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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 : :

  • Defining Technologies Barriers (isolators, RABS, air speed, classification of the critical zone, tolerated leak rates, etc…). Discussion on the revised edition of Annex 1 (if available)
  • Control equipment: Transfers, cleaning and bio-decontamination (including fast systems), response management, component integrity
  • Campaign mode (Validation: simulation of aseptic processes and environmental 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

The visits of the Pierre Fabre site of Amatsi DBI Idron and Pharmacy Pau CH will complete the program.

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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 Advanced aseptic barrier technology : definitions, regulatory framework, parameters (pressure, air flow, leak test…) (GIC)
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

Lilly Global Insulin Cartridge Program, RABS versus Isolator Environment

Antoine Adam - Lilly
13h00 Lunch

14h30

Campaign Mode: definition, validation, simulation of aseptic processes, environmental control (SG3)
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 trials: isolator fill & finish, component integrity, sterility and particle control
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

Closed systems thanks to single use systems

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 Donolato & Denis Decubber - salamanderU
09h30

Using an isolator for the production of Innovative Therapy Drugs prepared punctually

Laurent Laganier - Necker Hospital AP-HP
10h00 Break - Exhibition visit
11h00

The constraints automatic loading multiple freeze dryers under isolator

Saad Kedjar - GSK
11h30

RABS or isolator why this issue is or would even debate

Dominique Sierakowski - Octapharma
12h00

RTRT proposed for a sterile product manufacture in closed systems

Bernard Jouanneteau - IGL
12h30 Lunch
14h00  DePart site visit: Pharmacy Amatsi DBI or Pau or HospitalierePierre Fabre PFMP / API
 
 DBI AMATSI HOSPITAL PHARMACY
CH DE PAU
visiteamatsi chpausite
Under sterile manufacturing small batches of insulators of high-value and high activity product products (visiting a new line). 16 500 preparations produced per year (chemotherapy, monoclonal antibodies, pediatric parenteral nutrition bags, sterile preparations) as insulators in 2 classified and separated areas we visit.
17h30  Come back site visit and end time for days

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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CLOSEST HOTELS

Hotel Parc Beaumont *****
1 Avenue Edouard VII - Pau 64000
Such. 05 59 11 84 00

Villa Navarre *****
59 Avenue Trespoey, 64000 Pau
Such. 05 59 14 65 65

Quality Hotel****
80 Rue Emile Garet, Pau 64000
Such. 05 59 82 58 00

Hotel de Gramont ***
3 Place Gramont, Pau 64000
Such. 05 59 27 84 04

hotel Bristol ***
V3 Rue Gambetta, 64000 Pau
Such. 05 59 27 72 98

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