Blog: Solutions for Containing Pharmaceutical Agents
Cartridge leaking tests are essential procedures to ensure the proper delivery of such sensitive products. More often than not, one mishap is all it takes to destroy the products in their entirety.
Assortments of containers are used to contain pharmaceutical products. Most of them being syringes, cartridges, vials, and ampoules. Most of these containers are made of glass or similar material and are prone to be damaged. Cartridge leaking tests are usually carried out to figure out this kind of issue.
We can discuss the underlying issues when it comes to leaking or breakage of such vials. They usually contain very sensitive and often very expensive components. Being exposed to alien substances can effectively ruin these components. And so, cartridge leaking tests are often necessary.
Internal Stability
Breakage of the glass can make the substances inside exposed to all kinds of foreign agents. Microorganisms, humidity, etc., can degenerate the medical effects of the substances. They may even be oxidized and destroyed altogether. There are some that are very sensitive to moisture. These components are stored in vials and a cartridge leaking test can quickly help to determine the issue.
Integrity tests are done to figure out the risk biological degeneracy of parenteral drugs. Though they are very challenging, they usually produce good results. The complexity of these cartridge leaking tests just adds to the fact that pharmaceutical products should be produced with the utmost care. Any compromise in the methods can mean serious consequences.
HMS (Helium Mass Spectrometry)
Helium Mass Spectrometry is applied to non-porous containers, which includes syringes, vials, and cartridges. Even though cartridge leaking tests are very reliable on their own, the helium leak test is a much higher standard for sensitive agents. It is more of a deterministic method to produce more accurate results. We have already mentioned the vitality of these leakages.
Locating them is also one of the top priorities. Helium leaks are more often than not caused by an external force. Fortunately, Helium Mass Spectrometry can even help us determine the location and the position of the leaks, similar to cartridge leaking tests. This can go a long way to achieve better performance.
Mass Extraction Tech
The Mass Extraction method has to take place under suitable air pressure. Vacuumed space is ideal for carrying out this cartridge leaking test as this condition can help us achieve higher sensitivity. By fully acknowledging the principles of airflow, Mass Extraction ensures the best quality of packaging for their products. This method is more appropriate for packaging pharmaceutical products. Almost all kinds of defects can be detected through this test. Leaks or holes as small as 1 micrometer can easily be found out. This works on pouches and IV bags as well.
OES (Optical Emission Spectroscopy）
The OES or Optical Emission Spectroscopy does not necessitate any sort of tracer gas. Usually, some excess gases are present in the headspace of the container. Through the OES method, we utilize this gas to determine potential leaks of the cartridge. This kind of cartridge leaking test has been proven to be very efficient.
The mixture of gases inside the container usually has no degenerative effect on the components in it. But this method does not harm the substance in any way. The gas sensors are utilized to determine whether or not gas is coming out of the container.
Conclusion
Manufacturing pharmaceutical products are very complicated on their own, and often they are very sensitive to objects from the outside. That is why such precautionary measures need to be taken before putting them to use. And so, the packaging has to be done with much care.
