A3P Single Use Systems

New technologies / Implementation & validation / Securing of supplies / Integrity / Regulations & Annex 1

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Location

Hôtel Mercure Lyon Centre Château Perrache

Date

10 December 2020

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Format

Conferences, Workshops, Exhibition

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Programme

For more than 4 years now, the GIC A3P Single Use has been addressing challenges raised by single use. Divided into subgroups composed of suppliers and users, the GIC has worked on several tools:

  • An innovative approach of component selection (single-use connectors) through a weighted matrix. (Subgroup 1)
  • An implementation and life-cycle management guide of Single Use products. This thorough document is based on the various questions which may arise throughout the life cycle of the product, and summarise the available documents to this day (PDA, BPSA, BPOG). The objective is to guide the users in the implementation and help the most experts to ask themselves the right questions. (Subgroup 2)
  • An interactive PDF gathering all regulatory texts applicable to Single Use. Based on a biotech type production process, this document enables the user to know the various requirements at every stage of the process. (Subgroup 3)

 

After a succesful first day of exchange in October 2018, the members of the GIC would like to invite you on 10 December to introduce these finalised documents.

The day will be centred on various key moments

  • During plenary lectures, presentation of case study of single use selection and implementation by users
  • In workshops, members of the subgroups will welcome you to illustrate the use of tools.
  • A disscusion round table about the impact of the new revision of Annex 1 on single use systems (PUPSIT) will end the event.

Let’s meet on Thursday, 10 December 2020, in Lyon to exchange and discuss about this topical subject.

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

10 December 2020

Reception of participants
08:00 a.m.
The A3P Single Use Systems GIC (Common Interest Group) why and how ?
Camille DESROUSSEAUX - THERMOFISHER & François VANHERSECKE-ELANCO (leaders of A3P Single Use Systems GIC)
Retrospective of the Single Use GIC & Presentation of subgroups works, live demos and next steps
08:30 a.m.
User feedback - Definition of single use items user needs
Alain BRIERRE - SANOFI PASTEUR
The presentation will focus on various types of items : assemblies, ready-to-use or ready for sterilisation items for which a DBU was written as part of an « up stream » building project
09:00 a.m.
Interactive workshops - Session 1
Hosted by the members of the A3P Single Use Systems GIC - See proposed workshops
Interactive workshops organised by the members of the A3P Single Use Systems GIC are an opportunity for our experts to introduce you to the results of their work and to share their experiences. Other user feedbacks will enrich these data
09:30 a.m.
Break and Visit of the exhibition
10:30 a.m.
Feedback - The choice of Single Use and preliminary selection tests as part of a new plant project
Valérie KANDEL, Bénédicte BONFILS - LILLY
11:30 a.m.
Interactive workshops - Session 2
Hosted by the members of the A3P Single Use Systems GIC- See proposed workshops
12:00 p.m.
Lunch break on the exhibition
1:00 p.m.
Feedback - Tool for connectors selection
Céline GUERNIER - LFB
2:30 p.m.
Conference-Discussion: Waste Management from "Single use" systems
Members of the A3P Single Use Systems GIC
In progress
3:00 p.m.
Interactive workshops - Session 3
Hosted by the members of the A3P Single Use Systems GIC - See proposed workshops
3:30 p.m.
Coffee Break - Visit of the exhibition
4:30 p.m.
Round-table Q&A- Annex 1 : Sterilsing filtration and PUPSIT, impacts on single use systems
In progress
5:00 p.m.
End of the day
6:00 p.m.

Workshops

10 Décembre 2020

Workshop 1: Single-Use Bio-Process Container : Selection criteria and technological gap
Group 1 A3P Single Use GIC
- Selection criteria of a « Single Use Storage Solution », brainstorming and identification of unmet needs - Selection criteria of « Single-Use Mixing Solution », brainstorming and identification of unmet needs
Workshop 2: Implementation of sus - Point of attention & Feedbacks
Group 2 A3P Single Use GIC
- Group 1: A brainstorming session will allow for the construction of a feedback - Identification of vigilance points in in the implementation of Single Uses. - Group 2 : What are the steps of an implementation project of Single Use – Construction of a mind-map identifying the steps and topics to be addressed At the end of a subgroup work, une restitution commune permettra un partage à l’ensemble du groupe
Workshop 3: Applicable regulatory requirements definition tool
Group 3 A3P Single Use GIC
Review of applicable regulations and recommendations about the validation level to implement according to process steps as well as the allocation of responsibilities (supplier/user). Presentation of the tool prepared by the A3P GIC (interactive pdf) and illustration on case studies through a subgroup work: - Case of a intermediary formulation step - Case of a storage after sterilising filtration

Exhibition

If you wish to book a “Table Top” stand during this event, please fill the form below
and refere to the exhibition map to select le stand number of your choice according to availability

Map and listing of exhibiting companies

CompanyStand NumberCompanyStand Number
SARTORIUS STEDIM BIOTECH1PARKER BIOSCIENCE11
MERCK2ASEPTIC PROCESS EQUIPMENT12
ROMMELAG3NELSON LABS EUROPE13
PROMEPLA4STERIS14
CHARGEPOINT TECHNOLOGY5ALBHADES15
SGS LIFE SCIENCE6ELSCOLAB16
CONFARMA7HAMILTON BONADUZ17
ASSOCIATES OF CAPE COD8
CARSO LSEHL9
PHARMASEP10

Services included with the Table Top stand

  • A dedicated exhibition area on which you can install your communication products and tools: umbrella stand, roll-up, display, products, etc. …A basic equipment including a 180×80 cm table, 2 chairs and 1 electrical connection (2kw) without a protective circuit breaker, the loan of a Nespresso coffee machine with pods, sugar, cups…)
  • Breaks and meals listed in the programme
  • Unlimited Wifi
  • A badge that allows you free access to the entire technical and scientific programme
  • The list of the event participants

Services included with the stand

  • A dedicated exhibition area on which you can install your communication products and tools: umbrella stand, roll-up, display….delimited by a structure with partition walls.
  • A basic equipment including a 180 x 80 cm table, 2 chairs and 1 electrical connection (16A, 300 kw) without a protective circuit breaker, a rank of 2 spots, the loan of a Nespresso coffee machine with pods
  • Breaks and meals listed in the programme
  • Unlimited Wifi
  • A badge that allows you free access to the entire technical and scientific programme
  • The list of the event participants
  • Possibility to register an additional person at the accompanying rate (590€ excluding taxes)

Practical Information

Contact us

Depending on your requirements and preferences, you can contact Gregoire DURAND :

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

Accessibility

Hôtel Mercure Lyon Centre Château Perrache
12 Cours de Verdun Rambaud, 69002 Lyon.

Parking spaces

  • Parking Hôtel Mercure: upon reservation
  • Perrache Railway Station: Rue de Esplanade, 69002 Lyon
    EFFIA Lyon Perrache Station: 30 Cours de Verdun Gensoul, 69002 Lyon
    Q-Park Lyon Perrache Carnot: Cours Verdun, 69002 Lyon

Hotel reservation

Hôtel Mercure – Lyon Château Perrache
12 Cours de Verdun Rambaud,
69002 Lyon
Phone: +33 (0)4 72 77 15 00


Hôtel Ibis – Lyon Centre Perrache
28 Cours de Verdun Perrache,
69002 Lyon
Phone: +33 (0)4 78 37 56 55

Hôtel Campanile – Lyon Perrache
17 Place Carnot,
69002 Lyon
Phone: +33 (0)4 78 37 48 47


Hôtel Kyriad – Lyon Perrache
26 Cours de Verdun Perrache,
69002 Lyon
Phone: +33 (0)4 78 71 17 47

Hôtel des Savoies
80 Rue de la Charité,
69002 Lyon
Phone: +33 (0)4 78 37 66 94