Sterile Isolator for Weighing Compounding Dispensing of Toxic Oncology Products

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Shanghai Medigrade Industry Co., Ltd.

VIP   Audited Supplier 8 years
Profile Certified by SGS/BV
SGL-30
1 Year
Preparation Machinery
Capsule
High Precision
CE, GMP, ISO
380V
Computerized
Customized
New
Medigrade
Wooden Case Packing
700kg
Shanghai, China
8422303090
Product Description
Weighing isolator 



Main description

The use of weighing, proportioning and dispensing isolator.

The purpose of this isolator is to ensure the operator's safety giving the maximum protection during all handling operations, ensuring the separation between the external glove box environment. The operator works while standing and is completely isolated from the substance being manipulated.

Designed to provide containment(OEL to 0.5ugm/m3) for the purpose of potent products, this isolator is a double chamber unit, one for the drum loading and the other for the dispensing operators.  The isolator contains a weigh balance has a gull-wing door, glove ports and a wash in place system. The isolator operates at a negative pressure  with and in the case of a containment breach the system will alarm and provide air in rush protection.

The design has been ergonomically tested to ensure that the intended operations can be easily performed and is fully GMP compliant.

Main features
1. Fully PLC controlled
2. Software GAMP5 compliant
3. Friendly operator interface
4. Sliding tray
5. Pass through door for communication with adjoining chamber
6. 190mm glove flanges with gloves
7. 270mm glove flanges with gloves
8. Continuous film port diameter 380mm
9. H+T sensor for temperature and humidity internal monitoring
10. Magnetic manometers for the internal pressure control
11. Inverter for ventilation fan speed control
12. Automatic valves for air flow interception JUMO manometers
13. JUMO manometers to monitor inlet and outlet filters obstruction
14. Advance PUSH-PUSH system, bag in bag out system , RTP ,α/βvalve 

 

Technical parameters
ItemAPI weighing sampling isolator
Production capacity8hours*7days
Motor power4-0.8kw
Total power5-15kw/h
Power supply380V±38V/50±1Hz/60Hz
Dimension2800×855×2800
MaterialSS316L/304
Weight700kg
Noise70db(A)
OELOEB5
Air speed0.36-0.54m/s
Laminar flowVertical unidirectional flow/Turbulent flow
Tem/humidity online monitoringYes
Working pressure+45~-150Pa
Cleanliness levelA class environment
Structure modeModular + Expansion port
Leakage rate0.25%Vol/h
Illumination500Lux
Inner cavity materialAISI316L
Outside materialAISI304
H2O2 sterilizing time90min
Sterilization effect6LOG
Sterilization methodHydrogen peroxide vapor
Sterilization concentration>300PPM
Standard for residual VHP concentration after sterilization1PPM
Classification during equipment operationA LEVEL



If you are interested in this, please contact me: Nana Zhang
Shanghai Medigrade Industry Co.,Ltd
Waigaoqiao Free Trade Zone, Shanghai,China. 200137
 
 
 

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