A3P Barrier Technology
Appendix 1 - Gloves - MTI - Campaign Mode - Isolator - Decontamination H2O2

Place

Beaumont Palace, Pau

Date

19 & 20 March 2019

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Conferences, Exhibition, Partner Sessions

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After the success of 2017, A3P offers the 19 and 20 March 2019, new days A3P Barrier Technology, always in Pau.
These technologies, from RABS to isolators, enable the best personal / product cross-protection as the products become more and more active and the staff more and more exposed.
You will be able to familiarize yourself with the most advanced applications of the MTI to the field productions and make your own tests on the optimal use of gloves.
The GIC (Group of Common Interest) A3P Barrier Technologies and the A3P team are at your disposal to detail the program and remain attentive to your suggestions while waiting to welcome you to Pau.

Tuesday March 19

Welcome of participants
08:30
Introduction of A3P Barrier Technology Days
A3P Association
9:00
Barrier Technology: Regulatory Issue and New Requirements of Annex 1
Marc BESSON - GIC A3P and Julien TRIQUET - GSK
9:15
Is the decontamination by vapor phase hydrogen peroxide (VPHP) recognized as a sterilization process?
Benjamin BORGNE - GSK VACCINES
10:00
Coffee break & Exhibition visit
10:30
Gloves first source of contamination ... Control of the risk gloves / detection of holes (detail, practical approach, feedback)
Serge LA SPINA & Antoine TOUSSAINT - GSK VACCINES
11:30
Partner Session # 1 See the proposed workshops
BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - MERCK - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
12:00
Lunch & Visit of the exhibition
13:00
Partner Session # 2 See the proposed workshops
BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - MERCK - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
14:30
Partner Session # 3 See the proposed workshops
BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - MERCK - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
15:30
Coffee break & Exhibition visit
16:30
Annex 17 for ITNs: a tool for quality at the service of the patient
Laurent LAGANIER (GIC A3P Barrier Technology member) - HOPITAL NECKER
17:30
Hospital obligations during aseptic preparation à la carte in isolators
Pascal HILD - ROANNE HOSPITAL CENTER
18:00
Cocktail aperitif on the exhibition
18:30

Wednesday, March 20

Welcome of participants
08:00
Aseptic filling as an isolator: what if you were presented with the benefits of the campaign mode? Feedback from ASPEN Notre Dame de Bondeville
Aurélie DOWNES - ASPEN
08:30
Work in campaign under insulators: "lines of thought to take action"
Etienne HEMBERT & Eric VALENTI - GIC A3P Barrier Technology
09:00
Coffee break & Exhibition visit
09:30
Partner Session # 4 See the proposed workshops
BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - MERCK - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
10:30
Partner Session # 5 See the proposed workshops
BIOQUELL - GETINGE - JCE BIOTECHNOLOGY - MERCK - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
11:30
Lunch & Visit of the exhibition
12:30
Constraints and mode of production of biotech products in isolator
Ana ALVES - SANOFI
14:00
Challenges and feedback on the use of multi formats in campaign mode
Florelle TOURLET - OCTAPHARMA
14:30
Coffee break & Exhibition visit
15:00
The use of enhanced GMP manufacturing techniques The success of Broad Scale production of EMA-approved Cartilage Substitute
Andreas EBERLE - CO.DON AG & Marco FADDA - COMECER
15:30
Next Generation Isolator technology to optimize vaccine production
Andrew CHIAPPETTA - SANOFI PASTOR TORONTO & Bruno AZE - STERIS
16:00
End of days A3P Barrier Technology
16:30
Interactive workshops led by our partners (simultaneous workshops)
1 session: from 12h to 13h
March 19
Rogue Bi's: non-compliance of the decontamination cycle or non-compliance of the biological indicator?
BIOQUELL
It is not uncommon, during performance ratings of a decontamination system in an isolator, to observe nonconformities following the incubation of biological indicators. The investigations carried out, following these nonconformities, are often long, and can lead to a questioning of the developed cycle. Is it really a non-compliance of the decontamination cycle or non-compliance of the biological indicator?
The right choice of transfer system: reusable and single-use
Getinge
The choice of a transfer system will be based on the production process defined by the customer. The transfer system (= the transfer gate, including an Alpha part and an interconnectable part Beta) will optimize the time and the production process and make transfers of products, tools or components continuously, without breaking the sterility or confinement. It will also reduce the risk of contamination or cross-contamination, especially when using single-use products. This workshop will show you the advantages and disadvantages of 2 transfer solutions available: reusable (and re-sterilizable) and single-use.
PRESENTATION OF QUICK TRANSFER SYSTEMS (RTP)
JCE BIOTECHNOLOGY
Presentation of various secure transfer systems and their accessories - Use and manipulation of doors in real conditions - Presentation of an automatic door system - Presentation of a waste and liquid disposal system
All-in-one swabbing with ICR Swab for microbiological monitoring of critical surfaces in aseptic processes
MERCK
Summary to come
Contamination Control in RABS and Isolators beside VHP®
STERIS
Contact Bookmark and Share Mendeley EndNote Contamination Control technologies. During operation, it is not uncommon to face spillage of products, with multiple intervention using glove boxes. This expected and unexpected events are always in focus for review of risk mitigation practices. This workshop will help address the issue of decontamination techniques using sterile disinfectants, neutral detergents and sporicidal to cover risk for patients. We will also ensure that the audience understands the impact of biocides used in ISO 1 critical environments. A case study on the broad spectrum disinfectant will also be discussed to better control RABS and Isolators.
2 session: from 14h30 to 15h30
March 19
Introduction of the Qube concept and the benefit for sterility test
BIOQUELL
An illustration of how sterility testing in isolators with HPV decontamination
Waste management of a sterility test under isolator
Getinge
To ensure the sterility test of the finished products, it is very often necessary to use already sterile single use components (canisters etc.) guaranteeing a very high level of SAL. The sterility test generates a large volume of solid and liquid waste (filtrates). This waste is sometimes sterile, toxic or cytotoxic and must be removed from the isolator, preferably during the sterility test process to free space, improve productivity, avoid errors, or avoid risky debris associated, while maintaining the guarantee of sterility of the work volume. Getinge offers different solutions, thanks to the DPTE® system, single-use or reusable, to avoid any risk of corruption of the results. These solutions are proven and validated by the pharmaceutical industry.
PRESENTATION OF QUICK TRANSFER SYSTEMS (RTP)
JCE BIOTECHNOLOGY
Presentation of various secure transfer systems and their accessories - Use and manipulation of doors in real conditions - Presentation of an automatic door system - Presentation of a waste and liquid disposal system
Validation of decontamination with VHP of microbiological air sampling equipment with remote heads, the MAS ISO Multi Heads
MERCK
Summary to come
Performance of VHP® technology for the current needs of aseptic production and drifts observed during implementation
STERIS
Following the famous MHRA blog that generated more confusion and questions than clarifying a technology well established and recognized worldwide at all levels, the goal of the workshop is to show the usefulness and reliability of surface decontamination by VHP® technology and at the same time technically explain the shortcuts and pitfalls to avoid which have sometimes generated applications that do not correspond to the desired aseptic level
3 session: from 15h30 to 16h30
March 19
Implication of the Biocidal Product Regulation (BPR) in aseptic manufacturing
BIOQUELL
Summary to come
Good practices for using transfer systems
Getinge
It is recommended to use transfer systems that have been validated together (part Alpha and part Beta interconnectable) to avoid any risk for the product and the operator. The transfer system requires special attention in its use. It guarantees the maintenance of the confined state of the system. Especially in the case of sterility, it will be necessary to take adequate precautions to avoid the transfer of microbiological contamination. As part of a controlled maintenance policy and given the regulations in force, Getinge offers modern and connected integrity test tools to trace the service life and ensure the reliability of equipment over time.
PRESENTATION OF QUICK TRANSFER SYSTEMS (RTP)
JCE BIOTECHNOLOGY
Presentation of various secure transfer systems and their accessories - Use and manipulation of doors in real conditions - Presentation of an automatic door system - Presentation of a waste and liquid disposal system
Risk and impact of VHP on culture media during microbiological isolation monitoring
MERCK
Summary to come
General review of all methods and means for the development and validation of VHP® cycles
STERIS
Biological Indicators and their reliability are and remain the only way to validate a level of surface decontamination performance. This workshop focuses on the possibility of setting up a powerful cycle and being able to check it perfectly physically repeatable. The goal is to show that the entire dynamics of a VHP® cycle is perfectly measurable. Not only it is possible to adjust a more efficient or very fast cycle, but also for example during annual revalidation or new projects and in case of concerns of biological indicator either in raw resistance or in particular in variability in the same batch, it is possible to verify the integrity and efficiency of the process implemented before changing its parameters or even the installation
4 session: from 10h30 to 11h30
March 20
Rogue Bi's: non-compliance of the decontamination cycle or non-compliance of the biological indicator?
BIOQUELL
It is not uncommon, during performance ratings of a decontamination system in an isolator, to observe nonconformities following the incubation of biological indicators. The investigations carried out, following these nonconformities, are often long, and can lead to a questioning of the developed cycle. Is it really a non-compliance of the decontamination cycle or non-compliance of the biological indicator?
The right choice of transfer system: reusable and single-use
Getinge
The choice of a transfer system will be based on the production process defined by the customer. The transfer system (= the transfer gate, including an Alpha part and an interconnectable part Beta) will optimize the time and the production process and make transfers of products, tools or components continuously, without breaking the sterility or confinement. It will also reduce the risk of contamination or cross-contamination, especially when using single-use products. This workshop will show you the advantages and disadvantages of 2 transfer solutions available: reusable (and re-sterilizable) and single-use.
QUALIFICATION OF TRANSFER SYSTEMS
JCE BIOTECHNOLOGY
Validation and microbiological qualification between two compatible RTP systems (alpha and Beta) - Maintenance of sterility on transfer accessories
Isobag for fast and on-demand transfer of environmental agar plates in insulators
MERCK
Summary to come
Contamination Control in RABS and Isolators beside VHP®
STERIS
Contact Bookmark and Share Mendeley EndNote Contamination Control technologies. During operation, it is not uncommon to face spillage of products, with multiple intervention using glove boxes. This expected and unexpected events are always in focus for review of risk mitigation practices. This workshop will help address the issue of decontamination techniques using sterile disinfectants, neutral detergents and sporicidal to cover risk for patients. We will also ensure that the audience understands the impact of biocides used in ISO 1 critical environments. A case study on the broad spectrum disinfectant will also be discussed to better control RABS and Isolators.
5 session: from 11h30 to 12h30
March 20
Introduction of the Qube concept and the benefit for sterility test
BIOQUELL
An illustration of how sterility testing in isolators with HPV decontamination
Good practices for using transfer systems
Getinge
It is recommended to use transfer systems that have been validated together (part Alpha and part Beta interconnectable) to avoid any risk for the product and the operator. The transfer system requires special attention in its use. It guarantees the maintenance of the confined state of the system. Especially in the case of sterility, it will be necessary to take adequate precautions to avoid the transfer of microbiological contamination. As part of a controlled maintenance policy and in view of the regulations in force, Getinge offers modern and connected integrity test tools to trace the service life and ensure the reliability of equipment over time.
QUALIFICATION OF TRANSFER SYSTEMS
JCE BIOTECHNOLOGY
Validation and microbiological qualification between two compatible RTP systems (alpha and Beta) - Maintenance of sterility on transfer accessories
Microbiological Monitoring of the Environment of Barrier Technologies
MERCK
Summary to come
General review of all methods and means for the development and validation of VHP® cycles
STERIS
Biological Indicators and their reliability are and remain the only way to validate a level of surface decontamination performance. This workshop focuses on the possibility of setting up a powerful cycle and being able to check it perfectly physically repeatable. The goal is to show that the entire dynamics of a VHP® cycle is perfectly measurable. Not only it is possible to adjust a more efficient or very fast cycle, but also for example during annual revalidation or new projects and in case of concerns of biological indicator either in raw resistance or in particular in variability in the same batch, it is possible to verify the integrity and efficiency of the process implemented before changing its parameters or even the installation

You wish to reserve a stand, please consult our exhibitor file

Download the PDF file

Plan of the exhibition

Company No. Stand Company No. Stand
ILC DOVER 1 11
PROSYS GROUP 2 SKAN 12
BIOQUELL 3 SOLIDFOG TECHNOLOGIES 13
OPTIMA PHARMA 4 Getinge 14
STERIS 5 JCE BIOTECHNOLOGY 15
MERCK 6 AZBIL TELSTAR FRANCE 16
COMECER 7 Sidji 17
8 CONFARMA FRANCE 18
CONTEC 9 ERMAFLUX 19
10 DECON-O-LOGIC 20

Services included with the Table Top stand

  • A dedicated exhibition space on which you can install your products and communication tools: umbrella stand, roll-up, display, product, ... A basic endowment including table 180 × 80 cm, 2 chairs and 1 electrical connection (2kw ) without a circuit breaker, 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)

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Contact

According to your requirements and your preferences, you can contact Ludivine BAYLE:

Phone: +33 (0)4 37 28 30 46
Fax: +33 (0)4 37 28 30 60
E-mail : lbayle@a3pservices.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007

Accessibility

Hotel reservation

Hotel Ronceveau Pau
25 Louis Barthou Street, 64000 Pau
Phone: + 33 (0) 5 59 00 00 40

Hôtel Central
15 Rue Léon Daran, 64000 Pau
Phone: + 33 (0) 5 59 27 72 75

Best Western
2 Rue Maréchal Foch, 64000 Pau
Phone: + 33 (0) 5 59 27 69 31

Ibis.
26 Street Samonzet, 64000 Pau
Phone: + 33 (0) 5 59 83 71 83

Quality Hotel
80 Rue Emile Garet, Pau 64000
Phone: + 33 (0) 5 59 82 58 00