1、Document Type: Standard Operating Procedure(SOP)Document Name:HM AS-H1.5AMPOULE AUTOCLAVE 1.5M3 SOP Rev 1.01Document No.:HM2008Revision No.:1.01HM PHARMACHINE 安瓿滅菌器HM AS-H1.5AMPOULE AUTOCLAVE 1.5M3標準操作規程STANDARD OPERATING PROCEDURE (SOP)（供客戶參考，詳見使用說明書）This document is only reference for users，Refer

2、to instruction manual for details描述：Description 本文件由用戶和臺州惠美商貿有限公司雙方共同確認。This document is the approval of the protocol from both parties HM PHARMACHINE CHINA LTD. and user.本文件僅適用于下面所述項目。This documentation only applies to the project below described.沒有臺州惠美商貿有限公司同意，本文件不得被復制或提供給第三方。The documentation mus

3、t not be reproduced or given to third parties without being written allowed by HM。責任: Responsible臺州惠美商貿有限公司負責編輯設備確認草案并向客戶提交進行確認；用戶在執行前審核和批準本方案。The documentation must not be reproduced or given to third parties without being written allowed by HM。設備名稱：Equipment:設備型號：Equipment Type:設備編號：Equipment No:協

4、議批準Protocol Approval:標題Title名字Name 簽名Signature 日期Date Prepared byHM工程師HM Project Engineer復核人wed byHM 主管HM Director批準人Approved by客戶質量主管Customer Director of Quality and Regulatory審核人Approved by客戶技術經理Customer Technical Manager文件協調員Document Coordinator客戶確認Customer Validation協議完成（簽名后，協議就完全完成了）Protocol Co

5、mpletion (To be signed only after protocol has been completed):標題Title名字Name簽名Signature日期Date執行人員Executed By:客戶工程測試員Customer testing engineers審核 人員Approved by客戶質量主管Customer Director of Quality and Regulatory審核 人員Approved by客戶技術經理Customer Technical Manager文件協調員Document Coordinator客戶確認Customer Validat

6、ion A© 2012 HM PHARMACHINE SWISS GMBH.All rights reserved. No part of this work covered by copyright may be reproduced or copied in any form or by any means (graphic, electronic or mechanical, including photocopying, record taping, or information retrieval systems) without the written permissio

7、n of HM PHARMACHINE SWISS GMBH.目錄Table of Contents1、目的PURPOSE. 52、適用范圍RANGE .53、責任者RESPONSIBLE.54.、程序Procedure: 54.1設備描述 Equipment descripation54.2使用前準備：Preparation before for use.54.3開機前準備：Prepartion before opening machine64.4開機操作程序：Open machine operation procedure64.5 關機程序 Close machine procedure6

8、5、注意事項與日常保養.7一、目的：建立HM AS-H1.5安瓿滅菌器標準操作規程，使操作達到規范化、標準化，保證產品質量。I.Purpose:Establish HM AS-H1.5 Ampoule autoclave 1.5m3 standard operation procedure,make operation reached normalization,standardization,to ensure product quality.二、適用范圍：適用于HM AS-H1.5安瓿滅菌器標準操作。 Range:suitable for HM AS-H1.5 Ampoule autocl

9、ave 1.5m3 operators.三、責任者：操作工、車間管理人員。III.Responsible person: Operators ,workshop administrator四、程序：.Procedure:4.1設備描述 Equipment descripationHM AS-H1.5機動門安瓿滅菌器主要用于安瓿、口服液、小輸液瓶等藥品制劑的滅菌、檢漏和清洗處理。它利用壓力蒸汽作為滅菌介質, 可實現110127溫度區間的均勻滅菌，采用預真空升溫方式，保證滅菌室內冷空氣排除徹底，升溫迅速均勻, 并有效消除了因冷空氣存在而造成的溫度死角。工作過程中通過真空加色水檢漏，保證廢品檢出率1

10、00%。 HM AS-H1.5 series ampoule sterilizer is mainly used in the sterilization, leakage inspection and cleaning of ampoule, oral liquid or small transfusion bottle medicine. Steam of a certain pressure is used as sterilizing medium, even sterilization between 105127 can be achieved. Replacing gas exh

11、austing and heating is used, the cold air in chamber is discharged thoroughly, and the heating is even and fast, then temperature dead corner caused by cold air can be avoided effectively. Vacuum and color water are used in the leakage inspection, 100% nonconforming products can be identified. 4.1.1

12、主要技術參數 Main technical parameter額定工作壓力Technical parameter0.21 Mpa 最高真空度Highest vacuum degree：-0.089 MPa工作溫度范圍Range of working temperature:105127（建議滅菌溫度advise sterilize temperature）蒸汽源供給 Steam source pressure:0.30.5MPa真空泵水源Water source of the vacuum pump：0.20.5MPa壓縮空氣供給Compressed air pressure:0.40.8MP

13、a控制電源Controlling power:AC220V50Hz0.5KW動力電源Driving power:AC380V 50Hz滅菌時間范圍sterilizationTime range09999秒09999 seconds清洗時間范圍clean time range09999秒09999 seconds安全閥開啟壓力safety valve open pressure0.23 Mpa安全閥關閉壓力safety valve close pressure0.21 Mpa 4.2使用前準備：Preparation before for use4.2.1檢查現場是否達到清場要求 Check s

14、ite if reach site-clearing requirements.4.2.2將“清場合格證”副本附入輔助生產記錄。Make"site-clearing certificate " copy attached auxiliary production record.4.2.3操作者要熟悉本設備的每個組成部分，聯線操作時更應熟悉全部單機和周圍環境。 Operator should familiar with this equipment every part,and all the single machines and around environment wh

15、en connect wire operation. 4.2.4檢查外界電源、電壓與本機連接應正確、檢查各電機運行應正常；Inspect outside electrical source,voltage and this machine connecting if correct,inspect every motor if running normally.4.2.5檢查機器上的緊固件應無松動、脫落。Inspect fastener of machine should no loose,drop.4.3開機前準備：Prepartion before opening machine4.3.1

16、 啟動壓縮機，使壓力上升到需要值，然后打開壓縮氣閥。Ø將蒸汽管道內的冷凝水排放干凈，然后打開與滅菌器連接的蒸汽源開關，并檢查其壓力是否達到0.3 0.5Mpa。Start compressed machine, make pressure increased to required value, then open compressed air valve. Make steam pipe inside condensated water drained, then open steam source switch which connected with autoclave,and

17、 inspect its pressure if reach 0.3 0.5Mpa.4.3.2打開用戶色水源、備用水源、去離子水源閥門開關，為程序進行做準備。Open users color water source, ready water source, go ion water source valve switch, prepare for procedure processing.4.3.3打開真空泵水源閥門，并檢查水源壓力是否達到0.150.30MPa規定壓力值。Open vaccum pump water source valve, and check water source

18、pressure if reach 0.150.30MPa required value.4.3.5接通動力電源和控制電源。Get through power electrical source and control electrical source. 4.4開機操作程序：Open machine operation procedure4.4.1打開密封門，將裝載滅菌物品的內車推入滅菌室內。Open sealed door, make inside cart which loaded sterilization goods pushed into sterilizing room.4.4.

19、2關閉密封門，選擇滅菌程序，設置滅菌參數，當確認滅菌參數毋需修改后，啟動滅菌程序。Close sealed door,choose sterilize procedure,set sterilize parameter,when confirm sterilize parameter no need revise,then start sterilize procedure.4.4.3滅菌過程中，操作人員應密切觀察設備的運行狀況，如有異常，及時處理。In sterilize process,operators should observe equipment running status,if

20、 unnormal,solve in time.4.4.4.滅菌結束后，待室內壓力回零后，方可打開后門取出滅菌物品。After finish sterilization,after room inside pressure return 0,then can open back door to take out sterilize goods.4.4.5滅菌物品從車內取出后，應仔細檢點放置，并做好記錄。After take out sterilization goods form cart,should check carefully lay up,and record well.4.5 關機程序 Close machine procedure4.5.1打開前門，切斷設備