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E-mail
Ellasong@qiyi-china.com
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Phone
13296018069
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Address
Room A226, Building A, No. 58 Yindu West Road, Shanghai
Shanghai Qiyi Instrument Equipment Co., Ltd
Ellasong@qiyi-china.com
13296018069
Room A226, Building A, No. 58 Yindu West Road, Shanghai
The sealing integrity of packaging is directly related to the safety, effectiveness, and shelf life of the contents in the production and circulation of food, drugs, medical devices, cosmetics, and electronic products. Once there is a small leakage in the packaging, oxygen, moisture, or microorganisms in the air may invade, causing food spoilage, drug failure, medical device contamination, and even serious safety accidents. The traditional methods of relying on visual inspection or water immersion bubbling have strong subjectivity, low sensitivity, and cannot be quantified, making it difficult to meet the requirements of modern quality management systems for non-destructive, accurate, and traceable testing. In this context, packaging sealing detectors have emerged as a key equipment for ensuring product shelf life and consumer safety, known as "sealing guardians" due to their high sensitivity, non-destructive nature, automation, and compliance with international standards.
1、 Core detection principles and technical types
Modern packaging sealing detectors mainly adopt the following mainstream technologies, which are suitable for packaging of different materials and forms:
1. Vacuum Decay Method
Principle: Place the sample in a sealed testing chamber, evacuate it, and monitor the pressure changes inside the chamber. If there is a leakage in the packaging, the internal gas will escape, causing an abnormal rate of pressure rise.
Advantages: Non destructive, high sensitivity (leak detection aperture up to 5-10 microns), suitable for rigid/semi-rigid packaging (such as penicillin bottles, ampoules, aluminum-plastic blister caps);
Standard basis: ASTM F2338, USP<1207>, widely recognized by FDA.
2. High Voltage Leakage Detection (HVLD)
Principle: Apply a high-frequency high-voltage electric field to non-conductive packaging containing liquid. If there are pinholes, the current will form a path through the liquid, triggering an alarm.
Applicable: Packaging of liquid preparations such as glass/plastic ampoules and pre filled syringes;
Features: 100% online detection, speed up to 600 bottles/minute, widely used in sterile drug production lines.
3. Tracer gas method (such as helium mass spectrometry leak detection)
Principle: Fill the packaging with helium gas, place it in a vacuum chamber, and use a mass spectrometer to detect if helium has escaped.
Advantages: Sensitivity (up to 10 ⁻⁹ mbar · L/s), which is the "gold standard";
Limitations: High cost, slow speed, often used for research and development or high-value product validation.
4. Water bath bubbling method (improved version)
Although it is a traditional method, modern equipment uses a constant temperature water bath, high-definition cameras, and AI image recognition to automatically identify bubbles, improve objectivity, and is suitable for initial screening of flexible packaging such as soft bags and infusion bags.
2、 Typical application scenarios
1. Pharmaceutical industry
Sealing verification of penicillin bottles for freeze-dried powder injection after capping;
Integrity testing of pre filled syringes before and after sterilization;
Ensure that the sterile barrier system complies with GMP and USP<1207>requirements.
2. Food industry
Leak detection for vacuum packaged cooked food, coffee, and nuts;
Sealing control of nitrogen filled potato chip bags and dairy cup lids;
Prevent swelling, mold growth, or nutrient loss caused by poor sealing.
3. Medical devices
Sterile barrier integrity testing for disposable syringes, infusion sets, and catheter kits;
The packaging of implanted devices (such as heart stents) must pass 100% sealing testing.
4. Cosmetics and Electronics
Leak proof test of essence solution ampoule;
Factory verification of waterproof packaging for mobile phones (such as IP68 rating).
3、 Selection and usage points
Users should choose the appropriate technology based on the packaging type:
Rigid container (bottle, blister) → vacuum decay method;
Liquid preparation ampoule → HVLD;
High value product validation → helium testing;
Soft bag initial screening → automated water bath method.
Attention should be paid during use:
Establish a standard leak calibration system;
Control the temperature and humidity of the environment to avoid condensation interference;
Regularly verify equipment performance (such as using positive/negative control samples).
Although the packaging sealing detector does not directly participate in product manufacturing, it is the last line of defense to protect consumer safety. It transforms "invisible leaks" into "visible safeguards" with micrometer level insight, millisecond level response speed, and scientific data support. In an era where quality is life and safety is no small matter, this "sealed guardian" will continue to empower various industries, ensuring that every package of food can be safely consumed, every drug can be safely injected, and every device can be used reliably.