Aseptic Isolator

Aseptic Isolator is used for dangerous and highly sensitive products. This product can be adjusted in different pressures and has a cleanliness class of A and 4/5 OEB.

Characteristics of Aseptic Isolator

This isolator has the following specifications and features:

• Work Zone enclosure made of 316 grade L stainless steel with a thickness greater than 1.5 mm
• The pass box and outlet are made of 316 grade L stainless steel with a thickness greater than 1.5 mm.
• The structure of the device is stainless steel 304
• It has a drain drain and a portable SS 316 tank.
• Both Pass Boxes are active and are connected to the Work Zone compartment through glass doors
• It has 10 mm thick tempered glass and 4 Teflon ports for installing gloves
• After-box doors have interlocking
• Internal body of device with surface roughness 0.4 micron
• The external body of the device has a surface roughness of 0.8 microns
• Steel work surface with SS 316 scale stand
• INDOOR AIR WORK ZONE HAS AN ISO 8 CLEANING CLASS ACCORDING TO THE ISO14644 STANDARD
• All air passages, Seats of filters, Rear box doors, Gloves installation, Exhaust valves Fully air-sealed waste
• The installation location of the device is at 25°C with humidity of 30 to 70 percent
• The lowest amount of sound produced inside the laboratory while working with the device > 75
• Moving equipment to the work zone: Railway Floors
• The opening and closing of the doors are interlocks.
• Pass Box Entry: 2 doors with interlock lock
• Electricity Outlet in the Work Zone
• Vertical ventilation system (ceiling)
• Drain Directional Drain Tank

Filtration characteristics of negative pressure pharmaceutical isolator

The negative pressure pharmaceutical isolator filtration has the following features:

• The air used by the device is the background air of the room.
• Input Filter: After passing through the H14 HEPA filter, the incoming air enters the working area of all three sections of the machine.
• Output Filter: The exhaust air of the device is removed from the device after passing through the HEPA H14 filter.
• HEPA filters from FILLTECH France have a certificate and cleanliness class H14 with an efficiency of 99/995.
• Cleaning class according to the standard, ISO 10648 ISO14644 ISO 8 – OEB4

Characteristics of negative pressure medical isolator gloves

The gloves have the following features:

• Arrangement of gloves: Two pairs on Work Zone glass and one on Pass Boxes glass
• It has 4 glove ports with a diameter of 220 mm and a length of 800 mm made of CSM and AMBIDEXTROUS type on the Work Zone
• 1 port of gloves with a diameter of 220 mm and 800 mm length in CSM and ambidextrous type on each pass box
• The gloves are from Pircon France and have a certificate and test report.

Specifications and products of the electrical system of the machine:

The electrical system of this device has the following features:

• The control system is PLC type with a 7 inch color display
• The electricity of the device is 3-phase and grounded
• It has temperature and humidity sensors, cabin pressure sensor, filter pressure difference sensor for all three parts of the device separately
• The lighting is of LED type with uniform coverage throughout the device and the level of illumination is limited to 500 to 2000 lux
• Before the device starts working, all parts are automatically checked, including the condition of the doors, the condition of the inlet and outlet dampers, sensors, etc.
• If there is a defect in any section, it is not possible to enter another section and it will not be possible to check other sections until the defect is fixed
• Display of written alarms (SYSTEN RUN) and visual alarms of the white light of the cabins if the device is ready and after the defined conditions are stable.
• The possibility of specifying the working pressure desired by the user for the device and allowing it to start working after the conditions stabilize
• Error display and alarm in every part of the device if the device leaves the defined safe conditions
• Instant display of temperature, humidity, cabin pressure, filter pressure difference
• Displaying the lighting status and the possibility of turning each cabin on and off separately
• Displaying the status of all Pass Box doors and interior doors of cabins
• Displaying the status of the fans and the possibility of adjusting the speed of the fans according to the pressure chosen by the user
• Displaying errors when working with the device as a report on the screen
• Door open or closed alarm and enable or disable interlocks
• It has 4 cooling fans in the electronic board of the device to increase the life of the device and prevent damage
• It has an emergency stop button

Medical negative pressure isolator documents

This device has the following documents:

• The device has IQ, OQ, DQ qualifications.
• The device has a user manual and a PM checklist.
• The device has documents related to FAT and SAT.

Map of negative pressure pharmaceutical isolator:

Contaminated Isolator map