针剂车间空调净化系统验证方案.docVIP

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针剂车间空调净化系统

STP03-TY004-Ⅰ

验证方案

辽宁诺康生物制药有限责任公司设备工程部

目录

1目的··············································································3

2范围··············································································3

3职责··············································································3

4内容··············································································3

4.1概述············································································3

4.2验证小组成员及职责······························································3

4.3验证时间········································································4

4.4验证人员的培训··································································4

4.5文件检查········································································4

4.6性能确认········································································4

4.7空调系统的再验证周期···························································10

4.8漏项及偏差处理································································11

4.9验证最终结论··································································11

5附录············································································11

1目的

核实针剂车间空气净化系统的设计、安装符合要求，资料和文件齐全。为证明空调净化系统能够保证车间各洁净区域所需技术参数达到GMP（98年版）关于洁净厂房的要求，满足产品生产工艺对环境洁净级别的要求，特制订本验证方案。

2范围

本方案适用于针剂车间空气净化系统性能确认的验证。

3职责

验证小组对本方案的实施负责。

4内容

4.1概述

本次验证车间位于车间二楼，用于针剂生产车间，总面积1638m2，其中净化区面积905m2。由吉林医药设计院设计，沈阳天马医药工程安装有限公司施工。车间空气净化采用初、中、高效三级处理，洁净区内采用顶送侧下回，净化空调风量分别是14000m3/小时和15000m3/小时，万级净化空调风量27000m3/小时，送回风方式为顶送侧下回。在送风管道装有臭氧发生器用于系统消毒灭菌。

本公司针剂车间空调系统于2007年6月份完成了安装确认、运行确认、性能确认等系统验证，已经证明该系统可以保证针剂车间内洁净区所需技术参数达到GMP（98年版）关于洁净厂房的要求，且满足生产工艺。本次针剂车间空调系统再验证针对其性能进行检测，因此只做性能确认。

4.2验证小组成员及职责

4.2.1验证小组成员

小组职务

姓名

所在部门

职务

负责人

郁野

副总经理

组长

王弘

设备工程部

经理

组员

沈文彧

质量管理部

经理

组员

宋宇春

生产技术部

经理

组员

于彦

空调岗位

操作工

4.2.2验证小组成员职责

4.2.2.1验证小组负责人：负责验证方案、验证报告的批准；负责从验证方案的起草、方案的实施以及验证报告完成全过程的组织工作。

4.2.2.2组长部门：

设备工程部：负责验证方案的起草；组织验证方案的实施；参加验证方案、验