Inspectional Guidance-Microbiological Issues for Inspection of Pharmaceutical Manufacturing Facilities
1. Product Sterilization or bioburden reduction stage and validation- Aseptic/Filtration, steam, ETO, radiation, and other chemical processes
产品的灭菌或生物负载的降低阶段和验证-无菌/过滤、蒸汽、ETO、辐射和其他化学过程
2. Depyrogenation- dry heat ovens for glass containers, Wash/rinse for stoppers, adequacy of validation using spiked endotoxin, Recovery studies before depryrogenation, Filtration and column applications
去热源-玻璃仪器用的干热灭菌烘箱，瓶塞的冲洗，使用内毒素加标的验证，去热源前的回收研究，过滤器和柱的应用
3. Environmental monitoring- Types of equipment, calibration, operation and maintenance; Surface, Air, Personnel and Water; Critical work areas for aseptically filled products (class 100, isolators, etc); Process simulation (media fills) studies for process validation, growth promotion, reading turbidity, volume adequacy, surface contact, surface sanitizer neutralizing media (e.g., TSA w/ Lecithin & Polysorbate 80), sampling technique (observe), sample must represent dynamic/operational conditions, trending/CAPA, etc.
环境监控——设备型号，校准，运行和维护；表面，空气，人员和水；无菌灌装产品的关键工作区域（100级，隔离器等）；工艺验证：培养基灌装试验研究，促生长试验，浊度判断，足够的体积，表面接触，含中和剂的培养基（TSA含卵磷脂和聚山梨酸酯80），取样技术（观察），监测的环境样品必须是在动态或生产状态下的，趋势分析和纠正预防措施等。
4. Disinfection and sanitization- agents used (sporicidal?), preparation problems, (over dilution); Applicator (i.e., mop, spray. Aerosol), time of exposure, areas of contact, supervision; residues, UV lights, water systems, filling equipment, work surfaces, process columns, Verification and validation
消毒和灭菌——试剂的使用（杀孢子剂？），配制问题，（稀释过度 ）；使用工具（拖把、喷雾、气溶胶发生器），暴露时间，接触区域，监督，残留，紫外灯，水系统，灌装设备，操作工作表面，工艺柱，验证和确认。
5. Room design and Equipment- accessibility for disinfection and cleaning; ‘aseptic filling critical area; HEPA filter certification and maintenance , air flow patterns/smoke studies, change evaluation/re-certification (rearranging cleanroom, adding equipment, HVAC, etc.), test during dynamic/operational conditions with maximum number of personnel in place, personnel equipment traffic, room differential pressure and temperature; adequacy of primary and secondary barriers
洁净房间的设计和设备-易清洁和消毒；无菌灌装关键区域；HEPA过滤器确认和维护，气流组织烟雾测试，变更评估再确认（洁净区，补充设备，空调控制系统等等）
6. Water Purification and delivery system: Vulnerability of Distillation, RO, Deionizers, cartridge filters, etc; UV lights, dead legs, biofilm; corrosion ( heat exchangers); Water borne microorganisms (nanobacteria) and endotoxin production; Cold system problem, disinfection problems
水纯化和分配系统：蒸馏的防污染性，RO反渗透，去离子器，滤芯等；紫外灯，盲管，生物膜；腐蚀（热交换器）；水生微生物和内毒素；冷却系统问题，消毒问题。
7. Personnel- training procedures for aseptic technique, gowning procedures, Cleaning and maintenance personnel training for Class 100 room entry; Glove and garment monitoring and procedures
人员-无菌技术的培训，染色程序，100级区域的个人清洁和维护培训；手套和洁净服监控和程序
8. Product Sampling: representation of lot required minimum values per USP <71>: quantity per container & units per batch, sample storage (time and temp), sampling port sanitization or sterilization problems; problem with skip lot testing on raw material.
样品取样： 按照USP <71>要求的批最小代表量：每箱单元每批的数量，样品的储存（时间和温度），取样部件的消毒或灭菌问题；漏检批原料测试问题。
9. Maintenance records- determine dates, and location of equipment failure or out-of- service that may have an impact on microbial ingress; looks for signs of roof leaks and water stains on ceiling panels, the degree of dirt and dust accumulation on supply and exhaust vents; Ask about new construction, plumbing or air handling system and the reason for change.
维护记录-确定可能对微生物入侵造成影响的设备故障或停用的日期和位置;检查屋顶漏水和天花板上的水渍，以及供气和排气口上积聚的灰尘和灰尘的程度;询问新的建筑、管道或空气处理系统以及改变的原因。
10. Compressed Air Systems—sterile process air, microbial particulate filtration (0.2 µm, hydrophobic), condensate causing blockage & microbial growth, routine point-of-use sampling, maintenance, filter integrity test
压缩空气无菌空气处理过程空气微生物颗粒过滤(0.2µm,疏水性),冷凝造成堵塞和微生物增长,常规接入点采样、维护、过滤器完整性测试
本文来自Pharmaceutical Microbiology Manual2014
免责声明：上述内容仅供交流学习使用，对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。仅作参考，并请各位自行承担全部责任。版权归原作者所有，如遇版权问题请联系小编删除。
你的点的每一个好看，我都认真当成了喜欢
原文始发于微信公众号（药品微生物检测）：Inspectional Guidance 2-药品生产设施的微生物调查
