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2024年6月23日发(作者:)
Purified Water System Performance Qualification
纯化水系统性能确认
Code: VP402
编号:
Page: 1 OF 22
第 1 页 共 22 页
Version: A
版本:
Date:
日期:
EXECUTION APPROVAL SIGNATURES
批准执行签名
The signatures below indicate approval of this protocol and its attachments and indicate that it is ready for
execution. Any changes or modifications to the intent or the acceptance criteria of this protocol, following
approval, requires the generation of an amendment which must be approved prior to execution.
下面的签名表示批准本文件及其附件,且表明已经为执行作好了准备。在批准后,对本文件的目的或验收标
准进行的任何改变或修正都必须起改善的作用,在执行以前就必须取得批准。
Issued by
起草
Department & Site
单位部门
Reviewed by
审核
Authorized by
批准
Signature & Date
签名与日期
Purified Water System Performance Qualification
纯化水系统性能确认
Code: VP402
编号:
Page: 2 OF 22
第 2 页 共 22 页
Version: A
版本:
Date:
日期:
Contents
目录
1.0
2.0
3.0
4.0
5.0
6.0
7.0
SCOPE 范围 ....................................................................................................................................................... 3
PURPOSE 目的 .................................................................................................................................................. 3
BACKGROUND 背景 ....................................................................................................................................... 3
INTRODUCTION 介绍 ..................................................................................................................................... 3
REFERENCES 参考书目 .................................................................................................................................. 4
RESPONSIBLE PARTIES AND RESPONSIBILITIES 责任方及其责任 ................................................... 4
SYSTEM DESCRIPTION 系统说明................................................................................................................ 6
G
ENERAL
D
ESCRIPTION
总说明 ....................................................................................................................................... 6
P
RETREATMENT
U
NIT
预处理单元 .................................................................................................................................. 6
R
EVERSE
O
SMOSIS
(RO)
S
YSTEM
反渗透
(RO)
系统 ...................................................................................................... 7
M
IXED
B
ED
S
YSTEM
混床系统 ........................................................................................................................................ 8
M
ONITOR AND
C
ONTROL
S
YSTEM
监视和控制系统 ....................................................................................................... 9
8.0
9.0
TESTING PROCEDURES 检验程序 .............................................................................................................. 9
ACCEPTANCE CRITERIA 验收标准 .......................................................................................................... 10
A
TTACHMENT
1
-
V
ALIDATION
T
EST
E
QUIPMENT AND
M
ATERIALS
附件1
–
验证测试设备和材料 ............................ 11
A
TTACHMENT
2
–
PW
S
YSTEM
30
D
AY
S
AMPLING
P
LAN
D
ATA
S
HEET
附件2
–
纯化水系统30天取样计划数据表 . 12
ND
A
TTACHMENT
3
–
2
P
HASE
PW
S
YSTEM
S
AMPLING
P
LAN
D
ATA
S
HEET
附件3
–
纯化水系统第二阶段取样计划数
据表 ................................................................................................................................................................................ 15
A
TTACHMENT
4
-
PW
S
AMPLE
T
EST
R
ESULT
F
ORM
附件4
-
PW样品测试结果表 ...................................................... 18
A
TTACHMENT
5
-
S
IGNATURE
V
ERIFICATION
L
IST
附件5
-
签名确认清单 ................................................................... 19
A
TTACHMENT
6
-
P
ROTOCOL
D
EVIATION
L
OG
附件6
-文件偏差日志 ......................................................................... 20
A
TTACHMENT
7
-
P
ROTOCOL
D
EVIATION
R
ECORD
附件7
-
文件偏差记录 .................................................................. 21
A
TTACHMENT
8
-
P
ROTOCOL
E
XECUTION
A
PPROVAL
S
IGNATURES
D
ATA
S
HEET
附件8
-文件执行批准签名数据表 . 22
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