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 )