洁净室 英文ppt.ppt

Clean-rooms High frequency words contaminant [k?nt?min?nt] 污染物 particulate [p?tikjulit] 颗粒，微粒 personnel [,p?:s?nel] 人员，职位 sealed [si:ld] 密封的 impervious [imp?:vi?s] 不可渗透的 ceiling [‘si:li?] 天花板 Catalog Clean-room and pharmaceutical Contaminants The control of clean room Clean-room design Clean-room cleanliness level Clean-room and pharmaceutical Clean-rooms are environmentally controll-ed areas within the pharmaceutical facility in which critical manufacturing steps for injection/sterile (bio) pharmaceuticals must be undertaken. Clean-rooms are specifically designed to product from contamination. Contaminants Common potential contaminants include microorganisms and particulate matter. These contaminants can be airborne , or derived from process equipment , person-nel , ect. The control of clean room The transfer of processing materials , or entry of personnel into clean areas , carries with it the risk of reintroduction of microorganisms and particulate matter. The principles of GMP minimize such risks by stipulating that entry of all substances / personnel into a clean-room must occur via airlock systems. Clean-room design Ⅰ. All exposed surfaces should have a smooth , sealed , impervious finish in order to minimize accumulation of dirt / microbial particle ,and to facilitate effective cleaning procedures. Ⅱ. Floors , wall and ceilings can be coated with durable , chemical resistant materials. Clean-room design Ⅲ . Surfaces may be completely overlaid with smooth-vinyl-based（乙烯基） sheets , thermally welded to ensure a smooth , unbroken surface. Clean-room cleanliness level A basic feature of clean-room design is the presence in their ceiling of high-efficiency particulate air (HEPA filters). HEPA filters of different particulate-removing efficiency are available , allowing the construction of clean-room of various levels of cleanliness. Specification laid down for class A ,B,C and D clean-room as used