Microbiological Test

Medicilon has established a complete microbiological testing platform, and its microbiology laboratory complies with the GMP management system recognized by China, the United States and other countries. Environmental cleanliness and other items are in compliance with relevant regulatory requirements. The ultra-clean workbench, biological safety cabinet, incubator and other equipment involved in the test have been certified by 3Q and regularly maintained and calibrated to ensure the reliability, accuracy and authenticity of the data.

Medicilon can not only provide good microbiological research references for project research and development, but also develop new microbiological research businesses, provide customers with more personalized microbiological research services, and meet various customer needs, such as providing customers with raw materials method development, validation and detection of microorganisms and bacterial endotoxins in drugs and different types of preparations.

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Bacterial Endotoxin Test

Medicilon can provide clients with method development, validation and testing of microorganisms and bacterial endotoxins for APIs and different types of drug products. Bacterial endotoxins are cell wall components of gram-negative bacteria that are released when the bacteria die or autolyse. Its lipopolysaccharide (LPS) amphoteric macromolecule component is highly thermogenic. When endotoxin enters the human blood through injection or other methods, it can cause different diseases. In severe cases, it can cause shock or even death (pyrogen reaction). Therefore, pharmaceutical companies need to control bacterial endotoxins in all aspects including raw materials, packaging materials, original solutions, semi-finished products and finished products. The bacterial endotoxin test (BET) is a method that uses lysate reagent to detect or quantify bacterial endotoxins to determine whether the limit of bacterial endotoxins in the test product meets the regulations. Including gel method (limit test, semi-quantitative test), photometric method (turbidity method, chromogenic matrix method), any one of these methods can be used for testing. When the measurement results are controversial, the results of the gel method shall prevail unless otherwise specified. Medicilon has established a mature process for endotoxin testing and has completed endotoxin testing, method development and validation for hundreds of new drugs and generic drugs worldwide. The project cycle is short, fast and accurate, and it is widely praised by clients.

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