制药企业生产环境在线监测系统简介.pptx

制药企业生产环境在线监测系统;目录; “产品+定制” 相结合的开发模式保护企业投资;LightHouse公司;目录;颗粒对工艺流程起负作用 改变化学成分 影响稳定性 影响纯度 影响安全 影响可靠性 污染影响工艺流程的”良品率” 增加生产成本 增加保养或维修费用 增加持有成本 减少了重要设备的投资回报率 “最坏结果” 设备没到使用寿命就坏了 病人生病或死亡;活体颗粒计数 可被培养 将成长为”群体” 需要最适宜的生长媒质 需要充分的孵化 可计数为 群体-构成单位 活体单位 ;颗粒大小;颗粒大小;空气中颗粒的分布;目录;激光粒子计数器;侦测范围;光散射法颗粒计数仪;;光散射计数仪工作原理;高能量的激光二极管 稳定的光学系统 经过了耐久性测试 确认了激光的使用寿命 经过加速老化试验表明，仪器至少可以使用10年以上;颗粒大小;目录;洁净室空气颗粒监测的标准;首次公布时间1987年6月 新版本公布：2004年9月 公布的数据要求公制化 立方英尺----〉立方米 1个立方米=35.31立方英尺 涉及ISO 14644-1 FED209E百级?ISO 5级 针对0.5um限制颗粒数量3520个/立方米;主要关注潜在的产品暴露区，定义2个区域 Critical (similar to Grade A) 关键区 Controlled (similar to Grade C or D support areas)受控区 监控0.5微米 采样点位置 “Not more than 1 foot away from the work site, within the airflow, and during filling/closing operations” 在气流中和罐装区离工作区域不能大于1英尺 ;Contains Nonbinding Recommendations Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations would be of appropriate particle quality when it has a per-cubic-meter particle count of no more than 3520 in a size range of 0.5 μm and larger when counted at representative locations normally not more than 1 foot away from the work site, within the airflow, and during filling/closing operations. This level of air cleanliness is also known as Class 100 (ISO 5). We recommend that measurements to confirm air cleanliness in critical areas be taken at sites where there is most potential risk to the exposed sterilized product, containers, and closures. The particle counting probe should be placed in an orientation demonstrated to obtain a meaningful sample. Regular monitoring should be performed during each production shift. We recommend conducting nonviable particle monitoring with a remote counting system. These systems are capable of collecting more comprehensive data and are generally less invasive than portable particle counters. From Section IV. Buildings and Facilities, Sub-part A, Critical Area – Class 100 (ISO 5) ;EU GMP Annex I;修正了A区和B区的5微米限制 提到了在A区和B区的连续监测 介绍了日常测试必须采满1个