样品制备过程的挑战减少错误和超差（OoS）结果.pptVIP

Internal usage only Internal usage only Internal usage only Internal usage only 样品制备过程的挑战减少错误和超差(OoS)结果 梅特勒-托利多中国 天平部 2014年 内容 传统标样制备流程及面临的挑战 梅特勒-托利多重量法样品制备的解决方案 Quantos产品介绍 行业应用案例分享 ? 取样/二次取样 客户价值：过程安全性 可追溯性 ? 减少超差结果(OoS) 研发：未知危险级别 生产：4/5级 加入溶剂 溶解 HPLC 分析 样品清理的提取 溶液 / 稀释 转移 称量样品 HPLC分析过程 详细了解…… 超差结果(OoS) 实验室调查 检查清单：调查使用的标准品和样品。调查使用的分析方法… 确认实验室误差？ 重新测试替代 超差结果(OoS) 取样或生产的 变化或误差？ 否 是 根据SOP或协议重新测试 没有更多的超差结果(OoS) 停产 放行 更多的超差结果(OoS) 确认误差为取样环节 ? 重新取样 否 确认生产环节的变化 重新测试 — 在确定放行与否之前，如果可能使用原始样品，通常需要进行6~8次测试。所有结果(包括首次超差结果)将会记录。 超差结果(OoS)调查的正常过程 * 15 mg 30 g 现在的样品制备过程 Quantos GSP：简化称量和加样过程 节省90%的样品和溶液 避免60%的超差结果(OoS)来源 GSP的变化，比HPLC的变化更理想 十年间的一成不变 Quantos GSP 解决方案 Quantos 重量法样品制备(GSP) 通过简化称量和加样过程，避免超差结果(OoS)! 更少量的样品 更小的过程错误风险 避免接触样品 全球100家企业正在使用Quantos系统 通过 4 年的开拓：市场已经开始接受 Quantos 技术！ * 2nd Process: QA/QC Quality Assurance/Quality Control – process used throughout the pharma development and manufacturing process from screening of active ingredients through to QC of the finished pharma product. Complete workflow based on the use of a company internal SOP to ensure that the samples/standards are always prepared according to the same methodology. Process is quite complex from sampling through to analysis. Analysts spend much more time today on the sample prep than on the analysis; this is really the bottleneck in the process and the source of many errors. 3-10% of all analyses in pharma indusry are Out-of-Specification and the time required to deal with those is 3-4 hours per case. Any reduction in OoS would be improve process efficiency significantly. I would like to concentrate on the first 2 steps…sample weigh-in and liquid addition; these are steps which are responsible for ca. 50% of the OoS results obtained within the process * Now let us have a closer look at how Quantos with the GSP (Gravimetric Sample Preparation) concept improves your life: You place any target container (not necessarily a volumetric flask) on Quantos and automatically dose in powder. Qua