A3P Single Use Systems

New technologies / Implementation and validation of Single Use processes / Securing of supply / Integrity / Regulations

Location

Mercure Lyon Center Chateau Perrache Hotel

Date

July 2 2020

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Format

Conferences, Workshops, Exhibition

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Le GIC A3P Single Use has been working for more than 4 years now to respond to the problems posed by single use. Divided into different sub-groups made up of suppliers and users, the GIC worked on several tools:

  • An innovative approach to the selection of components (single-use connectors) through a weighted matrix. (Subgroup 1)
  • An implementation and life cycle management guide for the Single Use product. This very comprehensive document is based on the various questions that may arise throughout the life of the product, and summarizes the documents available to date (PDA, BPSA, BPOG). The objective is to guide users to the implementation and help the most experts to ask the right questions. (Subgroup 2)
  • An interactive PDF containing all the regulatory texts applicable to Single Use. Based on a typical biotech production process, this document allows the user to know the different standards required at each stage of the process. (Subgroup 3)

After a successful first day of exchange in October 2018, the members of the GIC would like to invite you to July 2 next in order to present these different finalized documents to you.

The day will revolve around different highlights

  • During plenary conferences, presentation of case studies of selection and implementation of single use by users.
  • In the workshops, the members of the sub-groups will welcome you to illustrate the use of the tools.
  • A round table discussion on the impact of the new revision of Annex 1 on single-use systems (PUPSIT) will close the event.

Appointment on Thursday July 2, 2020, in Lyon to exchange and debate on this topical subject.

Official language of conferences: French
Simultaneous translation of conferences: French <-> English

Thursday July 2

Welcome of participants
08:00
The GIC (Common Interest Group) A3P Single Use Systems why and how?
Camille DESROUSSEAUX - THERMOFISHER & François VANHERSECKE -ELANCO (GIC A3P Single Use Systems leaders)
GIC retrospective single use & presentation of the work of the sub-groups, live demos and next steps
08:30
Feedback - Definition of user needs single use articles
Alain BRIERRE - SANOFI PASTEUR
The presentation will focus on different types of articles: assemblies, ready-to-use or ready-to-sterilize articles for which a DBU has been drawn up as part of an up stream building project.
09:00
Interactive workshops - session 1
Led by members of the GIC A3P Single Use Systems - See the proposed workshops
The interactive workshops organized by the members of the GIC A3P Single Use Systems are the opportunity for our experts to present the results of their work and share their experiences. Feedback from other users will enrich this data
09:30
Break and exhibition visit
10:30
Feedback - Choice of Single Use and preliminary selection tests within the framework of a project for a new production unit
Valérie KANDEL, Bénédicte BONFILS - LILLY
11:30
Interactive workshops - session 2
Led by members of the GIC A3P Single Use Systems - See the proposed workshops
12:00
Lunch on the exhibition
13:00
Feedback - Tool for selecting connectors
Céline GUERNIER - LFB
14:30
Conference debate: Management of waste from "Single use" systems
Members of the GIC A3P Single Use Systems
in progress
15:00
Interactive workshops - session 3
Led by members of the GIC A3P Single Use Systems - See the proposed workshops
15:30
Break and exhibition visit
16:30
Q&A round table - Annex 1: sterilizing filtration and PUPSIT, impacts on single-use systems
in progress
17:00
End of the event
18:00

Thursday July 2

Workshop 1: Single-Use Bio-Process Container: Selection criteria and technological gap
Group 1 GIC A3P Single Use
- Criteria for selecting a “Single Use Storage Solution”, brainstorming and identification of unmet needs
- Selection criteria for a “Single-Use Mixing Solution”, brainstorming and identification of needs not covered
Workshop 2: Implementation of the above - Point of attention & Feedback
Group 2 GIC A3P Single Use
- Group 1: Brainstorming will allow the construction of feedback. - Identification of points of vigilance in the implementation of Single Uses.
- Group 2: What are the different stages of a Single Use implementation project - Construction of a mind-map identifying the stages and the themes to be addressed.
At the end of a sub-group work, a common restitution will allow sharing to the whole group
Workshop 3: Tool to help define the applicable regulatory requirements
Group 3 GIC A3P Single Use
Review of applicable regulations and recommendations concerning the level of validation to be implemented according to the process steps as well as the distribution of responsibilities (supplier / user).
Presentation of the tool prepared by the GIC A3P (interactive pdf) and illustration on practical cases via work in sub-groups:
- Case of an intermediate formulation step
- Storage after sterilizing filtration

You wish to reserve a stand " Table top During this event. Please complete the form below
and refer to the exhibition plan to select the stand number of your choice according to availability

Map and list of exhibiting companies

CompanyNo. StandCompanyNo. Stand
SARTORIUS STEDIM BIOTECH1PARKER BIOSCIENCE11
MERCK2ASEPTIC PROCESS EQUIPMENT12
ROMMELAG3THERMO FISHER SCIENTIFIC13
Promepla4STERIS14
CHARGEPOINT TECHNOLOGY5PALL BIOTECH15
SGS LIFE SCIENCE6ELSCOLAB16
CONFARMA7HAMILTON BONADUZ17
ASSOCIATES OF CAPE COD8
CARSO LSEHL9
PharmASep10

Services included with the Table Top stand

  • A dedicated exhibition space on which you can install your communication products and tools: umbrella stand, roll-up, display, product, etc. A basic equipment including a 180 × 80 cm table, 2 chairs, 1 electrical connection (2kw ) without a circuit breaker, the loan of a Nespresso coffee machine (with pods, sugars, cups, etc.)
  • Breaks and meals indicated in the program
  • Unlimited WiFi
  • A badge that allows you free access to all of the program's activities
  • List of participants in the event

Services included with the stand

  • A dedicated exhibition space where you can install your products and communication tools: umbrella stand, roll-up, display ... delimited by a structure with bottom walls and returns.
  • A basic endowment including 180 x 80 cm table, 2 chairs and 1 electrical connection (16A, 300 kw) without protective breaker, a row of 2 spotlights, the loan of a Nespresso coffee machine with pods
  • 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" (590 € HT)
  • Registration

  • Participant information

  • Billing information

  • A3P communications

  • Terms and conditions

  • This field is only used for validation purposes and should remain unchanged.

Contact

According to your requirements and your preferences, you can contact Gregoire DURAND:

Phone: +33 (0)4 37 28 30 42
E-mail : gdurand@a3pservices.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007

Accessibility

Mercure Lyon Center Chateau Perrache Hotel
12 Course of Verdun Rambaud, 69002 Lyon.

Parking

  • Parking Mercure Hotel: by appointment
  • Perrache Station: Esplanade Street, 69002 Lyon
    EFFIA Lyon Perrache station: 30 Cours de Verdun Gensoul, 69002 Lyon
    Q-Park Lyon Perrache Carnot: Cours Verdun, 69002 Lyon

Hotel reservation

Mercure Hotel - Lyon Château Perrache
12 Course of Verdun Rambaud,
69002 Lyon
Tel: 04 72 77 15 00


Hotel Ibis - Lyon Center Perrache

28 Cours de Verdun Perrache,
69002 Lyon
Tel: 04 78 37 56 55

Hotel Campanile - Lyon Perrache
17 Place Carnot,
69002 Lyon
Tel: 04 78 37 48 47


Kyriad Hotel - Lyon Perrache
26 Cours de Verdun Perrache,
69002 Lyon
Tel: 04 78 71 17 47

Hotel des Savoies
80 Rue de la Charité,
69002 Lyon
Tel: 04 78 37 66 94