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
- Development history of sterile isolators
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) |
- Sterile isolator features
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.
