KGL400型高速轧盖机的验证 毕业论文外文翻译.doc

appendixthe verification of kgl400 high-speed capping machineoverviewnanjing the solid extension pharmaceutical equipment co., ltd. to provide kgl400 high-speed capping machine is suitable for a variety of specifications vials, versatility, specifications fewer parts replacement, easy to replace. it adopts plc control, frequency control or hmi touch screen control technology, stable and reliable operation, compliance with gmp requirements.how it works: after packing, stoppard vials by flat belt fed smoothly into the screw, screw evenly feeding bottle dial; oscillator is fed through the hopper and track the composite lid or aluminum cover to the wear to cover station, dial into the bottle wearing the bottle cap into the capping station; center revolves around the station rolling hirable cam pressure, cover is pressed, the clutch is closed, propping seat with a glass bottle to start high-speed rotation, the disc rolling cutter fixed in the center of the station easy-to-digest gradually extruded aluminum cover, aluminum cover tightly wrap the bottle mouth; when the rolling the hirable rotation to the position of the highest point of the cam, and glass bottles moving away from dial out of the bottle, the bottle aside, into the bottles track, so as to complete the capping process.the verify of implementation the purpose of the verification is confirmed by pre-installation check, oq and performance confirmation from the installation and operation of the capping machine performance to meet the design requirements and gmp requirements, and performance to meet the technological requirements.1. design validation / pre-confirmation (dq)content: the technical indicators and their design requirements, including production capacity of equipment, materials, pressure control systems, ancillary facilities, size requirements; equipment manuals, operating instructions, and maintenance.according to the design and technical parameters of the equipment, design drawings, purchase orders, vendor-supplied technical information equipment with pre-determined evaluation confirmed include: equipment performance, quality, and applicability.the aim is to confirm the specifications of the equipment supplied shall conform to the requirements, the device technical information should be complete (operation guide, manufacturing and design standards, etc.).2. installation confirmations (iq)2.1 installation verification purposes: check to make sure kyg400 high-speed rolling cover random file and accessories should be consistent with the use and management requirements; also, check and high-speed rolling recognized kyg400 type the capping machine installed in accordance with design requirements; confirm the contents of random files and attachments; unpacking inspection and data confirmation of the attachment;basis high-speed kyg400 type capping machine packing list to confirm their standard models, random accessories and documents; according to the product manual, the use of high speed capping machine confirm kyg400 type with the design requirements; documentation inventory, collection and storage; confirm the test results recorded in the following table and make evaluations.2.2 installation acknowledgment: based on kyg400 type high-speed capping machine outline drawings and installation requirements, check the installation location and space can meet the needs of production and ease of maintenance; based on kyg400 type high-speed capping machine installation requirements, check the external public portion of the match and meet the requirements; based on kyg400 high-speed capping machine technical requirements, check the external power supply; based on kyg400 high-speed capping machine technical requirements, check the main parts of the material; appearance of the machine and drawings based on the kyg400 high-speed capping machine, check the integrity of the machine and other issues; installation confirm the test results recorded in the following table and make evaluations.the 3.3 installation sure conclusions3, operational qualification (oq)3.1 run confirm the purpose of: run the technical parameters of inspection and test equipment to confirm high-speed kyg400 type capping machine line with the antibiotic bottle capping requirements, the rubber plug is not loose and have a good seal; run according to the following table, and the test results recorded in the following table, and make evaluations.3.2 verify that the confirmation of test instrumentation used to validate the test instrumentation should be recognized, and to confirm the results recorded in the following table and make evaluations.3.3 run the project confirmedequipment operation confirmationdevice control confirmationequipment safety performance qualificationequipment the technical indicators confirmdevice operation confirmation：basis high-speed kyg400 type capping machine manual, 4 hours continuous operation at normal operating speed, the equipment operation inspection results recorded in the following table, and make evaluations. based on kyg400 type high-speed capping machine manual, the equipment of the technical indicators test results recorded in the following table and make evaluations.4 performance qualifications (pq)4.1 inspection and test equipment operation results confirm high-speed kyg400 type capping machine operates in accordance with antibiotics bottle capping requirements, the rubber plug is not loose and have a good seal.4.2 performance qualification projectactual production capacity of the device under load operationthe safety of the equipment in the load operationthe control accuracy of the equipment in the load operationcapping the rate of qualified productstightness testactual production capacity under load operation：based on kyg400 type high-speed capping machine manual, the actual production capacity of the equipment under load operation test results recorded in the following table and make evaluations. load operating conditions, according to high-speed kyg400 type capping machine manual, the equipment load operation under the control accuracy of the test results recorded in the following table, and make evaluations.test method: an appropriate volume of 3% try tone soy broth dispensed into sterile 2r glass bottle cap stoppers, sealed aluminum cap, 121 c for 15 min sterilization.preparation of a certain amount of 3% try tone soy broth, this medium into a enough to accommodate 150 bottles for the sample container, then this culture inoculated with e. coli based on 35 and 30 35 cultured for 48 h, when the medium turbidity, determination of the concentration of e. coli in the medium hungry.for the test product upside down into a horizontal immersed in the broth, and then cultured for 14 days at this temperature, then elevated for the sample from the broth, water and disinfectant leaching can be visually, in which. coli concentration in the culture medium at the same time should be measured again.test standard: check for the sample medium appears turbid, muddy vial is broken and should be examined, in addition to broken bottle can make an exception, the test sample shall bacteria.positive control: will be available for the test sample bottle of access about 50 e. coli cultured for 48 h at 35 , should be observed significantly longer bacteria, otherwise the test is invalid.附录kgl400型高速轧盖机的验证由南京固延制药设备有限公司提供的kgl400型高速轧盖机适用于多种规格的西林瓶，通用性强，规格件更换少，更换方便。该机采用plc总控制、变频调速或人机界面触摸屏控制技术，运行稳定可靠，符合gmp要求。工作原理：经过分装、加塞的西林瓶由平带平稳地送入螺杆，被螺杆均匀地分给进瓶拨盘；震荡器通过料斗和轨道把复合盖或铝盖送到戴盖工位，进瓶拨盘把瓶子戴盖后送入轧盖工位；绕工位中心公转的轧盖头被凸轮压下，把盖压紧，同时离合器合上，托瓶座带着玻璃瓶开始高速自转，固定在工位中心的圆盘轧刀由浅入深的逐渐挤压铝盖，使铝盖紧紧地包住瓶口；当轧盖头旋转至凸轮最高点位置时，与玻璃瓶逐渐脱离，瓶子由出瓶拨盘拨出，进入出瓶轨道，从而完成整个轧盖工序。验证实施验证的目的是通过预确认、安装确认、运行确认和性能确认，证明轧盖机的安装运行性能符合设计要求及gmp要求，且性能满足产品工艺要求。设计确认/预确认（dq）内容：设备的技术指标及其设计要求，包括设备的生产能力、材质、压力、控制系统、附属设施、尺寸要求；设备的说明书、操作指南、维护保养等。根据设备的设计方案及技术参数、设计图纸、采购订单、供应商提供的技术资料等进行设备的预确认，评价确认内容包括：设备性能、质量、适用性。目的是证实所供应的设备规格应符合要求，设备技术资料应齐全（操作指南、制造和设计标准等）。1、 安装确认（iq）1.1安装确认目的:检查并确认kyg400型高速轧盖机的随机文件以及附件应符合使用和管理要求；同时，检查并确认kyg400型高速轧盖机的安装符合设计要求;随机文件以及附件确认内容;开箱检查和资料附件的确认;依据kyg400型高速轧盖机的装箱单确认其规格型号、随机附件及文件资料;根据产品使用说明书，确认kyg400型高速轧盖机的使用范围是否符合2.2安装确认内容:依据kyg400型高速轧盖机外形图和安装要求，检查其安装位置和空间能否满足生产和方便维修的需要；依据kyg400型高速轧盖机安装要求，检查外接公共部分是否符合匹配和满足要求；依据kyg400型高速轧盖机的技术要求，检查外接电源；依据kyg400型高速轧盖机的技术要求，检查主要零件的材质；依据ky