Functional Test SpecificationsPage 2 of 53 ( PD1118 Rev. 1.0) Customer: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. TABLE OF MODIFICATIONS Functional Test SpecificationsPage 3 of 53 ( PD1118 Rev. 1.0) Revision Modification Request No. Modified byDateDescription of Modification Functional Test SpecificationsPage 4 of 53 ( PD1118 Rev. 1.0) INDEX:索引索引 1. INTRODUCTION 导言.5 2. GLOSSARY术语表5 3. DESCRIPTION AND TEST PLAN测试操作描述及测试表.6 3.1 Tested Areas测试范围.6 3.2 Untested Activities非测试范围9 3.3 Test Format测试格式9 3.4 Test Passing Criterion测试通过标准.10 3.5 Logging Test Results测试结果录入.10 3.6 Steps to Take if a Test Fails测试失败时采取的措施10 3.7 General Warnings for Carrying out the Test测试时的一般注意事项.11 3.8 Special Warnings for Carrying out the Tests测试时的特别注意事项11 4. DOCUMENTS AND TEST EQUIPMENT功能测试时所需文件及检测设备.12 5. TEST PROCEDURE测试步骤.13 5.1 Main Switch主开关.13 5.1.1Main Switch Tes主开关功能测试13 5.2 Control Panel控制面板功能测试14 5.2.1Language Selection操作界面语言选择14 5.2.2Pushbuttons Test: Machine Start, Machine Stop机器按钮功能测试：机器的 起动及停止.15 5.3 Capsule/Product Feeding Device胶囊（药品）供给装置功能测试16 5.3.1 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16 5.3.1.2Capsule Minimum Level胶囊最小料位17 5.3.1.3Sorting Unopened Capsules未打开胶囊分选.18 5.3.1.4Capsule Check Enabling空胶囊在位检测装置.19 5.3.2Mixer搅拌装置19 5.3.2.1Microdosing and Intelligent Hopper微计量及智能粉剂供给装置.21 5.3.2.2Mixer 1 Time搅拌器 1 时间设定23 5.3.2.3Mixer 2 Time搅拌器 2 时间设定25 5.3.2.4Powder 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）.27 5.3.2.5No Powder 2 (Intelligent Hopper)2 号位缺粉测试28 5.3.2.6Sucked Tank 1 and Slug Release 11 号位吸力槽及打击器29 5.3.2.7Sucked Tank 2 and Slug Release 22 号位吸力槽及打击器30 5.3.3Enabling the Units机器类型设置.31 5.4 Machine Safety Devices机器安全保护装置.33 5.4.1Handwheel手轮33 5.4.2Jog Max Run Time点动最长时间34 5.4.3Thermal relays热继电器35 5.4.3.1Overload Cutouts (Vacuum Pump/Aspirator) 过载断路器（真空泵及吸尘器） 35 5.4.4 Phase Sensors Check (Machine and Capsule Opening) 相位传感器检测（机器及胶囊打开） 37 5.4.5Slug Detachment Phase Sensor Check打击器的传感器时序检测38 5.4.5.1Slug 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38 Functional Test SpecificationsPage 5 of 53 ( PD1118 Rev. 1.0) 5.4.6Compressed Air Check压缩空气检测.39 5.4.7Machine Inverter Failure机器变频器故障检测40 5.4.8Machine Motor Brake电机刹车41 5.4.9Intelligent Hopper Inverter Failure智能粉剂供给装置变频器故障检测42 5.4.10 PLC Batteryplc电池43 5.4.11 Maximum Speed机器最高速运转检测.44 5.5 Operator Safety Devices操作者安全保护装置.45 5.5.1Emergency Buttons急停按钮45 5.5.2Safety Guards Open安全护罩打开46 5.6 Machine Parameters机器参数.47 5.6.1Machine Type机器类型47 5.6.2Capsules/Hour Speed每小时胶囊数量.48 5.6.3Machine Life in Hours机器运行时间49 5.6.4Machine Running Hours/Minutes机器运行小时/分钟.50 5.6.5Number of Produced Capsules已充填胶囊的数量.51 6. NOTES注释53 7. ENCLOSURES结束.53 Functional Test SpecificationsPage 6 of 53 ( PD1118 Rev. 1.0) 1. INTRODUCTION 导言导言 This document sets out the Functional Test Specifications of IMA Industria Macchine Automatiche 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 machine 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 Specifications (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 Documents”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） INCLUSION 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 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 buttons) 操作控制及保护装置 SIZE CHANGEOVER 模具更换 Function for managing the replacement and/or adju