Hangzhou Winteam Scientific Instruments Co., Ltd.
Hangzhou Winteam Scientific Instruments Co., Ltd. THE MISSION OF WINTEAM IS PROVIDE BETTER STERILITY TEST PRODUCTION
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membrane filtration isolators for pharmaceutical applications for cosmetic
WINTEAM's new generation of intelligent soft cabin sterility inspection isolator, which is the fourth generation of the isolation products of winteam. It has been upgraded from the appearance of the product or from the technical aspects of the product. The system is more powerful and laminar. The airlock transmission compartment is perfectly combined with the experimental cabin to realize the maximum operation space and the need for rapid sterilization and delivery of materials. It fully meets the USP/EP/CHP sterility test regulations and has stable performance; while ensuring the quality of the drug inspection, it is greatly improve the efficiency of inspection work:
First, modular design
WINTEAM's new generation of intelligent isolators adopts humanized design, and each component is integrated into modules, no longer worrying about installation space restrictions;
Second, the world's leading sterilized inspection management system
The system provides three functional modules of experimental product management, isolator operation and video recording system, so that each inspection link can be traced to ensure the integrity of sterilized inspection data and ensure the quality of inspection;
Third, hydrogen peroxide rapid sterilization technology
The third generation: In order to strengthen the risk control during the use of the sterile isolator and based on the occupational health considerations of the operators, the aseptic isolator develops into a stainless steel-based material, a unidirectional flow design, an integrated online environmental monitoring device, and vaporization. The hydrogen peroxide sterilization system is integrated with the isolator. With electronic signature and electronic record requirements, it achieves regulatory requirements for data integrity such as disaster recovery and audit trails.
The second generation: With the development of aseptic isolation technology and sterilization technology, the aseptic isolator developed into a stainless steel material as the main structural material, but the structure still retains the turbulent flow design in the cabin. The sterilization method is mainly based on a hydrogen peroxide device connected to an external vaporization or spray.
Isolation technology has been widely used around the world since the 1980s, and the laboratory sterility inspection industry, which was the first to introduce isolation technology in the pharmaceutical industry, has undergone several generations of changes in the international market.
The first generation: soft materials such as PVC as the main structural material, the air treatment system is designed as a turbulent structure; the operating parts are mainly gloves/sleeve components, half-length suits, and controlled by ozone or peracetic acid. The mainstream means of microbes.
Parameter
| model | YT-N1200A | YT-N1500A | YT-N1800A |
| size | 2000*800*2000 | 2300*800*2000 | 2600*800*2000 |
| size of operation | 1200*650*850 | 1500*650*850 | 1800*650*850 |
| Air lock chamber size | 750*650*850 | ||
| Power supply | AC220V 50Hz | ||
| Power | 800W | ||
| Operation port | single side 2+1 | single side 3+1 | single side 4+1 |
| Operating port size | 240mm diameter | ||
| Airflow mode | engineering turbulence | ||
| Maximum ventilation | 75m3/h | ||
| High efficiency filter | 99.98% H13 | ||
| Pressure control | -99Pa~0Pa | ||
| Operating port protection wind speed | 0.5m / s (refer to ISO 14644-7) | ||
| Hour leak rate | ≤0.5% (refer to ISO 14644-7) | ||
The advantages of sterile isolators compared to traditional clean technology:
1. Automatic gas sterilization saves time and effort, uniform gas distribution, good effect and easy verification.
2, completely isolated from the outside world, only through HEPA gas exchange and constant cabin pressure, to prevent external pollution.
3, double door express delivery system, to ensure delivery in a sterile environment, a high degree of sterility assurance.
4. The umbrella coefficient is high, the running noise is low, and the protection efficiency for operators is very good.
5. The risk of aseptic environmental pollution caused by misuse is very small.
6. The operating energy consumption is lower than that of the traditional clean room.
7, small footprint, does not affect other equipment, and can be flexibly designed according to customer requirements.