As a key medical device for precise drug delivery, the sealing reliability and integrity of sterile packaging of infusion pumps directly affect the safety and efficacy of patient treatment. Any small leak can lead to dosage errors, medication contamination, or system failure, posing serious clinical risks. Jinan Xio Electromechanical has launched a professional testing plan that strictly complies with regulations and standards for this high demand field——LTSealing tester for infusion pumpThis equipment is not only used to test the sealing performance of the final sterilization packaging of infusion pumps, but also to evaluate the sealing performance of key parts such as the pump body's pipelines and joints, providing full chain sealing integrity verification for products from research and development, production to release, ensuring the safety standards of drug device combination products.

1、 Core features of the product

Sealing tester for infusion pumpIntegrating high transparency observation, stable vacuum control, and intelligent operation, designed specifically for testing precision pharmaceutical and medical products:

• Complies with the dual standards of drug device combination products and packaging: Strictly followISO 11607-2(Medical device packaging)YBB 00112002-2015(Test Method for Sealing of Drug Packaging Materials) and other standards. By using negative pressure method, it is possible to simultaneously control the infusion pumpFinal sterilization packaging bagandThe sealing structure of the pump body itselfConduct integrity assessment with a comprehensive testing scope.

• Highly transparent and durable dedicated observation environment: AdoptingUltra thick vacuum organic glassThe vacuum chamber is made with transparency and aging resistance to ensure that the infusion pump product or package immersed in water can beClear observationEven tiny bubbles cannot be missed, and the result judgment is intuitive and reliable.

• High stability vacuum generation and intelligent controlThe core adopts branded vacuum generators and high-precision pressure sensors, which can quickly establish and maintain for a long timeStable maintenancePreset vacuum degree (adjustable from 0 to -90KPa). The system hasAutomatic vacuum maintenance and blowback unloadingThe functionality and testing process are fully automated to ensure consistency in testing conditions and reproducibility of results.

• Intelligent operation and data traceability managementEquipped with a 7-inch HMI human-machine interface touch screen, parameter settings and data display are intuitive. Five sets of independent test parameters can be pre-set and stored for quick access to different models of products. All testing process data, pressure curves, and results are automatically stored to meet the requirementsMedical Device Quality Management System (ISO 13485)Regarding the detection recordstraceabilityrequirement

• Powerful non calibration flexibilityThe standard vacuum chamber size is Φ 270mm × 210mm (H). For infusion pump products or large packaging of different sizes and shapes for customers,Various types of vacuum chambers can be customized according to different non-standard samplesAnd specialized fixed fixtures are used to ensure the applicability and accuracy of the testing.

2、 Testing principle

This device operates based on the principle of negative pressure method (water bubble method/vacuum decay method). During testing, immerse the sample to be tested (such as the infusion pump as a whole or a pump body with a simulated connector, or its sterilization packaging bag) in water inside the vacuum chamber. After starting the test, the instrument automatically draws the vacuum chamber to the preset negative pressure value and maintains it for the set time. During this process: 1Qualitative determination (bubble method)If there is any leakage in any part of the sample, air will escape from the leakage point and form a continuous stream of bubbles in the water, thus quickly and intuitively locating the leakage point (such as packaging heat sealing edges, pump body interfaces). twoQuantitative/High Sensitivity Determination (Vacuum Attenuation Method)The system can precisely monitor the pressure changes inside the vacuum chamber during the holding phase. By monitoring the rate of pressure decay, sensitive detection and quantitative determination can be made even for microscopic leaks that do not generate visible bubbles.

3、 Technical parameters

4、 Execution standards

The design and testing capabilities of this instrument fully cover the core standards of medical device and 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 a key equipment for the manufacturing and quality control of infusion pumps and related high-risk medical devices

• Manufacturer of drug device combination products such as infusion pumps and analgesic pumps: Used for productsSelf sealing performanceVerification of pipelines, joints, and shells, andFinal sterilization packagingFactory inspection of sealing integrity and verification of packaging process.

• Medical device packaging material supplierEnterprises that provide sterile barrier packaging (such as Tyvek bags and vacuum formed boxes) for infusion pumps for quality control of their own material sealing performance.

• Third party testing and medical device inspection institutionsAs:Sealing integrity testEquipment used for registration inspection, type evaluation, and market quality supervision of infusion pump products.

• Research and Quality Control LaboratoryUsed for sealing performance verification and comparative testing during the design phase of new infusion systems.

6、 Detailed explanation of testing process

A standardized testing process is the foundation for ensuring the validity of results:

1. Sample preparationPlace the infusion pump sample (when testing the sealing of the pump body, all ports should be closed and gas may be injected; when testing the packaging, immerse the packaging bag in water) in a vacuum chamber.

2. Parameter SettingsSelect the preset program (such as commonly used parameters according to ISO 11607) or manually set it through the touch screen, and enter the vacuum degree and holding time.

3. execute testsClose the vacuum chamber cover and start the fully automatic test. The instrument automatically completes the entire process of vacuum pumping, pressure holding, observation/monitoring, and pressure relief.

4. Result determination：

• Bubble methodDuring the pressure holding period, directly observe whether there are continuous bubbles generated on the surface of the sample. If there is, it is determined that there is a leak.

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

5. Record and ReportComplete test parameters, process curves, and judgment results are automatically saved and recorded, supporting electronic or paper report output.

7、 The Importance of Quality Control

For devices such as infusion pumps that are directly associated with continuous drug administration to patients, theirSealing integrityIt is the core safety attribute to prevent the incorrect release of medication, maintain drug sterility, and prevent air from entering the pipeline and causing embolism. Sealing failure is a serious medical device malfunction. strictly implementISO 11607Waiting for standards and verifying them through scientific sealing tests is not only to meet mandatory regulatory requirements such as China's NMPA, the US FDA, and the EU MDR, but also to facilitate the construction of production enterprisesRisk control systemThe cornerstone of ensuring patient safety and maintaining brand reputation.

8、 Customized service advantages

Jinan Xio Electromechanical provides customized solutions based on a deep understanding of the testing needs in the pharmaceutical and medical equipment industry

• Customization of non-standard vacuum chambers and specialized fixturesDesign and manufacture vacuum chambers with matching dimensions for large, irregular, or complex external joint infusion pump samples, and develop specialized testing fixtures such as sealing plugs and fixed brackets.

• Composite testing plan and program developmentBased on the characteristics of the customer's product, assist in designing a composite verification scheme that can test both packaging sealing and pump body sealing, and customize and develop corresponding automated testing programs.