Sterility Test Isolator

Introduction

Sterility Test Isolator is mainly used for the protection of key processes such as aseptic testing, aseptic product dispensing, etc. It is a man-machine separation purification equipment that meets the requirements of Class A environment. It can reduce the background environmental requirements, improve the reliability of the test results, comply with the Chinese GMP and Chinese Pharmacopoeia as well as EU GMP/FDA cGMP/USP-NF requirements, and can be used for "continuous" or "batch" operation.

Performance Features

1.New VHPS technology: it can control the concentration and saturation of hydrogen peroxide, good reproducibility of sterilization and shorten the time of chamber sterilization;

2.Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations, easy to install and transport;

3.Intelligent control system: adopts Siemens PLC+IPC control system, pressure, hydrogen peroxide solution concentration, ambient temperature and humidity, wind speed and other monitoring parameters, to realize intelligent alarm, the system has multi-level authority control, in line with the FDA 21 CFR part 11 requirements;

4.Provide CDCV services: carry out sterilization cycle development, validation research and services;

5.Wireless glove leak detector: can be matched with integrated glove leak detector or wireless glove leak detector;

6.Energy saving and consumption reduction: optimized design of the airflow processing system, 8 hours of continuous operation energy consumption by 20%;

7.Real-time monitoring of door status: online monitoring of door opening status, continuous monitoring of door gas sealing status;

8.Decomposition filter: exhaust can be equipped with decomposition filter can effectively shorten the degradation time after hydrogen peroxide sterilization, and effectively reduce the level of sterilization residual concentration;

Technical Parameter

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