制药生产设备培训试卷

the principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct Government credit + business credit credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create policy lowlands, Highlands, integrity of service land, development land as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the .Since the educational practice of the mass line of the party, himself seriously in the education, practical control central eight rules and opposing the four winds and practicing three Suns, and check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the partys political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the partys political disciplines. Conscientiously abide by the partys political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the partys political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further（生产设备培训试卷）部门： 姓名： 得分： 一、 填空题（15题 每题2分 共30分）1. 我公司使用的20D型万能粉碎机是固体制剂车间用于物料粉碎之用，该机粉碎细度可用（筛网）来调节。2. GF-30B型万能粉碎机生产能力是（30300）Kg/h；粉碎细度是（20200）目3. ZS515型振荡筛运转100小时后，机器上所有的螺帽、螺栓都须(彻底检查)一遍，如有松动，及时紧固；每运行500小时从加油嘴加2#（锂基脂）润滑脂一次。4. 我公司使用的热风循环烘箱适用温度范围是50140，适用的蒸汽压力范围是（0.20.8）MPa5. 我公司使用的热风循环烘箱使用时严禁将易燃、易爆物品或有（挥发性）物品置于箱内干燥。6. DPP-250型泡罩包装机在包装过程中，发生故障时应立即停机检查，自己无法排除的故障应及时通知（维修人员）解决，并将机中待包装胶囊戓药片、PVC、铝箔密闭存放，以防（污染）。7. 洁净区空调系统消毒频次为每周一次，停止运转（三天）以上（含三天）。8. 纯化水贮罐及循环管道消毒频次为每周一次或系统停止运转（一）天以上。9. PGL-40C型喷雾干燥制粒机在制粒过程中，应随时从（视镜孔）中观察物料流化状态和从（取样筒）取样观察成粒情况，并随时调节风量、风压、温度、雾化压力、喷液量等有关参数，便其达到最理想的（成粒）效果，调节以上参数配合，灵活运用。10. HZ-250B高效湿法制粒机是我公司固体制剂车间制粒之用。具有操作简便，工艺精简等优点，所得颗粒在（1680）目之间11. KZL-300型快速整粒机工作原理是：当物料由料斗进入机器工作腔时，由旋转的回旋刀对（原料）起旋流作用，并以离心力将颗粒甩向筛网板，同时由于回旋刀旋转与筛网板之间剪切作用，将（物料）整粒成小颗粒，并经筛网孔排出。12. NJP-2000ABC全自动胶囊充填机开机前应检查各紧固螺钉无松动、（损坏），设备所用零配件型号与生产胶囊型号一致；吸尘器、真空管道安装到位；四周防护门（安全设施）有效，有设备“完好”、“已清洁”状态牌。13. SHB-600L型三维摆动总混合机每次开机前，都要检查速度是否调在（零位），如不是请归零后再开机。14. DXD-KK80T自动包装机在调整热封压力时应反复细致地调整横封和纵封“调整螺钉”，给纵封减压也等于给（横封）加压。在调整热封压力时应使热封器与（制袋器）对正，并保证纵封与走纸方向平行。15. BLT-40A螺杆空气压缩机压缩机因空载运行超过设定时间时，会自动停机，此时，绝对不允许进行（检查）或（维修）工作，因为压缩机随时会恢复运行。二、 判断题（20题 每题2分 共.40分 正确打 错误打）1. 设备的设计、选型、安装、改造和维护必须符合药品生产特性及GMP要求，应当尽可能降低产生污染、交叉污染、混淆和差错的风险，便于操作、清洁、维护。（ ）2. 生产设备不得对药品质量产生任何不利影响。与药品直接接触的生产设备及管道应当平整、光洁、耐腐蚀，不得与药品发生化学反应、吸附或向药品中释放物质。（ ）3. 对生产中发尘量大的工序设备，如粉碎、过筛、混合、制粒、干燥、压片、包衣等，应选用自身带有捕尘、吸粉装置设备；（ ）4. 与药物直接接触的压缩空气应设置净化装置；干燥设备出风口应有防止空气倒灌的装置；经净化处理的空气应符合规定的空气洁净度要求；（ ）5. 在生产、包装、仓储过程中使用自动或电子设备的，应当按照操作规程定期进行校准和检查，确保其操作功能正常。校准和检查应当有相应的记录。（ ）6. 用于药品生产或检验的设备和仪器，应当有使用日志，记录内容包括使用、清洁、维护和维修情况以及日期、时间、所生产及检验的药品名称、规格和批号等。（ ）7. 不合格的设备如有可能应当搬出生产和质量控制区，未搬出前，应当有醒目的状态标识。（ ）8. 设备的日常清洁、润滑等维护保养由操作人员负责。设备的润滑应根据设备使用说明书或实际运行情况选用合适的润滑油品种，凡有可能与药品相接触的润滑点应选用食用油。（ ）9. 配制清洁剂、消毒剂均应有完整的记录，不得对设备、产品等产生污染。（ ）10. 每台设备都要有标明设备所处运行状态及清洁状态的状态标记牌，当设备所处的状态发生改变时，应及时更换标记牌，以防发生使用错误，所有的标记牌应挂在不易脱落的位置。（ ）11. 设备事故发生时，应立即停止操作，保护现场，不接触和移动现场物品，防止事态进一步扩大。同时操作人员应立即向使用部门主管报告，使用部门主管应立即通知设备维修管理员。（ ）12. 在启动空调系统前半小时应接通电源预热，并在车间生产前30分钟，启动空调系统进行系统及洁净室空气自净。（ ）13. 对纯化水系统的运行参数设定，必须有QA现场监控员及设备室设备管理员许可。一经设定，任何人不得随意更改或调整。（ ）14. 直接接触药品的压缩空气在确认合格后，日常监测由QC按洁净度监测管理规程执行。（ ）15. 微压差计安装应合理，应在有压差要求的房间之间和洁净区与非洁净区之间安装。（ ）16. 温湿度计的安装高度应在与眼睛平视的位置，安装位置应能代表房间温湿度（ ）17. 模具在使用过程中如果发现有影响产品质量的缺陷时，应停止使用，并上报车间主任、质量部QA和设备管理员及时解决。（ ）18. 本公司规定以质量标准中卫检指标限度的50%作为警戒限，以卫检指标限度的80%作为纠偏限。（ ）19. QC室电子天平每天第一次使用前自校一次，效期为24h；其他部门的电子天平及公司内的架盘天平、电子台秤、台秤每周第一天的第一次使用前自校一次，效期7天。如果不使用可不进行自校。（ ）20. 如有取样点水质化验不合格，应立即报告质量部负责人，启动实验室OOS处理程序，并通知纯化水站停止供水。（ ）三、 选择题（多项选择/可单选 15题 每题2分 共30分）1. 产尘操作间为了防止粉尘扩散、避免交叉污染并便于清洁，应当采取哪些措施？（ ）A:保持相对负压 B:采取捕吸尘等专门的措施 C:设置直排系统 D：不用采取措施2. 仓储区最少应当设置哪些区域？（ ）A:合格区 B:不合格区 C:待验区 D：退回区 E召回区 F收货区 G外包装清洁区3. 库内物料及产品应按哪些要求进行存放？（ ）A:分品种 B:分规格 C:分批号 D：固/液原辅料分开存放 E：不合格/退回/召回隔离存放4. 洁净区设置人员/物料气闸室的目的是？（ ）A:对进出人员进行控制 B:对进出物料进行控制 C:对气流进行控制 D：防止污染和交叉污染5. 洁净区内对清洁工具使用都有那些要求？（ ）A:定点存放 B:限定使用范围 C: 材质应当具备无脱落物、易清洗、易消毒，不易产生霉斑的特性 D：没有要求6. 消毒剂应按其性质和种类轮换使用，防止微生物产生耐药菌株，轮换周期是多长？（ ）A:15天 B:1个月 C: 2个月 D：三个月7. 进行压力容器的操作都有那些要求？（ ）A:操作工必须经过培训并取得相应合格证书 B: 必须严格按规定的操作压力、温度进行工作C: 不得在超压、超温下工作 D：生产中严禁带压检修和用重物敲打8. 当设备所处的状态发生改变时，应采取哪些措施？（ ）A:不用理睬 B:及时更换对应的标记牌 C: 上报设备管理员 D：上报质量部QA现场监控员9. 设备事故发生时，应采取哪些措施？（ ）A: 立即停止操作，保护现场 B: 不接触和移动现场物品，防止事态进一步扩大 C: 向使用部门主管报告10. 我公司洁净生产区域无特殊要求时，温湿度应控制在哪个范围？（ ）A:1025 35%RH60%RH B: 1030 45%RH70%RH C: 1825 45%RH65%RH D：1826 45%RH65%RH11. 我公司纯化水系统使用的紫外灯是国产品牌，公司文件中规定在那种情况下应当立即更换紫外灯？（ ）A:使用时长累计达到1000小时 B: 使用时长累计达到3000小时 C: 使用时长累计达到2000小时 D：紫外线强度(使用中的强度)低于70W/cm2（40W）时12. 设备在生产过程中出现故障而操作工又无法解除故障时应当采取哪些应对方法？（ ）A:没有办法、停机怠工 B: 通知班组长或部门主管，将责任转移 C：切断电源停机，通知维修人员或设备管理员13. 凡有可能与药品相接触的润滑点应选用那种油进行润滑？（ ）A:机油 B: 煤油 C：食用油 D：润滑脂14. 模具使用前必须检查哪些项目才能投入使用？（ ）A: 无缺损、划伤、变形 B: 润滑是否良好 C：是否洁净无污渍 15. 公司目前需要进行内部自校的称量工具都有哪些？（ ）A:电子天平 B:架盘天平 D:电子台秤 C:台秤。发包人指定专人负责协调施工中的有关事宜，并监督施工进度、安全与文明施工。发包人对承包人施工中违规操作有权做好处理决定或经济处罚。streamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the four winds some outstanding issues 1, oppose formalism. One theory is that he didnt, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is the objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, . Im not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot