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Aseptic inspection isolator is an air purification product that separates the operator from the powder or liquid product in the laboratory or production process by means of a physical barrier. The isolator system can create a local Class A environment in a low-level background environment. In the biopharmaceutical industry, the physical isolation of products and personnel is a key factor, and the design and application of the isolator depends on the nature of the isolator use. According to the use characteristics, the design of the isolator's internal and external pressure difference, airflow, construction materials, environment, type, etc. According to the use of isolator system, it usually can be designed as positive pressure isolator and negative pressure isolator; pattern isolator sealing usually can be designed as completely sealed isolator (Isolator) and restricted access isolation system (RABS), while restricted access isolation system (RABS) can be divided into open restricted access isolation system (O-RABS) and closed restricted access isolation system (C-RABS).
Aseptic inspection isolator is a vertical unidirectional flow, providing local class A environment, man-machine separation of air purification equipment; it is widely used in the pharmaceutical industry to create a class A filling line environment in the background of class B clean environment.
The purpose of this isolator is to ensure operator safety, provide maximum protection during all handling operations, and ensure isolation between external glove box environments. The operator works standing up, completely isolated from the substance being manipulated.
The isolator is a dual chamber unit, one for drum loading and the other for dispensing operators, designed to provide containment for strong products (OEL to 0. 5ugm/m3). The isolator contains a weighing balance with gull-wing doors, glove ports and in-place cleaning system. The isolator operates under negative pressure and in the event of a containment rupture, the system will sound an alarm and provide emergency protective air.
The design has been ergonomically tested to ensure that the intended operation can be easily performed and is fully GMP compliant.
Main Features:
1. Fully programmable controller control.
2. Software GAMP5 compatible.
3. User-friendly operator interface.
4. Sliding tray.
5. Communicating adjacent rooms through doors.
6. 190 mm glove flange with gloves.
7. 270 mm glove flange with gloves.
8. Continuous film port diameter 380 mm.
9. H+T sensors for internal monitoring of temperature and humidity.
10. Magnetic pressure gage for internal pressure control.
11. Inverter for ventilation fan speed control.
12. Airflow interception JUMO manometer's automatic valve.
13. JUMO pressure gage monitoring inlet and outlet filters are clogged.
14. Advanced push-push system, bag-in-bag-out system, instant transfer protocol, α/β valve.
Aseptic dispensing isolation puts aseptic API out and crushing operation. In the isolator, the aseptic APL, which has been dry blasted, is discharged by manual, after which it enters the crushing station for crushing according to the process requirements, after which it enters the dispensing station for dispensing (sampling) or directly enters the dispensing station for dispensing (sampling), and finally the dispensed aseptic API enters the lid rolling station and is discharged at the end of lid rolling.
Protection type: Depending on the workstation, the airflow organization is determined, and the protection of products, people and environment is determined.
Processes:
1. Goods delivery area (in): negative pressure, turbulent flow
2. Goods buffer zone: negative pressure, turbulent flow
3, Crusher crushing area: negative pressure, turbulent flow, VHP sterilization
4. Goods feeding area: negative pressure, turbulent flow, VHP sterilization
5. Aseptic API weighing and dispensing area: negative pressure, turbulent flow, VHP sterilization
6. Aluminum barrel rolling lid area: negative pressure, turbulent flow
7. Goods delivery area (out): negative pressure, turbulent flow
The above-mentioned is a negative pressure system during functional operation, and a positive pressure system during VHP sterilization
Aseptic inspection isolator is an air purification product that separates the operator from the powder or liquid product in the laboratory or production process by means of a physical barrier. The isolator system can create a local Class A environment in a low-level background environment. In the biopharmaceutical industry, the physical isolation of products and personnel is a key factor, and the design and application of the isolator depends on the nature of the isolator use. According to the use characteristics, the design of the isolator's internal and external pressure difference, airflow, construction materials, environment, type, etc. According to the use of isolator system, it usually can be designed as positive pressure isolator and negative pressure isolator; pattern isolator sealing usually can be designed as completely sealed isolator (Isolator) and restricted access isolation system (RABS), while restricted access isolation system (RABS) can be divided into open restricted access isolation system (O-RABS) and closed restricted access isolation system (C-RABS).
Aseptic inspection isolator is a vertical unidirectional flow, providing local class A environment, man-machine separation of air purification equipment; it is widely used in the pharmaceutical industry to create a class A filling line environment in the background of class B clean environment.
The purpose of this isolator is to ensure operator safety, provide maximum protection during all handling operations, and ensure isolation between external glove box environments. The operator works standing up, completely isolated from the substance being manipulated.
The isolator is a dual chamber unit, one for drum loading and the other for dispensing operators, designed to provide containment for strong products (OEL to 0. 5ugm/m3). The isolator contains a weighing balance with gull-wing doors, glove ports and in-place cleaning system. The isolator operates under negative pressure and in the event of a containment rupture, the system will sound an alarm and provide emergency protective air.
The design has been ergonomically tested to ensure that the intended operation can be easily performed and is fully GMP compliant.
Main Features:
1. Fully programmable controller control.
2. Software GAMP5 compatible.
3. User-friendly operator interface.
4. Sliding tray.
5. Communicating adjacent rooms through doors.
6. 190 mm glove flange with gloves.
7. 270 mm glove flange with gloves.
8. Continuous film port diameter 380 mm.
9. H+T sensors for internal monitoring of temperature and humidity.
10. Magnetic pressure gage for internal pressure control.
11. Inverter for ventilation fan speed control.
12. Airflow interception JUMO manometer's automatic valve.
13. JUMO pressure gage monitoring inlet and outlet filters are clogged.
14. Advanced push-push system, bag-in-bag-out system, instant transfer protocol, α/β valve.
Aseptic dispensing isolation puts aseptic API out and crushing operation. In the isolator, the aseptic APL, which has been dry blasted, is discharged by manual, after which it enters the crushing station for crushing according to the process requirements, after which it enters the dispensing station for dispensing (sampling) or directly enters the dispensing station for dispensing (sampling), and finally the dispensed aseptic API enters the lid rolling station and is discharged at the end of lid rolling.
Protection type: Depending on the workstation, the airflow organization is determined, and the protection of products, people and environment is determined.
Processes:
1. Goods delivery area (in): negative pressure, turbulent flow
2. Goods buffer zone: negative pressure, turbulent flow
3, Crusher crushing area: negative pressure, turbulent flow, VHP sterilization
4. Goods feeding area: negative pressure, turbulent flow, VHP sterilization
5. Aseptic API weighing and dispensing area: negative pressure, turbulent flow, VHP sterilization
6. Aluminum barrel rolling lid area: negative pressure, turbulent flow
7. Goods delivery area (out): negative pressure, turbulent flow
The above-mentioned is a negative pressure system during functional operation, and a positive pressure system during VHP sterilization
