Sl. No.
A
Name of the Machine
Automatic Bottle Unscrambler 自动理
瓶机
Air Injector 空气喷射器
Electronic Counting Machine
电子数粒机
Desiccant Inserting Machine 双头柱干
燥剂塞入机
Capping Machine 星盘式锁盖机
Induction Sealing Machine 铝箔封口机
Model
HM BP-BU200 B
C HM BP-EC24
D HM BP-DS120
E
F
HM BP-CM120A
HM BP-AS140
瓶装生产线FAT 草案
THIS PROTOCOL IS VALID
FOR
MANUFACTURER : HM Pharmachine Swiss GmbH,China
Service Points are present and have clear and readable tags.
COMMENTS: 评注
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Objective:目标
To confirm the correct operation of the emergency stop button.
确认急停开关按钮的正确操作
Methodology:方法
Apply power to the machine and connect all necessary fittings. Start the machine and then push the emergency stop button fitted to the machine on control desk.
将机器接上电源，接上所有必须的装置，启动机器然后按下在控制台上安装在机器上的急
停开关按钮
Acceptance Criteria: 接受标准
When the emergency stop button is operated it must cease operation but display is On. The system can only be restarted manually by releasing the emergency stop button by pressing the reset button.
当急停开关按钮启动，机器必须停止运转但是显示开启。系统只有通过手动放开急停开关
按钮按下复原按钮才能重启
Results:结果
Comments:评注
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Objective:目标
To conform the correct operation of the guard switch fitted to the machine.
确认机器上的防护开关的正确操作
Methodology:方法
Apply power to the machine and connect all necessary fittings. Open each door in turn. Close all the doors and reset the machine at the control panel.
将机器接上电源，接上所有必需的装置。依次打开每一个门。关闭所有门然后在控制台重
设机器
Acceptance Criteria: 接受标准
When any door is opened, all moving parts on the system must cease operation. The system can only be restarted manually at the control panel after pressing start button.
当任一门打开，系统上所有运动部分都必须停止运行。系统只有通过手动按下控制面扳上启动按钮才能重启。
Results:结果
Comments:评注
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Objective:目标
To confirm the machine is able to stable the memory in case of intermittent power failure.
确认万一出现间发电源故障，机器能够保持存贮稳定
Methodology:方法
Start the machine setting required parameters. Observe the display. Shut off power source and after a few seconds restart the machine. Observe the display. Check the set parameters and performance data. 设置需要参数启动机器。观察显示。关闭电源然后过几秒后重启机器。观察显示。核对设置参数和运行（性能）参数。
Acceptance Criteria: 接受标准
Machine will display the set parameters with performance data.
机器显示的设置参数与运行（性能）参数一致
Results:结果
Comments:评注
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Objective:目标
To conform that rotary unscrambler machine operates satisfactory when bottle unscrambling.
确认当进行理瓶时旋转理瓶机运行令人满意。
Methodology:方法
Adjust the machine accordingly with the format place on the M/C. Place bottle on the infeed conveyor. Push START.
根据机器上的形式地点调整机器，将瓶子放在进料传送器上，按下开始。
Acceptance Criteria: 接受标准
The through speed will be -------bottle/hour. The machine performs with an error rate less than ---------- % 整个速度为-------瓶子/小时，机器运行误差率少于 ---------- % Results:结果
Comments:评注
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Objective: 目 标
To confirm that machine can not be operated with insufficient air pressure.
确认气压不足时，不能操作机器
Methodology: 方 法 Turn off the power and disconnect the air supply or reduce the pressure manually. Turn on the power. Activate the functions of the machine. 关闭电源，断开气体供应或手动减少压力。打开电源，启动机器
Acceptance Criteria: 接受标准
The machine generates signal at low/not available air pressure. 机器在低/无气体压力时产生信号
Results:结果
Comments:评注
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Objective:目标
To confirm that machine operate satisfactory during maximum speed. 确认在机器以最大速度运转时机器运转令人满意
Methodology:方法
Adjust the machine accordingly with necessary fittings and utilities. Run the machine.
根据必需的装置和设施，调整机器。运行机器
Acceptance Criteria: 接受标准
i)Machine will be operated at -----
ii)Machine will not be vibrated during operation.
iii)Machine will not produce abnormal sound.
iv)Output must be error free.
v)机器以-------运行
vi)机器在运行中不会震动（摇摆）
vii)机器不会产生异声
viii)产量必须完全无误差
Results:结果
Comments:评注
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Objective: To verify that I/O points specified conform to the manufacturer’s specifications.
目标：证实指明的输入/输出点符合生产商的说明
Test equipment: None 测试设备：无
Procedure:程序
1. Obtain a copy of the I/O points list and attach it to this page.
取得一张输入/输出点清单，将它附在该页上
2. Exercise the critical I/O points and randomly exercise some of the others.
演练关键输入/输出点，随意演练一些其他点
3. Mark with a “≤” each I/O point that has been verified.
在已证实的每个输入/输出点标上一个“≤”
4. At the end of the page person collecting data must sign and write the date.
在页末，收集数据人必须签名和署上日期
5. Anything that not meet customer specification must be detailed in section
5.0 Exceptional Conditions.
任何没有符合用户说明必须分部分详细说明
5.0 异常条件
Acceptance Criteria: 接受标准
?I/O points exercised conform to the manufacturer’s specifications.
输入/输出点演练符合生产商的说明
Objective: To confirm that the controls and indicators function as specified by the manufacturer.
目标：确认生产商指明的控制和指示器功能
Test equipment: None 测试设备：无
Procedure:程序
1. Follow the Instructions listed on the attached tables demonstrate or simulate the intended function.
遵照列入展示或模仿预期功能的附件表格中的指示
2. Record the result of the observed response on Controls and Indicators Data Sheet.
记录对控制和指示器数据单观察反馈的结果
3. At the end of the testing, ensure all switches are returned to their normal position.
测试末尾，确保所有的开关都返回到正常位置
Acceptance Criteria: 接受标准
1. All controls and indicators must function according to the manufacturer’s specifications.
所有的控制和指示器必须按照生产商的说明运行
Objective: All of product contact parts should be checked if there
is no problem product quality under the condition of User requirement.
目标：所有产品接触部分都应进行检查，在用户要求的条件下，是否无产品质量问题Method: Check the list for the product contact parts and the parts. Check the certificate for the written list
方法：检查产品接触部分和部分清单。检查书面清单证书
Acceptance Criteria: product contact parts material should be accord with the material of construction certificate (MOC).
接受标准：产品接触部分材料应该符合结构证书材料（材质证明）
Objective: To verify that the spare parts and the documentation are ready to be delivered with the machine.目标：证实备件和文件已准备好同机器一起出运
Test equipment: None 测试设备：无
Procedure:程序
1. Attach to this page the spare parts list appropriate for the machine.
附上的该页备件清单适合该机器
2. Check that all elements listed on the table attached table are ready to be delivered with the machine
检查所有列在附表上的元件已准备好同机器一起出运
3. Anything that not meet customer specification must be detailed in section 5.0
任何不符合用户说明的必须在 5.0 部分中详细说明
4. Exceptional Conditions. Spare parts and documentation are ready to be delivered with the machine.
异常条件，备件和文件已准备好同机器一起出运
Acceptance Criteria: 接受标准
Documentation requirements:需求文件
The following documentation, written in English is required.
Comments:评注13.C.0 Tool Box: 工具箱
Comments:评注
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Objective:目标
To clarify the following system. 详细说明以下系统
Objective: To verify that the alarms and interlocks function as specified by the manufacturer.目标：验证警报和互锁功能符合生产商的规定
Test Equipment: None
测试设备：无
Procedure:程序
1. Obtain a copy of the alarms and interlocks and attach it to this page.
取得一张警报和互锁清单然后附到该页上
2. Induce a malfunction for each alarm and interlock listed and mark it with “≤”.
引导产生列出的每个警报和互锁故障，然后标上“≤”.
3. At the end of the page person collecting data must sign and write the date.
在页末，收集数据人必须签名和署上日期
4. Anything that not meet customer specification must be detailed in section
5.0 Exceptional Conditions.
任何不符合用户说明的必须在 5.0 部分中详细说明
Acceptance Criteria:接受标准
?All alarms and interlocks must function according to the manufacturer’s specifications.
所有警报和互锁必须根据生产商的说明运行
Objective: To verify that the Operators Screens perform as intended according to design specification.
目标：验证操作员屏幕按照预期的设计说明运行
Test Equipment: None 测试机器：无
Procedure: 程序
1. Obtain a copy of the Operators Screens and attach it to this page.
取得一张操作员屏幕然后附到该页上
2. The intent of this procedure is to test all the signals shown on each screen of the operator’s panel to
verify they perform their intended operation.
程序内容是测试所有的显示在操作员面板的信号来验证它们按照预期运行
3. The machine should be fully operational to testing of the operator’s screens.
机器应该被完全操作来测试操作员屏幕。
4. The executor shall not make any program changes during this test.
执行者不应在测试中更改程序
5. The executor shall push the respective buttons or control keys to cause the screens to changes as
designed.
执行者应分别按下按钮或控制键使屏幕按照设计作出更改
6. The test should be started in the “Initial” screen.
测试应该在“初始”屏幕中开始
7. Test each screen and mark it with “≤”.
测试每个屏幕然后标上“≤”.
8. At the end of the page person collecting data must sign and write the date.
在页末，收集数据人必须签名和署上日期
9. Anything that not meet customer specification must be detailed in section 5.0 Exceptional Conditions.
任何不符合用户说明的必须在 5.0 部分中详细说明
Acceptance Criteria: 接受标准
?The operator screens move to other screens when the correct key is entered and return to the correct location when the correct input is entered. The operator screen meets the functional specifications and performs as designed.
当按下正确的按键，操作员屏幕移动到其他屏幕；当输入正确的输入，屏幕返回到正确的位置。操作
员屏幕符合功能说明，按照设计运行。
Objective: To verify that the PLC is protected to non authorized changes in machine
configuration parameters.
目标：验证PLC 被保护，无认可的机器配置参数更改
Test Equipment: None 测试设备：无
Procedure: 程序
1. Try to make changes in the machine configuration parameters using an incorrect password.
One attempt will be made.
设法使用不正确的口令更改机器配置参数，进行一次尝试
2. Try to make changes in the machine configuration parameters using a correct password.
One attempt will be made.
设法使用正确的口令更改机器配置参数，进行一次尝试
Acceptance Criteria: 接受标准
?The PLC only allows access to machine configuration parameters using the correct password.
PLC 仅仅准许用正确口令进入机器配置参数（更改）
A. PLC PASSWORD TEST (cont.) PLC 口令测试（内容）
COMMENTS:
评注
Objective: To verify the time need to do the changeover of the different formats.
目标：验证转换成不同形式所需要的时间
Test Equipment: Stopwatch 测试设备：马表
Procedure: 程序
3. Start this test with the machine completely prepared to work with the first format.
以机器完全准备好第一种形式工作开始测试
4. Change to another format and control the total time used in the operation until the machine
is perfectly set up.
更换到另一种形式和控制用在操作中直到机器完整建立的总时间
5. Record result on the attached test data table.
将结果记录在附上的测试数据表中
6. Repeat the above operation until all changeover time has been checked.
重复以上操作，直到检查所有的转换时间
Acceptance Criteria: 接受标准
?Time used to do every changeover does not exceed manufacturer’s specifications.
用于每个转换的时间不超过生产商的说明
GENERAL OPERATION TEST 一般操作测试