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    您好,欢迎进入河南佳景环保科技有限公司网站!
    您现在的位置:首页 >> 产品中心 >> 净化工程 >> 实验室净化 >> 河南实验室净化

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    • 更新时间:  2023-03-23
    • 厂商性质:  工程商
    • 所在地址:  河南郑州
    • 简单描述
    • 河南实验室净化包括:
      1.洁净厂房及配套工程的设计、安装、调试、维护等综合服务;
      2.医疗卫生行业无尘无菌室、手术室、实验室、ICU病房等设计、安装、调试;
      3.洁净度百级至三十万级制药、食品、化妆品、电子、光盘、科研实验等领域的洁净厂房、生物洁净室、实验中心等设计、安装、调试及技术服务;
      4.各类净化设备、配件的设计、安装与调试
    详细介绍
      河南实验室净化适用的范围:
      (一)微生物和细胞培养,包括DNA重组或杂交瘤技术;
      (二)生物组织提取;
      (三)通过胚胎或动物体内的活生物体繁殖。
      第二条 本附录所指生物制品包括:细菌类疫苗(含类毒素)、病毒类疫苗、抗毒素及抗血清、血液制品、细胞因子、生长因子、酶、按药品管理的体内及体外诊断制品,以及其它生物活性制剂,如毒素、抗原、变反应当原、单克隆抗体、抗原抗体复合物、免疫调节剂及微生态制剂等。
      第三条 生物制品的生产和质量控制应当符合本附录要求和国家相关规定。
      第二章 原则
      第四条 生物制品具有以下特殊性,应当对生物制品的生产过程和中间产品的检验进行特殊控制:
      (一)生物制品的生产涉及生物过程和生物材料,如细胞培养、活生物体材料提取等。这些生产过程存在固有的可变性,因而其副产物的范围和特性也存在可变性,甚至培养过程中所用的物料也是污染微生物生长的良好培养基。
      (二)生物制品质量控制所使用的生物学分析技术通常比理化测定具有更大的可变性。
      (三)为提高产品效价(免疫原性)或维持生物活性,常需在成品中加入佐剂或保护剂,致使部分检验项目不能在制成成品后进行。
      第三章 人员
      第五条 从事生物制品生产、质量保证、质量控制及其他相关人员(包括清洁、维修人员)均应根据其生产的制品和所从事的生产操作进行专业知识和安全防护要求的培训。
      第六条 生产管理负责人、质量管理负责人和质量受权人应当具有相应的专业知识(微生物学、生物学、免疫学、生物化学、生物制品学等),并能够在生产、质量管理中履行职责。
      第七条 应当对所生产品种的生物安全进行评估,根据评估结果,对生产、维修、检验、动物饲养的操作人员、管理人员接种相应的疫苗,并定期体检。
      第八条 患有传染病、皮肤病以及皮肤有伤口者、对产品质量和安全性有潜在不利影响的人员,均不得进入生产区进行操作或质量检验。

      第五章 动物房及相关事项
      第三十条 生产和检定用动物应当符合《中华人民共和国药典》的要求。
      第三十一条 应当对生产及检验用动物的健康状况进行监控并有相应详细记录,内容至少包括动物来源、动物繁殖和饲养条件、动物健康情况等。
      第三十二条 用于生物制品生产的动物房、质量检定动物房、生产区应当各自分开。动物房的设计、建造及动物饲养管理要求等,应当符合实验动物管理的相关规定。
      第六章 生产管理
      第三十三条 当原辅料的检验周期较长时,允许检验完成前投入使用,但只有全部检验结果符合标准时,成品才能放行。
      第三十四条 生产和检定用菌毒种应当建立完善的种子批系统(原始种子批、主代种子批和工作种子批)。菌毒种种子批系统的建立、维护、保存和检定应当符合《中华人民共和国药典》的要求。
      第三十五条 生产和检定用细胞需建立完善的细胞库系统(原始细胞库、主代细胞库和工作细胞库)。细胞库系统的建立、维护和检定应当符合《中华人民共和国药典》的要求。
      第三十六条 应当通过连续批次产品的*性确认种子批、细胞库的适用性。种子批和细胞库建立、保存和使用的方式,应当能够避免污染或变异的风险。
      第三十七条 应当在适当受控环境下建立种子批和细胞库,以保护种子批、细胞库以及操作人员。在建立种子批和细胞库的过程中,操作人员不得在同一区域同时处理不同活性或具有传染性的物料(如病毒、细胞系或细胞株)。
      第三十八条 种子批或细胞库和成品之间的传代数目(倍增次数、传代次数)应当与已批准注册资料中的规定*,不应随生产规模变化而改变。
      第三十九条 在人员的监督下,经批准的人员才能进行种子批和细胞库操作。未经批准不得接触种子批和细胞库。
      第四十条 种子批与细胞库的来源、制备、贮存及其稳定性和复苏情况应当有记录。储藏容器应当在适当温度下保存,并有明确的标签。冷藏库的温度应当有连续记录,液氮贮存条件应当有适当的监测。任何偏离贮存条件的情况及纠正措施都应记录。库存台帐应当长期保存。
      第四十一条 在贮存期间,主代种子批和工作种子批储存条件应当*;主代细胞库和工作细胞库的储存条件应当*。一旦取出使用,不得再返回库内贮存。
      第四十二条 不同种子批或细胞库的贮存方式应当能够防止差错、混淆或交叉污染。生产用种子批、细胞库应当在规定的贮存条件下在不同地点分别保存,避免丢失。
      第四十三条 应当进行培养基适用性检查试验。培养基中不得添加未经批准的物质。
      第四十四条 应当按照《中华人民共和国药典》中的“生物制品分批规程”对生物制品分批并编制批号。
      第四十五条 向发酵罐或其它容器中加料或从中取样时,应当检查并确保管路连接正确,并在严格控制的条件下进行,确保不发生污染和差错。
      第四十六条 应当对产品的离心或混合操作采取隔离措施,防止操作过程中产生的悬浮微粒导致的活性微生物扩散。
      第四十七条 应当采用经过验证的工艺进行病毒去除或灭活处理,操作过程中应当采取措施防止已处理的产品被再次污染。
      第四十八条 培养基宜在线灭菌。向发酵罐或反应罐中通气以及添加培养基、酸、碱、消泡剂等成分所使用的过滤器宜在线灭菌。
      第四十九条 不同产品的纯化应当分别使用的层析分离柱。不同批次之间,应当对层析分离柱进行清洁或灭菌。不得将同一层析分离柱用于生产的不同阶段。应当明确规定层析分离柱的合格标准、清洁或灭菌方法及使用寿命。层析分离柱的保存和再生应当经过验证。
      第五十条 使用二类以上病原体进行生产时,对产生的污物和可疑污染物品应当在原位消毒,*灭活后方可移出工作区。
      第五十一条 对用于实验取样、检测或日常监测(如空气采样器)的用具和设备,应当制定严格的清洁和消毒操作规程,避免交叉污染。应当根据生产的风险程度对用具或设备进行评估,必要时做到专物专区。河南佳景环保科技有限公司是一家从事净化环保事业的专业公司,凭借在净化领域的专业水平和成熟的技术,在净化领域迅速崛起,深受社会各界用户的信赖与支持。
      公司从事空气净化系统工程、空间杀菌系统工程的设计,施工,安装,调试。目前已在食品厂、实验室、水厂、烘焙食品、麻辣食品、添加剂行业、电子厂等空气处理领域成功合作了多家忠实客户,凭借着质量的可靠性、性能的完善性和良好的服务得到了广大客户及行业人士的*好评。
      公司拥有一批专业技能高,经验丰富的技术人员和经营管理人员。高素质的员工团队为公司参与市场竞争提供了可靠的保障。
      我公司奉行“质量为本,信誉至上”的方针,不断开拓创新,以技术为核心、视质量为生命,努力打造质量合格、服务到位,让客户满意的品牌

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