純化水系統(tǒng)安裝確認IQ(中英文)

1、 execution approval signatures 批準執(zhí)行簽名批準執(zhí)行簽名 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

2、an amendment which must be approved prior to execution. 下面的簽名表示批準本文件及其附件，且表明已經(jīng)為執(zhí)行作好了準備。在批準后，對本文件的目的或驗收標準 進行的任何改變或修正都必須起改善的作用，在執(zhí)行以前就必須取得批準。 department current good manufacturing practice for finished pharmaceuticals 21 cfr 第 210 和 211 部分：聯(lián)邦條例法典，成品藥 cgmp usp 28 - united states pharmacopeia, usp 28 美國藥

3、典 nist - national institute of standards and technology nist 美國國家標準技術研究所 draft sop of the pw system 純化水系統(tǒng)的 sop 6.0 responsible parties and responsibilities 責任方及其責任責任方及其責任 shanghai baoju fluid equipment engineering co., ltd. 納盛機電流體設備工程有限公司：. writing, of this protocol. 編寫本文件 review and approval of the

4、 original protocol. 審核和批準原始文件 review and approval of the completed protocol package 審核和批準完成的文件包 engineering / maintenance responsibilities: 工程/維護責任： execution of qualification packages. 執(zhí)行確認文件包 supply support and technical expertise needed in the preparation and execution of the protocol. 準備和執(zhí)行文件時提供

5、支持和技術意見 supply all documents, data, procedures, manuals, and drawings needed to generate and execute the protocol. 提供編寫和執(zhí)行本文件時所需要的所有文件、數(shù)據(jù)、程序、手冊和圖紙 manufacturing responsibilities: 生產(chǎn)責任 supply all procedures, data, manuals, drawings, and documentation needed to generate and execute the protocol 提供文件編寫

6、和執(zhí)行時所需的所有程序、數(shù)據(jù)、手冊、圖紙和文件 yung shin pharm.ind.(ks)co.,ltd： 永信藥品工業(yè)（昆山）有限公司: oversee the validation process. 監(jiān)督驗證程序 supply support needed in the preparation and execution of the protocol. 準備和執(zhí)行文件時提供需要的支持 review and approval of the original protocol. 審核和批準原始文件 review and approval of the completed protoco

7、l package 審核和批準完成的文件 7.0system description 系統(tǒng)說明系統(tǒng)說明 general description 總說明總說明 1)production capacity 產(chǎn)能 production capacity of the pw system is specified at 1000 liters per hour purified water (pw). 純化水系統(tǒng)的產(chǎn)能定為每小時 1000 升純化水（pw）。 2)quality standard of pw system 純化水系統(tǒng)的質量標準 the pw system will meet the f

8、ollowing criteria: 純化水系統(tǒng)將達到以下標準： pw quality standards as defined in usp 28 water for pharmaceutical purposes usp 28 制藥用水定義的純化水質量標準 meet gmp and fda requirements and pass appropriate qualification/validation 達到 gmp 和 fda 的要求，通過相關的確認/驗證。 3)distribution loop 分配回路 the pw system distribution loop will be

9、 constructed of 316l stainless steel pipe with orbital welded joints. complete specifications for the pipe, valves, pumps, and connectors are provided in the technical specification of purified water system for yung shin pharm.ind.(ks)co.,ltd. project. the pw system distribution loop distributes pur

10、ified water to the use points listed below. 純化水系統(tǒng)的循環(huán)回路由帶軌道自動焊接焊點的 316l 不銹鋼管道建造。 永信藥品工業(yè)（昆山）有限公司純化水系統(tǒng)技術規(guī)范中說明了關于管道、閥門、泵和接頭的詳細規(guī)范。 純化水系統(tǒng)循環(huán)回路分配純化水到下面列出的使用點。 4)purified water (pw) loop 純化水回路 一樓軟膏調劑室 一樓洗滌室 一樓混合造粒室 一樓洗滌室 一樓洗滌室 三樓洗盤室 三樓洗烘衣 m130 三樓潔具 三樓洗滌 三樓洗滌 m110 色水罐 三樓洗手 三樓手消 三樓洗手 pretreatment unit 預處理單元預處理

11、單元 the pretreatment unit consists of the following components, listed in the order of process flow: 預處理單元包含以下部件，按流程圖的順序列出依次為： 1)chemical container and dosing pump 化學容器和計量泵 a 80 liter pe tanks and dosing pumps are used to add flocculating and anti-scaling agents to the raw water. 用一個 80 升的 pe 箱和計量泵在原

12、水中加入絮凝劑和反垢劑。 2)sandfilter 沙濾器 the sand filter unit employs quartz sand in a 304 stainless steel housing to remove suspended solids and colloidal materials from the incoming water. 沙濾器單元利用 304 不銹鋼罐體中的石英砂來除去進水中的懸浮物質和膠質材料。 3)heat exchanger (pretreatment)熱交換器 (預處理) a heat exchanger is used to maintain w

13、ater temperature at 25oc for optimum purification performance. and also it is used to maintain water temperature at 80 when sterilizing the carbon filter。 為了達到最佳凈化性能，使用熱交換器使水溫保持在 25oc 。在碳過濾器滅菌時，使用熱交換器使水溫 保持在 80，達到滅菌效果。 4)activated carbon filter 活性炭過濾器 the activated carbon filter uses activated carbo

14、n in a 304 stainless steel housing to remove organic compounds, chlorine, odors, and reduce turbidity from the incoming water. 活性炭過濾器在 304 不銹鋼罐體內(nèi)使用活性炭來除去進水中的有機化合物、氯、氣味和減少濁度。 5)softener 軟化器 to reduce raw water hardness by softener. 用軟化器降低原水的硬度。 6)brine tank 鹽水箱 the auto control valve on the top of so

15、ftener periodically adopts brine from the brine tank for the use of softener regeneration. 軟化器上的自動頭定時從鹽箱中抽鹽水,以再生軟化器. 7)precision filter 精細過濾器 the precision filter employs a 5-micron membrane filter to remove any remaining particles to prevent contamination of the reverse osmosis (ro) membranes. 精細過濾

16、器采用 5 微米膜過濾來除去任何殘留的微粒，以防止對反滲透（ro）膜的污染。 reverse osmosis (ro) system 反滲透反滲透 (ro) 系統(tǒng)系統(tǒng) the r.o system is supplied from a standard water softener and pre-treatment system. r.o 系統(tǒng)的水來自標準水軟化器和預處理系統(tǒng)。 1)booster pump 增壓泵 a 4 kw pumps are used to pressurize the ro system. 用一個 4 kw 的泵來給 ro 系統(tǒng)增壓。 2)ro cleaning t

17、ank ro 藥洗箱 a 120 liter pe tank is used to feed cleaning agents, during period ro membrane cleaning process. 在 ro 膜潔凈程序中用一個 120 升 pe 箱來補充清潔劑。 3)ro water storage tank ro 貯水箱 the ro water storage tank will be constructed of 304 stainless steel. the tank capacity shall be 2 tons. ro 貯水箱由 304 不銹鋼制造。容量為 2

18、 噸。 mixed bed system 混床混床系統(tǒng)系統(tǒng) 1）mixed bed 混床 the mixed bed system adopts anion resin and cation resin to remove the cation and anion in the water and thus to reduce water conductivity. 混床系統(tǒng)利用陰陽離子樹脂來除去水中的陽離子和陰離子,降低水的電導率. 2）acid tank and alkali tank 酸堿水箱 the acid and alkali in the acid tank and alkali

19、 tank is used to regenerate the anion and cation in the mixed bed. 酸堿水箱中的酸和堿用于再生混床中的陰陽離子. 3）mixed bed regeneration pump 混床再生泵 the system adopts dual 480w regeneration pumps to feed acid and alkali separately into the mixed bed for generation. 系統(tǒng)使用兩個 480w 的再生泵分別將酸和堿打入混床進行再生. 4）micro filter 微濾器 the pr

20、ecision filter employs a 1-micron membrane filter to remove any remaining particles following the mixed bed system. 精細過濾器在混床后,采用 1 微米膜過濾來除去任何殘留的微粒， 核子級樹脂交換系統(tǒng)核子級樹脂交換系統(tǒng) resin exchange system 1)feed water tank 原水箱 the feed water tank is constructed of 316l with a capacity of 1000 liters. 給水箱材料為 316l，容量

21、為 1000 升。 2)feed water pumps 進料水泵 one 0.48 kw pumps provide feed water to the system. 一個 0.48 kw 的泵為系統(tǒng)給水。 3)nucleon-class resin tank 核子級樹脂罐 a fre nucleon-class resin tank with pe liner is adopted for ion exchange. 用一個 fre 襯 pe 的核子級樹脂罐中的核子級樹脂進行離子交換。 4)the precision filter 微濾器 the precision filter emp

22、loys a 0.22-micron membrane filter to remove any remaining particles. 精細過濾器采用 0.22 微米膜過濾來除去任何殘留的微粒。 4)ultraviolet sterilizer 紫外線消毒器 an ultraviolet sterilizer is installed to eliminate bacteria. 安裝一個紫外線消毒器來除去細菌。 monitor and control system 監(jiān)視和控制系統(tǒng)監(jiān)視和控制系統(tǒng) the entire pw/wfi system shall be automatically

23、 monitored and automatically controlled by plc (programmable logic control). 整個 pw/wfi 系統(tǒng)應該由 plc（可編程邏輯控制）自動監(jiān)視和自動控制。 本系統(tǒng)流程圖如下: 8.0testing procedures 檢驗程序檢驗程序 the installation qualification will be performed using the protocol attachments listed in section 10. all pertinent information will be recorde

24、d on these forms. copies of the forms may be made as necessary. document results and data concurrently with the execution of this protocol. mark through any unused spaces with a single line and initial and date. mark spaces that do not apply to the system being qualified with not applicable (n/a) an

25、d provide an explanation where appropriate. document any deviations or abnormalities observed during the execution of the protocol. 借助第 10 部分中列出的文件附件進行安裝確認。把所有有關信息記錄在這些表格中。必要時也可復 印表格。執(zhí)行文件的同時記錄結果和數(shù)據(jù)。未使用的地方用單線劃去，簽名，并注明日期。用不適用 （n/a）標明不適用系統(tǒng)的地方，并且在合適的地方寫明理由。記錄下執(zhí)行文件時發(fā)現(xiàn)的任何偏差或 不正常的情況。 note: any exceptions t

26、o this protocol must be fully investigated and documented. this iq can be considered acceptable with exceptional data only if the cause of the exception has been determined or an assignable cause can be attributed to it and it can be proven that such data will not invalidate the protocol studies. qu

27、ality assurance is responsible for determining the acceptability of any exceptional data. 備注：備注：對本文件中的任何例外進行完全調查和記錄。只有當例外的原因已經(jīng)確定，或可以歸結為特定的原因， 且能證明該數(shù)據(jù)不會使文件無效時，這個有例外數(shù)據(jù)的 iq 才可以接受，qa 有權決定是否接受例外數(shù) 據(jù)。 飲用水 砂濾活性炭軟水機 ro 系統(tǒng) 混床核子級樹脂 罐 2t 純化水桶 使用點 9.0acceptance criteria 驗收標準驗收標準 test equipment and materials - al

28、l test equipment used during protocol execution must be documented. if the test equipment is not calibrated, a reason must be recorded and justified. 驗證設備和材料- 文件執(zhí)行過程中的所有檢驗設備都必須有記錄。如果檢驗設備沒有校驗，必須寫 明并說明理由。 drawings and p&ids - all drawing must be current 圖紙和 p&id 圖所有的圖紙必須都是最新的圖紙 utility verification -

29、all utilities must be verified to meet the manufacturers specifications. 公用工程驗證 必須確認所有的公用工程都達到廠商的規(guī)范。 materials in product contact - materials in product contact must be as designed and/or appropriate for the process and product. any deviation in materials must be justified. 與產(chǎn)品接觸的材料- 與產(chǎn)品接觸的材料必須符合設計要

30、求和/或適合于工藝和產(chǎn)品。材料有任何偏 差都必須調整。 standard operational procedures all standard operational procedures will be in draft format. 標準操作程序 所有的標準操作程序都有草案。 critical and non critical equipment lists - all critical instruments must be currently in calibration. 關鍵和非關鍵設備清單- 所有的關鍵儀器都必須處于最近的校驗有效期中。 spare parts -a spar

31、e parts list must be available for the system and its associated pieces of equipment. 備件 系統(tǒng)及設備的相關零件必須有備件清單。 components labeling - all instruments and critical components must be identified. 部件標簽 所有儀器和關鍵部件都已經(jīng)識別。 installation/startup procedures - all system installation and startup procedures must hav

32、e been properly executed and documented. 安裝/啟動程序 準確的執(zhí)行和記錄所有的系統(tǒng)安裝和啟動程序 all data forms required for execution of the protocol must be completely, accurately, and properly filled out. 執(zhí)行文件時所有必需的數(shù)據(jù)表都必須完整、準確，且正確填寫。 all criteria specified on the data sheets must be met. 符合數(shù)據(jù)表中指定的所有標準。 all deviations must

33、have been corrected or an action plan for correction of the deviation(s) must have been developed. 所有的偏差必須糾正，或提出一個糾偏計劃。 attachment 1. - validation test equipment and materials 附件附件 1驗證驗證測試設備和材料測試設備和材料 list the instruments/equipment/materials not installed on or part of the equipment and/or system be

34、ing qualified that are used for the installation qualification. 在下表中列出安裝確認中要使用，但未安裝的儀器/設備/材料，或需鑒定的設備和/或系統(tǒng)的一部分。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 description 說明說明 calibrated (y/n) 已校驗已校驗 （是（是/否）否） id no./ serial no. . id 號號 系列號系列號 calibration date 校驗日期校驗日期

35、 calibration due date 校驗到期日校驗到期日 copies of the most recent calibration reports for applicable instruments are: 儀器的最近校驗報告復印件在 ( ) attached附件中 comments: 注釋： acceptance criteria: all test equipment used during protocol execution must be documented. if the test equipment is not calibrated, a reason must

36、 be recorded and justified. 驗收標準：驗收標準：記錄下文件執(zhí)行過程中所有的檢測設備。如果檢測設備沒有校驗，則記錄原因，說明理由。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) compiled by 編輯: date 日期: attachment 2. - specification and purchase order verification 附件附件 2 規(guī)范和采購單確認規(guī)范和采購單確認 list the specifications and purchase orders associ

37、ated with the equipment and/or system being qualified. 列出與需要確認的設備和/或系統(tǒng)有關的規(guī)格和采購單 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 purchase order no. 采購單編號采購單編號 vendor specification description 制造商規(guī)范說明制造商規(guī)范說明 specify location of purchase order and specification 指定采購單和規(guī)指定采

38、購單和規(guī) 范存放地點范存放地點 copy attached? (y/n) 有復印附件嗎？有復印附件嗎？ （是（是/否）否） acceptance criteria: all associated purchase orders with this equipment will be attached. 驗收標準驗收標準：所有與該設備有關的采購單都附在文件之后。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) compiled by 編輯: _date 日期: _ attachment 3. - engineering dr

39、awing list 附件附件工程圖紙清單工程圖紙清單 copies of the latest revisions are attached to the protocol 最新的修改版本附在文件后。 signature of shanghai baoju or ysp ks personnel confirms that drawing has been finalized 由納盛機電或昆山永信公司人員簽名，確認圖紙完成。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 drawi

40、ng number 圖紙編號圖紙編號 latest rev. no. 最近修改最近修改 版本號版本號 issue date 出圖紙出圖紙 日期日期 title 標題標題 verified by/date 審核人審核人/日期日期 acceptance criteria: all drawing must be current. 驗收標準：驗收標準：所有圖紙都是最新的。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) compiled by 編輯: _date 日期: _ attachment 4. - standard op

41、erating procedures list 附件附件 4標準操作程序清單標準操作程序清單 identify operational procedures for the system and/or equipment and list below. 確認系統(tǒng)和/或設備的操作程序，在下面列出。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 title 標題標題 sop no./rev sop 編號編號/版本版本 comments 注釋注釋 acceptance criteria:

42、all standard operational procedures will be in a draft format. 驗收標準：驗收標準：所有的標準操作程序都已有草案。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) compiled by 編輯: _date 日期: _ attachment 5. - operation and maintenance manual list 附件附件 5操作和維護手冊清單操作和維護手冊清單 equipment manuals may include installation,

43、start-up, operation, and troubleshooting procedures. list manuals below and note the location where they are kept. 設備手冊包括安裝、啟動、操作和故障處理程序。在下面列出手冊，注明其存放地點。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 manual title 手冊標題手冊標題 revision or date 版本或日期版本或日期 location 地點地點 acc

44、eptance criteria: list all operational and maintenance manuals associated to this equipment. 驗收標準：驗收標準：列出與該設備有關的所有操作和維護手冊。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) compiled by 編輯: _date 日期: _ attachment 6. - major component labeling list 附件附件 6 主要部件標簽清單主要部件標簽清單 all major component

45、s, sensors, transmitters, gauges, valves and controlled devices must be listed. 列出所有的主要部件、傳感器、變送器、儀表、閥門和控制設備。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 component requiring labeling 需要貼標簽的部件需要貼標簽的部件 correctly labeled 標簽已經(jīng)正確貼好標簽已經(jīng)正確貼好 verified by/date 審核人審核人/日期日期 a

46、cceptance criteria: all major components must be identified. 驗收標準：驗收標準：所有主要的部件都已經(jīng)識別。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) compiled by 編輯: _date 日期: _ attachment 7. - critical instrument list 附件附件 7 關鍵儀器清單關鍵儀器清單 instruments are classified as critical or non-critical. critical i

47、nstruments are defined as those whose performance directly affects the quality of the process utility or product produced by the system. an instrument must be defined critical if it provides data that is recorded in a manufacturing record, provides a reading by which product quality decisions are ma

48、de, or provides data by which product specifications are developed. non-critical instruments are those provided for information or convenience only. all instruments will be calibrated before the execution of the oq protocol. 儀器分為“關鍵”和“非關鍵”兩種。關鍵儀器指的是其性能直接影響工藝效果或系統(tǒng)產(chǎn)品質量的儀器。一個儀器， 如果它提供的數(shù)據(jù)被記錄在生產(chǎn)記錄中，或者它顯示

49、的讀數(shù)是產(chǎn)品質量的決定因素，或者它提供的數(shù)據(jù)是起草 產(chǎn)品規(guī)范的依據(jù)，那么它就應該屬于關鍵儀器。非關鍵儀器只提供信息或只是為了便利。執(zhí)行 oq 前所有的儀 器必須已校驗。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 id no. id 號號 description 說明說明 manufacturer 生產(chǎn)商生產(chǎn)商 model no. 型號型號 serial no. 系列號系列號 last cal. 上次校驗上次校驗 next cal. date 下次校驗日期下次校驗日期 accept

50、ance criteria: all critical instruments must be currently in calibration. 驗收標準：驗收標準：所有的關鍵儀器都必須處于最近的校驗有效期中。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) verified by 校驗人: date 日期: attachment 8. - non-critical instrument list 附件附件 8非關鍵儀器清單非關鍵儀器清單 instruments are classified as critical or

51、 non-critical. critical instruments are defined as those whose performance directly affects the quality of the process utility or product produced by the system. an instrument must be defined critical if it provides data that is recorded in a manufacturing record, provides a reading by which product

52、 quality decisions are made, or provides data by which product specifications are developed. non-critical instruments are those provided for information or convenience only. all instruments will be calibrated before the execution of the oq protocol. 儀器分為“關鍵”和“非關鍵”兩種。關鍵儀器指的是其性能直接影響工藝效果或系統(tǒng)產(chǎn)品質量的儀器。一個儀器

53、， 如果它提供的數(shù)據(jù)被記錄在生產(chǎn)記錄中，或者它顯示的讀數(shù)是產(chǎn)品質量的決定因素，或者它提供的數(shù)據(jù)是起草 產(chǎn)品規(guī)范的依據(jù)，那么它就應該屬于關鍵儀器。非關鍵儀器只提供信息或只是為了便利。執(zhí)行 oq 前所有的儀 器必須已校驗。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 id no. id 號號 description 說明說明 manufacturer 生產(chǎn)商生產(chǎn)商 model no. 型號型號 serial no. 系列號系列號 last cal. 上次校驗上次校驗 next cal.

54、 date 下次校驗日期下次校驗日期 acceptance criteria: all non-critical instruments have been listed in the above table. 驗收標準：驗收標準：所有非關鍵儀器都已經(jīng)在上表列出。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) verified by 校驗人: date 日期: attachment 9. - spare parts list 附件附件 9備件清單備件清單 generate or attach an itemized li

55、st of the manufacturer recommended spare parts. attachments may be copies of spare parts lists provided in individual equipment operation or maintenance manuals. spare parts are items used to replace worn-out or broken items. 在備件清單中逐項列出生產(chǎn)商推薦的備件?？梢杂脝蝹€設備的操作或維護手冊上的備件清單的復印件作為附件。 備件指的是用來代替磨損或破壞部件的部件。 if

56、a manufacturer recommended spare parts listing is available it may be attached to this datasheet. 如果有生產(chǎn)商推薦的備件清單，可以附上。 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 part no. 備件編號備件編號 description 說說 明明 equipment 設設 備備 acceptance criteria: a spare parts list must be ava

57、ilable for the system and its associated pieces of equipment. 驗收標準：驗收標準：系統(tǒng)和設備都有備件清單。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) compiled by 編輯: _date 日期: _ attachment 10. - installation procedures verification data sheet 附件附件 10安裝程序確認數(shù)據(jù)表安裝程序確認數(shù)據(jù)表 procedure 程序weld log verification 焊接

58、記錄 performed by 執(zhí)行人 documented by 記錄人 document location 文件位置 document location 文件位置 procedure 程序pressure testing 壓力測試 performed by 執(zhí)行人 documented by 記錄人 document location 文件位置 procedure 程序cleaning and passivation 清洗和鈍化 performed by 執(zhí)行人 documented by 記錄人 document location 文件位置 procedure 程序pure steam

59、sterilization 純蒸汽滅菌 performed by 執(zhí)行人 documented by 記錄人 document location 文件位置 acceptance criteria: all system installation and startup procedures must have been properly executed and documented. 驗收標準：驗收標準：所有的系統(tǒng)安裝和啟動程序都已經(jīng)正確執(zhí)行和記錄。 meets acceptance criteria 符合驗收標準符合驗收標準: yes 是是( ) no 否否 ( ) verified by

60、 校驗人: date 日期: attachment 11. - utility data sheet: electrical 附件附件 11公用工程數(shù)據(jù)表：電公用工程數(shù)據(jù)表：電 note: this sheet may be copied, if necessary.注：如果需要，該表可以復印。page _ of _ 第_頁 共_頁 equipment:設備 equipment no.:設備號 location: 位置 ( ) switch gear 開關裝置 ( ) panel 面板 ( ) motor control center 馬達控制中心source 電源: id # volts 伏