Physical and chemical environment, nutrients and culture containers are the three essential elements of cell culture. There are many factors affecting cell growth, among which whether the raw materials of cell factory contain components that are unfavorable to cell growth is also a very important aspect.

The United States Pharmacopeia Medical Materials classification is class 6, ranging from USP class I to USP class VI, with USP class VI being the highest grade. In accordance with the USP-NF general rules, plastics subjected to in vivo biological reaction tests will be classified into designated medical plastic grades. The purpose of the tests is to determine the biocompatibility of plastic products and their suitability for medical devices, implants and other systems.

The raw material of the cell factory is polystyrene and the API meets the USP Class VI standard. A plastic rated as the sixth medical plastic in the United States means that comprehensive and rigorous testing has been established. Us medical Materials Level 6 is now the gold standard for all types of medical-grade raw materials and a very high quality choice for medical device manufacturers. The test items included systemic toxicity test (mice), intradermal reaction test (rabbits) and implantation test (rabbits).

Only polystyrene raw materials tested to meet the requirements of USP class VI can be used in cell factory production. In addition, cell culture containers need to be produced in a C-class purification workshop, in line with ISO13485 quality management system requirements, strictly control product quality from the production process, to ensure the qualified rate of finished products.