Sterilizing filtration validation is the process of removing all microorganisms, excluding viruses, from a fluid stream. A sterilizing filter must remove all microorganisms present in a fluid stream without adversely affecting product quality. The sterilization filter needs to pass the challenge test of 1×107cfu/cm2 microbial load to evaluate its retention capacity, and the filter integrity needs to be evaluated after the challenge test.

Package integrity, also known as container-closure integrity, is the ability of a package to prevent product loss, to block microorganism ingress, and to limit entry of detrimental gases or other substances, thus ensuring that the product meets all necessary safety and quality standards. Our integrity service platform is the first comprehensive innovation research platform established in China. With the most advanced detection technology, top scientific research team and rich domestic and international application experiences, we provide integrated services including positive control preparation, methodology development and validation (on-line and off-line), sample detection, integrity assessment, etc. as well as online guidance, technical training and other technical output services. Our services run through all phases of the product life cycle (packaging selection, process validation, commercial manufacturing and stability study) ensuring that the product meets all necessary safety and quality standards.

Interactions between a material and the pharmaceutical product it contacts are well documented. These interactions involve the transfer of substances between the material and the pharmaceutical product and include sorption (binding), the transfer of product components (such as the active ingredient) into the material, or leaching, the transfer of material components (such as plastic additives) into the pharmaceutical product. Compatibility research is a process of establishing extractable and leachable profiles and gathering sorption information to perform scientific assessment on the risk of drug quality and safety.

We have the leading technical level in the field of compatibility research and have assisted our customers to obtain more than 100 drug production licenses and IND licenses.

The compatibility research involves packaging systems (vials, ampoules, prefilled syringes, cartridges, etc.), manufacturing systems (silicone tube, stainless steel tank for liquid preparations and storage bag for bio-products) and delivery systems (disposable syringes, infusion sets, atomizers, etc.).

According to Pharmacopoeia of the People's Republic of China (2020 edition), we should build a comprehensive drug testing capability, pay attention to the safety of medicinal raw and auxiliary materials, and provide standard testing services for raw materials and auxiliary materials.

The Medical Device Division strives to provide services for biocompatibility, chemical characterization (leachables study) preclinical large animal experimental research, physico-chemical properties testing and microbial test of implantation and outer communication products classified as category II and III. It is complied with global regulations implementation of GLP quality system of OECD, FDA, NMPA and ISO.

Conduct human clinical tests according to the usage and efficacy of products