The importance of bacterial endotoxin testing
23-01-09 14:59
The bacterial endotoxin testing method is widely adopted by many national pharmacopoeias such as USP23, EP98, JP13, due to its high sensitivity, wide detection range, accurate results, and broad application. It is currently not limited to the pharmaceutical field and has rapidly developed in various aspects such as medicine, microbiology, clinical disease diagnosis, and food.
1. Application of bacterial endotoxin testing in the pharmaceutical field
Bacterial endotoxin testing is mainly applied in the control phase and monitoring of bacterial endotoxin contamination in final products during drug production (such as radiopharmaceuticals, non-enteral drugs, injectables, influenza vaccines, antibiotics, etc.). The Chinese Pharmacopoeia (2000 edition) includes 69 types of drugs that have undergone endotoxin testing. This is also one of the widely used areas. Especially with the continuous development of the pharmaceutical industry and many ongoing developments and research efforts, traditional methods like the pyrogen rabbit test can no longer meet the requirements for rapid detection. In these cases, quantitative bacterial endotoxin testing is more suitable. For example, certain colored drugs and traditional Chinese herbal injections in our country. At present, quantitative bacterial endotoxin testing is also a major development direction internationally. Currently abroad, it is common to use quantitative bacterial endotoxin methods for controlling production stages and final product testing in formulations, accounting for over 70%.
2. Application of bacterial endotoxin testing in medical devices
Medical tools refer to disposable infusion and blood transfusion tools used for medical purposes, artificial organs, and sterile products used within the body. Among these tools, external contamination by endotoxins has received attention both domestically and internationally, especially in the examination of endotoxins in infusion tools and blood transfusion equipment. Previously, monitoring for pyrogenic substances in these tools generally relied on traditional pyrogen rabbit methods; however due to time constraints, effort required and interference factors leading to poor reproducibility of measurement results that do not meet practical inspection requirements have led to their decreased usage. Currently both domestically and internationally rapid checks are being conducted using bacterial endotoxin testing methods.
3. Application of bacterial endotoxin testing in water and food
When drinking water and food are contaminated with endotoxins it can cause various adverse reactions in the body; severe cases may lead to physiological malignancies within the body. Therefore effective prevention and monitoring of pollutants in drinking water sources and food are crucial.
4. Application of bacterial endotoxin testing in environmental monitoring
The impact of endotoxin levels in indoor air on lung diseases has increasingly attracted attention; currently researchers from some European countries have begun research work in this area and have gained some experience. Additionally, measuring endotoxins in marine environments has also received increasing attention.
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