ISO 14644-1:2015粒子计数信息的完整来源
ISO 14644-1:2015继续对洁净室管理者和制造商提出挑战。我们提供了一些信息来源,以帮助您详细地了解ISO规则。
阅读以下文章或在右边观看录制的网络研讨会,查看ISO 14644-1:2015摘要。
阅读以下文章,了解与ISO 21501-4校准标准密切相关的内容,以及它们如何为您服务。
您是否存在问题?了解常见问题(见右下角),或向PMS专家团队提出问题。
您是否需要支持ISO 21501-4校准的ISO 14644-1:2015兼容产品?如有需求,请查看页面底端的产品列表。
知识 / 单页
ISO 14644-1:2015 Revisions Summary
The recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper highlights the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.
Complete the form to download a free copy of the ISO 14644 Revisions Summary paper, complete with all tables and graphs.
理解ISO标准:ISO 14644-2:2015洁净室监测 [Webinar Presentation]
ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control.
ISO 14644-1:2015 常见问题解答 (FAQs)
The newly updated ISO14644-1:2015 has caused some confusion and raised concerns by companies who want to ensure that they are fully compliant. To address these issues, Particle Measuring Systems is sharing our industry expertise and have provided an ISO 14644-1:2015 summary paper, an on-demand webinar, and are now providing you with answers to many of the questions that our customers frequently ask.
您的粒子计数器是否符合 ISO 14644-1标准?
Are your particle counters ISO 14644-1 compliant and able to be calibrated to all required tests according to ISO 21504-4?
ISO 14644-1:2015 合规产品 支持 ISO 21501-4 认证校准
Lasair® III 便携式粒子计数器
LASAIR®III便携式粒子计数器充分满足了便携式粒子计数器的标准,符合ISO1464—1:2015和ISO21501-4要求。
IsoAir® 310P尘埃粒子传感器(已停产)
简化远程监测
IsoAir® 310P粒子传感器实时粒子监测给出粒子异常的快速通知,检测GMP和FDA遵从的0.5和5μm
FacilityPro®软件
FacilityPro®软件提供对接,数据管理以及环境监控系统报告功能。
AirNet® II XR粒子传感器
AirNet® II粒子传感器符合标准ISO 21501-4的要求,可以监测气悬浮粒子的大小和数量。