Bio-Pro Auto Chromatography System
Bio-Pro automatic chromatography system is suitable for the pilot and large-scale production in purification process of biopharmaceuticals. The system is designed according to the related requirements of ASME BPE and GMP, and the integrated module design can be configured according to the specific requirements of customers. The system conducts balance, sample, washing, elution, automatic collection, online cleaning (CIP) process and other technological process through manual or automatic, which is stable and reliable. The development, design and production process of Bio-Pro automatic chromatography system are conducted with strict verification, which can provide customers with a full set of validation documents complying with the requirements of GMP, including DQ\IQ\OQ, etc.
l The system complies with requirements of GMP and strictly meets ASME BPE standard
l Key parts of the system are famous brands imported, stable and reliable
l Pipeline design adopts ASME BPE standard and inner wall is electrolytic polished with automatic welding, Ra 0.4um.
l The receiving material conforms to USP Class VI and FDA standards
l System control software, secondary development based on GE ifixes software , comply with the requirements of FDA 21 CFR Part11
l Comprehensive files and services are provided for GMP verification
l It can monitor all operating parameters and set four alarm levels, such as pressure, bubble, etc
l It has good interface and easy operation to realize various functions
l It has multi-mode operation, including debugging mode, manual mode, automatic mode
l It has functions of electronic signature and electronic records, in line with the GMP and FDA 21 CFR Part11 regulations
l It has function of multi-level user rights management, with the system divided into four-level user rights
l It has multi-task hyper-thread data processing, with quick system response and processing
l It has complete audit trace function and perfect data operation log