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| After-sales Service: | 1 Year |
| Layers: | Customized |
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Introduction
This sterility testing isolator has optimized design of airflow handling system; energy consumption of eight-hour continuous operation reduces by 20%. Engineered with a focus on both performance and environmental responsibility, it offers a comprehensive solution for modern laboratories and pharmaceutical facilities. This isolator equipment is designed to create a highly sterile environment, ensuring the accuracy and reliability of sterility testing procedures. It employs advanced sealing and filtration technologies to prevent any external contaminants from entering the testing chamber, thereby safeguarding the integrity of samples and test results.
Drug quality: sterility check and microbial limit test of injections, biological products and vaccines
Medical devices: Initial contamination bacteria detection of implants, catheters and surgical instruments
Laboratory research and development: sterility verification of cell therapy products and gene drugs
Hospital pharmacy: aseptic operating environment in infusion dispensing centers (PIVAS)
Performance and Features
1.New VHPS technology: control the concentration and saturation of H2O2; good sterilization reproducibility; shorten the sterilization time of the chamber;
2.Modular design: including transfer chamber, operation chamber, bacteria collector and other functional modules and configurations; easy to install and transport;
3.Intelligent control system: Siemens PLC+IPC control system; intelligent alarms of pressure, H2O2 solution concentration, temperature and humidity, air speed and other monitoring parameters; the system has multi-level access control; comply with FDA 21 CFR part 11 requirements;
4.CDCV service: sterilization cycle development, validation studies and services;
5.Wireless glove leakage detector: integrated or wireless glove leakage detector is optional;
6.Energy saving and consumption reduction: optimized design of airflow handling system; energy consumption of eight-hour continuous operation reduces by 20%;
7.Real-time monitoring of door status: it can monitor the door opening online and continuously monitor the airtight seal of the door;
8.High-quality manufacturing materials: the inner chamber is made of 316L or PTFE, and the chamber polishing grade is 0.4μm~0.6μm;
9.Decomposition filter: the air exhaust module can be equipped with a decomposition filter can effectively shorten the degradation time after H2O2 sterilization, and effectively reduce the concentration level of residues;
10.Simple maintenance: the maintenance surface is on the front, and the space required for the laboratory is not big.
Product Parameters
| Name | Parameters |
| Material | 316L |
| Polishing grade | 0.4μm~0.6μm |
| Protection level | OEB 5 (OEL<1ug/m³) |
| Internal arc angle | R≥20 |
| Cleanliness level | Class C |
| Power supply | 380V 50Hz (Note: Other voltages require a transformer) |
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