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微生物鉴定
与生物制品部联系
首次应用即获成功
Life Technologies MicroSEQ快速微生物鉴定系统已在世界范围内的顶尖药物公司中得到了广泛应用，完美适用于小分子和生物制药生产和服务实验室中的环境监测、污染调查、根本原因分析，原材料检测和微生物鉴定等应用。该系统同时也适于在公共卫生实验室、化妆品及个人护理产品制造间、食品检测实验室和学术研究中心内使用。
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微生物鉴定为何那么重要？
有害细菌和真菌会污染原料、生产设备和品牌产品。预期的监管内容包括精确鉴定环境分离物，来支持药品制造环境（作为cGMP一部分的）中正在进行的环境监测计划，以及在产品和加工过程启用精确的纠正与预防措施（CAPAs）来降低污染风险。美国、欧洲和日本的药典指南建议，针对细菌和真菌的微生物基因型鉴定应达到种属水平。核糖体DNA（rDNA）比较基因序列分析被证明在微生物鉴定系统技术中具有最高的精确度，并已在超过十年的时间里被考虑作为微生物鉴定的金标准方法。
在何处检测细菌和真菌？
采用3500型基因分析仪的MicroSEQ快速微生物鉴定系统
进入分子领域。DNA就是谜底
是时候将微生物鉴定的工作推进到下一水平了；是时候使用快速分子方法中领先的认证技术了；是时候将MicroSEQ快速微生物鉴定系统引入您的QC微生物实验室了。本系统基于我们多年的专业分子知识，在细菌和真菌的鉴定工作中，能够以单一的易用平台为您提供无可比拟的精确性和获得结果的速度。
- 基于16S rRNA基因检测的细菌精确的基因型鉴定
- 基于26S rRNA基因D2区域检测的真菌精确的基因型鉴定
- 简单高通量的工作流程、通常在少于五小时的时间里即可获得精确结果
- 四个月之内可实现完全认证和启用
- 符合联邦法规21章第11款的要求
微生物鉴定与检测产品的分步指导
您可使用PrepMan ® Ultra样品制备试剂从细菌或真菌中提取DNA。您的样品可为单克隆或纯培养物。理想的细菌菌落大小为1-2mm，真菌菌落则为3mm。您于本步中提取的DNA将成为PCR步骤所使用的模板。
Use the MicroSEQ ® Microbial PCR Kit that matches .your needs. Each kit contains reagents for amplification (PCR) reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the PCR products for the subsequent step using the MicroSEQ® clean-up kits.
Use the MicroSEQ ® Microbial Sequencing Kit that matches .your needs. Each kit contains reagents for cycle sequencing reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the products for the subsequent steps using the MicroSEQ® Clean-up kits. Next, sequence your sample automatically by running it on a genetic analyzer (DNA seqeuncer). Choose the system configuration that meets your throughput needs.
Use the MicroSEQ® ID Analysis Software to match sequences in your sample with sequences in our validated libraries. The software also enables you to create custom libraries and search public libraries.
Learn more about:
您可使用PrepMan ® Ultra样品制备试剂从细菌或真菌中提取DNA。您的样品可为单克隆或纯培养物。理想的细菌菌落大小为1-2mm，真菌菌落则为3mm。您于本步中提取的DNA将成为PCR步骤所使用的模板。
Use the MicroSEQ ® Microbial PCR Kit that matches .your needs. Each kit contains reagents for amplification (PCR) reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the PCR products for the subsequent step using the MicroSEQ® clean-up kits.
Use the MicroSEQ ® Microbial Sequencing Kit that matches .your needs. Each kit contains reagents for cycle sequencing reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the products for the subsequent steps using the MicroSEQ® Clean-up kits. Next, sequence your sample automatically by running it on a genetic analyzer (DNA seqeuncer). Choose the system configuration that meets your throughput needs.
Use the MicroSEQ® ID Analysis Software to match sequences in your sample with sequences in our validated libraries. The software also enables you to create custom libraries and search public libraries.
Learn more about:
IQ/OQ服务
通过一项与Applied Biosystems的合作关系，来克服安装认证和运行认证（IQ/OQ）等启用过程中所遇到的严格挑战。
- 咨询客户以确定需求
- 通过工作声明来定义项目
- 详细的验证测试计划与记录
- 系统安装验证
- 系统操作认证的顺序
- 微生物鉴定验证
- 准确报告
- 系统软件安装和安全验证
- 软件导出、导入、存档和验证
- 系统树和定制文库验证
- 详细数据分析和回顾
- 查阅实验进程和结果
- 性能认证(PQ)推荐指南
启用计划
针对您实验室的特定需求进行实验室设计和培训的定制，力求在六个月的计划时间框架内完成性能认证(PQ)。
微生物鉴定与检测产品的分步指导
您可使用PrepMan ® Ultra样品制备试剂从细菌或真菌中提取DNA。您的样品可为单克隆或纯培养物。理想的细菌菌落大小为1-2mm，真菌菌落则为3mm。您于本步中提取的DNA将成为PCR步骤所使用的模板。
Use the MicroSEQ ® Microbial PCR Kit that matches .your needs. Each kit contains reagents for amplification (PCR) reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the PCR products for the subsequent step using the MicroSEQ® clean-up kits.
Use the MicroSEQ ® Microbial Sequencing Kit that matches .your needs. Each kit contains reagents for cycle sequencing reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the products for the subsequent steps using the MicroSEQ® Clean-up kits. Next, sequence your sample automatically by running it on a genetic analyzer (DNA seqeuncer). Choose the system configuration that meets your throughput needs.
Use the MicroSEQ® ID Analysis Software to match sequences in your sample with sequences in our validated libraries. The software also enables you to create custom libraries and search public libraries.
Learn more about:
您可使用PrepMan ® Ultra样品制备试剂从细菌或真菌中提取DNA。您的样品可为单克隆或纯培养物。理想的细菌菌落大小为1-2mm，真菌菌落则为3mm。您于本步中提取的DNA将成为PCR步骤所使用的模板。
Use the MicroSEQ ® Microbial PCR Kit that matches .your needs. Each kit contains reagents for amplification (PCR) reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the PCR products for the subsequent step using the MicroSEQ® clean-up kits.
Use the MicroSEQ ® Microbial Sequencing Kit that matches .your needs. Each kit contains reagents for cycle sequencing reactions. Run the reactions on the Veriti 96-Well thermal cycler. Clean up the products for the subsequent steps using the MicroSEQ® Clean-up kits. Next, sequence your sample automatically by running it on a genetic analyzer (DNA seqeuncer). Choose the system configuration that meets your throughput needs.
Use the MicroSEQ® ID Analysis Software to match sequences in your sample with sequences in our validated libraries. The software also enables you to create custom libraries and search public libraries.
Learn more about:
IQ/OQ服务
通过一项与Applied Biosystems的合作关系，来克服安装认证和运行认证（IQ/OQ）等启用过程中所遇到的严格挑战。
- 咨询客户以确定需求
- 通过工作声明来定义项目
- 详细的验证测试计划与记录
- 系统安装验证
- 系统操作认证的顺序
- 微生物鉴定验证
- 准确报告
- 系统软件安装和安全验证
- 软件导出、导入、存档和验证
- 系统树和定制文库验证
- 详细数据分析和回顾
- 查阅实验进程和结果
- 性能认证(PQ)推荐指南
启用计划
针对您实验室的特定需求进行实验室设计和培训的定制，力求在六个月的计划时间框架内完成性能认证(PQ)。
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