【導(dǎo)讀】..19Chapter7

　　

【正文】 護(hù)產(chǎn)品和人員的要求。各潔凈區(qū)的著裝要求規(guī)定如下： Article 24 The garment and its quality should be appropriate for the process and the grade of the working area. It should be applied in such a way as to protect the products and personnel from contamination. The description of gowning required for each grade is given below: D級(jí)潔凈區(qū)：應(yīng)當(dāng)將頭發(fā)、胡須等相關(guān)部位遮蓋。應(yīng)當(dāng)穿合適的工作服和鞋子或鞋套。應(yīng)當(dāng)采取適當(dāng)措施，以避免帶入潔凈區(qū)外的污染物。 ??Grade D: Hair and, where relevant, beard should be covered. A general protective suit and appropriate shoes or overshoes should be worn. Appropriate measures should be taken to avoid any contamination ing from outside the clean area. C級(jí)潔凈區(qū)：應(yīng)當(dāng)將頭發(fā)、胡須等相關(guān)部位遮蓋，應(yīng)當(dāng)戴口罩。應(yīng)當(dāng)穿手腕處可收緊的連體服或衣褲分開的工作服，并穿適當(dāng)?shù)男踊蛐?。工作服?yīng)當(dāng)不脫落 纖維或微粒。 ??Grade C: Hair and where relevant beard and moustache should be covered. A face mask should be worn. A jump suit or twopiece trouser suit, gathered at the wrists and with high neck and appropriate shoes or overshoes should be worn. They should be virtually free of fibres or particulate matter. A/B級(jí)潔凈區(qū)：應(yīng)當(dāng)用頭罩將所有頭發(fā)以及胡須等相關(guān)部位全部遮蓋，頭罩應(yīng) 18 當(dāng)塞進(jìn)衣領(lǐng)內(nèi)，應(yīng)當(dāng)戴口罩以防散發(fā)飛沫，必要時(shí)戴防護(hù)目鏡。應(yīng)當(dāng)戴經(jīng)滅菌且無顆粒物（如滑石粉）散發(fā)的橡 膠或塑料手套，穿經(jīng)滅菌或消毒的腳套，褲腿應(yīng)當(dāng)塞進(jìn)腳套內(nèi)，袖口應(yīng)當(dāng)塞進(jìn)手套內(nèi)。工作服應(yīng)為滅菌的連體工作服，不脫落纖維或微粒，并能滯留身體散發(fā)的微粒。 ??Grade A/B: Headgear should totally enclose hair and, where relevant, beard and moustache。 it should be tucked into the neck of the suit。 safety goggles should be worn。 a face mask should be worn to prevent the shedding of droplets. Appropriate sterilised, nonpowdered rubber or plastic gloves and sterilised or disinfected footwear should be worn. Trouserlegs should be tucked inside the footwear and garment sleeves into the gloves. The sterilized jump suit should be used. The suit should shed virtually no fibres or particulate matter and retain particles shed by the body. 第二十五條 個(gè)人外衣不得帶入通向 B級(jí)或 C級(jí)潔凈區(qū)的更衣室。每位員工每次進(jìn)入 A/B級(jí)潔凈區(qū)，應(yīng)當(dāng)更換無菌工作服；或每班至少更換一次，但應(yīng)當(dāng)用監(jiān)測(cè)結(jié)果證明這種方法的可行性。操作期間應(yīng)當(dāng)經(jīng)常消毒手套，并在必要時(shí)更換口罩和手套。 Article 25 Outdoor clothing should not be brought into changing rooms leading to grade B and C rooms. Every worker should change clean sterile protective garments at every time when he enters a grade A/B area。 or at least once a shift while feasibility of the methods should be verified by the results from monitoring. Gloves should be regularly disinfected during operations. Masks and gloves should be changed when necessary. 第二十六條 潔凈區(qū)所用工作服的清洗和處理方式應(yīng)當(dāng)能夠保證其不攜帶有污染物，不會(huì)污染潔凈區(qū)。應(yīng)當(dāng)按照相關(guān)操作規(guī)程進(jìn)行工作服的清洗、滅菌，洗衣間最好單獨(dú)設(shè)置。 Article 26 Clean area garments should be cleaned and handled in such a way that it does not introduce additional contaminants which can later contaminate clean areas. The operations should follow written procedures. Separate laundry facilities for such clothing’s cleaning and sterilisation are desirable. 19 第七章 廠房 Chapter 7 Premises 第二十七條 潔凈廠房的設(shè)計(jì)，應(yīng)當(dāng)盡可能避免管理或監(jiān)控人員不必要的進(jìn)入。 B級(jí)潔凈區(qū)的設(shè)計(jì)應(yīng)當(dāng)能夠使管理或監(jiān)控人員從外部觀察到內(nèi)部的操作。 Article 27 The design of the clean premise should avoid the unnecessary access of supervision or monitoring person . Grade B area should be designed as that the inside operations could be monitored by supervision or monitoring person from outside 第二十八條 為減少塵埃積聚并便于清潔，潔凈區(qū)內(nèi)貨架、柜子、設(shè)備等不得有難清潔的部位。門的設(shè)計(jì)應(yīng)當(dāng)便于清潔。 Article 28 To reduce accumulation of dust and to facilitate cleaning there should be no uncleanable recesses on shelves, cupboards and equipment in cleaning area. Doors should be designed to avoid those uncleanable recesses. 第二十九條 無菌生產(chǎn)的 A/B級(jí)潔凈區(qū)內(nèi)禁止設(shè)置水池和地漏。在其它潔凈區(qū)內(nèi)，水池或地漏應(yīng)當(dāng)有適當(dāng)?shù)脑O(shè)計(jì)、布局和維護(hù)，并安裝易于清潔且?guī)в锌諝庾钄喙δ艿难b置以防倒灌。同外部排水系統(tǒng)的連 接方式應(yīng)當(dāng)能夠防止微生物的侵入。 Article 29 Sinks and drains should be prohibited in grade A/B areas used for aseptic manufacture. In other areas, sinks and drains should have proper design, layout and maintainance. Cleanable facilities with air break function should be fitted to prevent backflow. The connection with outside drain system should be designed to prevent microbial contamination. 第三十條 應(yīng)當(dāng)按照氣鎖方式設(shè)計(jì)更衣室，使更衣的不同階段分開，盡可能避免工作服被微生物和微粒污染。更衣室應(yīng)當(dāng)有足夠的換氣次數(shù)。更衣室后段的靜態(tài)級(jí)別應(yīng)當(dāng)與其相應(yīng)潔凈區(qū)的級(jí)別相同。必要時(shí)，可將進(jìn)入和離開潔凈區(qū)的更衣間分開設(shè)置。一般情況下，洗手設(shè)施只能安裝在更衣的第一階 段。 Article 30 Changing rooms should be designed as airlocks and used to provide physical separation of the different stages of changing and so minimize microbial and particulate contamination of protective clothing. They should be flushed 20 effectively with filtered air. The final stage of the changing room should, in the atrest state, be the same grade as the area into which it leads. The use of separate changing rooms for entering and leaving clean areas is sometimes desirable. In general hand washing facilities should be provided only in the first stage of the changing rooms. 第三十一條 氣鎖間兩側(cè)的門不得同時(shí)打開?？刹捎眠B鎖系統(tǒng)或光學(xué)或（和）聲學(xué)的報(bào)警系統(tǒng)防止兩側(cè)的門同時(shí)打開。 Article 31 Both airlock doors should not be opened simultaneously. An interlocking system or a visual and/or audible warning system should be operated to prevent the opening of both doors at a time. 第三十二條 在任何運(yùn)行狀態(tài)下，潔凈區(qū)通過適當(dāng)?shù)乃惋L(fēng)應(yīng)當(dāng)能夠確保對(duì)周圍低級(jí)別區(qū)域的正壓，維持良好的氣流方向，保證有效的凈化能力。 應(yīng)當(dāng)特別保護(hù)已清潔的與產(chǎn)品直接接觸的包裝材料和器具及產(chǎn)品直接暴露的操作區(qū)域。 當(dāng)使用或生產(chǎn)某些致病性、劇毒、放射性或活病毒、活細(xì)菌的物料與產(chǎn)品時(shí)，空氣凈化系統(tǒng)的送風(fēng)和壓差應(yīng)當(dāng)適當(dāng)調(diào)整，防止有害物質(zhì)外溢。必要時(shí)，生產(chǎn)操作的設(shè)備及該 區(qū)域的排風(fēng)應(yīng)當(dāng)作去污染處理（如排風(fēng)口安裝過濾器）。 Article 32 A filtered air supply should maintain a positive pressure and an air flow relative to surrounding areas of a lower grade under all operational conditions and should flush the area effectively. Particular attention should be paid to the protection of the zone of greatest risk, that is, the immediate environment to which a product and cleaned ponents which directly contact the product are exposed. The various remendations regarding air supplies and pressure differentials may need to be modified where it bees necessary to contain some materials, . pathogenic, highly toxic, radioactive or live viral or bacterial materials or products. Decontamination of facilities and treatment (eg. Install a filter at the exit) of air leaving a clean area may be necessary for some operations. 第三十三條 應(yīng)當(dāng)能夠證明所用氣流方式不會(huì)導(dǎo)致污染風(fēng)險(xiǎn)并有記錄（如煙霧試驗(yàn)的錄像）。 Article 33 It shoul