Qualified Services Quality without Limits

3- ARTICOLO SU ASCCA SISTEMI DI MONITORAGGIO Sistema di monitoraggio in continuo in una clean room“La gestione di ambienti a contaminazione controllata è una realtà sempre più diffusa in ambito ospedaliero, per la produzione di prodotti biologici assimilabili ai farmaci, nel campo degli studi clinici o pre-clinici”Articolo su rivista ASCCA 2007 Gennaio/Marzo n°1 ( M. Petrone Qua.Ser.) Details...

1-SERVICE DI WATER laboratori della Qualified Services ( a richiesta anche i ns clienti ) utilizzano acqua purificata generata da un gruppo studiato appositamente per le esigenze, le caratteristiche finali dell’ acqua sono:Conducibilità: 0,055 microS/cm.Resistività : 18.2 Mohm.TOC: minore di 5ppb.Particelle: meno di 1000 per litro da 50 nanometriL' Elix con delle resine e filtri organici esegue un pre trattamento dell' acqua di rete e convoglia l' acqua in un serbatoioda 300 litri. Una pompa preleva l' acqua mediante una pompa e la fa passare in una lampada UV, in modo da abbattere l' organico e trasformarla in CO2. Poi attraversa due batterie a scambio ionico per togliere tutta la CO2 infine attraversa l' ORGANEX (il filtro toglie gli ultimi residui organici nell' acqua).Infine passa attraverso un filtro da 40 nanometri e la mette in circolazione nel loop. Details...

8- Comparazione USP 24 con USP 25 Chapters Total Organic Carbon Comparing USP 24 and USP 25 Chapters <643> Total Organic Carbon &<645> Water ConductivityOBJECTIVE:To communicate an understanding of changes made to chapters <643> Total Organic Carbon and <645>Water Conductivity in USP 25 (from USP 24) and the impact on TOC measuring practices using SieversTOC instrumentation.CONCLUSION:Aside from one change prescribed in the use of Reagent Waters (RW), there were no other changesmade to TOC chapter <643> in USP 25. This change did not affect the use of Sievers TOC analyzers,nor did it affect the preparation of Sievers certified reference standards. No changes were made inchapter <645>.DISCUSSION:The following provides a comparison of chapters <643> and <645> as they appear in both USP 24 andUSP 25. The only change made relates to the acceptance criteria for reagent water. A reduction inacceptable reagent water TOC level from 0.25 mg per liter in USP 24 to 0.10 mg per liter in USP 25 isstated. Additionally, there is a note indicating that the equipment manufacturer may specify a conductivityrequirement in addition to the TOC requirement for reagent water.This change has no impact on the use or validation of Sievers Model 800 and Model 400/400ES seriesTOC analyzers used to monitor TOC in pharmaceutical waters.Additionally, this change has no impact on the certified reference standards prepared by Sievers. The TOClevels for reagent water provided by Ionics Instruments has been consistently lower than those levelsstipulated in USP 25; continued verification and guarantee of conformance with USP 25 will occur. For itsSievers Model 400 TOC analyzers, it is the recommendation of Ionics Instruments that Sievers certifiedreference standards be used for all instrument operation verifications and calibrations. For Sievers Model800 TOC analyzers, Ionics Instruments recommends that Sievers certified reference standards, or standardsprepared with de-ionized water having less than 100 ppb TOC, be used. Details...