Laminar Flow Ss304 Sterility Test Isolator For Pharmaceutical Applications

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.

1. 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.
2. 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.
3. 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.

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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.