In the modern pharmaceutical industry, sterile sealed container leak detectors have become a key equipment to ensure the sterility and quality of drugs. It ensures the sealing integrity of drug packaging and prevents microbial contamination through high-precision detection technology, and is widely used in drug production, packaging, and quality control.

1、 Detection principle

The core technology of sterile sealed container leak detector is based on multiple detection methods, among which the most common are vacuum attenuation method and micro mass flow detection method. Taking the vacuum decay method as an example, its detection process is divided into three stages: first, place the test container in a sealed testing chamber, and use a vacuum pump to reduce the pressure inside the chamber to -90kPa; Subsequently, activate the dual sensor system to monitor real-time changes in vacuum level; Finally, the vacuum decay rate is analyzed through algorithms to determine if there is a leak. This technology can detect micropores with a diameter of 1 μ m, equivalent to 1/50 of human hair strands, and the detection sensitivity is 100 times higher than traditional staining methods.

The micro mass flow detection method breaks through the limitation of traditional methods on the volume of packaging headspace by quantitatively extracting gas from the container and analyzing changes in mass. For example, the ME2 leak detector launched by Shanghai Qiyi Instrument adopts the vacuum mass extraction method. When detecting 5ml ampoules, it can complete the detection within 30 seconds, which is 40% more efficient than the vacuum attenuation method, and the detection accuracy reaches the level of helium mass spectrometer leak detectors.

2、 Technical features:

1. Non destructive leak detection: The detection process does not damage the container and drugs, ensuring that the tested drugs can still be used normally.

2. Quantitative detection: Replace the traditional vacuum colorimetric method to provide more accurate quantitative detection results.

3. No need for daily calibration: simple maintenance reduces the complexity of daily operations.

4. Wide detection range: not affected by packaging headspace space and temperature, suitable for various packaging types.

5. High detection accuracy: It can detect defects and leaks with a diameter of 1um, ensuring the sterility of the drug.

6. Quick detection: The detection time is short and faster than the vacuum decay method.

3、 Application areas:

1. Pharmaceutical industry: used to test the sealing integrity of pharmaceutical packaging such as penicillin bottles, ampoules, pre filled syringes, infusion bags, etc., to prevent microbial contamination.

2. Medical devices: Test the packaging integrity of implantable drug delivery devices and other medical devices to meet the ISO 11607 standard.

3. Food industry: Ensure the sealing of food packaging to prevent food spoilage.

In short, sterile sealed container leak detectors have become equipment in the pharmaceutical industry due to their high precision, non-destructive, and rapid detection characteristics. It not only ensures the sterility and quality of drugs, but also promotes technological progress and sustainable development of the entire industry.