世界衛(wèi)生組織hvac非無菌制藥指南(中英對照)who-937-資料下載頁
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【正文】 uced into the controlled space and then mixes with room air by means of induction.亂流，或是指無具體方向性的流動，這是空氣粒子的無規(guī)則運動。亂流通常被引入特定的房間，然后和房間內(nèi)空氣相混合。unidirectional airflow (UDAF) 單向空氣流（UDAF）Unidirectional airflow is a rectified airflow over the entire crosssectional area of a clean zone with a steady velocity an approximately parallel streamlines (see also turbulent flow). (Modern standards no longer refer to laminar flow, but have adopted the term unidirectional airflow.)單向性空氣流是經(jīng)調(diào)整過的有穩(wěn)定速度的平行空氣流，它吹過清潔區(qū)特定區(qū)域。Validation 驗證The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results.在文件指導(dǎo)下的操作程序、生產(chǎn)過程、設(shè)備、物料及生產(chǎn)活動，這些能夠產(chǎn)生所期望的實驗結(jié)果。validation master plan (VMP) 驗證總體規(guī)劃VMP is a highlevel document which establishes an umbrella validation plan for the entire project, and is used as guidance by the project team for resource and technical planning (also referred to as master qualification plan).驗證總體規(guī)劃是管理文件，它為整個項目建立了總體規(guī)劃，是項目研究小組的技術(shù)指導(dǎo)。4. Protection 保護(hù) Product and personnel 產(chǎn)品和人員 Areas for the manufacture of pharmaceuticals, where pharmaceutical starting materials and products, utensils and equipment are exposed to the environment, should be classified as “clean areas”.藥品制造的區(qū)域，藥品的原料藥、產(chǎn)品、容器和設(shè)備所暴露的環(huán)境中，定義為潔凈區(qū)。 The achievement of a particular clean area classification depends on a number of criteria that should be addressed at the design and qualification stages. A suitable balance between the different criteria will be required in order to create an efficient clean area.特定清潔區(qū)的劃分取決于藥品設(shè)計和驗證階段的一系列標(biāo)準(zhǔn)。不同標(biāo)準(zhǔn)之間達(dá)到合理平衡是創(chuàng)造高效清潔區(qū)域的前提。 Some of the basic criteria to be considered should include:基本標(biāo)準(zhǔn)包含以下方面：? building finishes and structure 操作間結(jié)構(gòu)和建設(shè)? air filtration空氣過濾? air change rate or flushing rate空氣改變速率? room pressure房間壓? location of air terminals and directional airflow空氣終端點和直接性氣流? temperature溫度? humidity濕度? material flow 物流? personnel flow 人員流動? equipment movement 設(shè)備運轉(zhuǎn)52? process being carried out 實施過程? outside air conditions 戶外空氣條件? occupancy 占有情況? type of product. 產(chǎn)品種類 Air filtration and air change rates should ensure that the defined clean area classification is attained. 空氣過濾和空氣改變數(shù)率可定義清潔潔凈區(qū)的等級。 The air change rates should be determined by the manufacturer and designer, taking into account the various critical parameters. Primarily the air change rate should be set to a level that will achieve the required clean area classification.考慮到多種重點參數(shù)，空氣改變數(shù)率可由藥品生產(chǎn)者或設(shè)計者設(shè)定。更主要的是，空氣改變數(shù)率應(yīng)該設(shè)定到能達(dá)到潔凈區(qū)等級的范圍內(nèi)。 Air change rates normally vary between 6 and 20 air changes per hour and are normally determined by the following considerations:空氣改變數(shù)率通常是每小時變化6到20空氣變化值，并且常受以下因素影響：? level of protection required 受到保護(hù)需求的等級? the quality and filtration of the supply air 所提供空氣的質(zhì)量和過濾性? particulates generated by the manufacturing process生產(chǎn)過程所產(chǎn)生的微粒? particulates generated by the operators操作者生產(chǎn)造成的微粒? configuration of the room and air supply and extract locations房間的配置以及空氣的供給和過濾。? sufficient air to achieve containment effect 過多空氣造成的污染? sufficient air to cope with the room heat load 過多空氣造成房間的熱負(fù)荷? sufficient air to maintain the required room pressure. 過多空氣維持所需的氣壓 In classifying the environment, the manufacturer should state whether this is achieved under “asbuilt” (Fig. 2), “atrest” (Fig. 3) or “operational” (Fig. 4) conditions.在環(huán)境的分類中，生產(chǎn)者應(yīng)該規(guī)定Figure 2 Figure 3圖2 圖3 53內(nèi)容總結(jié)
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