CS-Prep system consists of infusion section, injection section, test section, fraction collection section, control section and data processing section. The overall design of the equipment conforms to GMP, cGMP, FDA and other relevant regulatory requirements, and the integrated module design can achieve balance, sample loading, washing, elution, automatic collection, online cleaning (CIP) and other processes, stable and reliable, and can provide validation documents in accordance with GMP and other relevant regulatory requirements.
Comply with GMP, cGMP and FDA regulations
Key components are imported famous brands
System high precision, high stability
The control software is based on the secondary development of IFix software and meets the requirements of FDA 21CFR Part11
Based on the design and implementation process of GAMP5, complete GMP verification files and services are provided