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water for injection

2008-11-07 15:28:38| 分类： QA | 标签： |举报 |字号大中小订阅

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General Comments:

总体评论

As per USP for Chemical Analysis, TOC and Conductivity is OK, but if Chinese (CP) requires more tests, please feel free to perform and adjust attachments accordingly.

1．按照USP进行化学分析，总有机碳（TOC）和电导率的检测是可行的，但是如果中国药典需要更多的检测，请随意执行并对附件作相应的调整。

Please note file the raw data with the final PQ report, however, summary Tables are designed for the entry of Micro, Endotoxin and Chemical testing data of Phase-I & II. These sheets contains 7 days entries (including weekends), therefore copy these sheets for the two weeks data. It is acceptable and instructions are added in the protocol.

2. 请注意用最后的性能确认报告（PQ）递交原始数据，然而，概述表格是被设计在用于阶段-I&II的微生物，内毒素和化学检测数据的输入。这些表格包括7天的数据输入（包括周末），因此复印这些表格用于输入两个星期的数据。是可接受的，说明包括于方案中。

System Name

系统名称

WFI System

WFI(注射用水)系统

System Number

系统号

System Type

系统类型

Utilities

公用设施

Protocol Number

方案号

Protocol Type

方案类别

Performance Qualification

性能确认(PQ)

Location

位置

Revision History

修改情况

Rev. Number

修改号

Date

日期

Description

叙述

By

修改人

1.0 PRE- EXECUTION APPROVAL

1.0 执行前批准

Author’s Signature ：编写人签名：

Name

姓名

Department

部门

Title

头衔

Signature

签名

Date

日期

Author:

编写人

Reviewer’s Signature：审核人签名

Name

姓名

Department

部门

Title

头衔

Signature

签名

Date

日期

Reviewer:

审核人

Reviewer:

审核人

Reviewer:

审核人

Reviewer:

审核人

Approver’s Signature：批准人签名

Name

姓名

Department

部门

Title

头衔

Signature

签名

Date

日期

Approver：

批准人

Approver：

批准人

2.0 TABLE OF CONTENTS

1.0 PRE- EXECUTION APPROVAL....................................................................... 2

执行前批准

2.0 TABLE OF CONTENTS...................................................................................... 2

3.0 Purpose............................................................................................................. 4

目的

4.0 Qualification Scope................................................................................... 4

确认范围

5.0 Responsibilities............................................................................................ 4

职责

6.0 Execution Procedure.............................................................................. 4

执行方法

7.0 System OVERVIEW.......................................................................................... 4

系统概况

8.0 PQ DOCUMENTATIONS VERIFICATION ................................................... 4

PQ文件确认

8.1 SOP List ............................................................................................................ 5

SOP 列表

8.2 Test Instrument and Calibration................................................................... 7

检测仪器和校正

9.0 Testing Program of Performance Qualification ................. 8

PQ确认的检测程序

9.1 Sampling Method and Sampling Plan........................................................... 9

取样方法和取样计划

9.2 Test Program .................................................................................................. 10

检测程序

10.0 disposal of Accident, Deviation and nonconformance.. 11

事故，偏差和不符合的处理

10.1 Purpose............................................................................................................... 11

目的

10.2 Procedure........................................................................................................... 11

方法

10.3 Acceptance Ctriteria ................................................................................... 12

认可标准

11.0 Log of attachment................................................................................... 15

附件记录

12.0 REFERENCES................................................................................................... 17

参考文献

13.0 Conclusion Report.................................................................................. 18

结论报告

14.0 Conclusion of verification................................................................ 20

确认结论

3.0 Purpose

目的

Brief descriptions on the purpose of this protocol

对此方案的目的作简明叙述

4.0 Qualification Scope

确认范围

Brief descriptions on the scope.

对确认范围作简明叙述

5.0 Responsibilities

职责

List the names of the team leader and team members for this protocol.

列出此方案工作小组的领导和成员的姓名

List the department names for these members. Production, Engineering and Maintenance, Validation, QC and QA should be part of the team.

列出这些成员的部门名称。生产部，工程部和维护部，验证，QC和QA应是工作小组的一部分

Describe in detail the responsibilities of each member.

详细叙述每一成员的职责

6.0 Execution Procedure

执行方法

Write a detail procedures on how to prepare and approve this protocol; how to execute this protocol; how to handle accidents, deviations and non-conformances during protocols execution; and how to do sampling; how to analyze the executed data; how to write report.

编写出详细方法, 关于如何准备和批准此方案；如何执行此方案，如何处理方案执行中的事故，偏差和不符合，以及如何取样，如何分析执行后的数据，如何编写报告.

7.0 System OVERVIEW

系统概况

Write a detail procedures on how to prepare and approve this protocol; how to execute this protocol; how to handle accidents, deviations and non-conformances during protocols execution; and how to do sampling; how to analyze the executed data; how to write report.

编写详细方法,关于如何制订和批准此方案，如何执行此方案，如何处理方案执行时的事故，偏差和不符合，如何取样，如何取样，如何分析执行后的数据，及如何编写报告。

8.0 PQ DOCUMENTATIONS VERIFICATION

PQ文件确认

The table below lists out all documentations needed to be completed for performance qualification of WFI system.

如下表格列出了所有的WFI系统PQ需要完成的文件

Number

编号

Documentation to be verified

需要确认的文件

Required(Y/N)

要求（是/否）

8.1

Sop list

标准操作规程列表

Y

是

8.2

Test Instrument and Calibration

检测仪器和校正

Y

是

8.1 SOP List

SOP列表

Table 8.1 SOP list

表8.1 SOP列表

Doc. Name

文件名称

Doc. Number

文件号

Type

类型

Effective Date

有效日期

Verified by

确认人

Date

日期

Sampling SOP for WFI

WFI取样SOP

Operation

操作

Specification and test procedure WFI

WFI质量标准和检测方法

Operation

操作

SOP for conductivity meter

电导仪SOP

Operation

操作

SOP for pH Meter

pH计SOP

Operation

操作

SOP for microbiological limit test

微生物限度SOP

QC

Test procedure for bacterial endotoxin

细菌内毒素检测方法

QC

SOP for TOC tester

总有机碳检测仪SOP

Operation

操作

SOP for monitoring tendency analysis and risk assessment of water system

检测趋势分析和水系统风险评估SOP

Operation

操作

Remarks：

附注：

Result (Please tick at the appropriate boxes below :)

结论（请在下面合适的空格中打勾）

Pass 5 Fail 5

通过未通过

Verified by

确认人

Signature

签名

Date

日期

Reviewed by

审核

Signature

签名

Date

日期

8.2 Test Instrument and Calibration

检测仪器和校正

All instruments and equipments used during WFI performance qualification which required calibration has been listed in table 8.2-1. All deviation shall be explained in comment part of the table.

所有的在WFI PQ中使用的仪器和设备，它们需要校正，在表8.2-1列出。所有的偏差须在表格的评论部分解释

Result Sheet 8.2-1 – Test Instrument and Calibration

结果表8.2.1—检测仪器和校正

Name of Instrument

仪器的名称

Number of Equipment

设备号

Function

功能

Validity Period of calibration

校正的有效期

Check-ed by

审核

Date

日期

pH meter

pH计

Test the pH value of WFI

检测WFI的pH值

Conductivity meter

电导仪

Test the conductance of WFI

检测WFI的电导率

Remarks：

附注：

Result (Please tick at the appropriate boxes below :)

结论（请在下面合适的空格中打勾）

Pass 5 Fail 5

通过未通过

verified by

Signature

Date

Reviewed by QA

Signature

Date

确认人

签名

日期

QA审核

签名

日期

9.0 Testing Program of Performance Qualification

PQ检测程序

Attach the WFI schematic including all the pint of use.

附上WFI示意图，包括使用的品脱.

PQ will be performed in three phases as per current industry trend.

按照当前行业趋势，PQ分三个阶段进行

During performance qualification studies, the still and its distribution system will be sampled and tested as given below:

在PQ研究中，蒸馏釜和其分布系统按如下方法取样及检测：

Phase I: During this phase, the frequency of cleaning and sanitization of WFI system and its storage and distribution lines will be established. The water samples will be taken daily including weekends for four consecutive weeks from xxxx locations and will be tested for chemical, microbial and endotoxin level. In addition to WFI water, the feed water (Purified water from RO system) will also be tested. This is considered development stage, if during actual execution, any problem encountered, the duration of this stage can be prolonged until problem is resolved satisfactorily.

阶段I：在此阶段，WFI系统清洁和消毒频率以及储存和分布线需要确定。水样需从XXXX位置每天取，包括周末，连续取四周，需要检测化学，微生物和内毒素水平。除了WFI水，饮用水（来自反渗透RO系统的纯化水）也需要检测。这被认为开发阶段，若在实际的执行过程中，碰到任何问题，这一阶段可以延长直至问题得到满意的解决。

Phase II: During this phase, the WFI system will be operated and maintained according to the parameters established during Phase-I. Phase-II study will be performed to demonstrate the effectiveness of cleaning /sanitization method, its frequency and other operating parameters like operating temperature and water flow rate. The water samples will be taken daily including weekends for four consecutive weeks from xxxx locations and will be tested for chemical, microbial and endotoxin level. In addition to WFI water, the feed water to WFI (Purified water from RO system) will also be tested.

简短II：在这一阶段，WFI系统应根据阶段I建立的参数操作和维护。进行阶段II研究以证明清洁/消毒方法，频率和其它的操作参数，如操作温度和水流速的有效性。水样从XXXX位置每天取，包括周末，连续取四周，要检测化学，微生物，和内毒素水平。除了WFI水，饮用水（来自反渗透RO系统的纯化水）也需要检测。

Upon successful completion of above two Phases, a report will be written and approved and WFI system can be used for its intended use. However Phase-III testing will be continued for a year.

在成功完成上面两个阶段后，编写报告，批准。WFI系统可以用于指定的用途，然而，阶段III检测还需要持续进行一年。

Phase III: As per this protocol, the Phase-III study consists of a one-year sampling period after the completion of Phase-II. During the phase III, the WFI will be tested as per routine monitoring SOP # xx Title” xxxx” . During this phase, it will be verified that the WFI system is capable of continuously producing quality WFI water for a long period of time. Upon completion of Phase-III study, the data will be trended and evaluated to determine any seasonal affect or the variation in the quality of feed water which may adversely affect the final water of Injection quality. A phase-III Summary Report will be submitted for review and approval.

阶段III：按照此方案，阶段III研究包括在阶段II完成后一年的取样期。在阶段III期间，WFI将按照常规检测SOP#XX 标题XXXX”检测。在这一阶段，可以证明WFI系统可以持续地长期地生产WFI质量的水。在阶段III完成的基础上，分析数据趋势，并评估确定饮用水质量季节性的影响或变化，其可以对最后注射水有不利的影响。递交阶段III概述报告，以审核和批准。

Testing: The WFI will be tested for Physical, Chemical, Microbial and Biological quality.

检测：注射用水WFI需要检测物理的，化学的，微生物的和生物的质量

Physical: Appearance, Conductivity -USP <645>

物理的：外观，电导率-USP<645>

Chemical: Total Organic Carbon USP <643> (TOC),

化学的:总有机碳 USP <643> (TOC)

(Sulfate, Oxidizable substances, Chloride, Carbon dioxide, ammonia, Calcium),

(硫酸盐,氧化物质,氯化物,二氧化碳,铵,钙)

Microbial: Total Count by Membrane Filtration Method USP<1231>

微生物: 膜过滤总菌数 USP<1231>

Biological: Endotoxin Level by LAL Testing USP <85>

生物的: LAL检测的内毒素水平 USP<85>

Sampling Sites: The sites to be sampled and tested are given in below. For their actual location, refer to the attached Figure -1 titled “Schematic of WFI system”.

取样点: 取样和检测的地点如下给出.对实际的位置, 参考附图-1 WFI 示意图

S.No

编号

Sections

部分

Sampling Site ID # 取样点 ID

Site description and usage

取样点叙述和使用

1

Feed (source )

饮用水

PW-1

Feed water from RO system

来自RO系统的饮用水

2

WFI system

(Generation)

WFI系统

3

4

Storage

储存

5

6

Points of Use

使用点

7

8

9

10

11

Data Entry: Raw data can be entered on the Lab sheets designed for specific test, however, upon completion of each phase the data will be summarized on the appropriate Attachments provided at the end of this protocol.

数据输入:原始数据可以输入到实验室特定检测用的表格中,然而,基于每一阶段的完成,数据需要根据本方案后提供的附件进行概述.

9.1 Sampling Method and Sampling Plan

取样方法和取样计划

Use sampling techniques as per Sampling SOP for WFI

按照WFI取样SOP使用取样技术

Sampling of WFI shall be conducted at both upstream and downstream of WFI system during each phase., During Phase-I and II, all sites will be tested, however during Phase-III, strategic locations, which present overall quality of WFI will be tested as a part of routine monitoring.

WFI的取样应在每一阶段的上流和下流进行.在阶段I和II中,所有的位置都要检测,然而,在阶段III, 主要的位置, 其可以代表WFI的总体质量, 要检测. 作为常规检测的一部分.

The WFI system is consist of three main sections:

WFI系统包含三个主要的部分

1) WFI processing and generation ；

WFI处理和产生

2) Storage( WFI Tank) ；

储存(WFI水槽)

3) Points of use (distribution system).

使用点(分布系统)

9.2 Test Program

检测方法

Purpose: To verify that WFI system is capable of continuously and consistently producing water which meets the USP30 specification for WFI.

目的: 为确认WFI系统能够持续地,稳定地制备出符合USP30 WFI质量标准的水

9.2.1 Test Procedure ：

检测方法

Sampling / Testing:

取样/检测

1. Microbiological sampling: (for actual sampling sites, refer to Figure #1)

微生物取样(实际的取样点,参照图#1)

1.1 Aseptically collect 100ml of Sample in presterilized container for and forward the sample to Micro lab without delay for the Total Microbial Count by Filtration technique.

无菌收集100ml 样品于事先灭菌过的容器中, 直接送至微生物实验室，由过滤技术检测总的微生物菌数。

1.2 Aseptically collect 100ml of sample in a presterilized and depyrogenated container and labeled it appropriately and forward to micro lab for LAL testing as per USP<85>.

无菌收集100 ml 样品于事先灭菌过的, 去热原的容器中，贴上合适的标签，并发送给微生物实验室，根据USP<85>LAL检测

1.3 These sample must be tested without unnecessary delay (within 2 hours), but if any delay expected, store sample at 2-8oC for not more than 12 hours.

这些样品必须在无拖延的情况下（2小时内）检测，但如果有任何拖延，储存在2-8oC，不超过12小时。

1.4 For Chemical analysis, collect 1L of sample in an appropriately cleaned and dried container and forward it to chemistry Lab for testing.

对于化学分析，收集1 L 样品于合适的干净的, 干的容器中，送化学实验室检测

1.5 For more details refer to SOP for chemistry and microbiological sampling and testing of WFI.

更多的详细情况，参照WFI化学和微生物取样和检测的SOP

1.6 Samples will be taken daily including weekends for Phase-I and Phase-II studies from all locations indicated in Table-1, including purified feed water.

阶段I和阶段II研究的来自表格I指定的位置的样品需每天都取，包括周末。纯化水也需要取

1.7 Operators, who perform the sampling, must complete the Table-1 and Table-2 for Phase-I and Phase-II respectively. Sign and date in an appropriate box for the confirmation of sampling for each site. The dates of cleaning /sanitization of water system will also be recorded in Table-1 and 2.

进行取样的操作者，必须分别完成阶段I和阶段II的表格I和表格II。在合适的空格处签名，写上日期，以对每一位置样品的证实。水系统的清洁和消毒的日期也应在表1和表2中记录。

1.8 For Phase III, the sampling plan and testing requirements for each week have been identified on Table- 3 & 4 respectively as per IOP and will be followed through out the year.

对于阶段III，每周的取样计划和检测要求在表格3&4中确定，根据IOP，并将贯穿整年。

5. Test results should be recorded in attachment 1 of SOP by QC, and data summary should be made.

检测结果应记录在QC SOP附件1中，制作数据概述。

6. For Microbial testing, all isolates will be gram stained and if gram negative (-ve) rods, will be identified using appropriate Microbial Identification test methods.

对于微生物检测，所有的隔离群是革兰氏染色体，若是革兰氏阴性菌，需要用适当的微生物确定检测方法来识别。

Acceptance Criteria:

认可标准

Water Specification: The water samples must meet the specification given below for WFI and Purified feed water.

水标准：水样必须满足如下WFI和纯化饮用水的质量标准

Specification for Water for Injection (WFI)

注射用水的质量标准（WFI）

Test

检测

USP 30/ CP

Test Method USP/HHCC

检测方法

USP/HHCC

Appearance

外观

Clear

澄清

Microbial Counts:

微生物菌数

<10cfu/100ml

Endotoxin Level:

内毒素水平

<0.25EU/ml

Conductivity

电导率

<1.1 ms/cm

Total Organic Carbon (TOC)

总有机碳

<0.5 PPM

Specification for Purified Feed water (PW)

纯化饮用水质量标准（PW）

Test

检测项目

USP 30 /CP

Test Method

检测方法

Appearance

外观

Clear

澄清

Microbial Counts:

微生物菌数

<100cfu/ ml

Conductivity

电导电导率

<1.1 ms/cm

Total Organic Carbon (TOC)

总有机碳（TOC）

<0.5 PPM

10.0 disposal of Accident, Deviation and nonconformance

事故,偏差和不符合的处理

10.1 Purpose

目的

The purpose is to record and dispose all accidents, deviation and non-conformance during the execution of the protocol. All actions taken for solving significant Problems must be recorded in the accident report.

目的是记录和处理方案执行时的所有事故,偏差和不符合.解决重大问题的所有措施必须记录在事故报告中.

10.2 Procedure

方法

If there is any failure/accident, deviation and non-conformance between acceptance criteria and test result, the following procedure shall be followed:

Begin to write accident report.

在认可标准和检测结果间,若有失败/事故,偏差和不符合, 应遵循如下的方法: 启动编写事故报告.

1) Use the protocol number as a unique serial number’s prefixes number. List accident number.

使用方案号码作为唯一的序列号码的首数字.列出事故号

2) List accident number and the accident description in Table 10.2-1

在表格10.2-1中列出事故号和对事故的叙述

Prepare accident report ：

制订事故报告

1) Use Table 10.2-2 (accident report).

使用表格10.2-2(事故报告)

2) Ask the relative qualification personnel how to solve the problem

咨询相关的确认人如何解决问题

The relative members of qualification team shall make decision based on the accidents investigation：

确认工作小组的相关人员应基于事故调查作出决定

1) The department shall assign personnel to sign the report after the disposal of the accidents

在事故处理后, 部门应指定人员对报告签字

2) The manager of engineering and maintenance dept. and QA manager must sign all accident reports.

工程和维护部的经理和QA经理必须对所有的事故报告签字.

10.3 Acceptance Criteria

认可标准

All reports of accidents, deviation and non-conformance are disposed.

所有的事故,偏差和不符合的报告要处理.

Table 10.2-1 Accident Log

表格10.2-1 事故记录

Accident No.

事故号

Accident Description

事故叙述

Recorded by

记录人

Date

日期

Note: If require during execution, copy this page and insert as Page__of __total pages.

备注:若在执行时,需要的话, 复印这一页,并以页码/总页码形式插入

Table 10.2-2 Accident Report

表10.2-2 事故报告

Accident Number

事故号

Test No.

检测号

Accident Description

事故叙述

　Reported by：　汇报人　　　　　　　　　　　　　Date：日期

Method to solve the problem

解决问题的方法

Offered by:提供人 Date:日期

Engineering Dept. 工程部: Date:日期

QA：QA Date日期

Result Verification

结果确认

Checked by: 审核人 Date:日期

Engineering Dept.: 工程部 Date:日期

QA： QA Date:日期

Note: If require during execution, copy this page and insert as Page__of __total pages.

备注:若在执行时,需要的话, 复印这一页,并以页码/总页码形式插入

11.0 Log of attachment

附件记录

All attachments during execution shall be recorded in Table 11.0.

在执行时,所有的附件应记录于表11.0中

1) In Table 11.0-1, each attachment shall have its own sequential number, marked with total pages, signature and date.

在表11.0-1中,每一附件应具有序列号,标出总页数,签名并写上日期

2) Enter the protocol number on the first page of the attachment, with signature and date.

在附件的第一页,输入方案号,签名并写上日期.

3) Each page of attachments shall be marked with attachment number # (consistent with the number in the table below), followed with page and total pages

附件的每一页应标出附件号#(和下表中的号码一致), 其后为页码和总页码.

Table 11.0- Attached Log

表11.0—附录记录

NO

编号

Description

叙述

Signature

签名

Date

日期

Note: If require during execution, copy this page and insert as Page__of __total pages.

备注:若在执行时,需要的话, 复印这一页,并以页码/总页码形式插入

12.0REFERENCES

参考资料

1) 21 CFR Part 210 and 211: cGMP for Finished Pharmaceuticals

21美国联邦法典210和211: 成品药cGMP

2) VALIDATION OF PHARMACEUTICAL PROCESSES OF STERILE PRODUCTS: Validation of Water System (edited by Frederick J.Carletton James P.Aglloco), First edition in Dec. 1998.

无菌产品中药品工艺的验证, 由Frederick J.Carletton James P.Aglloco编著,1998年第一版

3) USP30 <1231 > Nonmonographed Manufacturing Waters

USP30<1231>非专论的制造用水

4) FDA, Guide to Inspection of High Purity Water System

FDA, 高度纯化水系统审查指南.

13.0 Conclusion Report

结论报告

Table 13.0-1 Conclusion Report

表13.0-1 结论报告

Test Phase

检测阶段

Test Number

检测号

Completed

完成

Conclusion (pass/ failure)

结论(通过/失败)

Remark

备注

PQ documentations verification

PQ文件确认

8.1

8.2

PQ protocol

PQ方案

9.1

9.2

Handling of Accident, Deviation and Nonconformance

事故,偏差和不符合的处理

10.0

Log of Attachment

附件记录

11.0

Comments:

Result (Please tick at the appropriate boxes below :)

结论(请在下面适当的空格中打勾)

Qualified 5 Unqualified 5

合格不合格

Checked by

Signature

Date

Reviewed by QA

Signature

Date

审核人

签名

日期

QA审核

签字

日期

14.0 Conclusion of verification

确认结论

Team leader of qualification team

确认工作小组的领导

Conclusion：

结论

Signature ：签名 Date：日期

Production dept.: Comments

生产部: 评论

Comment：

Signature ：签名 Date：日期

Engineering and Maintenance Dept.: Review Comments

工程和维护部: 审核评论

Comment：

Signature ：签名 Date：日期

QA :Approval Comments

QA :批准评论

Approval Comments：

批准评论:

Signature ：签名 Date：日期

General Manager :Approval Comments

总经理:批准评论

Approval Comments：

批准评论

Signature：签名 Date：日期

Table- 1

表-1

Phase-I sampling

阶段-I取样

Feed

WFI System

Points of Use

使用点

S.No

编号

Sample Dates

取样日期

Feed water

饮用水

WFI

注射用水

Loop

回路

Tank

水槽

xx

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Dates System Sanitized:系统消毒日期Reviewed By: 审核人_ Date:日期

Approved By QA Manager: QA经理批准______________Date: 日期

Table- 2

表-2

Phase-II sampling

阶段-II 取样

Feed

WFI System

Points of Use

使用点

S.No

编号

Sample Dates

取样日期

Feed water

饮用水

WFI

注射用水

Loop

回路

Tank

水槽

xx

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Dates System Sanitized: 消毒日期

Reviewed By: 审核人______Date:日期__________________

Approved By QA Manager: QA经理审核__Date: 日期_______

Table- 3

表-3

Phase-III Weekly Sampling Frequency

阶段-III 一周取样频率

Source/Feed

来源

WFI System

*Points of Use

使用点

Sample Dates

取样日期

Purified Water

WFI

Xx

XX

xx

Monday D-1

星期一

X

-

X

Tuesday D-2

星期二

X

-

X

-

Wednesday D-3

星期三

X

-

X

-

Thursday D-4

星期四

X

-

X

-

Friday D-5

星期五

X

-

X

-

*These points will be sampled on a weekly rotation basis.*这些点每周循环取样

X = To be tested. X= 需检测

-= No sampling required. -不需要取样

Reviewed By: 审核人___________________Date:日期_____

Approved By QA Manager: QA经理批准 ______________Date: 日期

Table- 4

表-4

Phase-III - weekly Testing Requirements

阶段-III 每周检测要求

Feed or Source

WFI System

Points of Use

Test

检测

RO

water

WFI

Xx

XX

xx

Appearance

外观

X

-

Microbial Counts:

微生物数

X

Endotoxin Level:

内毒素水平

X

Conductivity

电导率

X

-

Total Organic Carbon (TOC)

总有机碳

X

-

Reviewed By: 审核人______________________Date:日期___________

Approved By QA Manager: QA经理批准______________Date: 日期________

Figure # 1

Schematic of WFI system and points of Use

图#1

WFI系统示意图及使用点

Volume Tested

Media Used

使用的培养基

Purified water

cfu/ml

WFI

Xx

cfu/100ml

WFI

Xx

cfu/100ml

WFI

xx

cfu/100ml

WFI

Xx

cfu/100ml

WFI

Xx

cfu/100ml

WFI

Xx

cfu/100ml

WFI

Xx

cfu/100ml

100 mL

Comments / Microbial Identification:

评论/微生物确定

_________________________________________________________________________________________________________________________________

Reviewed by: 审核______________________________________________ Date:日期 _____________________________

WFI Validation: Phase-I Endotoxin Testing

WFI 验证: 阶段-I 内毒素检测

Limits: Purified Water; for information only WFI Water: Endotoxin <0.25 EU/ml

限度 WFI 水: 内毒素

Date

Sampled & Tested

日期

取样&检测

Purified water

EU/ml

WFI

Xx

EU/ml

WFI

Xx

EU/ml

WFI

xx

EU/ml

WFI

Xx

EU/ml

WFI

Xx

EU/ml

WFI

Xx

EU/ml

WFI

Xx

EU/ml l

Comments:

评论_________________________________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________________

Reviewed by: 审核______________________________________________ Date:_日期____________________________

WFI Validation Phase-I Chemical Analysis

WFI 验证阶段I 化学分析

Limits: Total Organic Carbon (TOC) : <0.5PPM Conductivity (Cond) <1.1 ms/cm

限度总有机碳电导率

Date

Sampled & Tested

取样&检测日期

Purified water

cfu/ml

WFI

XX

WFI

xx

WFI

Xx

TOC

Cond

TOC

Cond

TOC

Cond

TOC

Cond

TOC

Cond

TOC

Cond

TOC

Cond

Comments

_________________________________________________________________________________________________________________________________

Reviewed by: _审核_____________________________________________ Date: 日期_____________________________

WFI Validation Phase-II Total Microbial Count

WFI 验证阶段 II 总微生物菌数

Limits: Purified Water < 100 CFU/100 mL WFI Water : <10cfu/100mL

Date

Sampled & Tested

取样检测日期

Volume Tested

Media Used

Purified water

cfu/ml

WFI

Xx

cfu/100ml

WFI

Xx

cfu/100ml

WFI

xx

cfu/100ml

WFI

Xx

cfu/100ml

WFI

Xx

cfu/100ml

WFI

Xx

cfu/100ml

WFI

Xx

cfu/100ml

100 mL

Identification: 确定

Reviewed by: 审核______________________________________________ Date: 日期_____________________________

WFI Validation: Phase-II Endotoxin Testing

WFI 验证: 阶段-II 内毒素检测

Limits: Purified Water; For information only WFI Water : Endotoxin <0.25 EU/ml

Date

Sampled & Tested

取样&检测日期

Purified water

EU/ml

WFI

Xx

EU/ml

WFI

Xx

EU/ml

WFI

xx

EU/ml

WFI

Xx

EU/ml

WFI

Xx

EU/ml

WFI

Xx

EU/ml

WFI

Xx

EU/ml l

Comments: 评论_________________________________________________________________________________________________________________________________

Reviewed by:_审核_____________________________________________ Date:日期_____________________________

WFI Validation Phase-II Chemical Analysis

WFI 验证阶段II 化学分析

Limits: Total Organic Carbon (TOC) : <0.5 PPM Conductivity (Cond) <1.1 ms/cm

Date

Sampled & Tested

取样检测日期

Purified water

cfu/ml

WFI

XX

WFI

xx

WFI

Xx

TOC

Cond

TOC

Cond

TOC

Cond

TOC

Cond

TOC

Cond

TOC

Cond

TOC

Cond

Comments评论

_________________________________________________________________________________________________________________________________

Reviewed by: 审核______________________________________________ Date: _日期____________________________

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