Pyrogens are agents produced by bacteria, molds, viruses, and yeasts, which are known for causing fever and fever-related illnesses (Yaman, 23). Pyrogens tend to cause fevers by causing unprecedented rises in body temperature, which then leads to fever. This is usually a response by the body when fighting against an infectious disease. Pyrogens are thus produced, where they travel to the brain and disturb the hypothalamus which regulates temperature(pg. 24).
Since pyrogens are harmful when they are injected into human bodies, they have to be minimized. The process of removing pyrogens in pharmaceuticals is called depyrogenation. It is usually difficult to carry out, because of the high changeability of the molecular weight. A number of factors are considered during depyrogenation: pyrogens are thermally stable as well as insensitive to changes in pH (Sandle). Thus, here are three depyrogenation measures based on the nature of pyrogens
Chromatography (Ion exchange): The anion exchanger is filled with negatively charged endotoxins. The target substance is then passed through the exchanger. If the target chemical or pharmaceutical does not contain negative charges, the column simply allows it to go through and separation is done effectively. In the same way, cation exchange can be used, where the solution is charged positively (Yaman, 32).
Ultra-filtration: Since endotoxins usually have a high molecular weight, ultra-filtration performs a separation based on the size. This process, however, is useful in separating endotoxins more than 300,000 Da since there exists a high variability of endotoxins size. Thus, it is usually difficult to select the correct membrane (Yaman, 36).
Distillation: Distillation is based on heat stability as well as the molecular weight of endotoxins. Solvents whose molecular weight is low are simply purified through boiling, after which the resultant condensed vapor is collected in a vessel free of endotoxins. The large molecules are not easily vaporized. Thus, they are left in the container (Yaman, 44).
The above three methods are all useful in eliminating or minimizing pyrogens in order to prevent harmful effects on the human body. Furthermore, the design of the facility must be built according to the set standards. The airlocks and rooms in the areas of processing should be validated using an HVAC test. Besides, the WFI systems must be monitored continuously to ensure that they are qualified at all times (Vincent 240). Furthermore, equipment like pipes should be thoroughly confirmed, while the sample products should be taken to authenticate the actual pharmaceutical so as to ensure that no abnormal changes occur. Finally, the final products of drug injections should be kept in large bags at very low temperatures in order to maintain the nature of the solution (Vincent 255).
Works cited
Sandle, Tim. "A Comparative Study of Different Methods for Endotoxin Destruction".Americanpharmaceuticalreview.com.N.p., 2016. Web. 15 Apr. 2016.
Yaman, A. “Engineering Considerations in sterile powder processes”. RW Johnson Pharmaceutical Research Institute.,Print.
Vincent, W. “Design, Construction, Commission, and Qualification of Critical Utility Systems”. Journal of Validation of Technology. 2005. Print. 16 Apr 2016.
