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Testmethoden für vorbefüllte Spritzen

Sep 28, 2017
Berlin, Germany

This course will be held in German! Dieser 1-Tageskurs gibt einen Einblick in die Eigenschaften der verwendeten Materialien, die in der Entwicklung und Fertigung von solchen Spritzensystemen eingesetzt werden. Der Fokus dieses Workshops liegt jedoch auf den relevanten Test Methoden, anwendbar für den jeweiligen Entwicklungsstand und Einsatz der Spritze.

  • Education
  • Europe
Program Highlights
This course will be held in German!

Overview

Vorbefüllte Spritzen (Pre-filled Syringes - PFS) werden für verschiedenste Anwendungen und in den unterschiedlichsten therapeutischen Bereichen eingesetzt. Sie sind erhältlich aus Glas oder Kunststoffen, in den Versionen Luer Konus, Luer Lock oder bereits als Nadelspritze.

Vorbefüllte Spritzen haben zwei Hauptaufgaben: sie dienen als Aufbewahrungsbehälter, aber auch gleichzeitig als Injektionsvorrichtung, in ein und demselben System.
Je mehr Komponenten solch eine Spritze beinhaltet, desto komplexer wird das ganze System, vor allem, wenn solche vorbefüllte Spritzen in Autoinjektoren verwendet werden.

Dieser 1-Tageskurs gibt einen Einblick in die Eigenschaften der verwendeten Materialien, die in der Entwicklung und Fertigung von solchen Spritzensystemen eingesetzt werden. Der Fokus dieses Workshops liegt jedoch auf den relevanten Test Methoden, anwendbar für den jeweiligen Entwicklungsstand und Einsatz der Spritze.

Zielgruppe:

Dieser Trainingskurs wendet sich an alle Personen, die in den folgenden Bereichen tätig sind:

  • Produktentwicklung
  • Qualitätsmanagement
  • Regulatory Affairs / Zulassung
  • Fertigung von Spritzensystemen und verwandten Geräten

Zielsetzung:

Nach Abschluss des Kurses

  • Kennen Sie die Vor- und Nachteile der verschiedenen Materialien für vorbefüllte Spritzen
  • Können Sie bestehende Standards und Monografien der spezifischen Spritzentests anwenden
  • Können Sie die Gründe erklären, warum die jeweiligen Testmethoden in den verschiedenen Phasen angewendet wurden
  • Können Sie einen eigenen Testplan für Ihre konkrete Anwendung erstellen

Agenda

  • Trainer

    Horst Koller,CEO, HK Packaging Consulting GmbH
    Bevor Horst Koller als Berater tätig wurde, arbeitete er mehr als 20 Jahre für Abbot Diagnostik und SCHOTT Pharmaceutical Packaging in der Industrie. Sein Beratungsunternehmen fokussiert sich auf die Technische, Regulatorische und QM-Unterstützung im Bereich Primär- und Sekundärpackmittel sowie Medizinprodukte. Er ist ein aktives Mitglied in den ISO TC 76 und TC 84 Ausschüssen und ein aktiver Sprecher bei internationalen Kongressen. Horst Koller ist Dipl.-Ing. der Biotechnologie, FH Mannheim.


    Donnerstag, 28 September 2017

    9:00
    Willkommen

    9:15
    Einführung in Spritzensysteme und Komponenten

    • Kunststoff-Spritzen
    • Glas-Spritzen
    • Gummi-Komponenten und –Verschlüsse

    10:00
    Luer Konus und Luer Lock Compliance Tests für Polymer- und Glas-Spritzen

    10:15
    Kaffeepause

    11:00
    Anforderungen an die leere, sterile, vormontierte und zum Befüllen bereite Spritze

    • Konus Bruch
    • Fingerflansch Bruch
    • Leckage
    12:30
    Mittagspause

    13:30
    Anforderungen an die leere, sterile, vormontierte und zum Befüllen bereite Spritze - Fortsetzung

    • Haft- / Gleitreibung
    • Nadeleinstichkraft
    • Partikelanforderungen (nicht sichtbare Partikel)
    • Endotoxin Spezifikation

    14:30
    Anforderungen an die bereits vorbefüllte Spritze

    • Arzneimittelbücher (Pharmacopoeia)
    • FDA Anforderungen
    15:30
    Kaffeepause

    16:00
    Weitere Tests für die Anwendung in nadelbasierten Injektionssystemen

    • Autoinjektoren
    17:00
    Ende des Trainingskurses

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Travel

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Sofitel Berlin Kurfürstendamm

Augsburgstrasse 41
Berlin, Germany

How to Get Here

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Directions

Registration Fees

Regular Price

4 Ways to register

  • Online Registration
  • FAX: +49 30 436 55 08 66
  • [email protected]
  • Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

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If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

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Registration Fees

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845 Euro

All fees given in Euro and excluding VAT (7%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0)30 43 655 08-10
Fax: +49 (0)30 43 655 08-66
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