1、Validation編號(hào):No.OQ-542-JK-1HVAC系統(tǒng)運(yùn)行確認(rèn)OQ of HVAC頁(yè)碼:Page37 of 37株洲千金藥業(yè)股份有限公司女性健康產(chǎn)業(yè)基地綜合廠房HVAC系統(tǒng)運(yùn)行確認(rèn)（JK-1系統(tǒng)）協(xié)多力驗(yàn)證部2009年9月HVAC系統(tǒng)運(yùn)行確認(rèn)方案OQ Protocol Of HVAC 制訂人：Author 制訂部門(mén)：Department 審核人：Reviewed By 審核日期：Reviewed Date 協(xié)多力公司驗(yàn)證部Validate Department審核人：Reviewed By 審核日期：Reviewed Date 批準(zhǔn)人：Approved By 批準(zhǔn)日期：Approv

2、ed Date 株洲千金藥業(yè)股份有限公司分發(fā)部門(mén)：Distributed To替換文件：Replaced For修訂記錄：Revised Record目錄1.通則QENNRAL RULE51.1目的Purpose51.2范圍Scope51.3文件管理規(guī)范Good Document Practice51.4各方職責(zé)71.41協(xié)多力公司的職責(zé)The Responsibilities Of Suntec Include The Followings:71.42株洲千金藥業(yè)股份有限公司的職責(zé)包括但不僅僅限于以下:The Responsibilities Of qianjin Include,But N

3、ot Limited To:72.系統(tǒng)的描述DESCRIPTION SYSTEM921JK-1系統(tǒng)的系統(tǒng)描述 Description for JK-1 System922JK-1系統(tǒng)的控制系統(tǒng)描述Contorl System Description for JK-1 System1023設(shè)計(jì)要求：Design Requirements1324GMP適用要求：GMP According Requirements133.測(cè)試描述和可接受標(biāo)準(zhǔn)TEST DESCRIPTION AND ACCEPTANCE CRITERIA143.1先決條件Requisites143.2驗(yàn)證儀器校準(zhǔn)的確認(rèn)Validat

4、ion Instrument Calibration Verification143.3口令的確認(rèn)Password Verification153.4房間送風(fēng)量和換氣次數(shù)Room Supply Flow Rate And Air Changes153.5房間壓差Room Differential Pressure163.6房間溫度和相對(duì)濕度Temperature And Relative Humidity In Room173.7房間潔凈度的測(cè)試（靜態(tài)）Non Viable Particle Count Of Room “At Rest”183.8人員的確認(rèn)PERSONNEL IDENTIFI

5、CATION204.偏差報(bào)告DEVIATION REPORT205.注釋COMMENT SECTION206.偏差清單LIST OF DEVIATION207.附件清單LIST OF ATTACHMENT218.審核和批準(zhǔn) EXECUTION REVIEW AND APPROVAL219.改造和更改控制MODIFY AND CHANGE CONTROL2110.測(cè)試報(bào)告目錄 INDEX OF TEST REPORT22TEST REPORT 1 測(cè)試報(bào)告123TEST REPORT 2 測(cè)試報(bào)告224TEST REPORT 3 測(cè)試報(bào)告325TEST REPORT 5 測(cè)試報(bào)告527TEST

6、REPORT 6 測(cè)試報(bào)告628TEST REPORT 7 測(cè)試報(bào)告729TEST REPORT 8 測(cè)試報(bào)告830TEST REPORT 9 測(cè)試報(bào)告931TEST REPORT 10 測(cè)試報(bào)告1032TEST REPORT 11 測(cè)試報(bào)告1133TEST REPORT 12 測(cè)試報(bào)告1234TEST REPORT 12 測(cè)試報(bào)告12351. 通則QENNRAL RULE1.1 目的Purpose本運(yùn)行確認(rèn)是為了確認(rèn)位于中國(guó)湖南株洲的千金藥業(yè)股份有限公司（簡(jiǎn)稱(chēng)“千金藥業(yè)”）的生產(chǎn)車(chē)間的潔凈空調(diào)系統(tǒng)的運(yùn)行是否符合設(shè)計(jì)標(biāo)準(zhǔn)和工藝要求。本方案規(guī)定了運(yùn)行確認(rèn)的內(nèi)容、測(cè)試方法和測(cè)試表格。另外運(yùn)行確認(rèn)也

7、被視作為在進(jìn)行性能確認(rèn)之前對(duì)潔凈空調(diào)系統(tǒng)進(jìn)行的質(zhì)量審核。 The Operation qualification protocol is to verify that the HVAC system of production workshop of Customer Co., Ltd. (briefly called as “qianjin”) located in zhuzhou, China Has Been Properly Operation According To Design Specification And Process Requirement. The Protocol

8、 Prescribes The Content、Test Method And Test Forms Of The Operation Qualification. OQ Serves As A Quality Audit Of HVAC System Prior To PQ 1.2 范圍Scope 本運(yùn)行確認(rèn)對(duì)位于株洲新建的綜合生產(chǎn)車(chē)間中潔凈室空調(diào)凈化系統(tǒng)中JK-1凈化空調(diào)系統(tǒng)的運(yùn)行進(jìn)行確認(rèn)。本方案將包括測(cè)試規(guī)程、證明文件、參照資料、標(biāo)準(zhǔn)和可接受的限度，以說(shuō)明JK-1系統(tǒng)的運(yùn)行符合設(shè)計(jì)要求、廠家建議和當(dāng)前的GMP規(guī)范。This OQ is for JK-1 HVAC Operation Qu

9、alification system in powder preparation workshop.This OQ Including testing rule ,certification documents, reference documents ,standard and the acceptable level to prove JK-1 system fits designing ,requirements by clients GMP.1.3 文件管理規(guī)范Good Document Practice 下面說(shuō)明了一些進(jìn)行記錄測(cè)試數(shù)據(jù)工作的通用標(biāo)準(zhǔn)：Below Are Indicat

10、ed Some General Criteria For Test Data Recording: 保證每一文件是可追溯的，它應(yīng)有標(biāo)題，系統(tǒng)參考（例如項(xiàng)目號(hào)），文件中應(yīng)有設(shè)備的系列號(hào)。 Get Assurance That Every Document Is “Traceable ” That Is: It Has A Title, System Reference (For Example : Item Number), If It Is Applicable (For Example Checks About A Tank), It Is Necessary To Report Seria

11、l Number Of The System That Is Contained In The Document. 文件中每個(gè)注解、記錄等都應(yīng)該清楚、易讀、有日期和簽名。不能使用鉛筆，而應(yīng)使用藍(lán)色鋼筆或水筆記錄數(shù)據(jù)。 Every Annotation, Recording Etc, On A Document Must Be Clear, Readable, Dated And Signed. 每次測(cè)試須遵循以下原則：For Each Test Executed Is Necessary To: - 如果結(jié)果是某一數(shù)值時(shí)，只填寫(xiě)“通過(guò)/不通過(guò)”是不充分的 - It Is Not Suffici

12、ent Pass/Fail If The Result Is A Value - 如果某測(cè)試沒(méi)有寫(xiě)明具體的測(cè)試程序，則應(yīng)注明參考出處- Refer At The Procedure Used For The Test If This Is Not Described In The Body Format Used - 附上在測(cè)試過(guò)程中所產(chǎn)生或打印出來(lái)的圖，簽名并注明日期 - Attach Each Print-Out/Attachment Produced During The Test Execution, Signing And Dating It. - 每次測(cè)試應(yīng)簽名和注明日期（需有執(zhí)行

13、人和審核人的簽名） - Sign And Date Each Tests(Signature Of The People That Executes And Approves Test Must Be Present) - 如果有些測(cè)試沒(méi)有進(jìn)行，則應(yīng)在備注或偏差記錄中寫(xiě)明未執(zhí)行的原因和預(yù)計(jì)執(zhí)行的日期 - If Some Test Is Not Executed, Indicate The Reason Why It Happened, Giving, In The Deviation Form, A Possible Date For The Execution. 所有測(cè)試日期的格式為 日/月

14、/年，如12/08/2004 Format Of Date Is Dd/Mm/Yyyy. 在文件中不能使用修正液，修改錯(cuò)誤必須使用以下正確的方式 Do Not Use Covering Liquids Or Materials On Documents, To Correct Errors, Every Writing Mistake Must Be Correct Like The Following Example: System XX 簽名System YZ 日期對(duì)于不使用的部分， 必須如下面所示的劃掉。或者，填寫(xiě)“NA”，表示不適用Pace Not Used Must Be Barre

15、d As Indicated Blow.Or Fill Out “NA”, It Means Not Applicable. 對(duì)于在執(zhí)行本方案過(guò)程中所發(fā)生的每個(gè)偏差， 應(yīng)填寫(xiě)包括以下一些內(nèi)容的偏差報(bào)告 For Each Deviation That Should Occur During The Execution Of This IQOQ Protocol, Compile A Report For Non Conformity/Deviation Management (Attached To This Protocol) Recording - 偏差號(hào) - Deviation Numbe

16、r - 偏差描述和發(fā)現(xiàn)人簽字及日期 - Deviation Description & Sign And Date Of The People That Finder - 必要糾偏措施 - Activity Necessary To Resolve The Deviation - 糾偏措施批準(zhǔn)人簽字和日期 - Date Of Deviation Resolution . - 偏差解決的日期 Re-Check Results After Resolution 1.4 各方職責(zé)1.41 協(xié)多力公司的職責(zé)The Responsibilities Of Suntec Include The F

17、ollowings: 1. OQ方案的編制。OQ Protocol Writing 2. 提供校準(zhǔn)測(cè)試儀器的相關(guān)證書(shū).Supply Correlative Certificate Of Calibration Test Instrument 3. 收集原始數(shù)據(jù)并填寫(xiě)在OQ方案中.Collect Original Data And Fill In The OQ Protocol4. 記錄發(fā)生在OQ過(guò)程中的不一致項(xiàng)/偏差.Record Non Conformity/Deviation Occurred During OQ5. 偏差報(bào)告的整理Deviation Reports Compilation

18、6. 編寫(xiě)OQ報(bào)告.OQ Report Writing1.42 株洲千金藥業(yè)股份有限公司的職責(zé)包括但不僅僅限于以下:The Responsibilities Of qianjin Include,But Not Limited To: 1. 提供為此次執(zhí)行本方案所必要的所有的程序、數(shù)據(jù)、手冊(cè)、圖紙和文件，并完成最終報(bào)告。Supply All Procedure, Data, Manuals, Drawing And Documentation Necessary For The Generation And Execution Of Protocols And The Completion O

19、f Final Report. 2. 如果需要時(shí)， 提供必要的人員協(xié)助進(jìn)行系統(tǒng)或設(shè)備的運(yùn)行。Provide Personnel, When Necessary, To A Ssist In The Operation Of Equipment Of Equipment And System. 3. 如果需要時(shí)，提供必要的人員進(jìn)行校準(zhǔn)關(guān)鍵和非關(guān)鍵的測(cè)量、記錄和/或控制儀表。Provide Personnel, When Necessary, To Calib Rate Critical And Non-Critical Measuring,Recording, And Controlling I

20、nstrumentation. 4. 針對(duì)不一致項(xiàng)界定解決方法Define Solution For Non Conformity. 5. 審核并批準(zhǔn)本方案和最終驗(yàn)證報(bào)告 The Review And Approval Of This Protocol And The Validation Final Report. 2. 系統(tǒng)的描述DESCRIPTION SYSTEM21 JK-1系統(tǒng)的系統(tǒng)描述 Description for JK-1 SystemJK-1系統(tǒng)主要服務(wù)于車(chē)間D級(jí)凈化區(qū)域的溫度、濕度、壓差和潔凈度，請(qǐng)見(jiàn)附圖“JK-1空調(diào)系統(tǒng)流程圖”。JK-1 system is solved

21、 for temperature, humidity, Press and cleaning in walkway by class D area. Details pls see the attachments “JK-1 system layout “2.1.1 空調(diào)凈化系統(tǒng)包括潔凈間、氣閘和B區(qū)潔凈走道等房間的凈化區(qū)域。為達(dá)到最理想的空氣凈化效果，車(chē)間采用上送下（側(cè)）回的空氣流通方式。排風(fēng)由排風(fēng)機(jī)排到室外。排風(fēng)需經(jīng)中效過(guò)濾器處理后排出室外，如圖中的PJ1.HVAC system including production material in EPO and cleaning area

22、in B clean walkway. To get a good clean effect, the airflow by supplying from the top, return by the bottom. EF exhale the wind outside the cleanroom. The wind should be filter by the middle filter, finally be out of the room.2.1.2 JK-1系統(tǒng)送風(fēng)量為21663m3/h，回風(fēng)量為16845 m3/h，新風(fēng)量為4818 m3/h，新風(fēng)比為22%。Wind supply

23、ing should be 21663m3/h, wind returning should 16845 m3/h, fresh air should be 4818 m3/h The rate should be 22% by the system.2.1.3 各室溫濕度要求Humidity Requirements for the rooms 夏季t=（22±4），=（55±10）% summer t=（22±4），=（55±10）%冬季t=（22±4），=（50±10）% winter t=（22±4），=（50

24、77;10）%2.1.4 各室潔凈等級(jí)按D級(jí)設(shè)計(jì)，相當(dāng)于ISO標(biāo)準(zhǔn)7級(jí)。D級(jí)潔凈室的換氣次數(shù)為16次/小時(shí)。D class for the cleanroom ,it means ISO 7. air change should be 16/h for D class cleanroom2.1.5 空氣流程為新風(fēng)在依次經(jīng)初效過(guò)濾器、中效過(guò)濾器處理后再經(jīng)過(guò)空調(diào)處理室和回風(fēng)混合后再經(jīng)過(guò)表冷器，再由風(fēng)機(jī)經(jīng)過(guò)蒸汽加熱器和蒸汽加濕器經(jīng)中效過(guò)濾器再處理，再通過(guò)裝于房間頂部的高效過(guò)濾器送入各室，然后進(jìn)行重復(fù)循環(huán)，各室的送、回、排風(fēng)均有風(fēng)閥調(diào)節(jié)至設(shè)計(jì)風(fēng)量。詳見(jiàn)“JK-1系統(tǒng)控制原理圖”。Air Flow pr

25、ocess as follows, fresh air by first filter and middle filter，the fresh air and return air mixed in the air-condition by coolers, heater, humidifier and middle filter send to all the rooms by the HP-Filter on the top, cycle by times . there are wind damper to adjust the wind ,see the “JK-1 Control d

26、rawing”2.1.5.1 空氣冷卻器，主要功能用在夏天，使空氣減溫、減濕，控制送風(fēng)溫度，使之符合設(shè)計(jì)要求，具體數(shù)據(jù)詳見(jiàn)空調(diào)流程及控制圖。air-cooler which reduce the temperature, humidity of the air, control the wind temperature. It will make all tech. accord the design requirements. Details pls see the Drawings.2.1.5.2 空調(diào)處理室的空氣加熱器，主要功能在冬天開(kāi)啟。夏天由于室外溫度較高，所以一般不會(huì)使用。 the

27、 air humidifier, it used while the winter. Because of the not temperature ,it is not used while summer.2.1.5.3 初效過(guò)濾器除塵效率大于65%，初阻力為45Pa.。當(dāng)終阻力達(dá)到90Pa時(shí)，說(shuō)明該過(guò)濾器容塵量達(dá)到飽和，必須更換或清洗過(guò)濾器。圖中壓差表能反映中效過(guò)濾器的阻力。Dedusting efficiency should be more than 60%, the least resistance should be 60Pa by the middle filter. When t

28、he finally resistance reaches 120 Pa, the dust has been saturation, the filter should be clean or changed. The press dispatch form will reflect the resistance of the filter.2.1.5.4 中效過(guò)濾器除塵效率大于60%，初阻力為60Pa.。當(dāng)終阻力達(dá)到120Pa時(shí)，說(shuō)明該過(guò)濾器容塵量達(dá)到飽和，必須更換或清洗過(guò)濾器。圖中壓差表能反映中效過(guò)濾器的阻力。Dedusting efficiency should be more tha

29、n 60%, the least resistance should be 60Pa by the middle filter. When the finally resistance reaches 120 Pa, the dust has been saturation, the filter should be clean or changed. The press dispatch form will reflect the resistance of the filter.2.1.5.5 在初、中效過(guò)濾器的前后安裝微壓計(jì)，如圖中所示，最小單位為10Pa。Install the Min

30、i pressure plan between the first fiter and middle filter as the drawing ,the unit should be 10 Pa.22 JK-1系統(tǒng)的控制系統(tǒng)描述Contorl System Description for JK-1 System2.2.1 空調(diào)處理箱中的空氣加熱器采用0.3Mpa的蒸汽加熱，蒸汽凝結(jié)水回到蒸汽凝結(jié)水管中。Heater in the air-condition worked with 0.3Mpa steam heating ,steam coagulate as water back to t

31、he pipes.2.2.2 空調(diào)處理箱中的表冷器的冷源來(lái)自冷凍機(jī)房的7的冷凍水。冷凍水回水的溫度控制在12以下，冷凍水回水電動(dòng)閥的開(kāi)啟大小由送風(fēng)管中的溫濕度傳感器來(lái)控制。The cold origin of the cooler in air-condition is from 7 freeze water in the freeze plant. Water back for the freeze water is down of 12, electrical valve will be controlled by temperature sensor in blast pipe.2.2.

32、3 蒸汽加濕器的閥開(kāi)啟程度由回風(fēng)管中的溫濕度傳感器來(lái)控制。Humidifier damper will be controlled by temperature sensor in return pipe.2.2.4 防火閥與空調(diào)風(fēng)機(jī)連鎖，當(dāng)防火閥關(guān)閉，空調(diào)風(fēng)機(jī)停止運(yùn)轉(zhuǎn)并報(bào)警。Fireproofing damper and fan chain, the fan stopped working and give an alarm while he fireproofing turn off.JK-1系統(tǒng)功能表：房間名稱(chēng)Room Name房間編號(hào)Room NO.凈化等級(jí)Clean Class換氣次

33、數(shù)(次/h)溫度T()濕度RH(%)相對(duì)非潔凈區(qū)壓差Differential pressures to Non clean area制漿一步制粒-1D161826456510制漿一步制粒-3D161826456510工作站-1D161826456510工作站-2D161826456510溶膠-1D161826456510走道1D161826456510潔具清洗-1D161826456510潔具存放-1D161826456510工作站-3D161826456510工作站-4D161826456510潔具清洗-2D161826456510潔具存放-2D161826456510走道2D1618264

34、56510溶膠-2D161826456510工作站-5D16182645651023 設(shè)計(jì)要求：Design Requirements 客戶要求該新建綜合生產(chǎn)車(chē)間的設(shè)計(jì)能同時(shí)符合中國(guó)和歐盟的GMP認(rèn)證要求?？蛻粢惨笤撛O(shè)計(jì)能符合中國(guó)的“藥品生產(chǎn)質(zhì)量管理規(guī)范-1998版”（以下簡(jiǎn)稱(chēng)“中國(guó)GMP” ）的要求和中華人民共和國(guó)國(guó)家標(biāo)準(zhǔn)：建筑設(shè)計(jì)防火規(guī)范（GB50016-2006）。中國(guó)潔凈室廠房設(shè)計(jì)規(guī)范（GB50073-2001）歐洲聯(lián)盟藥品生產(chǎn)質(zhì)量管理規(guī)范（EU GMP）以及美國(guó)FDA標(biāo)準(zhǔn)。The Design Should Accorded By Chinese And URP GMP. It S

35、hould Be Accorded By GB50016-2006, GB50073-2001, EU GMP And American FDA該工程的工程設(shè)計(jì)方-中國(guó)醫(yī)藥集團(tuán)重慶醫(yī)藥設(shè)計(jì)院完成了工程設(shè)計(jì)。The Designer Is CPWPIDI潔凈室施工單位-昆山協(xié)多力公司為施工單位。Construction Unit Suntec Cleanroom & HVAC Engineering Co.,Ltd24 GMP適用要求：GMP According Requirements要求符合標(biāo)準(zhǔn)：Requirements up to sunff- 中國(guó)：“藥品生產(chǎn)質(zhì)量管理規(guī)范”（19

36、98年修訂）China: Chinese GMP (1998 edit)- 中華人民共和國(guó)國(guó)家標(biāo)準(zhǔn)：GB50073-2001 潔凈廠房設(shè)計(jì)規(guī)范。National standards of the People's Republic of China: GB50073-2001 Cleanroom design specification可以參考標(biāo)準(zhǔn)： reference standards - 美國(guó)：21 CFR Part 210-211 “GOOD MANUFACTURING PRACTIC” 2000- 歐洲：GMP 20023. 測(cè)試描述和可接受標(biāo)準(zhǔn)TEST DESCRIPTIO

37、N AND ACCEPTANCE CRITERIA 3.1 先決條件Requisites 目的Purpose確認(rèn)所有進(jìn)行運(yùn)行確認(rèn)的先決條件已經(jīng)得到滿足 。All Prerequisites Necessary To The OQ Execution Have Been Satisfied. 程序 Procedure 確認(rèn)本方案已得到批準(zhǔn)。Verify That OQ Protocol Has Been Approved. 可接受標(biāo)準(zhǔn) Acceptance Criteria 開(kāi)始執(zhí)行本方案之前，所有的先決條件必須得到滿足。All The Prerequisites Must Be Satisfi

38、ed Before The Beginning Of The Execution Of IQ Test. 測(cè)試報(bào)告 Test Report 填寫(xiě)“測(cè)試報(bào)告1”。Fill In Test Report No.1. 在偏差報(bào)告中記錄在測(cè)試過(guò)程中所發(fā)生的偏差 Recording The Deviation Occurred During The Test Execution On The Deviation Report.3.2 驗(yàn)證儀器校準(zhǔn)的確認(rèn)Validation Instrument Calibration Verification 目的 Purpose確認(rèn)對(duì)每一臺(tái)驗(yàn)證所用的儀器的校準(zhǔn)情況。

39、Verify Calibration State Of Every Validation Instrument. 程序 Procedure 對(duì)每一臺(tái)驗(yàn)證所用的儀器應(yīng)標(biāo)識(shí)出生產(chǎn)廠家、型號(hào)、系列號(hào)、校準(zhǔn)日期、有效期。必須附上校 準(zhǔn)證書(shū)。 For Every Validation Instrument Product Factory、Type、Series Code、Calibration Date、Period Of Validity Should Been Marked. Attach Calibration Certificate. 可接受標(biāo)準(zhǔn) Acceptance Criteria 所有儀表

40、已經(jīng)得到校準(zhǔn)，并在它們的校準(zhǔn)有效期內(nèi)，校準(zhǔn)證書(shū)是可用的并附在本方案中。 Verify That The All Instruments Have Been Calibrated, Are Within Their Calibration Period. Verify The Availability Of The Calibration Certificates And Attached This Protocol. 測(cè)試報(bào)告 Test Report 填寫(xiě)“測(cè)試報(bào)告2”。Fill In Test Report No.2. 在偏差報(bào)告中記錄在測(cè)試過(guò)程中所發(fā)生的偏差 Recording The D

41、eviation Occurred During The Test Execution On The Deviation Report. 3.3 口令的確認(rèn)Password Verification 目的 Purpose 確認(rèn)只有預(yù)先授權(quán)的口令可以進(jìn)入控制系統(tǒng) Verify That Only The Authorized Password In Advance Can Be Allowed To Enter The Control System. 程序 Procedure 對(duì)每一個(gè)進(jìn)入控制系統(tǒng)的人機(jī)界面和訪問(wèn)等級(jí)，輸入相應(yīng)的口令并確認(rèn)允許進(jìn)入控制系統(tǒng)，使用相同步驟輸入錯(cuò)誤的口令，拒絕進(jìn)入。F

42、or Each Man-Machine Contact Surface And Visit Rank To Enter Control System，Input The Corresponding Password And Conform To Permit To Enter The Control System；Use The Same Step But Input The Wrong Password，Then Refuse To Enter. 可接受標(biāo)準(zhǔn) Acceptance Criteria 只有在輸入相應(yīng)正確的口令可以進(jìn)入控制系統(tǒng)，錯(cuò)誤的口令將自動(dòng)拒絕 Only When Input

43、 The Corresponding Correct Password，It Can Enter The Control System；The Wrong Password Will Be Automatically Reject. 測(cè)試報(bào)告 Test Report 填寫(xiě)在“測(cè)試報(bào)告3 Fill In Test Report No.3. 在偏差報(bào)告中記錄在測(cè)試過(guò)程中所發(fā)生的偏差 Recording The Deviation Occurred During The Test Execution On The Deviation Report. 3.4 房間送風(fēng)量和換氣次數(shù)Room Supply

44、 Flow Rate And Air Changes 目的 Purpose 檢查房間的送風(fēng)量和均勻性 Inspect The Supply Flow Rate And The Uniformity Of The Rooms檢查每個(gè)房間的換氣次數(shù) Inspect The Air Change Of Each Room. 程序 Procedure （風(fēng)量罩法） (Airflow Hood)- 取得一已校準(zhǔn)過(guò)的風(fēng)量測(cè)量裝置 - Take A Calibrated Instrument Of Airflow Hood. - 對(duì)每間房間的每個(gè)過(guò)濾器進(jìn)行測(cè)試 - Test Every Filter Of

45、Every Room. - 在進(jìn)行測(cè)試時(shí)，所有的門(mén)必須關(guān)閉，空調(diào)系統(tǒng)已運(yùn)行 - When Process Test，All Doors Must Be Close，And The HVAC System Is Going On. - 記錄測(cè)量裝置的風(fēng)量讀數(shù) - Record The Reading Of Air Rate Of Test Instrument. - 計(jì)算進(jìn)入房間的總風(fēng)量 - Calculate The Total Air Rate Entering The Room. - 記錄房間的容積 - Record The Cubage Of The Room. - 計(jì)算換氣次數(shù) - C

46、alculate The Air Changes. - 附上房間的過(guò)濾器的布置圖和編號(hào) - Attach The Layout Of The Room Filters And Series Number. 可接受標(biāo)準(zhǔn) Acceptance Criteria 換氣次數(shù)設(shè)計(jì)標(biāo)準(zhǔn)的90% The Air Changes 90% Of Design Standard 測(cè)試報(bào)告 Test Report 填寫(xiě)在“測(cè)試報(bào)告4 Fill In Test Report No.4. 在偏差報(bào)告中記錄在測(cè)試過(guò)程中所發(fā)生的偏差 Recording The Deviation Occurred During The T

47、est Execution On The Deviation Report. 3.5 房間壓差Room Differential Pressure 目的 Purpose 確認(rèn)不同潔凈等級(jí)的不同房間的壓差，確認(rèn)特殊房間之間的壓差 Verify The Differential Pressure Of Different Room Of Different Clean Level. Verify The Differential Pressure Between The Special Rooms. 程序 Procedure 方法一Method No.1 - 把待測(cè)試房間與參照房間連往精密壓力計(jì)（

48、通過(guò)硅樹(shù)脂管道），測(cè)量靜態(tài)壓差 - Connect The Test Room With Reference Room Toward The Precision Pressure Instrument (Through Silicone Resin Pipeline)，Measure The Differential Pressure Of Static State. - 檢驗(yàn)所得數(shù)值是否符合可接受標(biāo)準(zhǔn) - The Value Through Test Is Accordant With The Acceptance Criteria. 方法二Method No.2 - 利用已安裝的，并且得到

49、校準(zhǔn)的微壓差計(jì)來(lái)測(cè)量不同房間的靜態(tài)壓差 - Test The Static Differential Pressure Of The Different Room By The Installed And Calibrated Micro-Pressure Instrument. 可接受標(biāo)準(zhǔn) Acceptance Criteria 壓差在設(shè)計(jì)標(biāo)準(zhǔn)±5Pa范圍之內(nèi) The Differential Pressure Is Within ±5Pa Of Design Standard. 不同潔凈度的不同房間的壓差12.5Pa The Differential Pressure

50、Of Different Room Of Different Clean Level12.5Pa測(cè)試報(bào)告 Test Report 填寫(xiě)在“測(cè)試報(bào)告5” Fill In Test Report No.5. 在偏差報(bào)告中記錄在測(cè)試過(guò)程中所發(fā)生的偏差 Recording The Deviation Occurred During The Test Execution On The Deviation Report. 3.6 房間溫度和相對(duì)濕度Temperature And Relative Humidity In Room目的 Purpose 確認(rèn)房間內(nèi)的溫度和相對(duì)濕度達(dá)到設(shè)計(jì)標(biāo)準(zhǔn) Validate

51、 Temperature And Relative Humidity In Room Gets Design Requirements 程序 Procedure 測(cè)點(diǎn)選擇高度應(yīng)離地面0.8m，距設(shè)備周?chē)?.8m以外處，并應(yīng)避開(kāi)出、回風(fēng)口處 The Test Point Should Choice The Point That The Distance From The Test Point To The Ground Is 0.8m,The Distance Around The Equipments Is Outside 0.8m，And Should Avoid The Exhaust V

52、ent And The Return Vent. 可接受標(biāo)準(zhǔn) Acceptance Criteria 房間內(nèi)的各測(cè)點(diǎn)溫度和相對(duì)濕度在設(shè)計(jì)范圍內(nèi) The Temperature And Relative Humidity Of Each Test Point In The Room Is In Design Range. 測(cè)試報(bào)告 Test Report 填寫(xiě)在“測(cè)試報(bào)告6 Fill In Test Report No.6 在偏差報(bào)告中記錄在測(cè)試過(guò)程中所發(fā)生的偏差 Recording The Deviation Occurred During The Test Execution On The

53、Deviation Report. 3.7 房間潔凈度的測(cè)試（靜態(tài)）Non Viable Particle Count Of Room “At Rest” 目的 Purpose 確認(rèn)房間的潔凈等級(jí)。測(cè)試是在靜態(tài)的環(huán)境下進(jìn)行, 即設(shè)備不運(yùn)行，無(wú)工作人員 Verify The Clean Level. The Test Is Carrying On Under The Static Environment, Namely The Equipment Does Not Move, Non- Staff. 程序 Procedure 1、使用一已校準(zhǔn)的顆粒計(jì)數(shù)器 Take A Calibrated Particle Counter. 2、保證房間已清潔過(guò) Verify That The Room Has Been Cleaned. 3、儀器自凈 The Instruments Clean Themselves. 4、確定取樣點(diǎn)的數(shù)量： Verify The Amount Of The Sampling Point A: 表示房間面積N:表示取樣點(diǎn)數(shù)量。指明取樣點(diǎn)的位置。取樣點(diǎn)的數(shù)量不少于2點(diǎn)。 A: Room Area N: T