Pharmaceutical Sterility Test Isolator
Pharmaceutical Sterility Test Isolator

Pharmaceutical Sterility Test Isolator

Sterility Test Isolator is used to provide a highly controlled sterile environment in key links such as drug production and inspection, effectively isolate external pollutants, prevent microorganisms and particles from contaminating products.
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Introduction

 

Sterility Test Isolator is used to provide a highly controlled sterile environment in key links such as drug production and inspection, effectively isolate external pollutants, prevent microorganisms and particles from contaminating products, and can operate independently or in conjunction with other aseptic equipment such as filling machines and lyophilizers to meet the strict requirements of aseptic operation.

           Sterile Isolator 1                                   Sterile Isolator 2

                                                                                        

Performance Features

 

1.The design and manufacture of the isolator complies with the requirements of GMP and ISO;

 

2. The isolator can be equipped with a matching integrated glove leak detector, and the data is integrated on the isolator control system;

 

3. The isolator can provide CDCV services which carry out sterilization cycle development, validation research and services;

 

4.The hydrogen peroxide sterilization cycle is controlled by PLC, and the steps/modes of the sterilization cycle can be displayed on the control screen;

 

5.The isolator can be equipped with a compressed air pressure detection device to detect whether the compressed air pressure is sufficient and have an alarm for insufficient pressure.

 

Technical Parameter

 

Materials inside the chamber

316L or PTFE

Protection level

OEB5 protection level

Chamber polishing grade

0.4μm~0.6μm

Cleanliness Degree

Class A

Control system

Siemens PLC+IPC control system

CDCV service

Provided

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