Medical equipment and tools are one of the most sensitive and need to be kept in a highly hygienic state so that they can be used on human bodies without any grave consequences.
In order to keep the pharmaceutical products and medical equipment free from pathogens before they are inserted into the human body, there are several measures that need to be taken, such as due diligence consulting, product accreditation, chemical testing, bacterial endotoxin testing, and accreditation from one or more of the most important health and pharmaceutical boards.
This ensures that the drug that is used is below the suggested guidelines for toxins or pathogens and makes sure that they do not cause any grave effect on the human body besides treating and curing elements.
What is the bacterial endotoxin Test?
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Endotoxin is a toxin, as suggested by the name, which is produced by the disintegration of gram-negative bacterias in the chemical composition of the medicine. It is quite impossible to control the level of endotoxin in medical equipments and medicines, but pharma companies can take various measures to make sure the level is as low as possible. There are various norms with relation to the level of endotoxin that is permissible based on the treatment and the drug used.
For different procedures, there are different levels of the permissibility of the level of endotoxin in the sample. In many cases, the norm is 0.5 Endotoxin Unit (EU) per ml, or below but in some severe cases based on the criterion, the labs could require as little as 0.25 EU per ml as well.
Why is Bacterial Endotoxin Test Required?
Bacterial endotoxin, if present in a higher amount, can be adverse for the human body. It can cause septic shock, fever, a severe form of allergy, organ failure, and, in worst cases, even seem fatal to the patient. Therefore it is very important that pharmaceutical products and equipment undergo the bacterial endotoxin test so that such scenarios can be controlled.
Bacterial endotoxin is a pyrogen that is present everywhere in the environment. It is quite difficult to control the amount of the endotoxin level due to the universal factor of its presence. It is also very difficult to control and remove the presence of this toxin once the drug is completed or prepared. The endotoxin is present in the outer shell of the bacteria and is seen in the destruction of the gram-negative bacterias.
The bacterial lining is quite harmless when it is outside the body and even inactive in its form. But once the endotoxin enters the human body, either through the bloodstream or introduced in the spinal fluid, it can start to deconstruct itself and cause severe symptoms, which may be fatal.
The symptoms of endotoxin poisoning
When the bacteria endotoxin, which is a pyrogen, enters through a pharma drug into the bloodstream, it can cause irreversible symptoms and consequences to the human body. Some of the majorly noticed symptoms of endotoxin poisoning are as mentioned below:
The bacterial endotoxin has the ability to cause intense fevers, and therefore this would be the primary symptom of pyrogen poisoning in the bloodstream.
2. Organ failure
Another major symptom of high levels of bacterial endotoxin in blood work is the failure of kidney and lung functions if the dosage of the endotoxin is much higher.
Another major symptom is the coagulation of the intravascular system causing the inability to breathe and retrieve fresh oxygen resulting in severe breathlessness.
4. Septic Shock
Severe inflammation of the tissues and organs can lead to septic shock and can cause severe complications to the patient, often creating irreversible effects on the organs.
If the condition of the patient is delicate, then a combination of a high dose of bacterial endotoxin and the symptoms caused by it can sometimes lead to fatal results in a patient.
Bacterial endotoxin testing that detects a high level of pyrogens
Rabbit Pyrogen Test was the most used method to detect the presence of bacterial endotoxin. The fever-inducing property of the bacterial endotoxin was the key feature to be detected in this test. The test required the rabbits to be exposed to the sample, and if the rabbits recorded high temperatures, the test was positive. This test is no longer used due to its long-time consumption and inaccurate results.
LAL test (Limulus Amebocyte Lysate) is the most common method to detect higher amounts of bacterial endotoxin testing, which is derived from specialized blood cells of Horseshoe Crabs. This a more reliable test used widely by testing labs.