Sterility Test Isolator

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CellExpress-ST3 sterility test isolator is designed for the sterility test of aseptic products. It is highly integrated with equipment and instruments, easy to operate, shortens the disinfection and sterilization time, etc., greatly saves overall test time, minimizes sample circulation time between production and testing, and provides good environmental control to minimize false positive interference during aseptic testing.

CellExpress-ST3 sterility test isolator provides a low-cost, efficient clean inspection environment, ensures the product sterility requirements, and ensures the sterility test and aseptic operation of the product sterilization function.























1.Operation chamber & buffer chamber with 50~100 Pa positive pressure protection.

2. Automatic Leakage test (pressure holding test), The leakage rate is ≤ 2.5 x 10-3 vol/hr.

3. HEPA (H14) filter & laminar flow for Class A cleanliness in isolator.

4. Integrated VHP sterilization system, VAISALA (Finland brand) H2O2 concentration sensor for on-line monitoring.

5. 7" SIEMENS touch screen for operation, parameter setting, door control management & VHP sterilization.

6. Alarm: velocity, pressure difference, H2O2 concentration, door open, temperature, humidity.

7. Intelligent door control system, interlock design.

8. 3-level password authority for HMI.

9. Material: Interior SUS316L, T= 4.0mm, other parts SUS304 with spraying.

10. 3 pcs of Piercan (USA brand) 8-inch CSM gloves.

11. EBM (Germany brand) brand blower for air circulation.

12. Wing opening front door for operation chamber, equipped with air support structure. Opening angle ≥ 90°.

13. Optional on-line glove integrity tester, supplied with wireless printer.

14. Optional sterility test pump, can be installed at factory upon request. 

15. IQ/OQ/PQ validation.



Main Parts


No.

Contents

1.       

Pressure difference monitoring

2.       

HMI,   touch screen system

3.       

Buffer chamber

4.       

VHP   generator system

5.       

Printer

6.       

Air   inlet

7.       

Air outlet

8.       

HEPA   filter & blower

9.       

Glove port

10.     

Operation   chamber

11.     

Electrical system

12.     

Waste   liquid collection system


ItemQty 
HEPA Filter2
Primary Fiter2
VHP Decomposition Filter2
Door Seal3
Switch Button3


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