PDA：微生物污染调查指南！
本文出自PDA技术报告《微生物污染调查》，供大家参考：QUESTION/DATA TO BE REVIEWED需要回顾的问题/数据FINDINGS调查结果What were microbiological results on the same day for:当天的微生物结果如何：Complementary tests at same location:在同一位置进行补充检测：Air sample/Settling plates/Contact plates/Swabs浮游菌/沉降菌/接触皿/棉签Other locations in class 100 zone in same room同一房间A级区域的其他位置Air samples/Settling plates/Contact Plates/Swabs浮游菌/沉降菌/接触皿/棉签Class 1000/10000 surrounding/adjacent area(s)周边背景区域/临近区域Operator’s gloves/gowns操作人员手套/衣服What were results for particle counts (total particles) on the same day:当天悬浮粒子监测结果：Same location同一位置Other locations in class 100 zone in same room同一房间A级区域其他位置Class 1000/10000 surrounding/adjacent area(s)周边背景/临近区域Were pressure differentials within limits/usual values:压差是否在限度/日常范围内？before/during/after the period of the high counts异常结果之前/期间/之后In adjacent rooms相邻房间Were relative humidity/temperature of rooms in limits/usualvalues房间相对湿度/温度是否在限度/日常范围内？before/during/after the period of the high counts异常结果之前/期间/之后Has there been any recent maintenance activity近期是否存在维修作业？in the area异常结果所在区域In adjacent areas/other air handling units相邻区域/其他空气处理单元Painting or repairs to facility in adjacent areas临近区域是否施工或维修Is it possible that air changes have altered换气次数（送风）是否可能已经改变？Is it possible that a HEPA filter was damaged高效过滤器是否可能已经泄漏？What do recent media fill data show最近一次模拟分装数据显示？Identify the operators working in the area at the time of the event确定异常时在该区域内工作的操作人员Experienced/Senior/New/Mixture经验丰富/资深/新人/都有Any noted behavioral problems with particularemployees任何值得注意的某个人员的特定行为Are employees gowning correctly人员是否穿衣正确Are they routinely following aseptic technique人员是否一如既往的遵循无菌操作How many employees were in the room房间内有多少人For how many hours at a time一次在该房间待了几个小时？How many shifts are working几个班Has there been a recent increase in numbers of shifts or quantities produced近期班次或生产数量是否有所增加？Has the contamination该污染Been identified是否已被鉴定？Been compared with bioburden isolates是否与分离菌比较？Previously been isolated in environmental monitoring (library species)是否先前在环境监测中分离（实验室菌株）Source been considered考虑其来源Been tested for susceptibility to the specificdisinfectants used in the area (is it resistant)检测其对该区域内使用的特定消毒剂的敏感性（是否耐受）Other (specify)其他
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