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

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

2023-01-30

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

What is the Bacterial Endotoxin Detection Method?

What is the Bacterial Endotoxin Detection Method?

2023-02-01

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

The importance of bacterial endotoxin testing

The importance of bacterial endotoxin testing

2023-01-09

The bacterial endotoxin detection method is widely adopted by many national pharmacopoeias such as USP23, EP98, JP13, due to its high sensitivity, broad detection range, accurate results, and wide application. It is currently not limited to the pharmaceutical field but is also rapidly developing in various areas such as medicine, microbiology, clinical disease diagnosis, and food. 1. Application of bacterial endotoxin detection in the pharmaceutical field Bacterial endotoxin detection 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 fields. Especially with the continuous development of the pharmaceutical industry and many ongoing developments and research efforts, traditional methods like the rabbit pyrogen test can no longer meet the requirements for rapid testing. In these cases, quantitative detection of bacterial endotoxins is more appropriate. For example, certain colored drugs and traditional Chinese herbal injections in our country. At the same time, quantitative detection methods for bacterial endotoxins are also a major direction of international development. Currently abroad, it is common to use quantitative methods for bacterial endotoxins to control production stages and test final products.

What are the characteristics of sterile barrier system testing?

What are the characteristics of sterile barrier system testing?

2022-12-21

　　The manufacturer of sterile barrier system testing believes that the packaging design of sterile medical devices must go through a series of systematic steps. It is essential to select not only the correct compliant materials but also suitable packaging forms based on product characteristics. The appropriate packaging form can protect the product, facilitate access, or reasonably save costs for manufacturers. Strict sterilization of specific pathogens requires a complete packaging design plan, packaging validation plan, and a series of necessary packaging experimental plans to demonstrate that the packaging system is qualified for sterilization against specific pathogens. The manufacturer of sterile barrier system testing categorizes sterile barrier systems into three types: disposable sterile barrier systems; disposable or reusable packaging materials; and reusable sterile barrier systems. Among them, disposable sterile barrier systems achieve sterility through sealed packaging. The manufacturer believes that due to the pressure difference inside and outside the package during sterilization and transportation of medical devices, if the loaded instruments are too tight or if the sealing strength of the sterilization package is insufficient, it may lead to potential risks of leakage and rupture. This highlights the importance of sealing strength and sealing integrity at the edges. In practical applications, sealing (peel) strength tests and burst tests are typical sealing strength tests.

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