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.
Get a summary of ISO 14644-1:2015 by reading the paper below or watching the recorded webinar at the right.
Read the papers below 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? If yes, see our list of products at the bottom.
Knowledge / Papers
Récapitulatif des révisions de l’ ISO 14644
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 underlines the major changes between the previous version of ISO 14644-2 and the latest, second edition, dated December, 12th 2015. A specific approach to the best practices to be adopted for an efficient and compliant cleanroom monitoring process are discussed.
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
Compteur de particules pour air Lasair® III 110
Un vrai compteur de particules de 0,10 μm, permettant la mesure en temps réel des particules limitant le rendement, avec trois configurations.
IsoAir 310P – Détecteur de particules en suspension dans l’air
Surveillance en temps réel des particules, pour une indication rapide des anomalies particulaires, avec détection de 0,5 et 5,0 µm pour la conformité aux normes GMP et FDA.
FacilityPro® Software
Le logiciel FacilityPro fournit l’interface, la gestion des données et l’établissement des rapports pour un système de surveillance environnementale…
AirNet II – Détecteur de particules à deux canaux
Répond aux spécifications de la norme ISO 21501-4 pour mesurer la taille et le nombre de particules en suspension dans l’air pour une surveillance en temps réel des particules causant des défauts.
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.
