All pharmaceutical products have to be free of any contamination or toxins. Otherwise, they can create severe problems as soon as they come into contact with human bodies. That is why the bacterial endotoxin test is conducted on these products. The testing ensures that the device can be used on patients without any worry, and it will not cause any problem.
Here, we have included all the details about the bacterial endotoxin testing that you must be aware of.
What Is Bacterial Endotoxin?
Endotoxins, also known as pyrogens, are toxins produced by the disintegration of gram-negative bacteria. If present in significant amounts, these toxins can cause fever and other problems in human bodies.
This can include organ failure, septic shock, and even death in some of the cases. Because of these severe consequences, medical suppliers have to remain extra careful about the presence of endotoxins in their products.
What Is the Acceptable Endotoxin Level?
As stated above, bacterial endotoxin creates a problem when introduced into the body in high concentrations. Considering this factor, the FDA has regulated an acceptable level of endotoxin contamination in medical devices.
It states that up to 0.5 endotoxin units per mL can be present in the given sample. However, the manufacturer will land in trouble if this quantity exceeds even by decimals because then their devices can harm the patients.
Moreover, you need to know that this limit is different for particular cases. For example, the FDA has specified a limit of 0.25 EU per mL in several use cases of the pharmaceutical industry. It means that you need to check your individual purpose to ensure that your products remain below the endotoxins’ acceptable limits.
What Is Endotoxin Testing?
We hope you must have understood all the dangers associated with bacterial endotoxin in medical products by now. This is where endotoxin testing comes into the role.
It is a procedure where the given samples are checked for the presence of these toxins. After that, the results are compared with the specified limits by the FDA. Therefore, ensuring that the products are safe to be used for the patients.
The bacterial endotoxin test procedure also helps check the quality control of the medical devices and other products. In this way, the manufacturer can ensure that their products are of the best quality, and they will not cause any inconvenience to the users.
Usually, all injectable pharmaceutical products or implantable devices of the medical industry have to undergo the bacterial endotoxin test. As these come in direct contact with the blood cells, they can cause severe damage to the body by exposing it to endotoxins. Other products may or may not undergo the endotoxin testing, depending on their usage in the domain.
Endotoxin Testing Methods
From 1942 to 1983, almost everyone opted for RPT (Rabbit Pyrogen Test) to test pyrogens’ presence in medical products. Under this, rabbits were exposed to the stock that required testing for gram-negative bacteria or gram-positive bacteria. However, it was only in 1983 that the industry experts realized that these tests were time-consuming and expensive. Plus, it was not specific to the detection of bacterial endotoxins.
That is when the LAL testing came into existence. In this, LAL stands for Limulus Amebocyte Lysate. It consists of a LAL reagent that is created from Atlantic horseshoe crabs’ specialized blood cells.
These cells generally form a clot whenever they come into contact with endotoxins or some other pathogens. Hence, it can easily detect the presence of these toxins in the given product. The major reason why this test got opted was due to its high reliability, specificity, and sensitivity towards the determination of endotoxins.
Endotoxin Test Procedure at Our Lab
We conduct comprehensive LAL testing to offer you a detailed report on the presence of any bacterial endotoxins. Our labs are accredited by the authorities, and our experts have been performing the tests for years. Thus, you will get reliable results from us that you can use further for improving the quality of your products.
You can reach us through the given ‘Quick Query’ form for any other details or call us on +91-11-45754575 to opt for the bacterial endotoxin test of your products. Our team of professionals will be happy to assist you with everything.