Laminar flow ss304 isolators for pharmaceutical applications
hydrogen peroxide vapor for cosmetic
Sterile isolator
Aseptic isolators are a highly viscous, continuous and effective
operating space brought about by the use of aseptic isolation
technology. It minimizes the contamination of microorganisms and
various particles, thus improving the accuracy of sterility
testing. The use of sterile isolators has two simple purposes. One
is to protect the sample from environmental contamination, which
includes contamination from the operator and the inspection
environment. The second is to protect the operator from toxic and
harmful substances. Aseptic isolators are used in a wide range of
applications, especially for the production of sterile
pharmaceuticals. The application of sterile isolators to the
production of sterile pharmaceuticals not only ensures the quality
of the drugs but also reduces costs.
Development history of sterile isolators
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.
- 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.
- 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.
Parameter
| Model | size of machine | Size of operation | Air lock chamber size | description |
| YT-R1500 | 1500*750*2100 | 1500*650*800 | NO | Single-sided hard cabin turbulence isolator 3 gloves |
| YT-DR1500A | 2100*1100*2100 | 1500*1000*800 | 500*600*500 | Double-sided hard cabin turbulence isolator 3+3 gloves |
| YT-R1800 | 1800*750*2100 | 1800*650*800 | NO | Single-sided hard cabin turbulence isolator 4 gloves |
| YT-DR1800A | 2400*1100*2100 | 1800*1000*800 | 500*600*500 | Double-sided hard cabin turbulence isolator 4+4 gloves |
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.
