This article is provided by Jinan Saicheng Electronic Technology***.
Ampoules are often used to store drugs, vaccines, serums, etc. for injections. If the sealing performance of the ampoule is not good, it may lead to the leakage of the liquid medicine, contamination, and seriously affect the patient's best effect. At the same time, if the ampoule leaks, oxygen and microorganisms in the air can invade the container, so that the product filled inside may be oxidized, affecting the stability of the product. If the filled product is suitable for the growth of microorganisms, the microorganisms will multiply rapidly, which may pose a risk to the patient's life.
Ampoule micro-leak tightness tester adopts non-destructive test method and uses the vacuum attenuation test principle, which is professionally suitable for micro-leakage and package seal integrity testing of ampoules, vials, injection vials, lyophilized powder injection bottles and pre-filled packaging samples.
Ampoule Micro Leak Leak Tester Test Principle
Fully compliant with ASTM F2338-09 and USP 40-1207 regulations, based on the principle of vacuum attenuation method for dual-sensor technology, dual-circulation systems. Connect the micro-leak leak tester to a test chamber specifically designed to accommodate the packaging to be tested. The instrument vacuums the test chamber, the pressure difference between the inside and outside of the package is formed, and the gas in the package diffuses to the test chamber through the leakage hole under the action of pressure, and the double sensor technology detects the change relationship between time and pressure, and compares it with the standard value to determine whether the sample leaks.
Ampoule Micro Leak Leak Tester Product Features:
The corresponding test chamber can be selected for different test samples, which can be easily replaced by users, so as to minimize user expenses and make the instrument have better detection adaptability in the case of more kinds of samples.
It is suitable for detecting small leaks, and can also identify large leakage samples, and give qualified and unqualified judgments.
The non-destructive testing method is used to detect the leakage of the packaging containing the drug, and the sample is not damaged after the test, which does not affect the normal use, and the test cost is low.
The test results are non-subjective, and the testing process of each sample is completed in about 30s without manual participation, which ensures the accuracy and objectivity of the data.
The instrument uses both deterministic and quantitative detection methods.
Imported brand vacuum components are used, with stable performance and durability.
It has sufficient password protection function, divided into four levels of authority management, and each operator has a unique login and password combination to enter the instrument operation.
The data that meets the requirements of GMP is stored locally, automatically processed, and the test data is statistically analyzed, and exported in a format that cannot be modified or deleted to ensure the permanent preservation of the test results.
The instrument comes with a micro printer, which can print complete test information such as equipment serial number, sample batch number, experimenter, test results, and testing time.
The original data is backed up on the computer in the form of a database that cannot be changed, and can be exported in PDF format.