 0.4-0.7 MPa
Temperature 15C - 40C
Machine Weight 38 kg
Specimen Size Customized or up to 350 mm width
Mounting Type Benchtop
Equipment Type Seal Integrity Testing Instrument
Accuracy 1% F.S.
Port Size 6 mm (air connector)
Test Range 0-1000 N
Control Mode Microcomputer/Touch Screen
Response Time 1 s
Usage Laboratory/Quality Control
Application Medical packaging seal integrity testing
Power Supply AC 220V, 50/60Hz
Automation Grade Semi-automatic
Number of Specimens 1-3 (simultaneous/batch)
Test Width 0-350 mm

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 Seal Integrity Assessment

This instrument offers both pressure decay and bubble emission test methods, making it versatile for assessing the integrity of numerous medical packaging types. Whether for single samples or batch testing, it guarantees reliable and consistent results to meet rigorous standards.

User-friendly Digital Operation

Featuring intelligent, semi-automatic operation, the testing instrument utilizes a digital LED or LCD screen interface. Microcomputer and touch screen controls streamline test set-up, execution, and data management, providing a swift and efficient workflow in laboratory settings.

Built for Medical Compliance and Safety

Designed to fully comply with ISO 11607, ASTM F1140, and ASTM F2054, the instrument ensures your testing protocols meet global medical packaging standards. Safety features like over-temperature and over-pressure protection safeguard users and samples, supported by low noise and efficient operation.

FAQ's of Medical Packaging Seal Integrity Testing Instrument:

Q: How does the Medical Packaging Seal Integrity Testing Instrument evaluate the integrity of medical packaging?

A: The instrument uses pressure decay and bubble emission methods to detect leaks and assess the quality of sealed medical packaging. By monitoring pressure changes or observing bubbles, it reliably identifies breaches and weak points in a variety of packaging materials.

Q: What types of packaging materials are compatible with this testing instrument?

A: This device is designed for a wide range of medical packaging materials, including medical paper, Tyvek, blister packs, aluminum foil, and plastic film, which makes it suitable for most commonly used sterile barrier systems in healthcare.

Q: When should seal integrity testing be performed in the packaging process?

A: Seal integrity testing should be conducted after sealing and before product release during quality control checks, as well as periodically during production runs to ensure consistent package performance and compliance with regulatory requirements.

Q: Where can this seal integrity tester be used most effectively?

A: Ideal for laboratory and quality control environments, this benchtop instrument can be deployed in medical device manufacturing sites, packaging development labs, or contract testing facilities to validate and monitor packaging seal performance.

Q: What is the process for running a test using this instrument?

A: Operators mount the specimen, set desired parameters through the microcomputer or touch screen, and start the test. The device automatically applies controlled pressure, records real-time data, and outputs a printable or stored test report, supporting both single and multiple sample testing.

Q: What benefits does this instrument offer for medical packaging manufacturers and exporters?

A: It ensures compliance with ISO and ASTM standards, provides highly accurate and repeatable results (1% F.S.), simplifies data management with report printing and ample storage, and enhances productivity with adjustable test speeds and semi-automatic operation.

Q: How does the external calibration function enhance testing reliability?

A: External calibration enables precise adjustment and verification of system accuracy, helping maintain consistent and traceable test results over time. This ensures reliable data integrity during quality assurance and regulatory inspections.

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