Rigid Sterility Isolator

Introduction

Zhejiang Tailin bioengineering Co.,Ltd. has been committed to the development of isolation technology and the applied research of pharmaceutical industry for a long time. We can provide comprehensive technology solutions with a variety of isolators, ranging from the QC department’s sterility test technology, biosafety containment, the isolator technology for production (sterile packing, weighing, ingredients, crushing, sampling, etc.) to RABS. The latest sterile isolators for QC and R & D laboratory detection, is almost suitable for all sterile testing of sterile preparations and sterile bulk drugs (API),which based on the pharmacopoeia statutory methods (membrane filtration method and  the direct inoculation method).

Features

1. Rigid structure composed of stainless steel and tempered glass, the internal environment is dynamic class A;

2. Operate with gloves(thick anti-breakage gloves or thin sensitized gloves);

3. Adopt H14 grade HEPA, scan through the PAO leak test;

4. The system reserves an interface and a valve for connecting the Vapor Hydrogen Peroxide Generator (VHPS ®); the internal part is sterilized by hydrogen peroxide vapour, the effectiveness     of killing spores in the cabin air and the exposed surface achieves lg6 ;

5. Deliver goods through various ways, for instance, docking to the transfer bag of being able to be steam sterilized , or to the transfer passageway with RTP system , etc. ;

6. Built-in power can be installed in the isolator, you can install the connectors for compressed air and for clean water with valves to take in water and air;

7. Systems with Siemens Logic Controller (PLC) for controlling pressure and air volume fully automatically, , and with under-voltage alarm function;

8. Industrial grade  PC control, meet  the  computer system validation requirements  as 2010 version GMP.

Parameters

1. Power supply: 380V±38V，50±1Hz（HTY-1800G4、HTY-1800AG4）； 220V±22V，50±1Hz（HTY-1250G2）；

2. Power: ≤4000W（HTY-1800G4、HTY-1800AG4）；≤3000W（HTY-1250G2）；

3. Touch screen: 7.5 inches

4. Cabin pressure control range: -80Pa ~ 80Pa

5. Humidity Resolution: 0.1%

6. Temperature Resolution: 0.1 ℃

7. Pressure Resolution: 0.1Pa

8. Isolation cabin airflow model: vertical unidirectional flow

9. Air speed: 0.36～0.54m/s；

10. Impermeability: Leakage rate per hour ≤ 0.5% when conducting pressure maintaining test under 60Pa positive pressure.

11.  Air: Filtered compressed air or nitrogen, air supply pressure 0.4 ~ 0.6MPa;

Basic dimensions:

Applications

Sterility test, sampling, weighing, packaging of high-allergenic or high active materials etc., double protection for material and operator.