Wireless Temperature Measurement in Lyo Process Development, Validation and Production

Abstract

Wireless temperature measurement during lyo process development, validation and production with the aim to apply process control. This is performed by the determination of product temperature Tp in critical positions ("hot" and "cold" spots). Also it is explained how this approach was implemented into the Common Technical Document (CTD) regulatory submission and that it was successfully approved. How to use the Tp measurement as a key element of the continuous process verification is also demonstrated.

Full text

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ECV · Editio Cantor Verlag
Bestellung
Tel. +49 (0)711-6672-1924 · Fax +49(0)711-6672-1974
eMail svk@svk.de · Webshop, Leseproben und Inhaltsverzeichnisse
Auslieferung und Rechnungsstellung unserer
Produkte erfolgt durch unseren Vertragspartner
Stuttgarter Verlagskontor SVK GmbH. www.ecv.de
Das Buch Nichtinterventionelle Studien in
Deutschland beschreibt die regulatorischen
Vorgaben für NIS in Deutschland, die optimale
Planung inkl. der methodischen Aspekte sowie
die richtige – an der Fragestellung orientierte
– Durchführung. Dazu gehören die Auswahl
des richtigen Studiendesigns, der statistischen
Planung und Auswertung sowie Aspekte der
Qualitätskontrolle. Andere Aspekte der Durch-
führung sind die vertragsrechtliche Konstella-
tion der Beteiligten sowie Sicherheitsaspekte
des beobachteten Produkts.
Alle diese wichtigen Teilaspekte einer Beob-
achtungsstudie werden durch Fachexperten be-
schrieben, sodass für Anwender ein Leitfaden
entsteht, mit dem sie NIS optimal selbststän-
dig planen und durchführen können.
Zielgruppen
• Medizinproduktehersteller
• Auftragsforschungsinstitute / CRO
• Zulassungsbehörden
• Ethikkommissionen
• Universitätskliniken
• Großkrankenhäuser
• Prüfärzte
• Studienteams
• Study Nurses
• Klinische Monitore / CRA, Auditoren
Nichtinterventionelle Studien
(NIS) in Deutschland
Hinze C, Gleiter C H, Herbold M (Hrsg.)
ISBN 978-3-87193-442-1
• 78,11 €
• 1. Auflage 2018
• 14,8 x 21 cm, Softcover, 212 Seiten
Simply Wireless
WTMplus 2.0 temperature measurement
Martin Christ Gefriertrocknungsanlagen GmbH
An der Unteren Söse 50
37520 Osterode • Germany
Tel. +49 (0) 55 22 50 07-0
info@martinchrist.de
www.martinchrist.de
WTMplus 2.0 is dedicated for Christ pilot units as well as production
units, particularly together with our autoloading system LyoShuttle.
• Fully integrated in our automated systems and process
documentation LPCplus
• GMP-design for best cleaning results
• Small and robust, also for 2R vials and bulk
• High accuracy ± 1 K, resolution 0.1 K
• Covers the entire process
(temperature range – 60 °C ... + 135 °C, sterilizable)
• No plugs and wires with cleaning and contact problems
• Up to 16 sensors can be used in one freeze dryer
everywhere on all shelves

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