The Technology & the rCPC Design Process and GMP Qualification Cleaning Validation and Cleaning Method Software Design Standards Material Traceability and Certificates Unmet Needs and Current Industry Approach Proposed Added Valu

Research & Production CPC Platform with GMP-compliant design. RotaChrom engineers designed the rCPC platform for pilot-scale purification tasks within a laboratory environment. It is ideal for all batch sizes, smaller or larger, or campaign type of research work, and continuousbatch production. Centrifugal partition chromatography (CPC) is a liquidliquid chromatographic technique, in which separation occurs between two immiscible liquid phases. Both the mobile and stationary phases are liquids, and the liquid stationary phase is immobilized by a strong centrifugal force. The solute’s retention...

Software Design Standards Unmet Needs and Current Industry Approach The rCPC comes with a software solution with qualification and testing documents available that are designed for : • FDA 21 CFR part 11 • GAMP 5 and Eudralex Volume 4., Annex 11 compliance. Security and Acces Levels The software offers several features which allow its personnel to define security and access levels for all users. This means certain features are tied to specified security-levels that can only be accessed by those who meet the defined security requirements. Audit Trail and Backup GMP regulations are strict and require...

Applications Isolation of an Antibiotic Oligopeptide (Cyclosporine A) Active Pharmaceutical Ingredient (API): Cyclosporine A (CsA) Goal: Purification Cyclosporine A is a cyclic oligopeptide, with a lipid side-chain. It is produced by fermentation. The result of fermentation is usually a mixture of products with closely related structural properties. These are usually purified by classical purification methods: a combination of crystallization and preparative HPLC. To avoid costly two-step purification methods, RotaChrom developed a CPC solution which can produce pure Cyclosporin in 15 minutes on...