工作人员着装管理规程
一．目的Objective
规范工作人员着装管理，从服装的颜色和式样区别不同工作区域及工作职能人员，确保人员服装符合生产质量管理的要求，减少污染及交叉污染。
Standardise the management of staff dressing，make different areas and jobs of people from the color and style of clothing，ensure that staff dress in conformity with the requirements of production of quality management，reduce air pollution and cross contamination.
二．适用范围Scope
适用于生产区工作人员、化验室工作人员、辅助车间工作人员、来访人员的着装要求。
The requirements of dressing for visitors and staff in working area of Production and Ancillary Workshop、labouratory、warehouse.
三．责任者Responsibilities
来访人员、车间工人的职责：严格按照本规程相关内容执行。
Visitor/operator：Perform according to the relevant content of this SOP strictly.
班长、卫生员的职责：按本规程要求指导并监督工作人员的着装。
The team leader、the sanitation man: Guide and supervise staff dressing according to this SOP.
四．相关定义Definition
1.二连体洁净服：立领，衣裤相连，直开拉链，可自由收腰的洁净服。可选配披肩
帽、口罩、手套、高筒鞋和衣袋。
Stand-up collar, integrated coat and trousers, straight-open zip, free tight waist design, Matched hood, mask, gloves and boots available.
2.四连体洁净服：帽、衣、裤、袜相连，可自由收腰的洁净服。可选配口罩、手套、
衣袋。
Integrated coat,cap,trousers and socks, free tight waist design. Matched mask, gloves, pockets and dustproof glasses available.
五．工作程序Procedure
1.一般生产区着装要求
The requirements of dressing in general area
1.1.服装材质要求：
Material of garment
—易加工缝制，为涤卡、棉纶、的确良等面料。
Easy sewing process for polyester card, cotton acrylic, Dacron and other fabrics.
—耐清洗，洗涤后不易皱折。
Resistant to cleaning, washing easy to fold.
—透明度低，柔软，穿着舒适，不妨碍动作。
Transparency is low, soft, comfortable, without prejudice to the action.
1.2.物料仓库、公用工程车间、药材前处理、提取车间、合成车间一般区穿灰色或黄
绿色两件套涤卡工作服或蓝色一件套长大褂（夏季上身穿短袖的确良工作服），穿
黄色胶鞋或橡胶靴。
In the general area of storehouse、utility workshop、medicinal herbs processing、extracting workshop、synthesis workshop, the staff should wear gray or kelly twinset polyester working-clothes and yellow liberation shoes, or rubber boot if necessary.
1.3.药材前处理人员可戴防护帽及口罩，提取卸料工段头戴安全帽，合成车间一般区
操作工头戴安全帽，可根据需要佩戴防毒面具。
In the general area of medicinal herbs processing ,the staff shoud wear protective caps and masks.The staff should wear helmet in the general area of extracting workshop and synthesis workshop,or wear gas masks if necessary.
1.4.中心化验室一般区工作人员穿白色一件套长大褂，穿白工作鞋或一次性鞋套。The staff in general area of labouratory should wear a long white coat and working-shoes，or disposable shoe.
1.5.制剂生产车间一般生产区工作人员穿白色一件套长大褂，戴白色帽或一次性帽子，
穿白色工作鞋或一次性鞋套，其中岗位操作人员穿蓝色衣领长大褂，其余人员穿黄色衣领长大褂。
The staff in general area of production workshop should wear a long white coat and working-caps and working-shoes，or disposable cap and disposable shoe.Among of the staff，post operator is distinguished by blue collar.
2.洁净区着装要求
The requirements of dressing in clean area
2.1.工作服的材质要求：
Material of garment
—应为防静的碳纤维长丝、聚酯纤维长丝和涤纶长丝化纤混织物（无菌内衣材质应为棉质或仿绸），都能经121℃，20min湿热灭菌。
The material of working-clothes are carbon fiber filament and polyester fibre of anti-static yarn and polyester filament fiber, they could be sterilized by 121℃，20min.
—颜色为蓝色、黄色、白色、绿色。
Color is blue，yellow，white，green.
—车间可根据员工不同职务为其分配不同颜色洁净工作服，以便于区分管理。Workshop according to different position staff assigns different color clean overalls.
—发尘量小，不脱落纤维或微粒并能滞留身体散发的微粒。
A small amount of dust, fibers or particles do not fall off the body and can remain distributed particles.
—耐有机溶媒，耐清洗，耐蒸汽灭菌。
Resistant to organic solvents, washing, and steam sterilization.
—透明度低，柔软，穿着舒适，不妨碍动作。
Transparency is low, soft, comfortable, without prejudice to the action.
2.2. D级区着装要求
The requirements of dressing in D-class clean area and 100000-clean areas
—以上区域人员穿上下两件套蓝色工作服（上衣可连帽，下衣可连脚套）或者蓝色连体工作服(后背拉链式），戴蓝色内帽、蓝色口罩（采用与工作服连体面罩的除外），领口和袖口、裤腰松紧带等应收紧，对身体应作最大程度地遮盖，并能保证将头发、胡须等相关部位完全遮盖，穿蓝色工作鞋或带钉防滑工作鞋或洁净拖鞋、安全鞋。The staff should wear twinset dacron (or other non-silk and anti-static material )
working-clothes (the frock can connect with cap) or blue twinset dacron working-clothes (zipper located in the back)，blue caps and blue masks(the overalls siamese except). Collar, cuffs, waistband elastic band should be tightened，The body should be covered as much as possible, the beard, the hair completely covered.They also should wear blue working-shoes or clean slippers、safety shoes.
2.3.C级区着装要求
The requirements of dressing in C-class clean area
—以上区域人员可穿二连体或四连体黄色连体工作服
The staff should wear two connected or four connected yellow twinset dacron
working-clothes
—以上区域人员若穿二连体黄色连体工作服，应戴与工作服相同材质和颜色的口罩（采用与工作服连体面罩的除外），戴黄色内帽，戴黄色披肩帽，应确保头发完全包裹在内帽中，并收紧内帽松紧，领口和袖口、裤腰松紧带等应收紧，对身体应作最大程度地遮盖，并能保证将头发、胡须等相关部位完全遮盖，穿高筒鞋套后穿洁净拖鞋或其它合适材料制得的防滑工作鞋。
The staff should wear two connected yellow twinset dacron working-clothes，yellow masks(the overalls siamese except). Wear yellow collar, shawl, cuffs, waistband elastic band should be tightened，The body should be covered as much as possible, the beard, the hair completely covered. They also should wear high boots and clean slippers（or non-slip work shoes.
—以上区域人员若穿四连体体黄色连体工作服，应戴与工作服相同材质和颜色的口罩（采用与工作服连体面罩的除外），戴黄色内帽，应确保头发完全包裹在内帽中，并收紧内帽松紧，领口和袖口、裤腰松紧带等应收紧，对身体应作最大程度地遮盖，并能保证将头发、胡须等相关部位完全遮盖，穿洁净拖鞋或其它合适材料制得的防滑工作鞋。
The staff should wear four connected yellow twinset dacron working-clothes，yellow masks(the overalls siamese except). Collar, cuffs, waistband elastic band should be tightened，The body should be covered as much as possible, the beard, the hair completely covered.They also should wear clean slippers or non-slip work shoes.
—大容量注射剂车间胶塞投料前，投料人员应穿戴半身防护服用于防止人体脱落物于胶塞上。
The cast material personnel of large capacity injection workshop should wear half protective clothing before adding rubber plug to prevent the falling off human bod particles into the rubber plug.
2.4. A/B级、非最终灭菌无菌制剂灌装区和分装区着装要求
The requirements of dressing in A/B-class clean area and aseptic area
—以上区域人员着装从上到下依次为：戴无菌内帽（采用与工作服连体内帽的除外），戴有鼻夹式的口罩（若果无菌外衣工作服连体口罩的除外），穿上下两件套无菌内衣，上衣应塞入下衣内，戴无菌头披（采用与工作服连体头披的除外）。再穿绿色或白色连体工作服，戴颜色与材质与工作服相同的口罩（采用与工作服连体面罩的除外），应当能够保证将所有头发以及胡须等相关部位全部遮盖。穿可耐受灭菌的洁净工作鞋/靴，戴两层经灭菌且无颗粒物散发的橡胶或塑料手套或无菌手套，袖口应塞入手套内。进入A/B级区、非最终灭菌无菌制剂灌装区和分装区操作的人员必须佩戴眼罩。
The staff wear from the top down as: first put on aseptic inner-caps(the overalls siamese except), wear nasal clip-on cap and twinset aseptic inner-clothers，the coat should be covered by pants，wear aseptic head of the beatles(the overalls siamese except).then a onepiece set of full-body overalls green or white aseptic anti-static working-clothes，the color and material of mask is same as working-clothes（the overalls siamese except), the body should be covered as much as possible, the beard, the hair completely covered.all the material of working-clothes are carbon fiber filament (anti-static yarn) and polyester filament fiber, wear clean slipper and two aseptic gloves(cuff should be stuffed gloves)，they could be sterilized by 121℃.the staff in A/B-class clean area or aseptic filling should wear goggles.
2.5.进入洁净区内的物料仓库配料员、公用工程、化验室工作人员及有关检查人员着
装要求同该区域的生产操作人员。洁净区人员在当班生产结束离开洁净区时，应将穿后的洁净服放入指定容器，不得重复使用。每位员工每次进入A/B级洁净区、非最终灭菌无菌制剂灌装区和分装区，应当更换无菌工作服和无菌手套。
The ingredients entering the clean area of the warehouse staff, utilities, laboratory staff and the inspector dress code with the production operators in the region. Officers are on duty clean out the production end of the clean area, should wear clean clothes after the containers into specified shall not be reused. Everytime staff enter A/B-class clean area or aseptic filling should change their aseptic working-clothes and aseptic glove.
2.6.进入C/D级洁净区若使用一次性口罩、鞋套、帽子，需在相应级别的洁净区才能
打开内包装，防止该类物料对洁净区的污染。
If the use of disposable face masks, shoe covers, hats, to enter the C/D-class clean area to be in the appropriate level of cleanliness within the district to open the packaging, to prevent such material contamination of clean areas.
2.7.同一生产车间不同洁净级别的工作区域，工作服的颜色应不相同。
The color of clean working-clothes is different. according to different clean area.
2.8.人员进入洁净区，应尽量减少人员自身衣物，特别是容易脱落毛丝纤维的衣物，
如毛衣等，进入A/B级区、非最终灭菌无菌制剂灌装区和分装区操作的人员须将衣物褪至内衣后穿戴无菌工作服。
The staff should reduce their own clothing as much as possible,specifically which easy to fall off wool silk and fibers,such as sweater. Everytime staff enter A/B-class clean area or aseptic filling should reduce theie own clothing to the underwear.
2.9.车间应建立人员净化管理规程，详细规定着装要求，根据具体情况在此基础上提
高要求，进一步防止污染或交叉污染。产尘量大或头孢、抗肿瘤车间，可根据需要佩戴防尘或防毒面罩。
The workshop should build up the SOP for personnel decontamination, describe the dressing requirements in detail.The staff of cephalosporin workshop or anti-tumor workshop could wear a dust-proof mask or anti-virus mask.
3.来访人员着装要求visiting staff dress code
3.1.来访人员在1.2和1.3范围内参观可穿随身衣服，若车间有管理要求，需按照相应
的要求执行。在1.4和1.5范围内参观穿白色参观服，戴一次性帽子，穿一次性鞋套。
The range of visitors who visit in the 1.2 and 1.3 player to wear clothes, if the plant has management requirements, they need to perform in accordance with the corresponding
requirements. In the range of 1.4 and 1.5 visits to visit wearing a white suit, wearing disposable cap and shoe covers.
3.2.来访人员进入生产车间一般生产区、洁净区时，来访人员接受车间提示、阅读指
导及更衣培训后需填写《车间生产区临时进入人员登记表1169》及《车间生产区临时进入人员核对表1034》经批准后方可进入，具体要求参照《生产区人员卫生管理规程1-00014》执行。进入A/B级区、非最终灭菌无菌制剂灌装区和分装区参照《无菌作业区人员资格确认程序1-00134》执行。
The visiting officer to enter the general workshop production area, clean area, visit the workshop staff to accept tips, read the guide should be completed, visit the workshop to guide personal hygiene, dressing and other proc edures, and fill out the “Registration Form for extra personnel temporary access to Workshop 1169” and “Check list of personnel temporary access to the workshop 1034”,should get approval before entering, and specific requirements refer to “SOP for personne l hygiene 1-00014” implementation. Staff enter A/B-class clean area or aseptic filling should specific requirements refer to “Confirmation process of qualification for staff in sterile operating area 1-00134”。
4.工作服管理要求uniform administrative requirements
4.1.工作服由使用部门指定专人管理，由管理人统计工作服编号和尺码，填写《车
间工作服、鞋编号4103》，并定期更换、报废工作服。其中A/B级区工作人员所穿戴无菌工作服可以不指定个人，根据车间所分配顺序号区间使用。
The clothing department designated person by the use of management, statistical work clothes from the manager number and size, fill in “No. of Wor kshop clothes, shoes.4103”, and change them regularly, scrap clothes. The clothing of A / B –class clean area was not designated individuals, uesd in accordance with the assigned sequence number interval.
4.2.各车间工作服报废更换期限：C级和A/B洁净服、筒鞋清洗灭菌次数不超过验证最大使用次数，破损或严重污染应及时更换，其中，无菌连体服袖口、脚口破损，或衣物表面出现破洞、衣物自身毛丝必须报废，无菌鞋鞋底变形或出现破损，必须报废；D级洁净服破损后作报废处理。洁净服的报废应有记录，并应注明报废原因，C级及以上区域洁净服的清洗灭菌应填写《车间洁净服清洗灭菌次数记录表1309》。
The service life of the clothes of A/B/C-class clean area could be sterilized not more than verification times. It must be replaced immediately when necessary. The service life of the clothes of D-class clean area must be replaced immediately when necessary. The clothes retirement should be recorded and should indicate the reasons for retirement，and fill in“Registr ation Form for the number of cleaning and sterilization of clean-clothes1309”。
—洁净工作服清洗时不得使用洗衣粉，可使用洗衣皂，防止带入颗粒性污染物。
Washing powder is prohibited for cleaning clean-clothes，it should use laundry soap. —灭菌次数填写完毕表示该套工作服需进行更换，更换后，须在最后一次洁净服清洗记录备注栏中记载该编号工作服已经更换。
It is time to change this clothes when the row is fill in completely. The change should be recorded in the cleaning records of the clothes.
—洁净服有破损或严重污染时及时更换，将本行记录中剩余表格写“N/A”，更换新工作服后重写进行记录，并在相应洁净服清洗记录备注栏中记载该编号工作服已经更