南宫NG28

Microbial Limit Check

Microbial limit is used to check the degree of microbial contamination of non-sterile products, their raw and auxiliary materials, and pharmaceutical packaging materials, and whether the limit requirements are met.
CTI provides method suitability (method validation) and testing services for total aerobic count, total mold and yeast count, and control organisms check according to the requirements of the Chinese Pharmacopoeia, the U.S. Pharmacopoeia, the European Pharmacopoeia, and other national pharmacopoeias.

Sterility Test

Sterility testing is a method used to check the sterility of sterile drugs, biological products, medical devices, raw materials, excipients and other species.
CTI offers method suitability and testing services for sterility testing in accordance with the pharmacopoeias of various countries.

Bioburden

Bioburden refers to the total number of microorganisms surviving on medical devices, semi-finished products and packaging. Bioburden is used to assess the degree of microbial contamination of products before sterilization.
CTI can develop test programs according to the needs of product characteristics and provide method applicability and testing services for bioburden.

Bacterial Endotoxin Test

Gram-negative bacteria can release endotoxin after death or autolysis, which can act on the thermoregulatory center to cause a feverish response. Bacterial endotoxin assay is used to detect the presence of this type of toxin in samples.
CTI provides method validation and testing services for endotoxin gel method, dynamic turbidimetric method and dynamic colorimetric method.

Bacteriostatic Efficacy ChecK

Bacteriostatic agents are substances that inhibit the growth of microorganisms. Bacteriostatic potency testing is used to determine the bacteriostatic ability of sterile and non-sterile preparations, and is used to guide the determination of the type and concentration of bacteriostatic agents in the preparation during the R&D stage of the product.
CTI provides bacteriostatic potency test neutralizer validation and testing services.

Culture Medium Quality Control Test

Culture medium is the basis of microbiological test, which directly affects the results of microbiological test, and the quality of culture medium can be assessed whether it meets the requirements of relevant regulations through the quality control test of culture medium.
CTI provides testing services for culture medium pH value, suitability check and sensitivity check.

Package Seal Study (Microbial Challenge Method)

The sealing integrity of sterile pharmaceutical packaging containers is an important quality attribute of the pharmaceutical packaging system, and its quality monitoring runs through the entire life cycle of pharmaceutical production.
CTI has research experience in a variety of rigid and flexible packaging materials, including glass ampoules, glass infusion bottles, polypropylene infusion bottles, non-PVC soft bags, prefilled injections, etc. We provide microbial challenge testing services and can design complete research plans, complete research experiments, and conduct correlation analysis of the results according to different product needs.

Disinfectant Validation

Disinfectant is a medium used to kill microorganisms. It is used for daily cleaning of clean areas and is an important means to ensure a clean environment. Disinfectant verification is used to check the ability of disinfectants to kill microorganisms on carrier surfaces (such as stainless steel, color steel plates, PVC, etc.) and to confirm the disinfection effectiveness of disinfectants.
CTI provides testing services for disinfectant quantitative killing experiments, carrier surface disinfection effect verification, and disinfectant validity period verification. Disinfectant verification solutions can be customized according to customer needs.

Microbiological Testing

he evaluation of microorganisms on medical devices, semi-finished products or packaging includes two aspects: the evaluation of the number of viable microorganisms and the evaluation of microbial characterization. Microbial characterization is necessary to discover changes in the microbiome of the product, which may affect the establishment of the sterilization process. Microbial testing includes aspects such as colony cell morphology, population morphology, biochemical properties and gene sequence.
CTI provides testing services such as microbial morphology, biochemical testing and DNA feature sequence testing.