Medical Device Packaging Material Sealing Strength Tester

In the field of medical device manufacturing, the sealing integrity of primary packaging is a decisive factor in maintaining product sterility and ensuring its safe and effective delivery to clinical use. The failure of the sterile barrier system means that the product may be contaminated by microorganisms, which will directly lead to serious medical risks. Jinan Xio Electromechanical deeply understands the high requirements of this industry and has launched professional testing equipment that complies with mainstream regulations——Medical Device Packaging Material Sealing Strength TesterThis instrument is strictly based onISO 11607Series standards provide scientific and objective packaging sealing performance verification solutions for medical device manufacturers, packaging suppliers, and quality inspection agencies. They are tools for packaging process confirmation and routine quality control.

1、 Core features of the product

• Compliant with international core standards for medical device packaging: Strictly followISO 11607-2(Final sterilization of medical device packaging)ASTM F2096(Packaging leakage detection) andYBB 00112002-2015Waiting for standards. Using negative pressure method (bubble method/vacuum decay method), scientifically evaluate the heat sealing edge and material of packagingSealing strengthAnd integrity.

• Highly transparent and durable dedicated observation room: AdoptingUltra thick vacuum organic glassManufacturing a vacuum chamber with transparency and long-term physical and chemical stability, effectively avoiding yellowing and cracking. Ensure that the packaging samples submerged in water are tested throughout the entire testing cycleClear and intuitive observationAny bubbles generated by leaks have nowhere to hide.

• High stability vacuum generation and intelligent controlThe core adopts branded vacuum generators and precision pressure sensors, which can quickly establish andStable maintenanceThe preset vacuum degree (adjustable from 0 to -90KPa). The system hasAutomatic vacuum maintenance and blowback unloadingThe functionality and testing process are fully automated, ensuring high repeatability and comparability of the test results.

• Intelligent operation and data traceability managementEquipped with a 7-inch HMI human-machine interface touch screen, with intuitive parameter settings and real-time digital display of pressure and time. Five independent test parameters can be pre stored for quick access to different product packaging. All test results are automatically counted and stored to meet the requirementsMedical Device Quality Management SystemRegarding the detection recordstraceabilityrequirement

• Powerful customization capabilityThe standard vacuum chamber size is Φ 270mm × 210mm (H). In response to customers' needs for oversized, irregular, or testing multiple small packages simultaneously,Support non-standard customization of various types of vacuum chambersAnd a dedicated sample rack, with strong flexibility.

2、 Testing principle

This device operates based on the principle of negative pressure method (water bubble method/vacuum decay method). During testing, immerse the packaging bag of the medical device to be tested (usually filled with porous material to open the package) in water inside the vacuum chamber. After starting the test, the instrument automatically draws the vacuum chamber to the standard negative pressure value and maintains it for the set time. During this process: 1Qualitative determination (bubble method)If there is a leak in the packaging heat sealed edge or the material itself, air will escape from the leak point and form a continuous stream of bubbles in the water, thus directly and intuitively locating the leak point. twoQuantitative/High Sensitivity Determination (Vacuum Attenuation Method)The system can precisely monitor the pressure changes inside the vacuum chamber during the holding phase. If the rate of pressure recovery due to leakage exceeds the preset threshold, even if no visible bubbles are generated, it can still be determined that there is a microscopic leakage, with higher sensitivity.

3、 Technical parameters

4、 Execution standards

This instrument is an ideal tool to meet the mainstream standards for medical device packaging sealing testing:

• International Core Standards for Medical Device Packaging：ISO 11607-2Packaging for terminally sterilized medical devices - Part 2: Confirmation requirements for forming, sealing, and assembly processes

• National standard for pharmaceutical packaging materials：YBB 00112002-2015Test Method for Sealing of Pharmaceutical Packaging Materials

• National General Packaging Standards：GB/T 15171-1994Test Method for Sealing Performance of Flexible Packaging Components

• International Standard for Common Testing Methods：ASTM D3078(Bubble method)ASTM F2096-11a(Packaging leakage detection)

• Other international standards：JIS Z 0238:2017(Packaging Sealing Performance Test)

5、 Application Fields

This tester is widely used in various links of the medical device and its packaging industry chain:

• Medical device manufacturing enterprises: Used forFinal sterilization of medical devicesFactory inspection of sealing of initial packaging (bags, covers, vacuum formed boxes) for surgical instruments, catheters, implants, etcPackaging process validationAnd further verification.

• Medical device packaging material supplierFor Tyvek ® Tyvek ®、 Medical dialysis paper, composite film and other material manufacturers provide sealing performance data to support customer audits.

• Third party testing and certification agenciesAs:Aseptic barrier system sealing testEquipment used for registration and inspection of medical device productsCE/FDACompliance testing and market supervision.

• Hospital Disinfection Supply Center (optional)Perform rapid sealing screening on the packaging of sterilized instruments after reprocessing.

6、 Detailed explanation of testing process

Standardized operations are the foundation for obtaining effective and reliable data:

1. sample preparationImmerse the medical device packaging bag sample in vacuum chamber water, and place a water absorbing sponge or gauze inside the bag to expand the heat sealed area for observation.

2. Parameter SettingsSelect the preset program (such as ISO 11607 common parameters) or manually set it on the touch screen, and enter the vacuum degree (such as -80kPa) and holding time (such as 60 seconds).

3. execute testsClose the vacuum chamber cover and start the fully automatic test. The instrument completes vacuum pumping, pressure holding, observation, and automatic pressure relief in sequence.

4. Result determination：

• Bubble methodDuring the pressure holding period, observe whether there are continuous bubbles generated on the heat sealed edges and surfaces of the packaging. If there is, it is determined that the seal has failed.

• Vacuum attenuation methodAfter the test is completed, the instrument automatically displays pressure attenuation data and makes an automatic judgment after comparing it with the preset standard.

5. Record and ReportAll test parameters, process pressure curves, and final judgment results are automatically saved, traceable, and printable, forming a complete quality record.

7、 The Importance of Quality Control

The integrity of the sterile barrier system isISO 13485Mandatory requirements for medical device quality management systems and regulatory agencies (such as China NMPA, US FDA, EU MDR). executeISO 11607Standardizing and verifying through scientific sealing tests is the core link in proving product safety and effectiveness, ensuring patient safety, avoiding product recalls and legal liabilities due to packaging defects.LTMedical Device Packaging Material Sealing Strength TesterThis provides validated and objective detection methods.

8、 Customized service advantages

Jinan Xio Electromechanical, with a profound understanding of the medical device industry, provides comprehensive customized services to meet diverse challenges

• Customization of non-standard vacuum chambers and specialized fixturesDesign and manufacture vacuum chambers and specialized fixing and supporting fixtures of corresponding sizes for special samples such as oversized instrument packaging, trays or vacuum formed boxes, and irregular packaging.

• Verification support services and program developmentAssist clients in establishing complianceISO 11607Develop a customized packaging verification plan and develop specialized testing procedures and acceptance criteria based on customer specific internal control standards or product characteristics.