A3P en Italie – Single Use
Regulatory – Risk assessment – User – Leachables & Extractables

Lieu

Courtyard by Mariott Rome Central Park à Rome

Date

14 mars 2019

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Format

Conférences, exposition, sessions partenaires

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Jeudi 14 mars

Accueil des participants
08:15
Regulatory watch and generic validation approach
Katell MIGNOT - SARTORIUS
09:00
Reduce the risks associated with single-use technologies
En attente - THERMO FISHER
09:30
Pause café - Visite de l'exposition
10:00
Sessions Partenaires partie 1 Voir le détail des sessions
MEISSNER - PALL BIOTECH - SARTORIUS - THERMO FISHER SCIENTIFIC
Les ateliers interactifs organisés avec les sociétés partenaires sont l’opportunité pour les participants de se familiariser ou d’approfondir leur approche technique.
11:00
Sessions Partenaires partie 2 Voir le détail des sessions
MEISSNER - PALL BIOTECH - SARTORIUS - THERMO FISHER SCIENTIFIC
Les ateliers interactifs organisés avec les sociétés partenaires sont l’opportunité pour les participants de se familiariser ou d’approfondir leur approche technique.
12:00
Déjeuner - Visite de l'exposition
13:00
Single Use material experience from an aseptic fill & finish CMO
Enrico ZANETTI - SWISSFILLON
14:30
Analytical challenges associated with leachables in Biopharmaceutical production
Andreas NIXDORF - SGS
15:00
Pause café - Visite de l'exposition
15:45
Single-use systems particulates risk management
Patrick EVRARD - PALL
16:15
Survey Suppliers/users
Brigitte DELAPLACE - MEISSNER
16:45
Conclusion de la journée
17:00
Subject 1 : CryoVault® : Scalable, robust, completely single-use freeze and thaw platform for biopharmaceuticals // Subject 2 : BioLink® Modular Overmolding Technology
Thomas VANDROMME - MEISSNER
Subject 1 : This end-to-end solution provides this industry leading implementation of the demanding Freezing and Thawing processing operation. Cryovault® has been designed as a modular system to accommodate a high degree of flexibility for different batch volumes. The single-use assemblies are rigid HDPE containers with configurable fluid path assemblies referred to as top works. BioLink® Modular Overmolding Technology // Subject 2 : BioLink® modular overmolding combines the best attributes of conventional overmolding with the flexibility and speed of processing often associated with traditional mechanical connections. It also offers enhanced process robustness over conventional overmolding, while facilitating additional secure connectivity to processing steps, such as pressure monitoring, filtration,…
Session 1
Implementing a single-use facility: how to ensure reliability and robustness?
Marco SANVITO - PALL BIOTECH
Implementing a single-use facility: from the user’s requirement specification to the selection of the solution – how to ensure reliability and robustness ? In this workshop participants will define the key steps in the project, main criteria to be considered for the choice of the most appropriate process solution. A new interactive tool for the design of single-use solutions will be demonstrated
Session 2
How to insure best robustness along all process steps while decreasing validation costs and change control burden when using single-use systems?
Miriam LAVIE - SARTORIUS
Our scalable Flexsafe® platform has already demonstrated its outstanding cell growth, robustness, integrity and ease of use for cell culture, liquid storage and shipping applications. Mixing and Large Volume Storage up to 3000L are now part of the Flexsafe® family and complete the Flexsafe® platform for upstream, downstream and final formulation. By using Flexsafe® storage and mixing solutions, end-user can benefit from most advanced film technology, designed and validated to provide consistent quality, reproducible performances, and long term supply. This ease the implementation process and reduces the time and the cost for process validation, and change control management.
Session 3 - partie 1
Single Use vs Stainless Steel challenge: which way to bet for Final Filling Operations?
Benoit DI MARINO - SARTORIUS
When 15 years ago almost nobody would have bet on Single Use Systems (SUS) to be effective in the very critical field of Final Filling, what is the status today? Despite the criticality of this application, the constant evolution of single use technologies has made possible to meet the industry challenges i.e. filling performances and patient safety. This presentation compares traditional Stainless Steel (SS) and SUS used for final filling operations. Key figures and elements will be used to address the main topics like dosing performances, productivity, validation and logistic aspects, etc.
Session 3 - partie 2
Titre en attente
THERMO FISHER SCIENTIFIC
Description en attente
Session 4

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Plan de l’exposition

Société N° Stand Société N° Stand
 ASSOCIATES OF CAPE COD 1 6
 PROMEPLA 2 ROMMELAG ENGINEERING 7
 SGS 3 PALL BIOTECH (partner) 8
4  SARTORIUS (partner) 9
 THERMO FISHER SCIENTIFIC (partner) 5  MEISSNER (partner) 10

Prestations comprises avec le Table Top

  • Un espace d’exposition dédié sur lequel vous pouvez installer vos produits et outils de communication : stand parapluie, roll-up, présentoir, produit, …Une dotation de base comprenant une table 180×80 cm, 2 chaises et 1 raccordement électrique(2kw) sans disjoncteur de protection
  • Les pauses et les repas indiqués dans le programme
  • Wifi illimité
  • Un badge qui vous permet le libre accès à l’ensemble du programme technique et scientifique
  • La liste des participants à l’évènement
  • Possibilité d’inscrire une personne supplémentaire au tarif spécial « accompagnant » (500€ HT)

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Contact

Pour plus d’informations, vous pouvez contacter Natalina SEMEDO :

Téléphone : +33 (0)4 37 28 30 52
Fax : +33 (0)4 37 28 30 60
Email : Natalina Semedo
Courrier : A3P, 30 rue Pré-Gaudry – Lyon 69007

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