Centrifugal partition chromatography system GMP rCPC

processfor pharmaceutical applicationslaboratory

The GMP rCPC is RotaChrom’s liquid-liquid centrifugal partition chromatography (CPC) platform, designed to adhere to GMP regulations. The GMP rCPC platform was designed 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 continuous-batch production. To accommodate a user-friendly operation, RotaChrom offers a turn-key solution package for semi-automated solvent handling (preparation and recovery) upon request. GMP rCPC can be utilized as an at-line purification platform besides our industrial-scale purification unit. This means your separation needs can be executed in an orthogonal manner. A category of its own, the GMP rCPC offers outstanding throughput, purity and yield, and does all that while remaining cost-efficiency. The GMP rCPC platform can be used for API-grade compound production and pilot-scale purification and research tasks in a pharmaceutical environment. It is possible to collect up to 9 COI fractions and 1 Impurity fraction. The GMP rCPC comes with material certification and traceability for all parts of the equipment: • The platform is designed and qualified according to Eudralex Vol. 4. • All wetted stainless-steel components conform to AISI 316L SS with EN 10204 3.1. material certificates. • Inner surface roughness is Ra≤0,8 µm. • All other wetted components come with FDA 21 CFR 177.2600 certificates, which is a must for pharmaceutical production. The GMP rCPC comes with a software solution with qualification and testing documents available that are designed for FDA 21 CFR part 11 and GAMP 5 compliance.