Cell growth has strict requirements on environment, temperature, PH value, etc., and the quality of cell consumables used in cell culture will also affect cell growth. Cell factory is a commonly used consumable for adherent cell culture, and its quality is mainly affected by four factors.
1, the production of raw materials: high quality raw material is the basis of high quality products, the cell factory raw material for polystyrene (PS), and must conform to the requirements of the USP Class VI level, word is testing the plastic material in the medical field and pipeline products in biomedical applications of more rigorous testing, is in accordance with the specification of non-clinical laboratory studies.
2, production environment: cells are particularly sensitive to the growth environment, so it is required that the consumables must not contain endotoxin and other harmful substances to cells, which puts forward higher requirements for the production environment. The consumables shall be produced in a dedicated ten thousand clean room, and shall undergo rigorous verification (detection of plankton, sedimentation bacteria and suspended particles). Quality management shall be carried out in accordance with GMP workshop to ensure the stability of the production environment.
3, production process control: this refers to the product in the production process of each link including, such as injection parameters, injection temperature, etc., which will affect the quality of the finished product.
4, quality inspection: quality inspection is an important process after the completion of cell factory production, the items to be tested include sealing, biological safety, physical and chemical safety, product validity verification, surface hydrophilicity, etc., through these tests to determine whether the products meet the quality standards.
The factors that affect the quality of cell factories mainly include the above four aspects. Only by controlling these factors well can we produce high-quality products and thus provide a good environment for cell growth.
Post time: Jul-20-2022