Packing Media Life Verifier Tester

In recent years, Sepfocus's Vscreening has been widely used in the life validation of downstream purification packings/media such as insulin analogs, somatostatin, liraglutide, etc. The Vscreening has been widely used in the production of biopharmaceuticals. Chromatographic packing/chromatography media are generally used in the final refining step of API in the production of biopharmaceuticals, which is a key raw material. In the 2015 edition of the Chinese Pharmacopoeia, the third part of "Quality Control Regulations for Raw Materials and Excipients Used in the Manufacture of Biological Products", chromatography packing is categorized as a Class 3 medium-risk raw material, which needs to be subjected to corresponding quality control. For insulin and GLP-1, as well as analogs, CDE requires manufacturers to provide filler life data prior to commercialization of their products. Reuse of fillers can significantly reduce manufacturing process costs, but at the same time the performance of fillers decreases as the number of times they are reused increases. Therefore, a rigorous and scientific definition of the lifetime of chromatography packings is also required from the point of view of process cost and process performance. A reduced model of the preparation of the chromatography step is able to fully reflect the performance of the commercial production process. Purification process validation includes the determination of working conditions and chromatographic parameters such as sample loading of the chromatographic column, cleaning and regeneration of the column. The purification department should specify the life cycle (number of runs and months of use) for each type of column, and the chromatographic packing also has a shelf life (typically 5 years) to ensure that the chromatographic packing is not used beyond its expiration date. For chromatography columns in the purification process, ensure that the plant has in-line cleaning and regeneration as well as storage protocols for axial compression columns and chromatography packing, and that standard operations are performed in accordance with the protocols. Model reduction is accomplished by reducing the column diameter and sample loading volume, maintaining column height, linear flow rate, gradient and sample loading volume. Volumetric flow rates and sample volumes are linearly reduced, and column preparation and buffer composition remain consistent with commercial production. The Safanco Vscreening Liquid Phase System with DAC30 allows for automated sample loading, fraction collection, and other fully automated labor-reducing, regulatory-compliant software. Consult with your Savantech product manager for detailed documentation and procedures.