Micro Leak Tightness Tester

Test items: Non-destructive inspection of packaging tightness by vacuum decay method

Fully comply with FASTM F2338-09 standard and USP40-1207 regulatory requirements, based on dual sensor technology, the principle of vacuum attenuation method of dual-circulation system. Connect the main body of the micro-leak tightness tester to a test cavity specially designed to contain the packaging to be tested. The instrument evacuates the test cavity, and a pressure difference is formed between the inside and outside of the package. Under the action of the pressure, the gas in the package diffuses into the test cavity through the leak. The dual sensor technology detects the relationship between time and pressure and compares it with the standard value. Determine whether the sample leaks.

Product Features
Leading the development of the industry. The corresponding test chamber can be selected for different test samples, which can be easily replaced by users. In the case of satisfying more types of samples, the user’s expenses are minimized, so that the instrument has better test adaptability.
The non-destructive testing method is used to conduct leak detection on the packaging containing the medicine. After the test, the sample is not damaged and does not affect the normal use, and the test cost is low.
It is suitable for detecting small leaks, and can also identify large leak samples, and give a judgement of qualified and unqualified.
The test results are non-subjective judgments. The test process of each sample is completed in about 30S, without manual participation, to ensure the accuracy and objectivity of the data.
Using branded vacuum components, stable performance and durable.
It has sufficient password protection function and is divided into four levels of authority management. Each operator has a unique login name and password combination to enter the instrument operation.
Meet the GMP requirements of data local storage, automatic processing, statistical test data functions, and export in a format that cannot be modified or deleted to ensure the permanent preservation of test results.
The instrument comes with a micro-printer, which can print complete test information such as equipment serial number, sample batch number, laboratory personnel, test results, and test time.
The original data can be backed up on the computer in the form of a database that cannot be changed, and can be exported to PDF format.
The instrument is equipped with R232 serial port, supports data local transmission, and has SP online upgrade function to meet the individual requirements of customers.

Comparison of common leakage detection methods of pharmaceutical packaging materials

Vacuum attenuation method test principle
It fully complies with the FASTM F2338-09 standard and the USP40-1207 regulatory requirements, based on the dual sensor technology and the principle of the vacuum attenuation method of the dual-circulation system. Connect the main body of the micro-leak tightness tester to a test cavity specially designed to contain the packaging to be tested. The instrument evacuates the test cavity, and a pressure difference is formed between the inside and outside of the package. Under the action of the pressure, the gas in the package diffuses into the test cavity through the leak. The dual sensor technology detects the relationship between time and pressure, and compares it with the standard value. Determine whether the sample leaks.

Product Parameter

Standard
ASTM F2338 uses the vacuum decay method to non-destructively inspect the standard test method of packaging tightness, SP1207 U.S. Pharmacopoeia standard

Instrument configuration
host, vacuum pump, micro printer, touch LCD screen, test chamber