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sumcso@sumspring.com
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15665715386
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Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd
Process principle and application of penicillin bottle vacuum tester
Date: 2025-09-15Read: 6
The penicillin bottle vacuum tester (also known as the vacuum decay leak detector) is a non-destructive testing equipment based on the principle of pressure change, mainly used to evaluate the sealing performance of penicillin bottles and other drug packaging. The process principle and application can be summarized as follows:
1、 Process principle
1. Core mechanism of vacuum attenuation method
By placing the penicillin bottle in a sealed testing chamber and creating a negative pressure environment (such as -60kPa) by vacuuming, a pressure difference is created between the inside and outside of the bottle. If there is a leak, the gas or volatile matter inside the bottle will diffuse into the testing chamber, causing a decrease in vacuum degree (i.e. "vacuum decay"). High precision sensors monitor pressure changes in real time and analyze the decay rate to determine the degree of leakage.
2. Key technical parameters
Vacuum value setting: A specific vacuum value of -60kPa can simulate actual transportation/storage scenarios and improve detection sensitivity for small leaks (1-5 μ m aperture).
Judgment criteria: including pressure attenuation (e.g. ≤ 50Pa within 60 seconds is qualified), vacuum degree change, and response time.
3. Standard compliance
This method complies with international and industry standards such as ASTM F2338, USP 1207, and YY/T 0681.18-2020, and is suitable for sealing verification of high-risk drug packaging such as injections and freeze-dried powders.
2、 Application advantages
1. Efficiency and Automation
The single test time is usually ≤ 30 seconds, supporting rapid detection on the production line.
Equipped with HMI interface and MES/LIMS system integration to achieve automatic data recording and analysis.
2. Non destructive testing
Compared to traditional water testing or staining methods, it avoids damaging the sample and is particularly suitable for finished product testing of filled drugs.
3. Multi scenario adaptation
It can be extended to different packaging forms such as ampoules, pre filled syringes, etc., to meet the full process needs of pharmaceutical companies in research and development, production, and quality inspection.
3、 Typical application scenarios
1. Pharmaceutical companies: used for testing the sealing of penicillin bottle aluminum caps to ensure the integrity of sterile barriers.
2. Packaging material production: Evaluate the sealing compatibility between the rubber stopper and the bottle mouth.
3. Third party testing: Container Closure Integrity Test (CCIT) that meets pharmacopoeia requirements.
Through the above technology, the vacuum attenuation method tester has significant value in ensuring drug safety, improving production efficiency, and reducing quality risks.
