PQ Protocol Master Document
document有安卓版吗Objectives目的: Use this document as the master test document to verify that the verify that the performance of the LYOTK15 lyophilizer is operated in accordance with the URS and the associated design specifications.
该文档作为测试主文档，用来验证LYOTK15冻干机的操作与URS及设计描述一致
Customer Name:
用户名:
XXXX股份有限公司
Document No:
文档编号:
DG13032-PQ-R1.0
Author 编制:
Name姓名Title职位Signature签字Date日期Reviewed By审核:
Name姓名Title职位Signature签字Date日期Approved By批准:
Name姓名Title职位Signature签字Date日期
Note: The expiry date of a paper copy of this document is the day it was printed.
注意: 该文档复印件仅在打印当日内有效。
Revision history版本记录:
Revision
版本号
Date日期Name名称Description描述
0.0 2012/10/08 YRX First revision, SIT master document release for the Lyotruking project 测试主文档第一次下发，初稿
1.0 2014/05/03 WYC Adapt for the project 为本项目而修改
List of content目录
1.Nomenclature and Abbreviations术语和缩写 (4)
2.System description系统描述 (6)
2.1Project Configuration 项目配置 (6)
2.2Acceptance Standard验收标准 (7)
3.Execution Requirements执行要求 (8)
3.1Execution Rules & Practices 执行标准&测试 (8)
4.Pre-Test Verification测试前的验证 (12)
4.1Test Equipment Calibration Review测试仪器标定审核 (12)
5.Performance Verification性能验证 (14)
5.1Heat distribution study (Unloaded) 热分布测试(空载) (14)
5.2Biological Indicators Challenge Study 生物指示剂挑战测试 (24)
5.3Freeze Drying Process Study(Full Load) 冻干工艺曲线测试（满载） (28)
5.4Product moisture test after Freeze Drying 冻干后水分测试 (31)
5.5Product visual inspection after Freeze Drying冻干后产品灯检 (33)
6.Exceptional Conditions偏差 (35)
1. Nomenclature and Abbreviations术语和缩写
The following nomenclature and abbreviations are allowed to be used in this master document and the appendices (where applicable) 本主控文件和附录允许使用以下术语和缩写（适用条件下）：TRK          Truking technology limited楚天科技股份有限公司
BOM      Bill Of Material材料清单
BPE          Bio-Processing Equipment 生物过程设备
CIP Clean In Place在位清洗
CFR  Code of Federal Regulations联邦法规
DP Differential Pressure差压
ECD  Electrical Circuit Diagrams电路原理图
E-Stop Emergency Stop紧停
F/W Firmware紧固件
FAT Factory Acceptance Test工厂验收检测
FIT Filter Integrity Test过滤完整性测试
FS Functional Specifications功能描述
GA General Arrangement总体布局
GB Chinese standard国标: 中国国标缩写
GMP Good Manufacturing Practices药品生产质量管理规范
HDS  Hardware Design Specifications硬件设计描述
H/W  Hardware硬件
HMI Human Machine Interface人机界面
I/O Input / Output输入/ 输出
IP Internet Protocol互联网协议
IQ Installation Qualification安装验证
LRP  Liquid Ring Pump(液环泵、水环泵)
N/A Not Applicable不适用
N/T Not Tested未检测
No. Number序号
OIP Operator Interface Panel操作面板
OQ Operation Qualification操作验证
P/N Part Number零件编号
P&I D Piping and Instrumentation Diagrams管道和设备原理图设计
PC Personal Computer个人计算机
PLC  Programmable Logic Controller可编程逻辑控制器
PQ          Performance Qualification 性能确认
PW Purified Water纯水
RTD  Resistance Temperature Detector热电阻
S/N Serial Number编号
S/W Software软件
SAT Site Acceptance Test现场验收检测
SCADA Supervisory Control And Data Acquisition上位机监视控制及数据采集
SDS  Software Design Specifications软件设计描述TBA  To Be Agreed待通过
TBD  To Be Determined待确定
UPS  Uninterruptible Power Supply不间断电源URS  User Requirement Specifications用户要求描述USB  Universal Serial Bus USB通用串行总线
SIT Supplier Internal Testing制造商内部测试
WFI Water For Injection注射水

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