药业公司胶囊充填机FAT设备功能测试报告

1、 imazibo/dr-z-02-03customer:revision: 1.0用户名：天士力帝益药业公司 版本： 1.0 天士力帝益药业公司 ima zanasi 85 e 胶囊充填机 fat 设备功能测试报告machine model: 机器型号：zanasi 85e serial n.:系列号：pd1118 ima reproduction of this document by any means, in whole or in part, is prohibited without the authorization of ima s.p.a.未经伊马公司授权，禁止私自拷贝该文件（

2、全部或一部分）。functional test specificationspage 2 of 53( pd1118 rev. 1.0)table of modificationsrevisionmodification request no.modified bydatedescription of modificationfunctional test specificationspage 3 of 53( pd1118 rev. 1.0)index:索引索引1. introduction 导言.52. glossary术语表.53. description and test plan测试

3、操作描述及测试表.63.1 tested areas测试范围.63.2 untested activities非测试范围.93.3 test format测试格式.93.4 test passing criterion测试通过标准.103.5 logging test results测试结果录入.103.6 steps to take if a test fails测试失败时采取的措施.103.7 general warnings for carrying out the test测试时的一般注意事项.113.8 special warnings for carrying out the te

4、sts测试时的特别注意事项.114. documents and test equipment功能测试时所需文件及检测设备.125. test procedure测试步骤.135.1 main switch主开关.135.1.1main switch tes主开关功能测试.135.2 control panel控制面板功能测试.145.2.1language selection操作界面语言选择.145.2.2pushbuttons test: machine start, machine stop机器按钮功能测试：机器的起动及停止.155.3 capsule/product feeding d

5、evice胶囊（药品）供给装置功能测试.165.3.1 capsule feeding device胶囊供给装置功能测试5.3.1.1capsule feeding activation胶囊供给装置激活.165.3.1.2capsule minimum level胶囊最小料位.175.3.1.3sorting unopened capsules未打开胶囊分选.185.3.1.4capsule check enabling空胶囊在位检测装置.195.3.2mixer搅拌装置.195.3.2.1microdosing and intelligent hopper微计量及智能粉剂供给装置.215.3

6、.2.2mixer 1 time搅拌器 1 时间设定.235.3.2.3mixer 2 time搅拌器 2 时间设定.255.3.2.4powder mixer 2 (intelligent hopper)2 号粉剂搅拌器参数设定测试（智能粉剂供给装置）.275.3.2.5no powder 2 (intelligent hopper)2 号位缺粉测试.285.3.2.6sucked tank 1 and slug release 11 号位吸力槽及打击器.295.3.2.7sucked tank 2 and slug release 22 号位吸力槽及打击器.305.3.3enabling

7、the units机器类型设置.315.4 machine safety devices机器安全保护装置.335.4.1handwheel手轮.335.4.2jog max run time点动最长时间.345.4.3thermal relays热继电器.355.4.3.1overload cutouts (vacuum pump/aspirator) 过载断路器（真空泵及吸尘器）.355.4.4 phase sensors check (machine and capsule opening)相位传感器检测（机器及胶囊打开） 375.4.5slug detachment phase sens

8、or check打击器的传感器时序检测.385.4.5.1slug detachment 1 and slug detachment 2 phase sensor check1 号位及 2号位打击器的传感器时序检测.38functional test specificationspage 4 of 53( pd1118 rev. 1.0)5.4.6compressed air check压缩空气检测.395.4.7machine inverter failure机器变频器故障检测.405.4.8machine motor brake电机刹车.415.4.9intelligent hopper

9、inverter failure智能粉剂供给装置变频器故障检测.425.4.10 plc batteryplc电池.435.4.11 maximum speed机器最高速运转检测.445.5 operator safety devices操作者安全保护装置.455.5.1emergency buttons急停按钮.455.5.2safety guards open安全护罩打开.465.6 machine parameters机器参数.475.6.1machine type机器类型.475.6.2capsules/hour speed每小时胶囊数量.485.6.3machine life in

10、hours机器运行时间.495.6.4machine running hours/minutes机器运行小时/分钟.505.6.5number of produced capsules已充填胶囊的数量.516. notes注释.537. enclosures结束.53functional test specificationspage 5 of 53( pd1118 rev. 1.0)1. introduction 导言导言this document sets out the functional test specifications of ima industria macchine au

11、tomatiche s.p.a. for the zanasi plus 85 e machine, serial number pd1118, developed for customer (wbs technical specifications reference wbs code).这是 zanasi plus 85 e（系列号是：pd1118）胶囊充填机的功能测试文件，以此满足客户的需求。the purpose of this document is to describe the tests to be carried out as evidence that the machin

12、e operates correctly, in compliance with the functional specifications.照此文件的描述进行功能测试，测试结果与文件要求一致，证明机器运转正常。this document was issued in conformity with the following standard operating procedures (sop) and work instructions (w_i) of ima s.p.a.:文件发行遵照伊马公司 sop 及 wi 的文件要求。-w_i9.9 “functional test specifi

13、cations (sw quality man.)”功能测试说明。-w_i4.4“standards applicable to quality system implementation documentation”该文件标准遵照“质量系统执行文件”标准。w_i4.6“coding applicable to quality system implementation and acceptance tests” 该文件编码遵照“质量系统执行及验收测验”标准。- w_i4.5“management applicable to quality system implementation docu

14、ments”该文件事后管理遵照 “质量系统执行文件”标准。- sop7(5).9 “tests, checks and final acceptance tests on machines and production lines”对机器和生产线进行测试，检查及最后验收测试。2. glossary术语表术语表electrical safety devices电器安全装置hardware protecting devices (magnetothermal circuit breakers, proximity switches, etc.)电器硬件保护装置（热磁断路器，接近开关等）inclus

15、ion包括product, machine and size datum, able to enable or disable the activity functioning (through the users interface)药品，机器，模具更换件，通过操作界对机器进行动作。jog点动machine run mode (the manual jog mode is envisaged for maintenance and/or size change operations)机器运转模式（维修及模具更换时用）operator interface操作界面machine-operator

16、 communication software program implemented on pc and/or via the operator terminal.人机可通过 pc 机或操作终端进行信息交流production机器运作group of functions associated with monitoring, final product quality control生产是集各种监测装置于一体，最后成品质量控制的多个功能相连的过程。safety devices安全装置operator commands and protection devices (such as: stop

17、 buttons)操作控制及保护装置size changeover模具更换function for managing the replacement and/or adjustment mode of the components based on the processed size基于既定型号的模具更换和调整的功能functional test specificationspage 6 of 53( pd1118 rev. 1.0)3.description and test plan测试操作描述及测试表测试操作描述及测试表the following sub-sections descri

18、be the structure of the test plan that has been set up for the zanasi plus 85 e machine and in particular, the machines activity groupings to be functionally tested and, within such groupings, any particular activities not subjected to functional testing and relative motivations. for those particula

19、r activities not subjected to functional testing, the check actions applied in any case are synthetically described.each test is logged with an identification code of its own. moreover if a test fails the steps to take are described.以下测试表里描述的是对 zanasi plus 85 e 胶囊充填机进行功能测试的说明，尤其是对机器的某些功能组进行测试，在这些功能测

20、试组里，若对一些功能没有相应的测试说明，测试人员要记录下来，并测试其功能。3.1 tested areas测试范围测试范围specific machine activity areas are functionally tested.对该机器的特殊功能进行测试for this reason, the functional test is represented by a number of tests as a whole which in turn are grouped according to the activity to be examined. in particular, the

21、 definition of the grouping can be singled out by the third and fourth character in the test identification code. the machine activities that are subjected to functional testing and the corresponding test identification code typologies are listed below.基于这个原因，功能测试总体上是由多个依次测试的内容编组而成。这些编组可以通过测试代码的第三个和

22、第四个字母进行区分。对机器进行功能测试的内容及代码如下表所示：activities subjected to functional test功能测试对象功能测试对象test identification code typology 测试识别代码类型测试识别代码类型production机器运作cfpr-machine inclusions 机器所配置的的元器件cfim-size changeover 模具更换cfcf-safety devices 安全继电器cfsi-electrical safety devices 电器安全装置cfel-functional test specificatio

23、nspage 7 of 53( pd1118 rev. 1.0)test plan功能测试表the check-list of the test plan relative to the zanasi plus 85 e serial number pd1100 is shown below.下表所示为 zanasi plus 85 e 系列号为胶囊充填机功能测试核对表。the functional test of the zanasi plus 85 e machine is carried out following the set order of the tests listed in

24、 this table:按下表中所示顺序对机器进行功能测试。test execution premisestest name测试名称测试名称test code 测试代码测试代码ima(fat)customer(sat)main switch test主电源开关cfel01language selection语言选择cfim01pushbuttons test: machine start, machine stop按钮测试：机器启动及停机按钮cfim02capsule feeding activation胶囊自动供给功能检测cfim03nanacapsule minimum level胶囊最小

25、料位cfim04sorting unopened capsules未打开胶囊分选cfim07capsule check enabling胶囊在位检测cfim08nanamicrodosing and intelligent hopper微计量及智能供粉cfim10nanamixer 1 time一号工位搅拌器时间设定cfim11mixer 2 time二号工位搅拌器时间设定cfim12powder mixer 2 (intelligent hopper) 二号搅拌器（智能供粉）cfim17nanano powder 2 (intelligent hopper)缺粉检测（智能供粉）cfim22n

26、anasucked tank 1 and slug release 1一号工位吸力槽及打击器功能测试cfim27nanasucked tank 2 and slug release 2二号工位吸力槽及打击器功能测试cfim28nanaenabling the units机器配置单元cfim50handwheel手轮cfcf01jog max run time点动最长时间检测cfcf02overload cutouts (vacuum pump/aspirator)真空泵吸尘器过载断路功能检测cfsi01phase sensors check (machine and capsule openi

27、ng)机器相位停机及胶囊打开传感器功能检测cfsi08nanaslug detachment 1 and slug detachment 2 phase sensor check一号及二号工位打击器的传感器检测cfsi14compressed air check压缩空气检测cfsi18machine inverter failure机器变频器故障检测cfsi20machine motor brake电机刹车cfsi21intelligent hopper inverter failure智能供粉电机变频器故障检测cfsi22nanaplc batteryplc电池 cfsi25maximum

28、speed机器最高速cfsi26emergency buttons急停按钮cfsi60safety guards open安全护罩打开cfsi61machine type机器型号cfpr01functional test specificationspage 8 of 53( pd1118 rev. 1.0)test name测试名称测试名称test code 测试代码测试代码test execution premisesima(fat)customer(sat)capsules/hour speed每小时所充填胶囊数cfpr02machine life in hours机器运行时间cfpr0

29、3machine running hours/minutes机器运行时间小时/分钟cfpr04number of produced capsules已充填胶囊总数cfpr05 functional test specificationspage 9 of 53( pd1118 rev. 1.0)3.2untested activities不需要进行的功能测试不需要进行的功能测试none3.3test format功能测试格式功能测试格式the formal structure of the functional test includes the following points:正式的功能测

30、试结构：-test identification code: (refer to section 3.1)功能测试识别代码（参阅 3.1 部分）。-functional specifications reference: section(s) of the functional specifications in which the functionality to be tested is described.关于此项功能的详细说明参考：参阅文件对此项功能有详细的描述。-purpose of test: synthetic description of the functional evid

31、ence that one wants to obtain by means of the test.测试目的：对此项功能进行检测并期望要得到的结果。-initial conditions: preliminary conditions to be met for the test to be carried out correctly.进行功能测试前的初始条件：正确的进行功能测试所需的预备条件。-test description/expected results: ta = operations to be carried out; ac = result that must be reac

32、hed.测试描述/期望结果：ta=测试描述。 ac=期望结果。-steps to take after the test: operations to be carried out at the end of the test, in general restoring operations or steps to be taken to face the successive test.测试完成后的操作：当一项功能测试完成后，一般是初始化机器状态，进行下一项功能测试。functional test specificationspage 10 of 53( pd1118 rev. 1.0)3.

33、4 test passing criterion功能测试通过标准功能测试通过标准each coded functional test is to be considered passed if each expected ac result is attained. overall, the functional test is to be considered positive if the machine has passed each coded test.如果功能测试项目达到所期望的结果（ac），则说明此项功能测试通过，进而说，每个编码的功能测试项目都通过则该机器通过功能测试。3.5l

34、ogging test results测试结果记录测试结果记录the test results must be formalized in the following manner:测试结果必须符合以下格式：-form frm7(5).6 “survey of the testing results” must be compiled for every coded test performed每个测试项目都要记录在测试结果调查表frm7(5).6 上。-the “test result sheet” must eventually be compiled for every coded te

35、st performed (upon customers request and/or if during the execution of the test one or more attachments are produced);记录测试项目的测试结果记录单最后必须整理汇编。（经客户要求，在测试时每个测试附件表都要求整理出来以备参阅）-if the test is passed, write “y” in the form frm7(5).6 “survey of the testing results”.如果测试通过，在 frm7(5).6 “测试结果调查表”相应表格处填写“y”-if

36、 the test is failed, write “n” in the form frm7(5).6 “survey of the testing results”.如果测试失败，在 frm7(5).6 “测试结果调查表”相应表格处填写“n”should an installation test be performed within a final acceptance test of one of the following types: preliminary test without customer, preliminary test with customer, accepta

37、nce test, the supervisors must sign the aforesaid forms as prescribed by sop7(5).9 “tests, checks and final acceptance tests on machines and production lines”.对机器进行以下最后验收测试时包括对机器进行安装测试，这些验收测试文件包括：“客户不在场的情况下对机器进行初测试”，“客户在场的情况下对机器进行初测试”，“验收测试”，验收监督人必须在以上文件中签字并按文件 sop7(5).9“对机器及生产线进行测试，检查及最后的验收测试”所描述的要

38、求做。the forms to utilize are provided along with this document. 以上表格同这份文件一起提供给相关人员。in case during the test a sheet will be printed out, this one will be signed, dated, referred to the test number and paged.把测试表打印出来，相关人员签字，录入日期，测试号并标明页数。3.6 steps to take if a test fails如果测试失败时：如果测试失败时：in this case, im

39、a refers to that which is prescribed in sop7(5).9 “tests, checks and final acceptance tests on machines and production lines”在此情况下，按文件 sop7(5).9“对机器及生产线进行测试，检查及最后的验收测试”所描述的要求做。functional test specificationspage 11 of 53( pd1118 rev. 1.0)3.7 general warnings for carrying out the test进行测试时一般注意事项：进行测试时

40、一般注意事项：with regard to tests that need to be carried out when the following safety guards are opened, the reduction of safety levels must be considered:进行相关测试时以下的安全保护装置会失效，保护等级会降低，测试者必须注意：- machine electrical equipment housing box doors电器柜门- machine guards 机器护罩successive tests are referred to zanasi

41、plus 85 e.之后测试参考 zanasi plus 85 e 文件3.8 special warnings for carrying out the tests进行测试时特别注意事项：进行测试时特别注意事项：the operation indicated as “start the machine” involves a series of special operations (see “basic machine functional specifications” doc. ref. pd1100sf001 chap. 1.3, unless a pre-starting sequ

42、ence is implicitly suggested.在做功能测试时按测试文件起动机器，之前需要对机器进行一系列的预操作（参阅文件 basic machine functional specifications” doc. ref. pd1100sf001 chap. 1.3），除非文件对机器预起动已有相关的说明。functional test specificationspage 12 of 53( pd1118 rev. 1.0)4. documents and test equipment测试所需文件及测试设备测试所需文件及测试设备documents文件-functional spe

43、cifications (doc. ref. pd1100sf) (*)功能说明书-forms for logging test results: frm7(5).6, frm7(5).8, test result sheet测试结果记录表frm7(5).6, frm7(5).8, test result sheet-electric technical documents of the zanasi plus 85 e serial no. pd1100 (doc. ref. epd1100) (*)zanasi plus 85 e 电气文件-instructions manual of t

44、he zanasi plus 85 e serial no. pd1100 (doc. ref. pd1100m22) (*)zanasi plus 85 e 操作说明手册-inverter instructions manual (sj200) sj200 变频器操作说明手册(*)any previous and/or subsequent revisions made to the document should be managed separately from this document.对这些文件的新旧版本应有所区分。instruments测试设备-workshop equipme

45、nt 设备-supplied guard keys安全门钥匙 -sample product unit with preset weight characteristics取样单元-reference balance所需用的天平5. test procedure测试步骤测试步骤5.1 main switch主电源开关主电源开关5.1.1 main switch test主电源开关功能测试主电源开关功能测试test identification code: 测试代码：cfel01functional specifications reference:pd1100sf001, 1.2.2.4相关功

46、能说明参考： pd1100sf001, 1.2.2.4purpose of test:测试目的：the purpose of this test is to check that when the qs0 main switch located on the panel is deactivated (off), the machine and the auxiliary units connected to it are electrically cut off and that when the qs0 main switch located on the panel is activat

47、ed (on), the board is powered.检测电气护罩板上的主电源开关 qso 动作时，机器及其辅件能否正确的通电和断电。initial conditions:初始状态：the qs0 main switch located on the panel must be deactivated (off).电气护罩板上的主电源开关qso 位于 off 档。test description/expected results: 测试描述/正确结果ta1press the machine run pushbutton sb1 twice, located on the control

48、panel, to start the pumps/aspirator.启动真空泵吸尘器按钮 sb1(位于控制面板上)。ac1the pumps/aspirator do not start. 真空泵吸尘器不动作。ta2activate the qs0 main switch located on the panel. qs0 位于 on 档functional test specificationspage 13 of 53( pd1118 rev. 1.0)ac2the dc voltage presence green led hd1 turns on. the ha1 audible

49、alarm cuts in. the display is enabled and a message corresponding to the machines state is displayed. 直流电压指示 灯发光二极管hd1 变亮，同时报警。显示器显示此时机器的状态。ta3press the machine run pushbutton sb1 on the control panel (only once) or press the function key f1 located on the control panel operator terminal 按下 sb1,或者按位

50、于控制面板上的 f1 键键ac3the green led associated to the key f1 light turns on and the pumps/aspirator starts.绿色发光二集管及 f1 键变亮，同时真空泵吸尘器启动。steps to take after the test: 测试完毕后操作：press and hold down the machine stop pushbutton sb2 for at least 5 seconds on the control panel to disable the pumps/aspirator.按下 sb2

51、持续 5 秒钟关闭真空泵吸尘器。functional test specificationspage 14 of 53( pd1118 rev. 1.0)5.2control panel控制面板控制面板5.2.1language selection语言选择语言选择test identification code:cfim01测试代码： cfim01functional specifications reference:pd1100sf, 3.1.8.3相关功能说明参考： pd1100sf, 3.1.8.3purpose of test:测试目的：the purpose of this test

52、 is to check the working efficiency of page 13 by which the desired language may be selected. 测试第 13 页的语言选取功能，能否正确的对目的语言进行选取。initial conditions: 初始状态：the qs0 main switch located on the panel must be activated (on).the machine must be stopped.the dosing unit (dosers) must not be installed on the mach

53、ine.qs0 主电源开关处于 on 档此时机器处于停机状态机器不要安装计量针组件。test description/expected results: 测试描述/正确结果ta1press the function key f12 located on the control panel operator terminal.using the dw and up keys, scroll to page 13 - language selection.激活控制面板上的操作终端上的 f12 按钮，通过使用 dw 及 up 按钮选取到第 13 页语言选取一栏。ac1page 13 is displ

54、ayed in which the language to be used may be selected.操作终端显示第 13 页，可以选择目的语言。ta2press the enter key.按下 enter 键ac2the blinking cursor will appear on the first value (n.).光标指针闪烁出现在第一种语言上。ta3type in 5.press the enter key.输入 5 并键入 enter。ac3the entered value is not accepted. 输入值系统不接受ta4type in the value c

55、onsistent with the language to be selected.press enter twice consecutively.输入目的语言的代表数值，连续按 enter 键两次。ac4the entered value is accepted. 系统接受输入值。steps to take after the test: 测试完毕后操作：reset normal machine operating conditions.把机器恢复到测试前的初始状态functional test specificationspage 15 of 53( pd1118 rev. 1.0)5.

56、2.2pushbuttons test: machine start, machine stop按钮功能测试：机器启动、停止按钮功能测试：机器启动、停止test identification code: 测试代码： cfim02functional specifications reference:pd1100sf001, 2.2.1, 3.1相关功能说明参考 ： pd1100sf001, 2.2.1, 3.1 purpose of test: 测试目的：the purpose of this test is to check the proper operation of the pushb

57、uttons: machine start, machine stop.测试机器启动及停止按钮动作是否正确。initial conditions: 初始状态：the qs0 main switch located on the panel must be activated (on) qs0 主电源开关处于 on 档the machine must be stopped.机器处于停机状态。the dosing unit (dosers) must not be installed on the machine. 机器不要安装计量针组件。test description/expected res

58、ults: 测试描述/正确结果ta1press the machine run pushbutton sb1 on the control panel (if the machine is starting for the first time, press the machine run pushbutton sb1 three times).激活控制面板上的机器启动按钮 sb1（如果是首次开机，需连续按 sb1 三次）ac1the green lamp hl1 turns on.the machine starts running. 绿色指示灯 hl1 变亮，机器开始运转。ta2press

59、 the machine stop pushbutton sb2 located on the control panel. 激活控制面板上的机器停机按钮 sb2ac2the machine stops and alarm message “010 operator stop” is displayed. the green lamp hl1 turns off. 机器停机，并显示报警信号“010 operator stop”ta3press and hold down the machine stop pushbutton sb2 for at least 5 seconds on the

60、control panel to disable the pumps/aspirator or press the function key f1 located on the control panel operator terminal.按下 sb2 持续 5 秒钟，或按 f1 键关闭真空泵吸尘器。ac3the pumps/aspirator stops.真空泵吸尘机停机。ta4press the machine run pushbutton sb1 on the control panel (only once). 激活控制面板上的按钮 sb1（只需按一下）ac4the pumps/as