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A3P Barrier Technology
14 & 15 March 2017
Pau (FR)

Within a goal for continuous improvement to eliminate any human intervention in the critical zone of production of sterile drugs, more and more bio-pharma industries are using Barrier Technologies.
The complex and various aseptic processes need tailored made solutions for implementing Barrier Technologies especially for the validations of the equipments (including the bio-decontamination), and for the routine use (transfer, cleaning, hidden surfaces, non programmed repairs, campaign mode, glove management, …) Moreover, the absence of any human biological presence makes possible the fact to consider different types of environmental controls different than the conventional A/B zones.

Since the beginning of 2016 an A3P common interest group (GIC) has been created to go deeply in these barrier technologies to propose recommendations vs the encountered problems. This very GIC gathers both routine endusers and inventive suppliers for technological developments.
To follow-up the 2015 Le Vaudreuil (F) first edition , the GIC members will display their latest conclusions in a 2 day event in Pau (F) on March, 14 & 15, 2017. Endusers will present their last evolutions completed by technical innovations coming from suppliers to solve the problems of these complex technologies.

The topics to be discussed during these two days will be : :

  • Definitions of Barrier Technologies (isolators, RABS, air speed, classification of the critical zone, tolerated leak rates, etc…). Discussion on the revised edition of Annex 1 (if available)
  • Mastering of equipments:transfer systems, cleaning, short time bio-decontamination processes, maintenance management, components integrity
  • Campaign mode (validation, Media Fill Test, EM controls)
  • Glove management
  • How to apply Real Time Release Testing to closed systems and Barrier Technologies
  • Production of Advanced Therapy Medecine Products using Barrier Technologies within manual process

This programme will be completed with visits of industrial sites of Pierre Fabre and Amatsi DBI

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Section EXHIBITION Form REGISTRATION
 

A3P Barrier Technology Days program
Congress Centre - Palais Beaumont, Allée Alfred de Musset, 64000 Pau (France)

  Tuesday March 15th
08h30 Welcome to participants at the Palais Beaumont
09h15 Introduction
Gérard Ecotière - A3P Association President
09h30 Barrier Technology definitions : air speed, airflow, air classification, leak rate, SU isolators ( A3P Common Interest Group TB SG1)
Marc Bertaud - Carbogen Amcis
10h00

Ensuring Sterility Assurance in filling isolators

Marc Besson - Sanofi
10h30 Break - Exhibition visit
11h30

Inter batch and transfer management, key points to consider in Sterility Assurance for isolators

Serge La Spina - GSK
12h00

H2O2 spray nozzle biodecontamination

Christian Doriath - Skan
12h30

In progress

In progress
13h00 Lunch

14h30

Campaign mode : definition, validation, media fill, EM (A3P Common Interest Group SG1)
Julien Triquet - GSK

15h00

What to Consider to Produce multi formats Within barrier systems?
Florelle Tourlet - Octapharma

15h30

Practises on aseptic filling line under RABS

Amandine Fruchard & Olivier Georges - Sanofi Pasteur
16h00 Break - Exhibition visit
17h00 Control of isolator gloves : a key element of Sterility Assurance
Marc Besson - Sanofi
Serge La Spina - GSK, Franck Arethuse - Piercan & Eric Gohier - JCE
17h30 RTU for clinical batches : Disposable Isolator for Fill & Finish, integrity of the components, sterility and particulate monirotirng
Jean-Pascal ZAMBAUX - Disposable Lab
18h00 NTT (No-Touch Transfer) proof of concept studies
James Drinkwater - Franz Ziel GmbH Lorenza & Bonaldi - Stevanato
18h30 Cocktail on the exhibition and a dinner in the "Salle des ambassadeurs" after

 

  Wednesday March 16th
08h00 Welcome to participants at the Palais Beaumont
08h30

Barrier Technology and closed systems for the production of vaccinal antigens

Jean-Yves Bauer - GSK
09h00

Innovative combination of a 2 in 1 solutiion of an insulator for cell therapy production with a vocal electronic batch record

Tony Donolatto & Denis Decubber - salamanderU
09h30

ATMP : ATMP processing within barrier technology

Laurent Lagagnier - Necker AP-HP
10h00 Break - Exhibition visit
11h00

Problems linked with the automatic loading of several freeze dryers in isolator

Saad Kedjar - GSK
11h30

RTRT for aseptic processing

Sophie Amadio - Lilly
12h00

RTRT proposed for a sterile product manufacture in closed systems

Bernard Jouanneteau - IGL
12h30 Lunch
14h00  Departure for plant visit: Pierre Fabre MP / API, or DBI Amatsi or Pau's CHU
17h30  Come back from plants visit and end of the event

Contact: Anastasia menteau - Mail. This e-mail address is protected against spambots. You need JavaScript enabled to view it. - Such. 33 + (0) 4 37 28 30 40


 















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