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Drug Conformance Evaluation with Vacuum Decay Leak Tester Recommendations December 27,2021.

Drug consistency evaluation is one of the drug quality requirements in the National Drug Safety "12th Five-Year Plan", that is, drug consistency research, that is, generic drugs must be consistent with the original drug "management consistency, intermediate process consistency, quality standard consistency and other process consistency "The high standard requirement.

The National Drug Safety "12th Five-Year Plan" clearly requires that generic drugs that do not pass the consistent evaluation of drug quality will not be re-registered and canceled its drug approval documents. Generic drugs and original drugs, brand-name drugs and small factory drugs, domestic drugs and imported drugs, the same drug, the content of impurities may not be the same, bioavailability is not the same, there are differences in side effects, the clinical safety and effectiveness of the natural different. Secondly, the way the drug is packaged, the impact played by packaging materials is also crucial. Therefore, drug consistency research must be conducted in order to improve the safety and efficacy of drugs, to ensure that people use drugs safely and effectively.


Packaging is also a very important part of the development process of a new product. The basic requirements of drug packaging are adaptability to the contents, protection, should be adapted to the needs of different circulation conditions and comply with relevant standards.     Packaging sealing performance is the core of packaging safety performance, usually detecting packaging leaks using the vacuum water bath method sealing tester to carry out, the advantages are: low cost, eye observation of continuous bubble rise will be more intuitive. The disadvantage is: it is difficult to detect (or difficult to observe) <10 microns of leakage, can not meet the user's needs for micro-leakage detection. Then there is the specimen once there is a leak, water in the pressure equilibrium stage will enter the package, causing the contents to be contaminated with waste. In particular, the cost of testing high value products such as pharmaceuticals, milk powder and health products increases, bringing unnecessary losses to enterprises.


How does the vacuum decay leak test work?

Vacuum decay test is a test method that has been proven for decades and improved with new technological innovations. The test method is simple in principle and is based on basic physical properties that challenge the integrity of the packaging. It involves evacuating the package in the test chamber and monitoring the vacuum level for any decay, which indicates the presence of a leak. The method establishes its position as a non-destructive alternative to water bath leak testing. It provides significant cost savings by not wasting product for leak testing and delivers a return on investment for many products in less than six months


GBPI's self-developed GBM-L1 Vacuum Decay Leak Detection Tester is based on the principle of vacuum decay method with dual sensor technology and dual circulation system. The main unit of the micro-leakage tester is connected to a test chamber specially designed to contain the package to be tested. The instrument evacuates the test chamber, forming a pressure difference between the inside and outside of the package, under the action of pressure the gas inside the package diffuses into the test chamber through the leakage holes, and the dual sensor technology detects the relationship between time and pressure changes, and compares it with the standard value to determine whether the specimen is leaking.

The instrument meets ASTM F2338-2009 (2013) standard test method for nondestructive detection of leakage in packaging by vacuum decay method, YY-T 0681.18-2020 test method for sterile medical device packaging, USP1207 standard, with an accuracy of up to 1μm, and is suitable for trace leak detection and integrity leak detection of various packaging containers. With the advantages of non-destructive, non-destructive and no sample preparation, it can be applied to leak detection of pharmaceutical packaging, food packaging and chemical industry packaging such as ampoules, celine bottles, HDPE bottles and pre-filled needles.

GBPI is a supplier of flexible packaging testing equipment, mask testing equipment, and testing solutions. It has more than 20 years of experience in the field of testing equipment.


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