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Sterile isolator
This equipment achieves bidirectional protection of personnel and the operational environment through a physical isolation barrier, ensuring a sterile condition throughout the production process and testing procedures while effectively safeguarding the safety of operators. Its sealed structural design complies with the ISO 14644-1 standard and can maintain absolute isolation between the internal space and the external environment.
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Sterile isolator
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This equipment achieves bidirectional protection between personnel and the operational environment through a physical isolation barrier, ensuring the sterility of both the production process and the testing procedure while effectively safeguarding the safety of operators. Its sealed structural design complies with the ISO 14644-1 standard and can maintain absolute isolation between the internal space and the external environment.
In sterile production applications, equipment continuously maintains an ISO Class 5 cleanroom environment through a HEPA filtration system, enabling comprehensive microbial control throughout the entire production process. In the testing phase, a controlled environment meeting the requirements of USP <1116> is established to ensure the integrity and traceability of test data.
The system features two airflow operation modes:
- **Laminar Flow Mode**: The unidirectional vertical airflow velocity is maintained at 0.45 m/s ± 20%, making it suitable for critical aseptic operations such as filling and transfer.
- **Turbulent Flow Mode**: Dynamically adjusts airflow to accommodate routine operational needs such as sampling and observation.
Under static conditions, the internal environment of the equipment meets Class A cleanliness standards (particle size ≥0.5 μm ≤3520/m³, probability of microbial contamination ≤1 CFU/m³).To meet the requirements of special operating conditions, this equipment offers a comprehensive customization solution—from cabin dimensions (supporting custom sizes from 2 to 20 m³) and materials (316L stainless steel or transparent polymers) to functional modules (rapid-transfer chambers and freeze-drying interfaces), ensuring physical compatibility and functional integration with existing facilities.
Product Model HUAKE ISO2050(S2) HUAKE ISO2450(S3) HUAKE ISO3150(S4) HUAKE ISO3150(W8) External dimensions 2050*850*2480 2450*850*2480 3150*850*2480 3150*1100*2480 Glove workstation 2 gloves 3 gloves 4 gloves 8 gloves Airflow organization Laminar flow Laminar flow Laminar flow Laminar flow Cabin airtightness Complies with the requirements of ISO10648-2 standard and meets the regulatory requirements of the European Union and the FDA. Door system Interlock system Filter G4 primary filter + H14 high-efficiency filter Control system PLC Intelligent Control System (Industrial PC, Siemens S7-1200 PLC, Three-Level Permissions, Electronic Signature, Audit Trail) Smart Monitoring Isolator cavity pressure differential Differential pressure of high-efficiency filters Air outlet wind speed Leak rate per hour Gas concentration Temperature and humidity Pressure detection ±80 Pa System integration Online monitoring of temperature and humidity, wind speed, hydrogen peroxide concentration, as well as online detection of particles and airborne microorganisms. Leak rate per hour <0.5% Vol/hr Power requirements 220V/5KW
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