Bio-Pro chromatography systems are suitable for pilot and large-scale production of biopharmaceutical purification processes. The system is designed with integrated modules according to ASME BPE and GMP requirements, and can be configured in various ways according to customer specific requirements. The systems can manually or automatically achieve processes such as balancing, sampling, rinsing, elution, automatic collection, clean in place.
All the devices come with verification documents that comply with GMP regulations.
Main features are:
- Key components of the system adopt internationally renowned brands, which are stable and reliable;
- The pipeline design adopts ASME BPE standard, with inner wall electric polishing, Ra ≤ 0.4um, and automatic welding;
- Provide FDA or USP Class VI material certification for non-stainless steel materials in contact with the sample;
- All stainless steel materials in contact with the sample have a serial number, serial number/furnace number to ensure traceability;
- The instrument adopts digital communication to overcome the problems caused by analog signals;
- HMI adopts self-developed software on the C # platform, which meets the requirements of FDA 21 CFR Part 11;
- Using a database to store data and having mature and reliable solutions to interface with various DCS systems;
- Provide complete GMP verification documents and services;
- Can achieve double-column position series-parallel connection.
