一次性自动超滤系统

Single-Use Automated Ultrafiltration System

A single-use automated ultrafiltration system is primarily composed of a single-use storage/feeding unit, single-use tubing assembly, single-use instrumentation (such as pressure sensors), pump heads, and a central control unit. It is designed to meet diverse functional requirements for various products and offers options for multiple instrument configurations and customized designs.

This system is suitable for products at laboratory, pilot, and production scales, including those that are toxic, have high product value, or are difficult to clean and validate. It is compatible with membrane cassettes or hollow fiber products from leading brands in the global market.

Typical Applications

Application Fields: Antibodies, blood products, vaccines, recombinant proteins, liposomes, small molecules (e.g., insulin, peptides, polysaccharides, monosaccharides), novel therapies (e.g., plasmids, viral vectors), traditional Chinese medicine injections, chemical drugs.
Concentration: Concentration of biological macromolecules.
Diafiltration: Buffer exchange, desalting, de-alcoholization.
Molecular Weight Cut-off (MWCO): Small molecules pass through the membrane, while large molecules are retained.
Endotoxin Removal: Product passes through the membrane, while pyrogens are retained.

Product Advantages

• Extremely low hold-up volume, enabling maximum product recovery.

• Automatic control of Transmembrane Pressure (TMP) and Differential Pressure (DP).

• Recipe-based management for flexible operation.

• Control system compliant with GAMP 5 and 21 CFR Part 11.

• Simple user interface with a stable control system.

• Compact design with a small footprint.

• Modular design, allowing the equipment to be fixed or freely moved.

• Customizable multifunctional design.

• Optional integration for online monitoring of pH, conductivity, UV, etc.

Technical Specifications

• Feed and retentate lines use Dow Corning brand silicone or braided tubing; permeate lines use 316L stainless steel tubing.

• Single-use instruments include Pendotech brand pressure sensors, temperature sensors, conductivity sensors, and rotor flow meters.

• Single-use Quattroflow brand PP pump heads for the quad-piston diaphragm pump.

• Power requirements: 220 VAC or 380 VAC, 50 Hz.

• Software functions include: user rights management, audit trail, data storage/backup, electronic signature, alarms, recipe management, domain control management, batch reporting, etc.

Technical Parameters Table

一次性自动超滤系统

一次性自动超滤系统主要由一次性储配液单元、一次性管路单元、一次性仪表及泵头等部件及控制单元组成。可满足不同产品的多种功能性需求，同时还可以提供多种仪表的选配及定制化设计。

一次性自动超滤系统适用于实验室、中小试及生产规模的产品，包含有毒、产品附加值比较高或不容易清洁验证的产品。同时，系统可搭配国内外主流市场品牌的膜包或中空纤维产品配套使用。

典型应用

应用领域：抗体、血液制品、疫苗、重组蛋白、脂质体、小分子（胰岛素，多肽，多糖，单糖等）、新型治疗（质粒，病毒载体等）、中药注射剂、化药。

浓缩：生物大分子浓缩

透析：洗滤、脱盐、脱醇、缓冲液置换

分子量切割：小分子透过膜，大分子被截留

除内毒素：产品透过膜，热源被截留

产品优势

极低的滞留量，可实现最大的产品回收率

跨膜压TMP/压差DP的自动控制

配方式管理，操作比较灵活

控制系统满足GAMP5，21CFR PART11   

操作界面简单，控制系统稳定

设计紧凑，占用空间小

模块化设计，设备可固定或自由移动

定制化多功能设计

可选配在线监测pH、电导率、UV等

技术参数

进液和回流管路采用道康宁品牌的硅胶或编织管，透过端采用316L材质的不锈钢管一次性仪表选用Pendotech品牌的压力传感器、温度传感器、电导率、转子流量计

一次性四元柱塞隔膜泵采用Quattroflow 品牌PP材质的泵头

电源需求为220VAC或380VAC，50Hz

软件功能包含权限管理、审计追踪、数据存储备份、电子签名、报警、配方管理、域控管理、批报表‍等

技术参数