GMP Standard Sterile Inspection Isolator
Brief introduction
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,
Description
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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
If you are interested in this, please contact me: Nana Zhang
Cell Phone: 0086-15800947006
https://medigrade.en.made-in-china.com/ made-in-china.com
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
Cell Phone: 0086-15800947006
https://medigrade.en.made-in-china.com/ made-in-china.com
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Featured Products
