| Customization: | Available |
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| Application: | Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Food Safety, Forensic Science, Pharmaceutical Industry |
| Certification: | CE, GMP, ISO |
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Introduction:
The sterile isolator is a cutting-edge decontamination equipment designed to separate operators from machines, meeting the stringent requirements of Class A environments. It is primarily used to protect critical processes such as sterile testing and the dispensing of sterile products. This advanced system reduces the need for stringent background environmental conditions, enhancing the reliability of inspection results. It complies with multiple international standards, including China GMP and Pharmacopoeia, EU GMP/FDA, and cGMP/USP-NF, and supports both "continuous" and "batch" operations.
| Feature | Description |
| Technology | New VHPS technology for precise H2O2 control and rapid sterilization |
| Design | Modular, including transfer chamber, operation chamber, bacteria collector |
| Control System | Siemens PLC+IPC with intelligent alarms and multi-level access control |
| CDCV Services | Comprehensive sterilization cycle development and validation |
| Glove Leak Detector | Optional integrated or wireless glove leak detector |
| Door Status Monitoring | Real-time door opening and sealing monitoring |
| Manufacturing Materials | 316L or PTFE inner chamber with 0.4μm~0.6μm polishing grade |
Conclusion
The sterile isolator is an indispensable solution for enhancing safety and efficiency in pharmaceutical production and testing. Its advanced features, combined with compliance to global standards, make it an ideal choice for pharmaceutical manufacturers aiming to optimize their aseptic processes.
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