Clean GradeClass A
PowerAC220V±22V 50Hz±1Hz
Sterilization Range0-1000ppm
Falling Air Velocity0.36--0.54m/S Adjustable
After Warranty ServiceField Training & Commissioning
Applicable IndustryHospital Ward, Laboratory
MaterialsPVC and SUS304
Laminar FlowVertical Unidirectional
Noise<=68dB(a)
Sterilization SystemVHP
CertificationCE, GMP, ISO, UL
HS Code8409919100
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.
| Parameters |
Specifications |
| Maximum power | ≤3000W |
| Touch screen size | 12.1" industrial control screen |
| Supply voltage | 220V±22V, 50±1Hz |
| Airflow model | Vertical unidirectional flow |
| Pressure control range | -80 ~+80pa, adjustable |
| Gas source | Clean compressed air or nitrogen (0.4-0.6 MPa) |
| Leakage rate | < 0.5%vol/ hour at 80Pa |
| Humidity/Temp Resolution | 0.1% / 0.1 ºC |
| Wind speed | 0.36~0.54m/s |
| Data tracking | Available (Electronic signature included) |
| Dimensions | 313×125×217.5cm (Customizable) |
| Operating space | 179×105×74cm (Customizable) |
1
Adopts a rigid-wall structure made of stainless steel and tempered glass with dynamic A-level environment.
2
Includes thickened anti-breakage or thin comfortable glove options for precision operation.
3
Utilizes H14 high-efficiency particulate air filters with PAO scanning leak detection.
4
Vaporized Hydrogen peroxide system kills 10^6 spores on all exposed surfaces.
5
Equipped with airlock and RTP system for safe material transfer.
6
Integrated Siemens PLC for fully automatic control of pressure and air supply with alarm functions.
7
Compliant with GMP verification requirements for computer systems.
Frequently Asked Questions
What is the primary function of the Sterility Test Isolator?
It is a sealed system designed to provide a dynamic A-level environment for sterility testing, aseptic subpackaging, and inspection, protecting both the product and the operator.
How is the interior surface decontaminated?
The system utilizes a VHP (Vaporized Hydrogen Peroxide) sterilization system that can effectively kill 10^6 spores on all exposed internal surfaces.
Is the airflow speed adjustable within the cabin?
Yes, the falling air velocity is adjustable within the range of 0.36 to 0.54 m/s to suit different operational requirements.
Does the isolator support data tracking and electronic signatures?
Yes, the system is equipped with an industrial control screen and software that supports data tracking and electronic signatures, conforming to GMP requirements for computer systems.
Can the equipment dimensions be modified?
Absolutely. While standard dimensions are provided, both the equipment size and the airlock/operating space can be fully customized based on client needs.
What certificates does this aseptic isolator hold?
The equipment is certified by CE, GMP, ISO, and UL, ensuring it meets international quality and safety standards for laboratory and hospital use.
U-Care Medical
