洁净区区环境卫生管理规程

目 录

1.目的···························································································································· 2

2.适用范围···················································································································· 2

3.责任···························································································································· 2

4.定义···························································································································· 2

5.程序···························································································································· 2

5.1.洁净区环境卫生要求···························································································· 2

1.目的：

建立洁净区环境卫生管理规程，保证环境卫生；防止污染、交叉污染。

2.适用范围：

洁净区的环境卫生管理。

3.责任：

车间操作人员、班组长、车间主任对本标准的实施负责；QA督导员、质量部经理、生产部经理负责监督执行。

4.定义：无

5.程序：

5.1. 洁净区环境卫生要求

5.1.1.车间内窗明壁净，设施（顶棚、灯具、送风口、墙壁、回风口、排风口等）见本色（无乳尘、无霉斑，无脱落），表面平整光滑，无不清洁死角。

5.1.2.地面光滑、平整、清洁、无积水、无残留物、无脱落；地漏密封、干净无积垢。

5.1.3.生产操作间安装照明设施应符合要求（主要工作室的照度宜为300勒克斯）。

5.1.4.设备、工作台必须保持表面整洁、完好、无脱落，摆放整齐，不得随意挪动。

5.1.5.一切非生产用品禁止带入洁净区，不得从事与生产无关的活动。

5.1.6.走廊、缓冲间不得放置任何物品，应保持通道的清洁、畅通。

5.1.7.洁净区的门及所有闭锁装置应完好，缓冲间（人流、物流）两侧门不能同时打开。

5.1.8.生产过程中产生的废弃物及时装入洁净的不产尘容器或口袋中密封→放指定地点，并按PMS《生产废弃物处理规程》执行，在工作结束后，将其清除出洁净区。

5.1.9.洁净区整体消毒按EOS《洁净区薰蒸消毒操作规程》执行。

5.1.10.消毒剂应