ASEPTIC PROCESSING
Isolators & RABS
Lugar
Hotel SB Diagonal Zero, Barcelona
Formato
Conferencias, Talleres, Exposición, Networking
Compartir
Tras varios años de gestación y múltiples versiones se ha publicado el nuevo Anexo 1 de las GMP.
Las últimas versiones corroboran el énfasis en la reducción de la interacción humana para minimizar riesgos de contaminación. Ya no cabe duda.
En el corazón de los procesos asépticos, el uso de aisladores y tecnologías de barrera será esencial para garantizar la calidad del producto. Por tanto, a partir de la publicación, el caballo de batalla en cuanto a cumplimiento será la transformación de equipos y procesos existentes utilizando estas tecnologías.
En este evento queremos que los fabricantes que llevan tiempo empleando tecnologías de barrera compartan su experiencia. A su vez, trataremos de analizar tanto su utilización práctica como su implementación desde el punto de vista técnico y operativo.
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27 de Octubre de 2022
Bienvenida y Desayuno
09:00
Introducción
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
Pausa – Café en la exposición
11:00
Workshops: Sesión 1 Ver los talleres propuestos
ECOLAB - MARCHESINI - OPTIMA - SALAMANDER U - TISELAB
Los talleres interactivos organizados por las empresas patrocinadoras son una oportunidad para que los participantes mejoren su nivel técnico.
11:45
Workshops: Sesión 2 Ver los talleres propuestos
ECOLAB - MARCHESINI - OPTIMA - SALAMANDER U - TISELAB
Los talleres interactivos organizados por las empresas patrocinadoras son una oportunidad para que los participantes mejoren su nivel técnico.
12:45
Almuerzo – Visita de la exposición
13:45
RABS/Isolator Gloves Management Overview - Key Principles for Good Glove Management
Ana ROMO - PFIZER
15:00
Workshops: Sesión 3 Ver los talleres propuestos
ECOLAB - MARCHESINI - OPTIMA - SALAMANDER U - TISELAB
Los talleres interactivos organizados por las empresas patrocinadoras son una oportunidad para que los participantes mejoren su nivel técnico.
15:30
Pausa - Café en la exposición
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
Fin de la jornada
18:15
Talleres ◊ Sesión 1 ◊ 11:45H
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
Talleres ◊ Sesión 2 ◊ 12:45H
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
“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 y Laura Alonso
Tiselab
Talleres ◊ Sesión 3 ◊ 15:30H
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
“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 y Laura Alonso
Tiselab
Formulario de inscripción
Inscríbase al evento A3P Aseptic Processing.
Precio: 500€
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Exposición completa
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| Empresa | Table Top | Empresa | Table Top | |
| FPS PHARMA | 1 | MK-VERSUCHSANLAGEN UND LABORBEDARF e.K | 9 | |
| DEVEA | 2 | SALAMANDER U | 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
