All the systems are customized and configured according to the customer’s needs and utilize the same software as non-disposable CIP/SIP down-stream equipment (complies with the requirements of FDA 21 CFR Part 11).

The pump heads, valves, probes (flow meters, pH, conductivity and UV detectors), tubing and other liquid contact components of single-use down-stream equipment are constructed as disposable replaceable parts, the “flow-path lines” are packaged aseptically in advance and installed directly after unpacking prior to use. 

Single-use design eliminates the needs of system cleaning between different batches and products and subsequent after-CIP validation; minimizes risk of cross-contamination; reduces facility area, production cycle time and cost; improves consistency and productivity for smaller scale facilities.

Hanbon provides FDA and USP VI certificates for non stainless steel materials in contact with the material liquid.

Main features are:

• Imported Schott finished glass tube, easy to seal, high strength;
• Easy to Operate: The side sliding design of the column head eliminates the need for manual handling;
• Convenient Replacement: The sieve plate can be directly replaced at the bottom without disassembling the column barrel;
• Original Sealing Form: Original and highly reliable column head sealing form, manual sealing or automatic sealing; 
• Highly Capable: Reliable, convenient and safe operation
• Excellent Performance: The flow path has no dead zone design and excellent cleaning and verification performance; 
• Certified: The liquid receiving material is made of EU and US origin materials, totally complying with USP Class VI and FDA standards; 
• Documents & Services: Producer provides complete GMP verification documents and services.

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.

All the models meet the GLP/GMP requirements, validation documentation (DQ/IQ/OQ) is providing with each system by default. Bio-Lab software conforms to GLP/GMP and FDA 21CFR Part11 requirements.

All the devices are configured according to the customer’s requirements basing on 4 main platforms: Bio-Lab 30 / 100 / 300 / 600.

reducing the risks caused by large differences between batches in the production process. ACC series of automatic chromatographic columns are suitable for most types of chromatographic resins and corresponding column loading methods in the biopharmaceutical industry, and meet the production requirements of diversified products.

Main features are:

• All the models are equipped with automatic column loading workstation, providing fully automatic column loading, unloading, cleaning, easy and convenient maintenance;
• Key components adopt international first-class brands;
• The upper and lower limits of the chromatographic column are protected by software, photoelectric sensors, and machinery to ensure the safety of equipment and personnel;
• Patented piston sealing design, better sealing performance;
• Patent piston exhaust structure design, convenient and fast exhaust;
• Hi-tech distributor structure design ensures uniform distribution of material and liquid;
• High precision servo motor drive, high operating accuracy;
• The hygiene grade design has no dead volume, and the liquid receiving materials comply with relevant pharmaceutical regulations such as USP VI or FDA;
• The column operation and control software meets the requirements of FDA 21 CFR Part 11 and meets the requirements for remote backup and storage of data.