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At present, the current packaging integrity/ sealing testing methods, domestic packaging integrity / sealing test standards are mainly GB/T 15171-1994 "soft packaging sealing performance test method."
By vacuuming the vacuum chamber of the test instrument, so that the sample immersed in the vacuum chamber water produces internal and external pressure difference, the test sample gas escape situation, if the sample in the vacuum and vacuum hold period without continuous bubble production, then the sample sealing qualified.
or by vacuuming the vacuum chamber, so that the sample produces internal and external pressure difference, by observing the expansion of the sample and releasing the vacuum after the sample shape recovery, to determine the sealing performance of the sample.
defects of the current method the above-mentioned traditional water inspection method can steadily detect the diameter of about 20 microns of leakage, then 20 microns below the leak will have any impact on the sealing of the packaging and the quality of the contents? Figures 1 and 2 give the answer.
1, we can find 1E-3mabr.L/S (0.001mbar. L/S) the leakage rate corresponds to about 6 to 10um right pore diameter.
figure 2, the leak rate can increase the oxygen content in the package from nearly 0% to 1.8% in about 100 days.
in the case of 1E-1mabr.L/s, i.e. 0.1mabr.L/S leakage rate (about 70um), the oxygen content increased from 0 to 2.5% in about 1 day.
For the sealing requirements of extremely strict pharmaceutical packaging, if the use of water inspection method, it is easy to ignore the leakage of 20 microns below the aperture caused by oxygen, water vapor infiltration, resulting in the quality of drugs during the shelf life deterioration.
, the water inspection method is far from meeting the sealing performance quality control requirements of pharmaceutical packaging. figure
: The correlation between leak aperture and leakage rate Figure 2: leak rate, storage time and oxygen content in the packaging is second, another defect of water inspection method is that the test results can not be quantitatively issued leakage value, through manual visual inspection whether to produce continuous bubbles to determine the sealing effect, the results are not reproduced, the human impact is greater. after
, but alsofatal drawback is that water testing is a destructive method, all water tested samples, whether qualified or not, can no longer be sold, which will cause extreme (separator) waste of samples, especially expensive drugs.
Innovative solution - vacuum attenuation sealing test currently in Europe and the United States and other developed countries of various types of non-destructive sealing testing methods have been widely used in pharmaceutical packaging seal detection, of which, vacuum attenuation method is a general solution for non-destructive sealing testing.
principle is to create a pressure differential environment between the package and the measuring chamber by vacuuming the measuring chamber to the target pressure.
In this environment, the gas escapes through the tiny leaks in the package and fills up in the measuring chamber, causing the pressure to rise in the measuring chamber, and the leakage rate can be calculated by using the increase in known pressure differentials, time intervals, and pressure pressures.
Labthink orchid vacuum attenuation seal tester test lower limit: less than 1 micron diameter leakage, industrylow test lower limit, you can call for advice.
Compliance: High sensitivity, high repeatability, high stability, etc. in accordance with ASTM, China GMP, U.S. Pharmacopeia, FDA, etc.? The instrument has unique features such as small size, low noise, no pollution, etc. , the use of built-in high-precision flow meter, easy to verify the linearity of the instrument, and no need to disassemble the machine can be metered and verified the new touch operating system, one-click operation, intuitive operating interface, can be remotely upgraded and maintained, vacuum, test and penetration time adjustable, stored in the database, to ensure the consistency of test conditions, test curve real-time display, data intelligence statistics, easy to quickly view the detection results, automatic data storage, automatic memory function Historical data can be quickly viewed and printed Printer and USB universal data interface for easy data output and transmission (optional). Multi-level user rights management, password login Professional software in line with GMP drug production quality management norms Test process 1, the test sample into the test cavity, according to the set vacuum degree of the test cavity vacuum.
in the vacuuming stage, if the actual vacuum can not reach the reference vacuum during the specified vacuum time, then the packaging has a large leakage.
2, in the pressure protection phase, if the specified pressure protection time, the actual vacuum can not reach the reference vacuum, then the packaging has leakage.
3, in the test phase, if the actual vacuum decay rate value is greater than the reference vacuum decay rate value, then the packaging has a slight leakage.
Test process step diagram Test application: Xilin bottle, ampoule bottle, infusion bottle, Ka's bottle, pre-charged needle, infusion bag, etc. Note: Labthink is always committed to product performance and functional innovation and improvement, for this reason, product specifications will change accordingly.
the above without notice, you can log on to Jinan Languang Company's website to obtaininformation.
Company reserves the right to modifythe right of final interpretation.