Containment Isolator Plants for Weighting Compounding Dispensing of Oncology Products in Pharmaceutical Sterilized Isolator

Product Details
Customization: Available
Warranty: 1 Year
Type: Preparation Machinery
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Type of Ownership
Limited Company
Management System Certification
ISO 9001, ISO 9000, GMP, ISO 13485
  • Containment Isolator Plants for Weighting Compounding Dispensing of Oncology Products in Pharmaceutical Sterilized Isolator
  • Containment Isolator Plants for Weighting Compounding Dispensing of Oncology Products in Pharmaceutical Sterilized Isolator
  • Containment Isolator Plants for Weighting Compounding Dispensing of Oncology Products in Pharmaceutical Sterilized Isolator
  • Containment Isolator Plants for Weighting Compounding Dispensing of Oncology Products in Pharmaceutical Sterilized Isolator
  • Containment Isolator Plants for Weighting Compounding Dispensing of Oncology Products in Pharmaceutical Sterilized Isolator
  • Containment Isolator Plants for Weighting Compounding Dispensing of Oncology Products in Pharmaceutical Sterilized Isolator
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Basic Info.

Model NO.
SGL-35
Finished Dosage Form
Capsule
Precision
High Precision
Certification
CE, GMP, ISO
Voltage
380V
Computerized
Computerized
Customized
Customized
Condition
New
Transport Package
Wooden Case Packing
Specification
700kg
Trademark
Medigrade
Origin
Shanghai, China
HS Code
8422303090
Production Capacity
100 Sets/Year

Product Description

Weighing isolator 

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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
Item API weighing sampling isolator
Production capacity 8hours*7days
Motor power 4-0.8kw
Total power 5-15kw/h
Power supply 380V±38V/50±1Hz/60Hz
Dimension 2800×855×2800
Material SS316L/304
Weight 700kg
Noise 70db(A)
OEL OEB5
Air speed 0.36-0.54m/s
Laminar flow Vertical unidirectional flow/Turbulent flow
Tem/humidity online monitoring Yes
Working pressure +45~-150Pa
Cleanliness level A class environment
Structure mode Modular + Expansion port
Leakage rate 0.25%Vol/h
Illumination 500Lux
Inner cavity material AISI316L
Outside material AISI304
H2O2 sterilizing time 90min
Sterilization effect 6LOG
Sterilization method Hydrogen peroxide vapor
Sterilization concentration >300PPM
Standard for residual VHP concentration after sterilization 1PPM
Classification during equipment operation A LEVEL



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

medigrade.en.made-in-china.com

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