1. Nominal volume: 50L~2.5KL

2. Height to diameter ratio: Standard disposable reaction bag (adjustable according to user needs)

3. Application field: Suitable for various cell cultures, mammalian cell cultures, antibody drug seed amplification, and vaccines, single batch continuous cultivation

4. Mixing form: upward oblique mechanical stirring&downward magnetic stirring

5. Control scope: Industrial Siemens PLC controller is adopted, and the software adopts WICC and configuration software, which can achieve centralized control of single and multiple units. Control data can be stored and remotely controlled, and web publishing function can be achieved for remote monitoring; Control points: stirring speed, pressure, liquid level, temperature, pH, DO, weighing, flow rate, etc., which can achieve independent control and chain related control

6. Verification: The GMP document provides 4Q+2T, and the computer complies with cGMP, 21CFR PART11, and GAMP regulatory requirements

ØConvenient installation and operation, saving space

Ø No need for cleaning, one control of multiple devices, high plug and play efficiency, strong interchangeability, and saving production turnover time

Ø Addressing the risk of cross contamination of products

Ø The mixing blade has no bearings and a shaft seal to avoid the risk of bacterial contamination caused by shaft seal failure

Ø Diversified mixing options for oblique insertion and bottom magnetic stirring

Ø Convenient liquid discharge without dead corners for easy emptying

Ø High safety: NxFlex with unique formula ™  F4000D1 Film film material, with over ten years of customer experience, has reliable biological stability and excellent mechanical processing performance, ensuring the safety and validation of materials for liquid preparation and cell culture

Ø Traceability: ISO Class 7 (10000 level) production environment that complies with GMP, ISO quality management system, 100% lamp inspection and integrity testing, supplemented by a comprehensive document system to ensure uniformity and reliable quality of each batch of culture bags

Ø Automation: Setting up a PLC to achieve automatic control effectively ensures the recording, control, and traceability of your cultivation data

Ø Informatization: Standard ProfiNET network interface, seamless integration with SCADA, LIMS/MES and other information software

Ø Compliance: The cultivation bag provides various quality documents that comply with USP, the control system complies with the requirements of 21CFR PART11 electronic signature and audit tracking, and can provide CSV computer system verification services based on GAMP5

Multi purpose: suitable for seed cultivation of monoclonal antibodies, virus preparation of vaccines, and cultivation of adherent cells such as 293T