A3P Barrier Technology

Annex1 / VHP / RTP systems / Managing holes in gloves / Leak test

Location

Palais des Congrès of Tours,26 boulevard Heurtloup, 37000 Tours

Date

14 & 15 september 2021

Format

Conferences, partner sessions, exhibition

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Pharmaceutical regulatory frameworks are constantly evolving as the demand for sterile drug production capacity grows. The draft of Annex 1 of the European GMP version 12 becomes the international reference text for the latest sterile drug manufacturing standards. It encourages the use of innovative technologies, including barrier technologies which are becoming essential.

While Annex 1 makes multiple references to « Barrier Technologies » with the main objective of reducing direct interactions between sources of contamination and aseptic processes, Chapter 4 provides many details on their design and management.

During these A3P Barrier Technologies 2021 days, we will address the future challenges of our industry through technical and regulatory topics and provide answers through practical applications:

– Update on regulations
Management of points of fragility : ergonomics, transfers, integrity, management of gloves and glove supply.
– Design of an isolator line to the highest standards and upgrading of a RABS filling line to RABS standards.
– Use of new technologies in the design phases.

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

Tuesday 14th September

Welcome of the participants
08:30
Introduction GIC Barrier Technology - link Annex1 V12
Julien TRIQUET - GSK & Didier MEYER - DM Compliance
Leaders of the GIC A3P Barrier Technology
08:50
Barrier technologies: Regulatory and scientific perspectives
Antoine AKAR - HUMANIM
09:00
Operational responses to regulatory requirements (including revised Annex1) on Barrier Technologies
Marc BESSON - MB GMP COMPLIANCE & Florelle TOURLET - OCTAPHARMA & Cyril MOUNIER - GETINGE
A3P GIC Barrier Technology Representatives
09:30
Coffee Break
10:30
Gloves of Isolator & RABS: what quality and operational criteria are used to select a supplier? What qualification program for gloves?
Antoine TOUSSAINT - GSK VACCINES
A3P GIC Barrier Technology Representative
11:30
Partners' Sessions +infos
ABC TRANSFER - BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - PIERCAN - STERIS
These sessions led by our partners are the opportunity for participants to manipulate and discover market innovations.
12:00
Lunch Break
13:00
Partners' Sessions +infos
ABC TRANSFER - BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - PIERCAN - STERIS
These sessions led by our partners are the opportunity for participants to manipulate and discover market innovations.
14:30
Partners' Sessions +infos
ABC TRANSFER - BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - PIERCAN - STERIS
These sessions led by our partners are the opportunity for participants to manipulate and discover market innovations.
15:30
Coffee Break
16:30
Presentation of tools developed by insulator users to make their daily life easier
Patrick COPPENS - ISOTEC'XEL
A3P GIC Barrier Technology Representative
17:00
ISO & RABS: How to secure tightness of barrier and connected equipment
Florelle TOURLET - OCTAPHARMA
A3P GIC Barrier Technology Representative
17:30
End of the first day
18:30

Wednesday 15th September

Welcome of participants
08:00
Feebdack on the meta survey across industry about pin holes on isolator and RABS gloves management: ways of working, microbial impact and best practices
Julien TRIQUET - GSK
A3P GIC Barrier Technology Representative
08:30
Analysis of potential microbiological ingress through macroscopic holes in isolator gloves
GIC A3P Technologie Barrière & Edith FILAIRE - LABORATOIRE ICARE
09:00
Coffee Break
09:30
Partners' Sessions +infos
ABC TRANSFER - BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - PIERCAN - STERIS
These sessions led by our partners are the opportunity for participants to manipulate and discover market innovations.
10:30
Partners' Sessions +infos
ABC TRANSFER - BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - PIERCAN - STERIS
These sessions led by our partners are the opportunity for participants to manipulate and discover market innovations.
11:30
Lunch Break
12:30
The digital smoke test applied to barrier, isolator or RABS technologies
Gerome AVENOSO - GAO EXPERTISE & Geneviève FRICKERT - LILLY France
14:00
From an open to a closed RABS in operation: 10 years of evolution in practices and design
Loïc DA COSTA NEIVA - OCTAPHARMA
14:30
Coffee Break
15:00
Use, implementation and deployment of disposable isolators on aseptic manufacturing processes (Advantages, disadvantages, limitations, recycling and ecology)
Franck PAVAN - GTP Nano
15:30
Pharmaceutical production of High Potent API under aseptic condition
Djuro RAIC - TEVA/PLIVA & Stefano BUTTI - FPS FOOD AND PHARMA SYSTEMS
16:00
End of the day
16:30

Speakers / LinkedIn

Gerome Avenoso

Gerome Avenoso / GAO Expertise  

Anonyme

Loic Da Costa Neiva/ Octapharma

Julien Triquet

Julien Triquet / GSK  

Marc Besson

Marc Besson / MB Compliance  

Anonyme

Florence Tourlet / Octapharma

Patrick Coppens

Patrick Coppens / Isotec’xel  

Antoine Toussaint

Antoine Toussaint / GSK Vaccines  

Tuesday 14 September

Alignment of PTRs with Annex 1 of the European GMP 1
ABC TRANSFER
Description coming soon
Session 1 : 12h00
Sterility testing : a comparison between the different approaches i.e. cleanroom, BSC, isolator
BIOQUELL
Description coming soon
Title to be confirmed
GETINGE
Ddescription coming soon
Presentation of liquid aseptic transfer systems - single use or autoclavable versions. Technology to create different diameters of aseptic pipes and fittings to suit the process.
JCE BIOTECHNOLOGY
Description coming soon
Criteria for choosing a glove supplier
PIERCAN
Description coming soon
Cleaning and Disinfection: Best Practices to Prevent Microbial Contamination in Aseptic Core
Bruno AZE & Walid EL AZAB - STERIS
The cleaning and disinfection program's purpose is to prevent microbial contamination of the cGMP environment and the product. Consequently, a pivotal element to contamination control risk assessment is to define the source of contamination. Based on the risk assessment results, appropriate cleaning and disinfection prgram to prevent contamination must be implemented. The goal of this presentation is to present best practices around cleaning and disinfection procedures to prevent microbial contamination in the the APA (Aseptic Processing Area). Also, during this presentation, I will share benchmark practices on aseptic and cell gene therapy APA cleaning and disinfection program.
Improving the ergonomics of RTP systems
ABC TRANSFER
Description coming soon
Session 2 : 14h30
EN 17272 (where it has come from, what it is, how you do it and what it means)
BIOQUELL
Description coming soon
Title to be confirmed
GETINGE
Description coming soon
Presentation of an RTP/DPTE door with automatic opening for filling systems
JCE BIOTECHNOLOGY
Description coming soon
Criteria for choosing a glove supplier
PIERCAN
Description coming soon
VHP® Validation: Means and Methods for the Validation of Surface Biodecontamination
Bruno AZE - STERIS
Current means for process verification and validation during initial start-up, annual revalidation or if needed for troubleshooting. We will screen all the different means available, their advantages, as well as their different weaknesses. Methods to ensure process validity and reproducibility. How to measure performance, its repeatability and define its necessary level of security.
Title to be confirmed
ABC TRANSFER
Description coming soon
Session 3 : 15h30
Impact of regulation on barrier systems (BPR, Annex 1 and the newly published EN ISO 13408-6 on isolator systems)
BIOQUELL
Description coming soon
To be confirmed
GETINGE
Description coming soon
Introducing an RTP Beta bag with "Ring of Concern" protection - a patented technological innovation that ensures/guarantees the integrity of the RTP/DPTE door seal when external elements are introduced
JCE BIOTECHNOLOGY
Description coming soon
Criteria for choosing a glove supplier
PIERCAN
Description coming soon
Case study for disinfection of RABS and Isolators during production interruptions
Frédéric BAR & Sylvie REBOUL - STERIS
Description coming soon

Wednesday 15 September

Title to be confirmed
ABC TRANSFER
Description coming soon
Session 4 : 10h30
Sterility testing : a comparison between the different approaches i.e. cleanroom, BSC, isolator
BIOQUELL
Description coming soon
Title to be confirmed
GETINGE
Description coming soon
Presentation of liquid aseptic transfer systems - single use or autoclavable versions. Technology to create different diameters of aseptic pipes and fittings to suit the process
JCE BIOTECHNOLOGY
Description coming soon
Criteria for choosing a glove supplier
PIERCAN
Description coming soon
Cleaning and Disinfection: Best Practices to Prevent Microbial Contamination in Aseptic Core
Bruno AZE & Walid EL AZAB - STERIS
The cleaning and disinfection program's purpose is to prevent microbial contamination of the cGMP environment and the product. Consequently, a pivotal element to contamination control risk assessment is to define the source of contamination. Based on the risk assessment results, appropriate cleaning and disinfection prgram to prevent contamination must be implemented. The goal of this presentation is to present best practices around cleaning and disinfection procedures to prevent microbial contamination in the the APA (Aseptic Processing Area). Also, during this presentation, I will share benchmark practices on aseptic and cell gene therapy APA cleaning and disinfection program.
Title to be confirmed
ABC TRANSFER
Description coming soon
Session 5 : 11h30
EN 17272 (where it has come from, what it is, how you do it and what it means)
BIOQUELL
Descripion coming soon
Title to be confirmed
GETINGE
Description coming soon
Presentation of an RTP/DPTE door with automatic opening for filling systems
JCE BIOTECHNOLOGY
Description coming soon
Criteria for choosing a glove supplier
PIERCAN
Description coming soon
VHP® Validation: Means and Methods for the Validation of Surface Biodecontamination
Bruno AZE - STERIS
Current means for process verification and validation during initial start-up, annual revalidation or if needed for troubleshooting. We will screen all the different means available, their advantages, as well as their different weaknesses. Methods to ensure process validity and reproducibility. How to measure performance, its repeatability and define its necessary level of security.

If you wish to book a stand, please fill in the exhibition form.

Exhibition form

Exhibition map

CompanyBooth no.CompanyBooth no.
JCE BIOTECHNOLOGY112
STERIGENE213
ILC DOVER314
AZBIL TELSTAR FRANCE4SOLDIFOG TECHNOLOGIES15
DEVEA ENVIRONNEMENT5TEMA SINERGIE16
ATEC TRANSFER SYSTEMS6OPTIMA PHARMA17
SKAN7FPS FOOD AND PHARMA SYSTEMS18
8GETINGE19
CAPE EUROPE FRANCE9BIOQUELL20
PIERCAN10ABC TRANSFER21
HAPTION11STERIS22

Services included with the Table Top stand

  • A dedicated exhibition space where you can install your products and communication tools: roll-up, product, … A basic equipment which includes 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
  • 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)

If you wish to book a stand, please fill in the exhibition form.

Exhibition form

Registration form

  A3P Barrier Technology

Once the form filled in and sent, you will receive a copy by email.

Registration fee : 1200€ HT  + Mandatory A3P membership 220€ HT  // (TVA 20%)

Contact

Depending on your requirements and preferences, you can contact Ludivine BAYLE (exhibition) or Natalina SEMEDO (conferences/registrations) :

Phone number : +33 (0)4 37 28 30 40
Email : lbayle@a3pservices.com – nsemedo@a3pservices.com

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