● Intelligent System-Data Management/Control System

Integrated intelligent control.Data management system designed with reference to 21CFR11 and GMP requirements.Realtime recording of workflow to meet GMP data integrity requirements.

● Full Compliance

Provide complete equipment manufacturing,validation documentation and implementation services to meet GAMP5 and GMP regulatory requirements for validation.

● Sterility Assurance

Integrated dry hydrogenperoxide sterilization,sterility assurance value SAL≤10-6

● Biological Assurance

Leakage rate of the chamber is less than 0.5%Vol/h at 2 times the working pressure,complying with PDA TR34 standard.

● Rapid residue removal

The patented technology of rapid debris removal rapidly removes hydrogen peroxide inside the chamber and improves the utilization efficiency of the equipment.

● Customized Configuration-Multi-module Combination of Chambers

Internal multifunctional interface is reserved,which can be configured with bacteria collector and other types of detection systems and other operating equipment such as centrifuges and incubators;it can realize the free arrangement and combination of multiple module modules to complete the operation,testing and other combined functions.