【正文】
YZ020xxxx( 1) 第 27 頁 /共 61 頁 Any national law existing content, will not repeat the provisions, the total removal of 79 and criminal law, repeat the content of the public security management punishment law, and other laws and regulations. In the general reiterated that party anizations and Party members must conscientiously accept the party39。s ideals and beliefs, excellent traditional style. The revised the code closely linked to the selfdiscipline, insisting on the positive initiative, for all members, highlight the vital few, emphasized selfdiscipline, focusing on the morality, and the majority of Party members and the ideological and moral standards. The revised Ji method separately, Ji, Ji Yan to GFG200 沸騰干燥機驗證方案 YZ020xxxx( 1) 第 22 頁 /共 61 頁 Method, as a negative list, emphasizing the heteronomy, focusing on vertical gauge. Is this one high and one low, a positive reaction, the strict party discipline and practice results transformation for the integration of the whole party to observe moral and discipline requirements, for the majority of Party members and cadres provides benchmarking and ruler. Third, insist on to. In view of the problems existing in the party at the present stage, the main problems of Party members and cadres in the aspect of selfdiscipline and abide by the discipline to make clearly defined, especially the party39。s 18 and the eighth session of the third, the spirit of the fourth plenary session, reflecting the experience of studying and implementing the General Secretary Xi Jinping series of important speech, reflects the party39。 以下條件發(fā)生改變時需要進行重新驗證 當(dāng)設(shè)備出現(xiàn)較大方面維修時 ,需要進行重新進行運行和性能驗證 ; 當(dāng)設(shè)備使用條件發(fā)生變更時需要重新進行運行和性能驗證; 當(dāng)設(shè)備連續(xù)使用 五 年后,對設(shè)備要進行重新 進行安裝、運行、性能 驗證; 再驗證周期 如各項驗證結(jié)果能夠證明設(shè)備滿足生產(chǎn)需求,且符合新版 GMP 要求,那么依次制定下次進行再次驗證周期為五年。 清灰 開關(guān) 按下清灰按鈕,過濾袋出現(xiàn)抖動。 檢查項目 要求 檢查結(jié)果 電源 開關(guān) 接通電源,電源指示燈亮 ,反之則指示燈熄滅。 驗 證小組成員 職務(wù) 分工 職責(zé) 生產(chǎn)副總 進度協(xié)調(diào)總指揮 對驗證工作總負(fù)責(zé),負(fù)責(zé)進度安排、廠 方協(xié)調(diào),人員調(diào)度 質(zhì)量受權(quán)人 驗證工作總指揮 負(fù)責(zé)驗證方案及驗證方案的審核、批準(zhǔn)、負(fù)責(zé)驗證工作的最終結(jié)果判定 工程部副部長 安裝確認(rèn) 依照生產(chǎn)工藝流程、確保安裝能保證生產(chǎn)操作的流暢、安全。 設(shè)備 相關(guān)參數(shù) 機器型號: GFG200 原料 容積: 670L 投料量: 150kg~ 250kg 蒸汽耗量: 285kg 進風(fēng)溫度:常 溫 ~ 170℃自由調(diào)節(jié) 操作時間: 20~ 60min(視物料) 物料收率: 98% 主機噪聲:≤ 75db 設(shè)備 工作原理 待干燥的物料(顆?;蚣?xì)粉)投入干燥器料斗,空氣經(jīng)中效過濾器除塵后,由加熱器升溫至干燥所需要的溫度,然后進入主塔,當(dāng)其穿過料斗底部的多孔板,使料斗內(nèi)物料流化同時除去水份而干燥,水份揮發(fā)后隨排風(fēng)經(jīng)布袋過濾器過濾后由風(fēng)機排出,干燥過程中隨風(fēng)上升的細(xì)粉則由布袋捕集,并通過清灰裝置返回流化床。物料在流化的同時被低速攪拌,因而避免結(jié)塊,對于含濕量偏高,帶粘性物料,其運用優(yōu)勢特別突出。 : 通過對 GFG200 型沸騰干燥床進行安裝、運行、性能確認(rèn),以使其能夠達(dá)到使用要求 ,且符合國家 GMP 要求 。 偏差 有( )偏差處理文件編號: 無( ) 檢 查人 日 期 復(fù)合人 日 期 儀器儀表 校驗 確認(rèn) 儀器儀表名稱 校驗編號 是否符合 GMP 標(biāo)準(zhǔn) 電流表 電壓表 壓力表 偏差 有( )偏差處理文件編號: 無( ) 檢查人 日 期 復(fù)核人 日 期 安裝確認(rèn)結(jié)論 及評價 檢查人: 日期: 運行確認(rèn) 設(shè)備功能調(diào)試確認(rèn) 在進行設(shè)備運行前需要先檢查水、電、氣管道的正確連接,設(shè)備已經(jīng)清潔、布 袋已經(jīng)安裝完成,儀器儀表已經(jīng)校驗完成。 加熱器 開關(guān) 設(shè)定好加熱溫度,按下加熱按鈕, 溫度上升。發(fā)放驗證證書,對驗證結(jié)果的評審應(yīng)包括: 證試驗是否有遺漏? ?修改原因 . 依據(jù)以及是否經(jīng)過批準(zhǔn)? 驗證記錄是否完整? 驗證試驗結(jié)果是否符合標(biāo)準(zhǔn)要求?偏差及對偏差的說明是否合理?是否需要進一步補充試驗? 驗證結(jié)論 檢查人: 日期: 具體依照生產(chǎn)時間安排。s leadership, to solve the masses of the people reflect a focus on the problem. The new revision of the code and rule , reflects the party39。s eighteen, ten eight plenary, the spirit of the Fourth Plenary Session of the Eleventh Central Committee and General Secretary Xi Jinping important instructions on the revised low political criterion and Regulations , highlighting the ruling party characteristics, serious discipline, the discipline quite in front of the law, based on the current, a longterm, advance as a whole, with Bu Xiuding independent rule and rule . Main principle is: first, adhere to the party constitution to follow. The constitution about discipline and selfdiscipline required specific, awaken the party constitution of party passes party consciousness, maintaining the authority of the constitution. General Secretary Xi Jinping pointed out that no rules, no side round. GFG200 沸騰干燥機驗證方案 YZ020xxxx( 1) 第 21 頁 /共 61 頁 Party constitution is the fundamental law, the party must follow the general rules. In early 2020 held the eighth session of the Central Commission for Discipline Inspection Fifth Plenary Session of the 16th Central Committee, Xi Jinping again pointed out that constitution is the party must follow the general rules, but also the general rules. the revision of the code and rule is Method in adhere to the regulations established for the purpose of bining rule of virtue is to adhere to the party constitution as a fundamental to follow, the constitution authority set up, wake up the party constitution and party rules the sense of discipline, the party constitution about discipline and selfdiscipline specific requirements. 4 second is to adhere to in accordance with the regulations governing the party and the party. The Party of rule of virtue de, mainly refers to the party39。s leadership and the party39。s image, the damage to the party, the state and the people39。s eighteen years implement the spirit of the central provisions of the eight, against the requirements of the four winds and transformation for disciplinary provisions, reflecting the style construction is always on the road, not a gust of wind. In the fight against corruption out of new problems, increase the trading rights, the use of authority relatives profit and other disciplinary terms. Prominent discipline of the masses, the new against the interests of the masses and ignore the GFG200 沸騰干燥機驗證方案 YZ020xxxx( 1) 第 28 頁 /共 61 頁 demands of the masses a