【Collection】Guide to airtightness testing in the medical industry! Ultra-high precision, non-destructive testing, data traceability

The medical industry has very high requirements for gas-tightness testing, which is critical to patient safety and product effectiveness. It is necessary to meet the requirements of strict regulations, high precision, sterile environment, data traceability and so on.Commonly used pressure decay, differential pressure, tracer gas method, and the need to use professionalAirtightness TesterThe

As an industry leader in airtightness testing for more than a decade, Precision Engineering provides customized, high-standard solutions to help ensure the quality of medical devices.

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I. Importance of airtightness testing in the medical industry

Second, the special requirements of the medical industry air tightness testing

III. Airtightness testing methods commonly used in the medical industry:

Fourth, the medical industry air tightness tester key performance indicators

V. Jingcheng Engineering Medical Industry Airtightness Testing Solutions

Summarize

I. Importance of airtightness testing in the medical industry

Safety of life is paramount:Implanted, interventional, respiratory, infusion and other medical devices are directly related to patients' lives, and leakage may lead to infection, dosage error, functional failure and other serious accidents. Gas tightness is the core guarantee of safety.
Efficacy and diagnostic accuracy:Negative pressure drainage devices, ventilators, anesthesia machines, biochemistry analyzers, and other equipment rely on precise airtightness to maintain performance, and leaks directly affect the effectiveness of treatment and the accuracy of diagnostic results.
Aseptic state maintenance:Syringes, infusion sets, surgical instruments and other sterile instruments, packaging airtightness is a key defense against microbial invasion and maintaining sterility.
The regulatory standards are stringent:ISO 13485, ISO 9001, YY/T 0242, GB/T 19633 and other regulations and standards put forward clear and stringent requirements for medical device airtightness, which must be strictly complied with.

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Second, the special requirements of the medical industry air tightness testing

Ultra-high precision and sensitivity:Medical device leakage standards are extremely stringent, requiring leakage detection at the milliliter/minute level and beyond, and detectors must be extremely accurate and sensitive.
High reliability and stability:Medical device production of large batches, high frequency of testing, the equipment needs to run continuously and stably for a long time, to ensure the consistency and credibility of the test results.
Principles of non-destructive testing:Medical device testing must be non-destructive to guarantee that high-value consumables can still be used safely after testing.
Clean and sterile environment compatible:Sterile medical device testing needs to be carried out in a clean room/sterile environment, and the equipment needs to be compatible with clean environment requirements to avoid secondary contamination.
Data integrity and traceability:The test data should be complete and traceable, in compliance with regulations and quality management requirements, and the equipment should be equipped with automatic data recording and uploading functions.
Ease of operation and error-proofing:The fast beat of the production line requires equipment that is easy to operate, easy to start, error-proof, improves efficiency and reduces human error.
Regulatory Compliance:The testing equipment itself needs to comply with medical device related regulations and standards, such as CE, FDA, NMPA certification, etc., to ensure that the equipment is safe, reliable and accurate measurement.

III. Airtightness testing methods commonly used in the medical industry:

Comparison Table of Medical Device Airtightness Testing Methods

Detection Methods	application scenario	vantage	Accuracy level
soak in water	Rapid sampling at the end of the medical device production line, initial evaluation at the R&D stage	Easy to operate, low cost, intuitive results, rapid initial screening	lower (one's head)
positive pressure	Infusion sets, catheters, respiratory lines, simple structural implants, etc.	Commonly used, cost-effective, fast testing, high degree of automation	moderate
Negative pressure vacuum method	Negative pressure drainage devices, negative pressure wound treatment equipment and other medical devices that require the maintenance of negative pressure.	Closer to the actual working condition, able to simulate the airtightness of negative-pressure medical devices in the real use of the environment.	high
differential pressure	Precision syringe pumps, microfluidic chips, endoscopes, implantable medical devices with complex structures, and other medical devices that require higher air tightness.	High accuracy and sensitivity to detect smaller leaks	your (honorific)
tracer gas method (e.g. helium leak detection)	Certain types of pacemakers, implantable drug delivery devices, artificial lungs, and other critical medical devices that have a direct bearing on the lives of patients	Extreme accuracy to pinpoint leaks and ensure product reliability under extreme conditions	extreme boundary

Soaking Method:Simple and intuitive initial screening, suitable for end-of-line sampling or R&D evaluation, not for final shipment.
Positive pressure method:Commonly used and cost-effective for infusion sets, catheters, etc., with high speed, moderate accuracy and high automation.
Negative pressure vacuum method:Negative pressure instruments are applicable, for negative pressure drainage devices, negative pressure wound treatment equipment, etc., to simulate real working conditions.
Differential pressure method:Highly accurate and sensitive choice for precision syringe pumps, endoscopes, complex implants, etc., can detect small leaks.
Tracer gas method (helium leak detection):Ultimate precision for critical devices, such as pacemakers, with high accuracy for locating leaks.

Fourth, the medical industry air tightness tester key performance indicators

Pressure accuracy:Pressure control and measurement accuracy of ±0.1% FS or better ensures accurate results.
Test speed:The single test time needs to be controlled in seconds to tens of seconds to adapt to high beat production.
Data storage capacity:Large-capacity storage, support for data export and network transmission, to meet the demand for data traceability.
Interfaces and Communications:Equipped with RS232/485, Ethernet, I/O interfaces for easy system integration.
Operator Interface:Color touch screen, friendly and intuitive, easy to operate.
Alarms and Alerts:Audible and visual alarms, clear Pass/Fail indications, and quick recognition of results.
Calibration and Maintenance:Easy to calibrate and maintain, providing perfect guidance to ensure the long-term stability and reliability of the equipment.

Medical device 3-way valveAirtightness Tester(with water detection)

V. Jingcheng Engineering Medical Industry Airtightness Testing Solutions

Customized inspection systems:Tailor-made automated/semi-automated inspection systems for different medical device characteristics and requirements, covering a wide range of inspection methods.
High precision medical gradeleak detector::Self-developed production, high precision, strong stability, leakage rate resolution of 0.1Pa, and through strict factory inspection and calibration.
Professional work attire that meets medical specifications:Designed by professional team, high precision, high sealing, easy to clean and sterilize, material meets medical grade requirements and workpiece verification.
Cleanroom Compatible Design:Equipment and systems meet the requirements of cleanroom environments, are easy to clean and sanitize, reduce dust production, and are available with optional HEPA filters.
Complete data traceability and management system:Equipped with powerful data software, it automatically records data, generates GMP/FDA electronic records, and seamlessly connects to MES/ERP systems to realize data traceability.
Perfect after-sales and technical support:7×24 hours rapid response after-sales service, providing installation, training, maintenance, calibration and regulatory compliance equipment verification services (IQ/OQ/PQ).

Summarize

The medical industry's stringent requirements for airtightness testing reflect a supreme responsibility for the lives and health of patients.Precision Industrial Technology, with deep technical accumulation and rich industry experience, to provide you with the most trustworthy medical device airtightness testing solutions, and jointly guard the quality and safety of medical care, for the protection of human health.

If you have any specific needs or questions about medical device airtightness testing, you can visit theJingcheng Gongke airtight official websiteOr contact us directlyWe will be happy to serve you with the most professional answers and customized solutions!

Original Statement: this paper was written byShenzhen Jingchenggongke Technology Co., Ltd.Written by the technical team, reproduced with attribution.Data sources:Precision Engineering internal test data and customer cases.