Cleanroom Contamination Control, Certification & Environmental Monitoring Services

控制药物和生物制品中的微生物污染对患者安全至关重要. 在制药领域拥有超过25年的洁净室污染控制和环境监测项目开发经验, 用于受控环境的制造和制药im体育平台app下载, im体育APP的全套洁净室测试服务旨在确保在关键环境中控制微生物污染物以及小分子和大分子药物的质量.

To protect the safety of patients, end-users, and equipment operators, 除了防止交叉污染和确保制造和包装设备的清洁度, 药品制造商和复方药房必须证明常规的设施清洁程序，根据文件规范限制潜在的污染. 对已在受控环境中建立的环境控制措施的评价, including cleanrooms and sterile compounding areas, 对减少和控制微粒和微生物污染物至关重要.

综合环境监测(EM)计划不仅包括微生物环境计划, 但也要评估员工的着装表现和无菌行为, 以及清洁和消毒程序的效果. im体育APP提供了一套全面的受控环境监测服务，以验证有效的清洁程序已经实施. 我们的监管和科学专家团队拥有数十年的经验，可以为领先组织设计符合微生物环境监测指南的强大程序, 从大型制药公司到复方药房和医院. Our expertise extends to the development, 实施和监测基于风险的环境监测项目. im体育APP’s consultative experts also offer wrap-around services, including environmental monitoring mapping, filter integrity testing, cleanroom training, training of staff in proper aseptic practices, and a broad range of cleanroom consulting services.

洁净室认证和受控环境监测服务

• 表面、活空气、总颗粒物空气(非活空气)取样
• Compressed 气体 contaminant testing
• Compressed air line 抽样
• Passive/setting plates
• 根据FFDCA章节503A或503B对复方药物进行高压灭菌器验证
• Primary Engineering Control (PEC) (laminar flow hoods, isolators, and Class I, II, III biological safety cabinets)
• Growth promoted media
• Calibrated equipment
• Incubation and enumeration
• Microbial identification
• Electronic reporting
• Customized environmental monitoring SOP generation

Cleanroom validation and facility validation support

• 环境监测绩效确认(EMPQ)和环境监测运行确认(EMOQ/EMPQ/OQ/PQ)
• Disinfectant and cleaning studies
• Water system qualifications
• Risk assessment
• Summary report

Environmental monitoring excursion investigations

• Root cause analysis
• Corrective action/preventative action (CAPA)
• Training (on-site and/or virtual)
• Investigational 抽样
• Excursion response SOP

Aseptic technique and 净化服 services

• On-site gown training and qualification
• Cleanroom behavior training
• Aseptic technique qualification

确保遵守微生物环境监测指引

im体育APP的丰富经验满足州和联邦监管期望, along with a quality-centric, “first time right” mentality, 确保环境监测项目的设计既能节约成本，又能获得高质量的结果. Our EM technicians are thoroughly trained on aseptic technique, 净化服, 抽样, 以及洁净室环境下的微生物学. This unparalleled blend of experience, staff development and training, and extensive regulatory, im体育平台app下载, 和科学知识使im体育APP能够提供im体育平台app下载领先的洁净室验证解决方案, including controlled environment monitoring, cleanroom testing services, and environmental monitoring of sterile compounding areas.

环境监测计划允许制造商和复合公司测量和监测其设施内的清洁度和污染水平. im体育APP provides comprehensive EM services, 以及对你们员工进行正确无菌操作的教育和培训. 我们将与您合作，验证您的清洁和消毒流程, as well as aseptic technique, to help you produce the safest possible product.

Environmental monitoring of sterile compounding areas

配药药房必须遵守清洁和消毒指南的详细说明 USP <797> for compounded sterile preparations (CSPs). Furthermore, when handling hazardous drugs in healthcare settings, the procedures and guidelines detailed within USP <800> must be followed. 无菌配药区域的环境监测对于证明遵守本法规指南至关重要. Specifically, 柜台和容易清洁的工作表面和地板需要每天清洁和消毒, and walls, 天花板, and storage shelving must be cleaned and sanitized monthly. Furthermore, ISO 5级PEC场所必须在每班开始时进行最低限度的清洁, before each batch, every 30 minutes when compounding, after spills, and when contamination is known or suspected.

环境监测程序检测复方药房的污染，是识别受控环境中导致微生物水平过高的条件的关键工具, which can include ineffectual cleaning, sanitation, aseptic technique, and insufficient hand hygiene and 净化服. im体育APP’s consultative teams of experts offer USP <797> testing, as well as comprehensive monitoring, qualification, 培训计划，确保洁净室和生产环境符合法规标准, including FDA, USP and ISO 13485 and ISO 14698 guidelines.

The im体育APP advantage

通过im体育APP全面的环境监测和洁净室认证和测试服务，在符合法规要求的同时，改进制造流程并保持低成本, customized to meet the specific needs of your facility, manufacturing processes, and finished product.

了解我们在生物制药生产设施中控制微生物污染物的定制方法, compounding pharmacies, 医院, 和更多的, or to speak with one of our experts, contact us 今天.