info@gbtest.cn
en
ru
es
ar
Pharmaceutical packaging materials such as vials, ampoules, cassettes, infusion bottles, etc. need to be picked up from a quality point of view.
Many pharmaceutical manufacturers are unaware of how to test the sealability of vials. There are three common methods for detecting leaks in pharmaceutical packaging materials：
Vacuum decay method
1. Convenient and fast testing
2. Traceable
3.Repeatable
4. Non-destructive testing
5. Small human factor
6. High sensitivity
7. Quantitative testing
8. Easier to detect smaller and leaky points zigzag leakage holes
1. Low cost
2. High industry acceptance
High instrument cost and high accuracy
1.Destructive testing
2. Subjective factors easily misjudged
3. Low sensitivity Difficult to judge microporous
4.Not traceable
1 Destructive testing
2. Long test time, non-actionable and non-traceable
The most effective, intuitive and efficient test, the sample will not be contaminated after the test, and can be used normally
In the actual test, it is difficult to observe the infiltration of liquid when a 5um microporous hole is encountered, thus leading to misjudgment. Moreover, the sample cannot be reused after this seal test.
The experimental process is long and cannot be used for sterile drugs out of the field inspection process
Color water method
Microbial Challenge Method
1. Visible results
2. Widely used
3. High industry acceptance
GBPI developed and produced Vacuum Decay Leak Detection Tester GBM-L1 for detecting tiny leaks, Micro Leakage Seal Tester adopts the principle of vacuum attenuation for micro leak detection of finished packaging, the tester is suitable for micro leak detection and leak detection of integrity of various packaging containers. 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.
Test principle
Based on the principle of vacuum decay test, the test sample is put into the special test chamber, the test chamber is vacuumed so that a certain pressure difference is formed inside and outside the package, and the gas in the package diffuses to the test chamber through the leakage hole under the action of pressure, and the relationship between the detection time and pressure change is compared with the standard value to determine whether the sample is leaking.
Vacuum Decay Leak Detection Tester main parameters indicators
Vacuum degree: 0 ~ -100KPa (standard)
Detection sensitivity: minimum 3μm
Vacuum resolution: 1Pa
Test time: 30s
Internal pressure: atmospheric pressure
Vacuum source: external vacuum pump
Dimension: 480mm(L)×330mm(W)×320mm(H)
Power supply: AC 220V 50Hz
Net weight: 18kg
Product features
1. Adopt vacuum decay method, in line with ASTM F2338 test requirements
2.7 inch color touch screen, humanized operation is more convenient
3. Using non-destructive testing method of hermetic testing, reusable after testing
4. For different test samples, support the customization of the appropriate test chamber to meet the needs of different tests
5. Automatically save the history of test records, local inquiries.
6. Equipped with micro printer, USB data interface, support PC software measurement and control operation, mbar, Pa units interchangeable.
Reference Standards
ASTM F2338-2009(2013) Standard Test Method for Non-Destructive Detection of Leakage in Packaging by Vacuum Decay Method, YY-T 0681.18-2020 Test Method for Sterile Medical Device Packaging, USP1207 Standard
GBPI is a professional supplier of packaging laboratory test equipment, with 20 years of experience in research and development of laboratory equipment, high quality products, and can provide customized laboratory equipment for various industries. We have a thousand square CNAS laboratory, providing one-stop experimental testing services for different industries, and our output of experimental reports are scientific and rigorous testing reports.
More communication! More communication! GBPI TESTER is looking forward to communicating and cooperating with more industries. To provide comprehensive technical solutions for your product production upgrade.