Vos sources d’informations de comptage de particules ISO 14644-1: 2015
ISO 14644-1: 2015 continue de poser des défis aux gestionnaires et fabricants de salles blanches. Ici, nous fournissons plusieurs sources d’informations pour aider tout le monde, des débutants à cette réglementation ISO aux vétérans dans ce domaine.
Obtenez un résumé de l’ISO 14644-1: 2015 en lisant le document ci-dessous ou en regardant le webinaire enregistré à droite
Lisez les articles ci-dessous pour en savoir plus sur les normes d’étalonnage ISO 21501-4 pertinentes et leurs applications.
Vous avez des questions? Lisez les questions les plus fréquemment posées (voir en bas à droite) ou soumettez votre propre question à l’un de nos experts.
Avez-vous besoin d’un produit conforme à la norme ISO 14644-1: 2015 pris en charge par l’étalonnage ISO 21501-4? Si oui, consultez notre liste de produits en bas de cette page.
Knowledge / Papers
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.
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
0.1 Micron Particle Counter: Lasair® III 110
The only true .1 micron particle counter, providing real-time measurement of yield-impacting cleanroom particles with three configurations.
OBSOLETE: IsoAir® 310P Remote Particle Sensor
Real-time remote cleanroom particle sensor gives quick notification of particle anomalies, detecting 0.3 and 5.0 µm for GMP and FDA compliance.
FacilityPro® Cleanroom Software for Pharmaceuticals
FacilityPro® Cleanroom Software for the Pharmaceutical Industry provides the interface, data management, and reporting for an environmental monitoring…
Airnet® II / IIs Remote Particle Sensors (2 Channels)
The Airnet particle sensor meets the specifications of EU GMP Annex 1 and ISO 21501-4 to measure the size and number of particles suspended in the air for real-time monitoring of defect-causing particles.
PMS fournit un service conforme certifié
Réparation de service et étalonnage
A Particle Measuring Systems, nous avons mis en place des processus et des normes strictes pour garantir le respect des normes de service et d’étalonnage telles que:
- ISO 21501-4:2007
- ISO 9001:2008
- ISO 17025
- En savoir plus sur nos solutions de service et et d’étalonnage.
