What is the Bacterial Endotoxin Detection Method?

What is the Bacterial Endotoxin Detection Method?  Bacterial endotoxin test is used to determine whether the bacterial endotoxin in the sample meets the requirements. Endotoxin is a lipopolysaccharide of the cell wall of Gram-negative bacteria, and its toxic component is lipid A. Cells are released after death and disintegration. Bacterial endotoxin detection includes gel method and photometric method, the latter includes turbidimetric method and chromogenic matrix method. Any of these methods can be used to test the test article. In case of any dispute regarding the assay results, unless otherwise specified, the results of the gel method shall prevail. The types and proportions of bacteria in the body are normal, and the human body is in a state of dynamic balance. The pyrogens are mainly endotoxins released by bacteria. Pyrogen entering the body's blood circulation system can cause a series of adverse reactions such as fever. Therefore, the detection of pyrogens or bacterial endotoxins for injection is an important quality index to ensure injection safety. Abnormal results: In clinical practice, when a large amount of intravenous infusion is performed, due to the presence of pyrogens in the drug solution, the patient will experience symptoms such as chills, high fever, sweating, dizziness, and vomiting within 0.5-1h, and the body temperature can reach up to 40 ℃, severe cases even shock. When establishing a bacterial endotoxin detection method, when calculating the endotoxin limit L, MVD and MVC, it is necessary to pay attention to important parameters, such as human body use

2023-02-01

Bacterial Endotoxin Testing Company: Some Common Sense of Sterile Barrier System Testing

 Bacterial Endotoxin Testing Company believes that data review, cleanliness requirements, microbial contamination level monitoring and automated visual inspection requirements will continue to be the focus of attention in the field as developing countries place increasing emphasis on patient safety and the networking of medical care. Meanwhile, green initiatives will start in the field of medical device packaging as hospitals look to reduce waste. The recyclability of medical packaging materials has been put on the agenda, and a professional medical device material recycling association composed of several companies has also begun to operate. With the development of the times, the improvement of laws and regulations, and the advancement of engineering technology, it is safer and more reliable. Green and recyclable medical packaging materials can fully protect the health and safety of patients and medical workers. Bacterial endotoxin testing companies believe that the functions of sterile medical packaging mainly include: (1) Provide microbial barrier and physical protection (2) Must be suitable for sterilization. (3) Keep sterile and intact before use. (4) Easy to open and aseptic transfer. (5) Identify the product and clearly mark the information and warnings. The Bacterial Endotoxin Testing Company believes that for the sterile medical device manufacturing industry, commonly used sterilization packaging materials include porous materials (that is, breathable materials, such as paper and Tyvek) and air-impermeable materials (such as plastic

2023-01-30

The Importance of Bacterial Endotoxin Testing

    Bacterial endotoxin detection method has been adopted by many national pharmacopoeias such as USP23, EP98, JP13, etc. due to its high detection sensitivity, wide detection range, accurate results, and wide application. Medicine, microbiology, clinical disease diagnosis, food and other aspects are developing rapidly. 1. The application of bacterial endotoxin detection in the pharmaceutical field Bacterial endotoxin detection is mainly used in the control stage of the drug production process and the monitoring of bacterial endotoxin contamination in the final product (such as radiopharmaceuticals, parenteral drugs, injections, influenza vaccines, antibiotics, etc.). The Chinese Pharmacopoeia (2000 edition) loaded 69 kinds of medicines in total, and carried out endotoxin inspection. This is also one of the widely used fields. Especially with the continuous development of the pharmaceutical industry, many continuous development and research, the traditional heat source rabbit method can no longer meet the requirements of rapid detection. In these cases the use of quantitative bacterial endotoxins is more appropriate. For example, certain colored medicines and Chinese herbal injections in my country. At the same time, the quantitative detection method of bacterial endotoxin is also the main development direction in the world. At present, the use of bacterial endotoxin quantitative method in foreign countries is very common in the control stage of preparation production and the detection of final products, accounting for about 70%.

2023-01-09

How to perform bacterial endotoxin test

Bacterial endotoxin is a unique structure of Gram-negative bacilli in the outer layer of the cell wall. As an exogenous source of heat, endotoxin can neutralize cells, etc., release endogenous pyrogens, act on the thermoregulatory center, and induce heat. Bacterial endotoxin detection is the structure of the outer layer of the cell wall of Gram-negative bacilli. As an exogenous heat source, neutrophils, etc. release endogenous heat source substances, which act on the body temperature regulation center to generate heat. The main chemical component of bacterial endotoxin is lipopolysaccharide (LPS). Lipopolysaccharide contains three components: fat A, core polysaccharide and O antigen. Among them, fat A is a kind of saccharin, which is the toxic part of endotoxin and is closely related to dental disease. relevant. Existing widely in nature, it is mainly released when Gram-negative bacilli die or attach to other cells. For example, the amount of endotoxin contained in tap water is generally 1 ~ 100 EU/ml. Endotoxins can enter the body through the digestive tract without causing harm. Entering human or animal blood by injection etc. can cause other diseases or death. Therefore, it is particularly important to detect bacterial endotoxins such as medical devices, pharmaceuticals, dialysis fluids, and injection water. At present, the detection method of bacterial endotoxin is mainly based on the reagent detection method. According to the particularity of some drugs, they cannot

2022-12-30

What are the characteristics of sterile barrier system testing

Sterile barrier system testing manufacturers believe that the packaging design of sterile medical devices must go through a series of systematic steps, not only to choose the correct and compliant materials, but also to choose the appropriate packaging form according to product characteristics. The right form of packaging can protect the product, provide easy access, or justify cost savings for the manufacturer. Strict aseptic specific pathogenic bacteria clearance requires a complete packaging design scheme, packaging verification scheme and a series of necessary packaging experiment schemes to prove that the packaging system is qualified aseptic specific pathogenic bacteria clearance. Sterile barrier system test manufacturers believe that sterile barrier systems are mainly divided into three categories: disposable sterile barrier systems; disposable or reusable packaging materials; reusable sterile barrier systems. Among them, the disposable sterile barrier system realizes the sterile barrier function through sealed packaging. Sterile barrier system test manufacturers believe that due to the pressure difference between the inside and outside of the packaging during the sterilization and transportation of medical devices, if the loaded devices are too tight or the sealing strength of the sterile packaging is insufficient, it will lead to potential risks of leakage and bursting, which fully reflects the The importance of edge seal strength and seal integrity. In practical applications, sealing (peeling) strength test and burst test are typical sealing strength tests. In the seal strength test,

2022-12-21

Some knowledge points of sterile barrier system testing

Sterile barrier system test manufacturers believe that the sterile barrier system has the function of blocking microorganisms from sterile medical devices under specific conditions. Typically, packaging on the inside that comes into contact with the product is used to sterilize specific pathogens for sterile medical devices. The types of sterile barrier systems include: disposable sterile barrier systems, which achieve sterile barrier function through sealed packaging; or single-use reusable packaging materials, which achieve sterile barrier function through airtight packaging; reusable sterile barrier The system can achieve sterile barrier function through valves or filter assemblies. Sterile barrier system testing manufacturers believe that since medical devices are sterilized after packaging, the packaging material and/or system should be able to withstand the sterilization process and meet the conditions required for sterilization in packaging. For sterile medical device manufacturers, the design and material selection of sterile packaging should take into account the specific characteristics, intended use, validity period, transportation and storage conditions of the medical device, and should be compatible with the sterilization process to meet the requirements of sterilization, packaging content Basic requirements for material protection and sterilization medium discharge. Sterile barrier system test manufacturers believe that the basic requirements of aseptic packaging mainly include the following aspects: (1) The integrity of the packaging. Including seal integrity and seal integrity; (2) Stability of packaging materials. keep packing material

2022-12-12