KGL400型高速軋蓋機(jī)的驗(yàn)證畢業(yè)論文外文翻譯

1、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

2、 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

3、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-s

4、peed 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

5、 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

6、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, a

7、ncillary 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: eq

8、uipment 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

9、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 requirem

10、ents; 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 spee

11、d 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 ins

12、tallation 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

13、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

14、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 kyg40

15、0 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 us

16、ed 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 indi

17、cators 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 m

18、anual, 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 cappin

19、g 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 qualifie

20、d 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

21、 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

22、 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, determi

23、nation 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 concen

24、tration 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 t

25、he 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.附錄kgl400型高速軋蓋機(jī)的驗(yàn)證由南京固延制藥設(shè)備有限公司提供的kgl400型高速軋蓋機(jī)適用于多種規(guī)格的西林瓶，通用性強(qiáng)，規(guī)格件更換少，更換方便。該機(jī)采用plc總控制、變頻調(diào)速或人機(jī)界面觸摸屏控制技術(shù)，運(yùn)行穩(wěn)定可靠，符合gmp要求。工作原理：經(jīng)過分裝、加塞的西林瓶由平帶平穩(wěn)地送入螺桿，被

26、螺桿均勻地分給進(jìn)瓶撥盤；震蕩器通過料斗和軌道把復(fù)合蓋或鋁蓋送到戴蓋工位，進(jìn)瓶撥盤把瓶子戴蓋后送入軋蓋工位；繞工位中心公轉(zhuǎn)的軋蓋頭被凸輪壓下，把蓋壓緊，同時(shí)離合器合上，托瓶座帶著玻璃瓶開始高速自轉(zhuǎn)，固定在工位中心的圓盤軋刀由淺入深的逐漸擠壓鋁蓋，使鋁蓋緊緊地包住瓶口；當(dāng)軋蓋頭旋轉(zhuǎn)至凸輪最高點(diǎn)位置時(shí)，與玻璃瓶逐漸脫離，瓶子由出瓶撥盤撥出，進(jìn)入出瓶軌道，從而完成整個(gè)軋蓋工序。驗(yàn)證實(shí)施驗(yàn)證的目的是通過預(yù)確認(rèn)、安裝確認(rèn)、運(yùn)行確認(rèn)和性能確認(rèn)，證明軋蓋機(jī)的安裝運(yùn)行性能符合設(shè)計(jì)要求及gmp要求，且性能滿足產(chǎn)品工藝要求。設(shè)計(jì)確認(rèn)/預(yù)確認(rèn)（dq）內(nèi)容：設(shè)備的技術(shù)指標(biāo)及其設(shè)計(jì)要求，包括設(shè)備的生產(chǎn)能力、材質(zhì)、壓力、控

27、制系統(tǒng)、附屬設(shè)施、尺寸要求；設(shè)備的說明書、操作指南、維護(hù)保養(yǎng)等。根據(jù)設(shè)備的設(shè)計(jì)方案及技術(shù)參數(shù)、設(shè)計(jì)圖紙、采購訂單、供應(yīng)商提供的技術(shù)資料等進(jìn)行設(shè)備的預(yù)確認(rèn)，評價(jià)確認(rèn)內(nèi)容包括：設(shè)備性能、質(zhì)量、適用性。目的是證實(shí)所供應(yīng)的設(shè)備規(guī)格應(yīng)符合要求，設(shè)備技術(shù)資料應(yīng)齊全（操作指南、制造和設(shè)計(jì)標(biāo)準(zhǔn)等）。1、 安裝確認(rèn)（iq）1.1安裝確認(rèn)目的:檢查并確認(rèn)kyg400型高速軋蓋機(jī)的隨機(jī)文件以及附件應(yīng)符合使用和管理要求；同時(shí)，檢查并確認(rèn)kyg400型高速軋蓋機(jī)的安裝符合設(shè)計(jì)要求;隨機(jī)文件以及附件確認(rèn)內(nèi)容;開箱檢查和資料附件的確認(rèn);依據(jù)kyg400型高速軋蓋機(jī)的裝箱單確認(rèn)其規(guī)格型號(hào)、隨機(jī)附件及文件資料;根據(jù)產(chǎn)品使用說明書，確認(rèn)kyg400型高速軋蓋機(jī)的使用范圍是否符合2.2安裝確認(rèn)內(nèi)容:依據(jù)kyg400型高速軋蓋機(jī)外形圖和安裝要求，檢查其安裝位置和空間能否滿足生產(chǎn)和方便維修的需要；依據(jù)kyg400型高速軋蓋機(jī)安裝要求，檢查外接公共部分是否符合匹配和滿足要求；依據(jù)kyg400型高速軋蓋機(jī)的技術(shù)要求，檢查外接電源；依據(jù)kyg400型高速軋蓋機(jī)的技術(shù)要求，檢查主要零件的材質(zhì)；依據(jù)kyg400型高速軋蓋