Microbiological detection is the key link to drug quality control. Microbial contamination of pharmaceutical products may lead to a reduction in the active ingredient activity of the drug, affecting its safety and effectiveness.
Our company has experienced R & D personnel, and we have established long-term friendly collaborations with many pharmaceutical enterprises and research institutes. We have a full range of testing capabilities for drugs, pharmaceutical packaging materials and pharmaceutical excipients, and a wide range of drug index methods development and verification capabilities. We can provide one-stop services for drug analysis and testing, drug consistency evaluation and other work.
Our Services
Microbiological detection is an essential part of drug quality assurance. Our company helps customers reduce R&D costs and risks through our industry-leading testing platform. We provide microbiological testing services for pharmaceutical products, including method development, method validation and sample testing.
We determine the type and acceptable criteria for microbial testing based on the nature of the substance, the mode of production and the intended use of the product. Our microbiological tests are carried out according to many different pharmacopoeia methods listed by regulatory bodies around the world, and the reports produced are fully qualified and legally binding.
Microbiological detection is crucial to drug quality assurance. Our company helps customers reduce R&D costs and risks through our industry-leading testing platform. We provide microbiological testing services for pharmaceutical products, including method development, method validation and sample testing. We determine the type and acceptable criteria for microbial testing based on the nature of the substance, the mode of production and the intended use of the product. Our microbiological tests are carried out according to many different pharmacopoeia methods listed by regulatory bodies around the globe, and the reports produced are fully qualified and legally binding.
Microbial limit
Microbial limit test method refers to the method of checking the degree of microbial contamination of non-specified sterilization preparations and their raw materials and auxiliary materials. In general, preparations are to be tested unless all raw materials have been tested prior to manufacture and it has been verified that they will no longer be contaminated by microorganisms or that microorganisms will not proliferate during production. The content of drug microbial limit tests generally includes a sterility test, microbial limit test, microbial total number test, and control bacteria test.
We provide methods for counting bacteria, molds and yeasts, as well as the development and validation of bacterial control methods. We can accurately detect bacteria, mold and yeast counts, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella.
Bacterial endotoxin
Bacterial endotoxin is one of the components of Gram-negative bacteria's cell wall, and its chemical essence is lipopolysaccharides. Bacterial endotoxin is characterized by heat resistance, heat resistance and high thermogenesis. The bacterial endotoxin detection method uses a limulus reagent to detect or quantify bacterial endotoxin produced by Gram-negative bacteria to determine whether the test product meets the regulatory limit for bacterial endotoxin. Limulus testing is the most sensitive and specific method of detecting endotoxins.
The methods for detecting bacterial endotoxins include the gel method and photometry. We can use any of these methods to perform bacterial endotoxin tests. We provide the development and validation of bacterial endotoxin tests for pharmaceutical products (limulus sensitivity, interference test validation), and sample testing services.
Bacteriostatic effect
Bacteriostatics are chemicals that inhibit microbial growth, sometimes called preservatives. The bacteriostatic efficacy test method is used to determine the antibacterial activity of sterile and non-sterile preparations, and to guide manufacturers to determine the concentration of antibacterial agents in the preparation of research and development stages.
We provide the development and validation of testing methods for the antimicrobial efficacy of drugs. Our antibacterial efficacy testing services cover Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus Niger.
Microbiological Detection Objects
- API
- Pharmaceutical excipients
- Various preparations (including tablets, capsules, injections, granules, plasters, etc.)
