It creates a continuous GMPA-level clean environment through physical barrier and VHPS vaporized hydrogen peroxide efficient sterilization, reduces the risk of exogenous pollution and cross contamination, complies with the requirements of China GMP and Chinese Pharmacopoeia as well as EU GMP/FDA cGMP/USP-NF, and can be operated “continuously” or “batch”.
| Power supply： | 380V 50Hz |
| Maximum power: | 3000W in sterilization cycle stage |
| Airflow mode: | unidirectional flow |
| System sterility maintenance working noise: | <65dB (A) |
| Sterility maintenance stage: | 2500W |
| Built-in bacteria collector: | 1 or 2 |
| Accessories: | Equipped with 12.1-inch industrial tablet computer/NetSCADA system |
Sterile isolators fundamentally avoid direct contact between operators and objects, so the samples and auxiliary facilities can be prevented from being contaminated during sterility testing. When the isolator is in a closed state, the interior is a sterile environment, and objects can only be transferred inside the isolator or through a special fast transfer warehouse.
1. A new generation of VHPS sterilization technology: the concentration and saturation of hydrogen peroxide are controllable, and the sterilization reproducibility is better; at the same time, the sterilization time of the transfer cabin and the operation cabin is shortened;
2. Optimized airflow handling system: Through computational fluid dynamics analysis (CFD), the design of the airflow handling system is optimized, the airflow is more uniform, and the residual discharge time is shortened;
3. Modular design, easy to transport and install;
4. Intelligent control system: designed according to the GAMP5 guidelines, new monitoring parameters such as hydrogen peroxide solution concentration, saturation, carrier dew point temperature, carrier flow, etc. are added, with multi-level customized authority control; with electronic data and electronic signature, in line with FDA 21 CFR part 11 requirements;
5. Ergonomic design, more convenient operation
6. Integrated functional modules and configurations, such as rapid sterilization transfer cabin, environmental detection system, bacteria collector, video traceability system, bag-in-bag-out high-efficiency filter, etc.
7. Provide sterilization cycle development, verification (CDCV) research and services
8.Energy saving and consumption reduction: Optimized air handling system reduces room fresh air volume demand and air conditioning system requirements, and energy consumption is reduced by 20% for 8 hours of continuous operation (including 1 sterilization cycle and maintenance
Put sterile products (containers, products, closures) into a sterile environment. Since no operator enters the sterile isolator and no non-sterile items are brought into the sterile isolator, these items remain sterile throughout the entire processing process.
The sterile isolator barrier is an absolute barrier that isolates sterile products from operators and the external environment, preventing the product from exchanging with the outside world. In addition to blocking the entry of external contaminants through physical sealing, the sterile isolator also uses the method of positive pressure in the inner room to achieve the purpose of effective sealing.
Operators skillfully operate the items by wearing gloves and protective clothing. All air entering the sterile isolator is filtered through an air pre-filtration system and a high-efficiency particulate air filter (HEPA). The typical outlet for exhaust air is filtered through a field PA grade filter.
1. Loading First, prepare all the test samples, culture media, buffers, filter tanks and corresponding tools that need to be placed in the sterile isolator. Place them in the isolator according to the verified loading method. Generally, the filter tank will be hung on the hook above the isolator, and the test samples, culture media and buffers will be placed on the shelves with gaps. The materials cannot be close together to avoid sterilization dead corners. After loading, close the isolator door and check whether the isolator door is closed and whether the isolator displays an alarm. Check the integrity of the gloves in the isolator by visual inspection or using a glove leak detector.
2. Sterilization Run the sterilization cycle of the sterile isolator according to the verified sterilization parameters. Depending on the size of the cabin, the loading situation and the room environment, the sterilization cycle time is 1.5~2.5 hours. After the cycle, check the residual concentration of hydrogen peroxide in the box, or read the reading of the online low-concentration hydrogen peroxide probe.
3. Arrange materials Rearrange the materials in the sterilized sterile isolator according to operating habits. So that you can get the required items after putting on the isolator gloves.
4. Environmental testing The environment needs to be monitored during the use of the sterile isolator. Generally, the isolator is integrated with an online particle counter and a floating bacteria sampling device.
It is mainly used for the protection of key process such as sterility testing and sterile product packaging.
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