生产工艺常用词汇：中文单硫酸卡那霉素硫酸氢钠枸橼酸钠硫酸溶液中性硼玻璃安瓿瓶安瓿瓶清洗安瓿瓶灭菌除热源配料过滤灌封灭菌和检漏测试灯检贴签和包装关键工艺参数升温段传送带压差时间间隔过滤器孔径过滤压力灌装量缓冲罐灌装前充氮保护灌装后充氮保护真空检漏测试内包材Kanamycin sulfatesodium bisulfatesodium citrate英文Sulfuric acid solutionNeutral borosilicate glass ampouleAmpoule washingAmpoule sterilization and depyrogenationBatchingFiltrationFilling and sealingSterilization and leakage testVisual / Lamp inspectionLabeling and packagingCritical Process Parameterheating sectionconveyor beltDifferential pressureTime intervalPore size of filterFiltration pressureFilling volumebuffer tankpre-filling nitrogen flushpost-filling nitrogen overlayVacuum leak testPrimary packaging materialProcess instructionLivzonGroupFuzhouPharmaceutical Co. Ltd.FuxingHunan Erkang Pharmaceutical Co., LtdHunan Huari Pharmaceutical Co., LtdGuangzhou Chemical Reagent FactoryZhuhai Da Lin Wan Industrial Gas Co., LtdSCHOTT Glass Technologies (Suzhou) Co.Ltdquality specificationCirculation waterQC 常用英文词汇中文物理性状外观不溶性微粒溶液颜色鉴别保留时间含量有关物质标示量可见异物无菌薄膜过滤法内毒素Rotating speed英文Physical attributesAppearanceParticulate matterSolution colorIdentificationretention timeAssayRelated substancelabeled amountVisible particlesSterilityMembrane filtration methodBacterial endotoxinsInitial bioburdenstirring uniformityashy toppointed endbubble head, flat head, broken ampoule,crooked ampoule, empty ampoule;中文药品生产质量管理规范英文GMP: Good Manufacturing Practice国家食品与药品监督管理局总则制剂原料药成品工序机构与人员专业知识生产经验组织能力技术人员实施药品生产质量管理质量检验专业技术培训基础理论知识实际操作技能高生物活性高毒性污染考核评估厂房与设施生产环境空气洁净级别昆虫洁净室（区）光滑无裂缝无颗粒物脱落耐受消毒无菌交界处State Food and Drug AdministrationGeneral Provisionsprep...
