Sterile Isolating Device Research And Its CFD Simulation

Drugs are special products used for prevention, treatment of disease, recovery and regulation the body functions. The use of them is directly related to the efficacy and people'health. However, in the manufacturing process, some of the drugs may be subject to microbial contamination or cross-contaminated. As a result, they may become harmful or even life-threatening to people.Years of practice and studies at home and abroad have shown that contamination or cross-contaminated of drugs mainly because of unqualified production environment, especially the factor of human beings. In order to avoid contamination or cross-contaminated of drugs, it is quite necessary to take effective measures to ensure that the drug production environment is highly clean. Isolating device installed in pharmaceutical equipment can effectively isolate the man from the pharmaceutical environment.This paper reviews the features and requirements of the pharmaceutical environment, introduces the classification and features of sterile isolators, points out the principles of achieving cleanness. By comparing isolators and conventional clean rooms, this paper finds the former superior to the latter. Besides, The modes of supply air and return air and factors of internal air flow organization are also analyzed in this paper. And on this basis, this paper gives some effective suggestions on pressure control.Taking Restrictive Access Barrier Systems (RABS) as an example, this paper describes the process of using Computational Fluid Dynamics (CFD) to authenticate and optimize the Preliminary design. By adopting Steady incompressible navier-stokes Renault time-averaged equation and k~εturbulent flow model, numerical simulation of the air flow organization in isolator in the preliminary design was carried out. What the numerical simulation revealed are as follow: Velocity distribution didn't meet the requirements, Streamline shifted apparently, and there was a circulation zones. Therefore, return air form is adjusted. The second numerical simulation of air flow suggests that the optimized organization makes the distribution of air flow organization much more satisfying.