A3P in Italy - Single Use
Regulatory - Risk assessment - User - Leachables & Extractables

Place

Courtyard by Mariott Rome Central Park in Rome

Date

March 14 2019

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Conferences, exhibition, partner sessions

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Thursday March 14

Welcome of participants
08:15
Regulatory watch and generic validation approach
Katell MIGNOT - SARTORIUS
09:00
Reduce the risks associated with single-use technologies
In attesa - THERMO FISHER
09:30
Coffee break - Visit of the exhibition
10:00
Partner Sessions Part 1 See the details of the sessions
MEISSNER - PALL BIOTECH - SARTORIUS - THERMO FISHER SCIENTIFIC
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
11:00
Partner Sessions Part 2 See the details of the sessions
MEISSNER - PALL BIOTECH - SARTORIUS - THERMO FISHER SCIENTIFIC
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
12:00
Lunch - Visit of the exhibition
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
Coffee break - Visit of the exhibition
15:45
Single-use systems particulates risk management
Patrick EVRARD - PALL
16:15
Survey Suppliers / users
Brigitte DELAPLACE - MEISSNER
16:45
Conclusion of the day
17:00
Subject 1: CryoVault®: Scalable, robust, completely single-use freeze and thaw for biopharmaceuticals 2: BioLink® Modular Overmolding Technology
Thomas VANDROMME - MEISSNER
Subject 1: This end-to-end solution provides this industry leading implementation of the 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 best practices with traditional mechanical connections. It also offers enhanced process robustness of overpressure
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, best suited for the choice of the most appropriate solution. A new interactive tool for the design of single-use solutions will be demonstrated
Session 2
How to insure best robustness along with all process steps while decreasing validation costs and change control when using single-use systems?
Miriam LAVIE - SARTORIUS
Our scalable FlexSafe® platform has already demonstrated its growth, robustness, integrity and ease of use for cell culture, liquid storage and shipping applications. Mixing and Large Volume Storage is now part of the Flexsafe® family and supplements the Flexsafe® platform for upstream, downstream and final formulation. By using Flexsafe® storage and mixing solutions, the end-user can benefit from most advanced film technology, and can provide reproducible performance, and long term supply. This is the implementation of the process and reduces the time and the cost for the validation process, and change control management.
3 session - part 1
Single Use vs Stainless Steel Challenge: Which way to bet for Final Filling Operations?
Benoit DI MARINO - SARTORIUS
When 15 years ago, I do not know what I mean in the field of Final Filling, what is the status today? Despite the criticality of this application, the constant evolution of single use technologies has made it possible to meet the challenge of performance 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 performance dosing, productivity, validation and logistic aspects, etc.
3 session - part 2
Title pending
THERMO FISHER SCIENTIFIC
Description pending
Session 4

You wish to reserve a stand, please consult our exhibitor file

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Plan of the exhibition

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

Benefits included with the Table Top

  • A dedicated exhibition space on which you can install your products and communication tools: umbrella stand, roll-up, display, product, ... A basic endowment including table 180 × 80 cm, 2 chairs and 1 electrical connection (2kw ) without protection circuit breaker
  • Breaks and meals indicated in the program
  • Unlimited WiFi
  • A badge that allows you free access to the entire technical and scientific program
  • List of participants in the event
  • Ability to register an additional person at the special rate "accompanying" (500 € HT)

Event Registration Form

At the end of this form you will receive a copy by email of the information provided.

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Contact

For more information, please contact Natalina SEMEDO:

Phone: +33 (0)4 37 28 30 52
Fax: +33 (0)4 37 28 30 60
E-mail : Natalina Semedo
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007

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