GMP Pharmarceutical Automatic Aseptic Filling Sterile Isolator

• Customization: Available
• After-sales Service: Provide Instructions and Videos, Online Video Guid
• Certification: CE, GMP, ISO, UL, GMP
• Model NO.: BD-SI-1800-P
• Condition: New
• Customized: Customized
• Voltage: 220V
• Warranty: 1 Year
• Core Components: PLC, Pump, Bearing, Gearbox, Motor
• Clean Grade: Class a
• Power: AC220V±22V 50Hz±1Hz
• Sterilization Concentration Range: 0-1000ppm
• Falling Air Velocity: 0.36--0.54m/S Adjustable
• After Warranty Service: Field Installation, Commissioning and Training
• Applicable Industrie: Hospital Ward, Airtight Cabin, Laboratory
• Materials: PVC and SUS304
• Keyword: Aseptic Isolator
• Certificate: CE, ISO, SGS
• Laminar Flow: Vertical Unidirectional Flow/Turbulent Flow
• Noise: <=68dB(a)
• Sterilization System: Vhp
• Equipment Size: Customized
• Data of Equipment: Iq Pq Oq Dq
• Precision: High Precision
• Computerized: Computerized
• Type: Aseptic Subpackaging and Inspection Machine
• Finished Dosage Form: Liquid and Powder
• Transport Package: Standard Export Wooden Case
• Specification: 1800*880*2250mm
• Trademark: BIOGREEN
• Origin: Wuxi, Jiangsu
• HS Code: 8409919100
• Production Capacity: 1000PCS/Month

Product Description

Product principle

As a sealed system, thesterility inspection isolator is designed to realize safe air exchange through
fan filter unit (high-efficiency particulate air(HEPA) filter) in a sealed environment, so as to continuously
control the particles and microorganisms in the internal environment. When closed, the sterility
inspection isolator undergoesbiological decontamination treatment for its interior surface. The fast
transfer channel or airlock is utilized to carry out aseptic transfer of materials to ensure the protection
fromoperators todrugs.

Maximum power	≤3000W
Touch screen size	12.1" industrial control screen
Supply voltage	220V±22V, 50±1Hz
Airflow model in isolator cabin	Vertical unidirectional flow
Pressure control range of cabin	-80 ~+80pa, to be adjusted
Gas source	Filtered clean compressed air or nitrogen with a pressure of 0.4-0.6 MPa
Leakage rate of the cabin	Conduct the testing of pressure maintaining at a positive pressure of 80Pa. The overall leakage rate of the isolator cabin is less than 0.5%vol/ hour
Humidity resolution	0.1%
Temperature resolution	0.1 ºC
Wind speed	0.36~0.54m/s
Electronic signature	Available
Online leak detection in cabin	Available
Online glove leak detection	Available
Data tracking	Available
Dimensions	313×125×217.5cm Can be customized
Operating space	179×105×74cm Can be customized
Airlock space	60×58×74cm Can be customized

Product features

1. It adopts a rigid-wall structure, madeof stainless steel and tempered glass, with dynamic A-level
internal environment;
2. The gloves,in thickened and anti-breakage type, or in thin and comfortable type,are used in the
operation.
3. It selects H14 high-efficiency particulate air filter and conducts scanning leak detection via PAO.
4. Hydrogen peroxide can kill 106 spores on the air and exposed surface in the isolator.
5. The safe entry and exit of materials can be realized by various means, such as airlock and transfer
cabin equipped with RTP system.
6. A built-in power supply is installed in the isolator, and compressed air connector provided with valve
and cleaning water
connector are equipped for the purpose of water and air intake.
7. This system is equipped with Siemens programmablelogic controller (PLC) for fully automatic control
of pressure and air supply,
and supports the alarm function for pressure loss.
8. The NetSCAD system of 10" touch screen/ 12.1" industrial tablet PC conforms to the verification
requirements of GMP for computer system in 2010.