[change country]- 21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
- Airborne Particle Counters: Further Information...
- Cleanroom Particle Monitoring
- DI Water Particle Monitoring
- GAMP Requirements and Solutions
- GMP and cGMP Particle Counting Requirements
- ISO 14644 Cleanroom Monitoring
- Monitoring Particles in Injectables for USP 788 and EP6
- Optical Haze Blurs the Bottom Line
- Particle Counters for Gas Applications
- USP 797 Particle Monitoring Solutions
- WET PROCESS CONTROL
- 21 CFR Part 11 Compliance
USP 797 Particle Monitoring Solutions
As of January 1, 2004, pharmacies compounding sterile preparations have been required to monitor their facilities and processes to standards mandated by USP 797. However, between the complicated language of the regulation and the expense of meeting some of the requirements, many compounding pharmacies are still not in compliance. We provide solutions to both USP 797 problems.
For specific questions concerning USP 797, please contact Mark Hallworth at mhallworth@pmeasuring.com or 303.443.7100.
Papers
Surveillance de particule pour satisfaire USP 797USP 797 Particle Monitoring (603.8 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
Résumé des documents de fonctionnement de l'USP 797 - Document complet fourni avec l'achat d'un Handilaz MiniSummary for USP 797 Operating Docs - Complete Document provided with Handilaz Mini Purchase (64.6 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
Guide de base pour le comptage de particulesBasic Guide to Particle Counters and Particle Counting (971.1 KB) Cette vue d'ensemble sur la contamination de particules débute en discutant des sources de contamination et des technologies de surveillance disponibles et continue en introduisant divers... Download above file for full tables and figures, or for overview, see HTML Version. |
Exigences de surveillance de particules dans les salles propres pharmaceutiques.Compteur de particules pour le contrôle et la certification en salle blanche (380.3 KB) Ce document traite des diverses exigences de microcontamination de la fabrication pharmaceutique, définit un environnement de fabrication propre et montre comment... Download above file for full tables and figures, or for overview, see HTML Version. |
Étapes rapides pour satisfaire la conformité USP<797>, 2006Quick Steps to Meet USP 797 Compliance (54.4 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
WEBÉMISSION : la vérité toute simple à propos d'USP 797Vous pouvez participer à cette webémission en direct le 30 janvier 2007, ou vous pouvez la regarder sur demande jusqu'au 30 janvier 2008. |
Products
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Compteur de particules manuel : Handilaz MiniUne autre solution économique pour la surveillance ponctuelle |
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Pharmaceutical Microcontamination Monitoring ServicesWe have managed over 150 fully integrated system projects worldwide in a variety of applications including: aseptic, tableting, powder fill, and medical devices. |
Options de location / crédit-bail de compteur de particulesIf you need a particle counter or molecular contamination monitor for a short-term project or troubleshooting, we offer a comprehensive rental program. |
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