PW系统PQ(中英文)

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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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