Aseptic Isolator

Aseptic isolator is also called aseptic test isolator and aseptic isolation system

Aseptic isolator is a highly clean, continuous and effective operating space brought about by aseptic isolation technology,

It can minimize the contamination of microorganisms and various particles, thus improving the accuracy of sterility test.

There are two simple purposes to use aseptic isolator. One is to protect samples from environmental pollution, which includes pollution from operators and test environment.

The second is to protect operators from the pollution of toxic and harmful substances.

The application of sterile isolator is very wide, especially in the production of sterile drugs. The application of sterile isolator in the production of sterile drugs not only ensures the quality of drugs, but also reduces the cost.

The isolator is used to prevent cross contamination between the closed working environment and the background environment of the surrounding personnel. Therefore, the materials in the isolator must be handled through gloves, suits or automatic operation.

The equipment is usually operated under full airtight air pressure, and it is required to effectively decontaminate and sterilize according to the procedures before use.

Generally, isolators for handling sterile materials should follow the following principles:

(1) All work and material handling in the isolator must be isolated and controlled. No person or body part can directly enter the isolator during operation.

(2) All materials entering the isolator must be decontaminated or sterilized, and must enter directly through the past pollution or sterilization system, or through the fast transfer cabin.

(3) Decontamination methods must be repeatable and quantifiable.

The isolator used for the production of sterile raw materials is equipped with HEPA high efficiency filter. In static state, the isolator shall conform to Class A determined in ISO14644. The air flow of the isolator used for the production of sterile raw materials is generally turbulent.

Although the isolation system is leak proof, it still needs to exchange gas with the surrounding environment. When there is an opening directly connected with the outside environment, the aseptic state in the isolator is maintained by maintaining a continuous positive air pressure to the outside.

Suzhou Pharma Machinery Co.,Ltd.

2022/11/05

Spencer