Aseptic Isolator Sterility Test Containment System with PVC Soft Chamber Sterile Isolator Toone

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Product Description

📋 Basic Information
Clean GradeClass A
PowerAC220V±22V 50Hz±1Hz
Sterilization Range0-1000ppm
Air Velocity0.36--0.54m/S
MaterialsPVC and SUS304
Noise<=68dB(a)
Sterilization SystemVHP
PrecisionHigh Precision
Voltage220V
ConditionNew
Production Capacity1000PCS/Month
CertificationCE, GMP, ISO, UL
🔬 Product Principle

As a sealed system, the sterility 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 undergoes biological 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 from operators to drugs.

⚙️ Technical Specifications
Parameter Specification Details
Maximum power≤3000W
Touch screen size12.1" industrial control screen
Supply voltage220V±22V, 50±1Hz
Airflow modelVertical unidirectional flow
Pressure control range-80 ~+80pa, adjustable
Gas sourceFiltered clean compressed air or nitrogen (0.4-0.6 MPa)
Leakage rate< 0.5%vol/ hour at 80Pa
Wind speed0.36~0.54m/s
Data trackingAvailable
Operating space179×105×74cm (Customizable)
🌟 Product Features
  • Adopts a rigid-wall structure made of stainless steel and tempered glass, ensuring a dynamic A-level internal environment.
  • Equipped with thickened anti-breakage or thin comfortable gloves for precise operation.
  • Utilizes H14 high-efficiency particulate air filters with scanning leak detection via PAO.
  • Hydrogen peroxide (VHP) sterilization capability to eliminate 10^6 spores on surfaces and air.
  • Safe material transfer through airlocks and transfer cabins equipped with RTP systems.
  • Includes Siemens programmable logic controller (PLC) for fully automatic control of pressure and air supply.
  • The 12.1" industrial tablet PC conforms to the GMP verification requirements for computer systems.
Frequently Asked Questions
What is the Clean Grade of the Aseptic Isolator?
The system maintains a dynamic Class A internal environment, ensuring the highest level of protection for sterility testing and aseptic subpackaging.
How is the decontamination process handled?
The isolator uses a Vaporized Hydrogen Peroxide (VHP) sterilization system, which is capable of achieving a 10^6 spore kill rate on all exposed internal surfaces.
Does the equipment comply with GMP requirements?
Yes, the control system and software conform to the GMP 2010 requirements for computer systems, including electronic signatures and data tracking.
Can the size of the isolator be customized?
Yes, while standard dimensions are provided (e.g., 1800*880*2250mm), the equipment size, operating space, and airlock dimensions can be fully customized based on client requirements.
What materials are used in construction?
The isolator is constructed using high-quality SUS304 stainless steel and tempered glass for the rigid walls, with PVC components where applicable.
What kind of air filtration does it use?
It utilizes H14 high-efficiency particulate air (HEPA) filters and supports scanning leak detection via PAO to ensure air purity.

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