STPYZ105-00SW-CJ-2FD型净化工作台验证方案.doc
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STPYZ105-00SW-CJ-2FD型净化工作台验证方案.doc
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大连昆阳制药有限公司 STP/YZ105-00 第7页共6页
SW-CJ-2FD净化工作台验证方案
起草人:
审核人:
批准人:
起草部门:
起草日期:
审核日期:
批准日期:
执行日期:
验证小组会签
部门
岗位
签名
签名日期
颁发部门:
[质量部]
Copy№:
[]
行政部[]物供部[]质量部QA[]质量部QC[]研发部[]生技部[]
疫苗车间[]分包装车间[]工程部[]保安部[]营销部[]财务部[]
变更记载:
修订号批准日期执行日期
00
变更原因及目的:
建立验证文件,并通过验证证明所验证对象有效、稳定、可靠。
目录
验证方案·····································································································································3
1概述···································································································································3
2目的···································································································································3
3职责···································································································································3
4内容···································································································································3
4.1预确认·······················································································································3
4.2安装确认·······························································································3
4.3运行确认···················································································································3
4.4性能确认···················································································································3
4.4.1目的·······················································································································4
4.4.2可接受标准···········································································································4
4.4.3静态尘埃粒子检测·······························································································4
4.4.4静态沉降菌检测···································································································4
5日常监控···························································································································4
附件1:
确认内容及可接受标准
附件2:
资料档案确认表
附件3:
安装确认记录表
附件4:
运行确认记录表
附件5:
静态尘埃粒子确认记录表
附件6:
静态沉降菌确认记录表
验证方案
1概述
净化工作台主要用于为试验提供百级试验环境,减少试验过程中微生物污染的机率,为试验检测数据的准确性提供重要的保障。
因此必须对净化工作台进行验证,以确保该设备能提供一个长期稳定的洁净环境,确保检验数据的真实可靠。
本方案规定了净化工作台的验证方案及接受标准,依据是净化工作台的使用说明书和《SW-CJ-2FD型净化工作台使用、维护保养标准操作规程》
2目的
对该设备进行验证,以确保该设备能提供稳定的洁净环境,确保检验数据的真实可靠。
3职责
质量部QC室:
负责起草质量部QC室净化工作台的验证方案,报告及验证实施。
工程部:
协助质量部进行净化工作台的验证实施。
验证小组:
负责验证方案的实施、验证方案与验证报告的审核会签。
验证管理员:
负责对验证过程进行协调检查。
QC检验员:
负责验证中的取样检验,测试检验数据,并出具准确的检验报告。
4验证内容
4.1预确认:
见附件1
4.2安装确认
4.2.1资料档案:
确认内容见附件2。
。
4.2.2安装确认:
确认内容见附件3。
4.2.3仪表检验尘埃粒子计数器由生产厂家进行校验。
4.3运行确认
4.3.1目的
4.3.1.1对标准操作规程的适用性进行确认。
4.3.1.2检查确认系统运转是否正常,并符合技术参数要求。
对操作规程的适用性进行确认。
4.3.1.3测试记录见附件4。
4.4性能确认
4.4.1目的
4.4.1.1检查确认系统运转是否正常,并符合技术参数要求,满足工作需要。
4.4.1.2对操作规程的适用性进行确认。
4.4.2可接受标准:
操作各控制器时,应灵活有效,洁净度应符合技术参数要求。
4.4.3静态尘埃粒子检测
4.4.3.1目的
考察设备运行时能否达到百级环境内尘埃粒子数的要求
4.4.3.2测试与方法:
4.4.3.2.1按《SW-CJ-2F型净化工作台使用、维护保养标准操作规程》进行操作,开启净化工作台通风30分钟。
4.4.3.2.2按《CLJ-BM型尘埃粒子计数器使用、维护保养标准操作规程》进行操作,将仪器自净20分钟后进行检测。
4.4.3.2.3取净化工作台左、中、右三个点进行检测,每个点打印数据三次(见附件5)。
4.4.4静态沉降菌检测
4.4.4.1目的
考察设备运行时能否达到百级环境沉降菌数≤1/皿的要求
4.4.4.2测试与方法:
4.4.4.2.1按《SW-CJ-2F型净化工作台使用、维护保养标准操作规程》进行操作,开启净化工作台通风30分钟。
4.4.4.2.2将已预孵合格的φ90mm琼脂平皿五个分别放置在净化工作台上两个、中一个、下两个,打开平皿盖子,暴露30分钟后盖上盖子,将平皿放入35~37℃恒温培养箱中培养48小时,记录菌落数(见附件6)。
5日常监控
(1)在日常运行中要经常检查设备的运行状况。
(2)日常监控:
QC人员每个月监测。
(3)正常情况下系统每年做一次验证。
附件1:
确认内容及可接受标准
确认内容
可接受标准
确认结果
确认人
电源电压
220V50Hz
尘埃粒子数(0.5μm)
≤3500个/m3
尘埃粒子数(5μm)
≤0个/m3
沉降菌数
≤1
平均风速
0.35M/S±20%
结论:
实施人:
日期:
审核人:
日期:
附件2:
资料档案确认表
确认内容
存放处
确认结果
确认人
使用说明书
产品合格证
结论:
实施人:
日期:
审核人:
日期:
附件3:
安装确认记录表
确认内容
接受标准
确认结果
确认人
主机外观
无损伤,表面喷涂处理或为不锈钢材料
安装位置
SW-CJ-2FD无菌检查室
环境要求
万级洁净室内,地面应平整
结论:
实施人:
日期:
审核人:
日期:
附件4:
运行确认记录表(无菌检查室)
确认内容
接受标准
确认结果
确认人
标准操作规程适用性
适用
仪器运转情况
正常
结论:
实施人:
日期:
审核人:
日期:
附件5:
静态尘埃粒子确认记录表(无菌检查室)
确认内容
可接受标准
确认结果
确认人
左侧
≤3500个/m3(0.5μm)
≤0个/m3(5μm)
中部
≤3500个/m3(0.5μm)
≤0个/m3(5μm)
右侧
≤3500个/m3(0.5μm)
≤0个/m3(5μm)
结论:
实施人:
日期:
审核人:
日期:
附件6:
静态沉降菌确认记录表(无菌检查室)
确认内容
可接受标准
确认结果
确认人
1
≤
2
≤
3
≤
4
5
结论:
实施人:
日期:
审核人:
日期:
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