Your Complete Source for ISO 14644-1:2015 Particle Counting Information
ISO 14644-1:2015 continues to pose challenges to cleanroom managers and manufacturers. Here we provide several sources of information to help everyone from those new to this ISO regulation to veterans in the field.
Our team of regulatory experts have put together a package of information so you can easily understand the requirements and what you need to do to meet them. Get a summary of ISO 14644-1:2015 by reading the paper below or watching the recorded webinar at the right. We also have FAQs and a paper to learn about the closely relevant ISO 21501-4 calibration standards and how they apply to you.
Have a question? Read some of the frequently asked questions we get (see the bottom right), or submit your own question for one of our experts.
Do you need an ISO 14644-1:2015 compliant product that is supported with ISO 21501-4 calibration? We have a complete offering of remote/continuous solutions as well as portable/mobile particle counters. Scroll to the bottom to see our list or view our cleanroom particle counters page and use the filters to find the right solution for your application quickly and easily.
ISO 14644 Knowledge / Papers
ISO 14644-1:2015 修訂摘要
The recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper will highlight 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.
ISO 14644-2:2015 Cleanroom Monitoring
This presentation underlines the major changes between the previous version of ISO 14644-2 and the second edition, dated December, 12th 2015.
Common ISO 14644-2:2015 Questions and Answers
The recently updated ISO14644-2:2015 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 providing you with answers to many of the questions that our customers frequently ask.
ISO 14644-2:2015 Cleanroom Monitoring
This document highlights the major changes in cleanroom monitoring, focusing on particle counters, between the previous version of ISO 14644-2 and the latest, second edition, dated December 12, 2015.
ISO 14644-1:2015 Frequently Asked Questions (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.
Are your particle counters ISO 14644-1 compliant?
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 Compliant Products
Supported by ISO 21501-4 Certified Calibration
Lasair® III 110 空氣粒子計數器
一個真正的 0.10μm 粒子計數器，依客戶需求打造三種不同的配置， 可即時量測影響產率的微粒子。
IsoAir® 310P 粒子感測器
即時 粒子監測 0.5 和 5.0 µm 粒子以符合 GMP 和 FDA 要求，並於發生異常狀況時可快速發出警報通知。
FacilityPro® 軟體
FacilityPro® 軟體提供環境監測系統的介面、數據管理和報告。
Airnet® II and IIs 2 Channel 空氣粒子感測器
符合 ISO 21501-4 規範，可測量懸浮在空氣中之粒子的大小和數量，以即時監測 造成產品缺陷的粒子。
HandiLaz® Mini II手持式空氣粒子計數器
這款粒子計數器符合人體工學設計，持握便攜，便於進行無塵室快速監測。
PMS Provides Certified Compliant Service
Service Repair & Calibration
At Particle Measuring Systems we have strict processes and standards in place to ensure that we meet and exceed service and calibration standards such as:
- ISO 21501-4:2007
- ISO 9001:2008
- ISO 17025
- Learn more about our service and calibration solutions.
