ASEPTIC PROCESSING
Isolators & RABS
Lieu
Hotel SB Diagonal Zero, Barcelona
Format
Conferences, workshops, Exhibition, Networking
Share
After several years of gestation and multiple versions, the new GMP Annex 1 has been published.
The latest versions corroborate the emphasis on reducing human interaction to minimise contamination risks. There is no longer any doubt.
In the heart of aseptic processes, the use of isolators and barrier technologies will be essential to ensure product quality.
Therefore, from the publication onwards, the compliance workhorse will be the transformation of existing equipment and processes using these technologies.
During this event we want manufacturers who have been using barrier technologies for some time to share their experience. In turn, we will try to analyse both their practical use and their implementation from a technical and operational point of view.
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schedules and order of conferences may be subject to change
Reception and Breakfast
09:00
Introduction
Comité A3P Spain
09:45
Entrenamiento del personal para el trabajo aséptico y claves para su adaptación al cambio en entornos “isolators/rabs”
Ricard CASTILLEJO - NoSIS GMP
10:00
Proyecto de mejora continua de una línea de fill&finish de estériles según el nuevo Anexo 1
Alfred TERÉS - ASEPTIC MIND & Adolfo LÓPEZ - CZ VACCINES
10:30
Coffee break – Visit to the exhibition
11:00
Partners’ workshops: Session 1 See the proposed workshops
ECOLAB - MARCHESINI - OPTIMA - SALAMANDER U - TISELAB
The interactive workshops organised by the partner companies are an opportunity for participants to improve their technical approach.
11:45
Partners’ workshops: Session 2 See the proposed workshops
ECOLAB - MARCHESINI - OPTIMA - SALAMANDER U - TISELAB
The interactive workshops organised by the partner companies are an opportunity for participants to improve their technical approach.
12:45
Lunch – Visit to the exhibition
13:45
RABS/Isolator Gloves Management Overview - Key Principles for Good Glove Management
Ana ROMO - PFIZER
15:00
Partners’ workshops: Session 3 See the proposed workshops
ECOLAB - MARCHESINI - OPTIMA - SALAMANDER U - TISELAB
The interactive workshops organised by the partner companies are an opportunity for participants to improve their technical approach.
15:30
Pause
16:30
Aseptic Process Simulation (APS) approaches
Rosana GARCÍA - ROVI
17:00
Risk assesment on definition of viables/ non viable sample points in isolators
Beatríz ROQUÉS - REIG JOFRE
17:30
End of the event
18:15
Our partners will offer you 3 workshops sessions during the day
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Workshops ◊ Session 1 ◊ 11:45
Understanding Regulations – examining the impact of the Biocidal Products Regulation (BPR) on automated airborne disinfection systems and their use in aseptic processing facilities
John Chewins
Ecolab
The European Biocidal Products Regulation (BPR) came into law throughout Europe in 2013, but delays in the product authorisation process have meant that users have yet to experience the potential impacts of the regulation in terms of loss of chemistry / product or inability to use a product as currently employed. Hydrogen peroxide vapour technology is widely used within pharmaceutical manufacturing facilities to provide high level disinfection of surfaces within large enclosures such as cleanrooms and also small enclosures such as isolators, filling lines, pass-throughs, etc. Product authorisations, particularly Europe-wide Union Authorisations, for hydrogen peroxide biocides intended to be used with automated airborne disinfection systems are starting to come into force. This presentation will provide a background understanding of the BPR, its requirements and application in relation to automated airborne disinfection systems and review some of the new hydrogen peroxide vapour and nebulisation product authorisations in relation to their authorised use scenarios. The BPR applies to both the marketing and USE of a biocidal product and thus product users must be aware of and understand the authorisations held by the products they use, to ensure that they are using products correctly and in accordance with the law.
New annex 1 impact regarding Isolator management
Eric Claessens & Claudio Viti
Marchesini
“Preliminary analysis of the impact of the new “Annex 1” on isolated filling lines management, and evaluation of possible main changes that pharma-industry may face in the coming months.
The goal is to highlight the main new requirements of the “Annex 1” and evaluate their possible interpretation.
A basic guideline on “how to apply the new requirements on the filling lines” a few weeks after the release.”
The goal is to highlight the main new requirements of the “Annex 1” and evaluate their possible interpretation.
A basic guideline on “how to apply the new requirements on the filling lines” a few weeks after the release.”
Isolator Requirements – Basics
Kenan Kanmaz
Optima
• Basics of isolators
• Air Handling Units
• integrated transfer systems, RTP Port and MTC
• DECOPulse® – integrated H2O2 Bio-decontaminationsystem”
Smart Isolators: from innovative construction materials to voice-controlled electronic batch records.
Yves Blandiaux, Philippe Neyt & Jordi Net (Netsteril)
Salamander U
Sistemas de alta contención para transferencia de tóxicos o estériles
Guillem Fibla
Tiselab
Workshops ◊ Session 2 ◊ 12:45
Understanding Regulations – examining the impact of the Biocidal Products Regulation (BPR) on automated airborne disinfection systems and their use in aseptic processing facilities
John Chewins
Ecolab
The European Biocidal Products Regulation (BPR) came into law throughout Europe in 2013, but delays in the product authorisation process have meant that users have yet to experience the potential impacts of the regulation in terms of loss of chemistry / product or inability to use a product as currently employed. Hydrogen peroxide vapour technology is widely used within pharmaceutical manufacturing facilities to provide high level disinfection of surfaces within large enclosures such as cleanrooms and also small enclosures such as isolators, filling lines, pass-throughs, etc. Product authorisations, particularly Europe-wide Union Authorisations, for hydrogen peroxide biocides intended to be used with automated airborne disinfection systems are starting to come into force. This presentation will provide a background understanding of the BPR, its requirements and application in relation to automated airborne disinfection systems and review some of the new hydrogen peroxide vapour and nebulisation product authorisations in relation to their authorised use scenarios. The BPR applies to both the marketing and USE of a biocidal product and thus product users must be aware of and understand the authorisations held by the products they use, to ensure that they are using products correctly and in accordance with the law.
New annex 1 impact regarding Isolator management
Eric Claessens & Claudio Viti
Marchesini
“Preliminary analysis of the impact of the new “Annex 1” on isolated filling lines management, and evaluation of possible main changes that pharma-industry may face in the coming months.
The goal is to highlight the main new requirements of the “Annex 1” and evaluate their possible interpretation.
A basic guideline on “how to apply the new requirements on the filling lines” a few weeks after the release.”
The goal is to highlight the main new requirements of the “Annex 1” and evaluate their possible interpretation.
A basic guideline on “how to apply the new requirements on the filling lines” a few weeks after the release.”
Sterilty Test Isolator STISO
Kenan Kanmaz
Optima
• Basics of Isolators• Test process inside isolator
• Technical solution for sterility test isolator
• Plug & Test – easy move-in concept
• Modular Design
Smart Isolators: from innovative construction materials to voice-controlled electronic batch records.
Yves Blandiaux, Philippe Neyt & Jordi Net (Netsteril)
Salamander U
Puntos críticos en trabajo en aislador/RAB’s
Mª Luz Checa & Laura Alonso
Tiselab
Workshops ◊ Session 3 ◊ 15:30
Understanding Regulations – examining the impact of the Biocidal Products Regulation (BPR) on automated airborne disinfection systems and their use in aseptic processing facilities
John Chewins
Ecolab
The European Biocidal Products Regulation (BPR) came into law throughout Europe in 2013, but delays in the product authorisation process have meant that users have yet to experience the potential impacts of the regulation in terms of loss of chemistry / product or inability to use a product as currently employed. Hydrogen peroxide vapour technology is widely used within pharmaceutical manufacturing facilities to provide high level disinfection of surfaces within large enclosures such as cleanrooms and also small enclosures such as isolators, filling lines, pass-throughs, etc. Product authorisations, particularly Europe-wide Union Authorisations, for hydrogen peroxide biocides intended to be used with automated airborne disinfection systems are starting to come into force. This presentation will provide a background understanding of the BPR, its requirements and application in relation to automated airborne disinfection systems and review some of the new hydrogen peroxide vapour and nebulisation product authorisations in relation to their authorised use scenarios. The BPR applies to both the marketing and USE of a biocidal product and thus product users must be aware of and understand the authorisations held by the products they use, to ensure that they are using products correctly and in accordance with the law.
New annex 1 impact regarding Isolator management
Eric Claessens & Claudio Viti
Marchesini
“Preliminary analysis of the impact of the new “Annex 1” on isolated filling lines management, and evaluation of possible main changes that pharma-industry may face in the coming months.
The goal is to highlight the main new requirements of the “Annex 1” and evaluate their possible interpretation.
A basic guideline on “how to apply the new requirements on the filling lines” a few weeks after the release.”
The goal is to highlight the main new requirements of the “Annex 1” and evaluate their possible interpretation.
A basic guideline on “how to apply the new requirements on the filling lines” a few weeks after the release.”
Smart Isolators: from innovative construction materials to voice-controlled electronic batch records.
Yves Blandiaux, Philippe Neyt & Jordi Net (Netsteril)
Salamander U
Soluciones para transferencia aséptica
Mª Luz Checa & Laura Alonso
Tiselab
Registration Form
Participate in A3P Aseptic Processing Event.
Price: 500€
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The exhibition is complete
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| Company | Table Top | Company | Table Top | |
| FPS PHARMA | 1 | SALAMANDER U | 9 | |
| DEVEA | 2 | MK-VERSUCHSANLAGEN UND LABORBEDARF e.K | 10 | |
| MESALABS | 3 | OPTIMA | 11 | |
| STERIS | 4 | BIOMERIEUX | 12 | |
| LITEK PHARMA | 5 | JACOMEX | 13 | |
| MARCHESINI | 6 | BECTON DICKINSON | 14 | |
| ECOLAB | 7 | JCE BIOTECHNOLOGY | 15 | |
| TISELAB | 8 |
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Services included with the Table Top stand
- A dedicated exhibition area where you can install your products and communication tools: umbrella stand, roll-up, display, product, …
A basic equipment including a 180×80 cm table, 2 chairs and 1 electrical connection (2kw) without circuit breaker - Breaks and meals as indicated in the program
- Illimited Wifi
- A badge that gives you free access to the entire technical and scientific programme.
- The list of participants to the event
Contact
Depending on your requirements and preferences, you can contact Florian Canuto:
Phone number: +33 (0)7 61 55 24 36
Email : fcanuto@a3pservices.com
How to access
Address
Plaça de Llevant, s/n, 08019 Barcelona, Spain
> Metro : El Maresme Fòrum
> Tram : Fòrum
