A3P Microbiology Meetings

Regulatory, Microbiological controls, Alternative methods

Location

Tours convention center

Date

18 & 19 March 2020

Save the date !

Format

Conferences, exhibition, partner sessions

Share

On March 18 and 19, 2020, the bi-annual A3P Microbiology event will take place at the Palais des Congrès in Tours. For this new edition, the program will deal with the following themes:

  • Alternative methods in microbiology
  • Microbiological controls of organic products
  • Microbiological controls "in-line / on-line"
  • Teachings to draw "warning letters" and injunctions, for microbiological reasons

We will tackle these concrete and topical issues in depth within our professional network around the sharing of experiences, conferences, an exhibition and interactive workshops.

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

Wednesday, March 18

Welcome of participants
08:30
Presentation of the GIC microbiology
Eric PETAT - GIC A3P Microbiology
08:45
Evolution of the main pharmacopoeias on texts concerning microbiology
Thierry BONNEVAY - SANOFI PASTEUR
09:00
Warning letters and injunctions related to microbiology in the pharmaceutical industries
Arnaud CARLOTTI - EUROFINS IDmyk
09:30
Coffee break - visit of the exhibition
10:00
Interactive workshops - See the proposed workshops
ASSOCIATE OF CAPE COD - BIOQUELL - BIOMERIEUX - CHARLES RIVER - LONZA - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
11:00
Implementation of an automated Bactalert ° direct seeding method for microbiological control
Guillaume PINON - ACM PHARMA
12:00
PCR- and microarray-based test system for rapid detection and identification of mycoplasma
Kathrin KOECK - GREINER BIO-ONE & Arnaud CARLOTTI - EUROFINS IDmyk
12:30
Lunch - visit of the exhibition
13:00
Interactive workshops - See the proposed workshops
ASSOCIATE OF CAPE COD - BIOQUELL - BIOMERIEUX - CHARLES RIVER - LONZA - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
14:30
Interactive workshops - See the proposed workshops
ASSOCIATE OF CAPE COD - BIOQUELL - BIOMERIEUX - CHARLES RIVER - LONZA - 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 - visit of the exhibition
16:30
Implementation of a microbial detection analyzer for real-time monitoring of microbial contamination for purified water
Natascha STAUB - MIBELLE GROUP
17:30
Case study for testing of on-line water bioburden analyzer (OWBA) in WFI systems
Jesper HJORTH - NOVO NORDISK
18:00
Limitation of conventional microbiology methods for the evaluation of bioburden in pharmaceutical waters
Tony DINIS - CEVA ANIMAL HEALTH
18:30
Dinner aperitif on the exhibition
19:00

Thursday March 19

Welcome of participants
08:00
Evaluation of the performance of the human eye in reading media for environmental monitoring
Laurent LEBLANC - BIOMERIEUX
08:30
Advancing environmental monitoring through a cross-industry collaborative study
Lucile PLOURDE - SANOFI PASTEUR & Arnaud PARIS - BIOMERIEUX
09:00
Coffee break - visit of the exhibition
09:30
Interactive workshops - See the proposed workshops
ASSOCIATE OF CAPE COD - BIOQUELL - BIOMERIEUX - CHARLES RIVER - LONZA - STERIS
The interactive workshops organized with partner companies are an opportunity for participants to become familiar with or deepen their technical approach.
10:30
Interactive workshops - See the proposed workshops
ASSOCIATE OF CAPE COD - BIOQUELL - BIOMERIEUX - CHARLES RIVER - LONZA - 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
Rapid sterility test validation using a defined method of stressing organisms
Lucia CERESA - CHARLES RIVER
14:00
Strategy for the implementation of an alternative sterility test method
Hugues DESREUMAUX - GUERBET
14:30
Coffee break - visit of the exhibition
15:00
Routine use of flow cytometry in a quality control laboratory
Julien WAWRZYNIAK - EUROFINS BACTUP
15:30
Continuous microbial air monitoring for aseptic filling lines
Kai NESEMANN - SARTORIUS
16:00
End of the event
16:30

Wednesday, March 18

Session 1
11h00
Detection of endotoxins with recombinant reagents: update on the current situation, regulatory impact and solution
Yohann CAHON & Christine CURAT
We will update the official texts in progress and to come, concerning the techniques using the recombinant factor. We will present the positioning and the solution provided by Associates of Cape Cod.
Atelier1 CAPE COD
New regulations and innovations for endotoxin dosing
Sylvie GENOUX-AUBERT
The EDQM has just adopted chapter 2.6.32 for the detection of bacterial endotoxins using recombinant Factor C. First adoption of a recombinant reagent going towards a more ecological test. During this workshop we will present how new eco-responsible solutions can limit errors and re-tests while meeting regulatory requirements and the strong societal commitment of the Pharmaceutical Industries.
Atelier2 BIOMERIEUX
Biological Indicators used within Aseptic Processing Environments: Manufacture, Regulations, Rogues & Validation
John CHEWINS
Providing an overview of the manufacturing process of a biological indicator and how that contributes to its resistance profile. The presentation will explore the regulations surrounding BI's in relation to aseptic processing and will provide guidance on the use of biological indicators in the validation of automated disinfection systems for aseptic processing environments
Atelier3 BIOQUELL
Are you ready for Schedule 1? How can a precise identification and environmental monitoring program ensure complete compliance?
Summary in progress
Atelier4 CHARLES RIVER
Automatic Sampling of WFI Water Supplies for Production Sites
Jens POSCHET
The sampling of WFI water system in production sites is a time consuming and costly process, which can be fraud with sampling errors and the risk of contamination the system. The Modular Automated Sampling Technology [MASTTM] from Lonza is a proven technology used for the aseptic collection of samples from up to 10 Bioreactors and subsequent delivery to up to four different analytical pieces of equipment such as bioanalysers, HPLC, UPLC or LC / MS. Here we will discuss how MAST technology can be employed to deliver WFI samples form online collection to testing laboratories or sample collection locations
Atelier5 LONZA
Environmental Monitoring (EM) Programs - Risk Based Development, Qualification, and Investigations
Jim POLARINE
The goal of this presentation is to support manufacturers in understanding the regulatory requirements and expectations for a Risk-Based EM Program. Topics discussed will include basic attributes for a compliant EM program including test methods, rationales for site selection and sample frequency, EM data trending, root cause (RC) investigations of excursions and appropriate corrective-preventive actions (CAPA). The discussion will also address shutdown recovery; suitable response plans to planned and un-planned loss of contamination control in cleanroom manufacturing facilities. Case studies will be presented to highlight “best practices” as well as pitfalls to avoid in evaluating EM data for trends and excursion investigations. Attendees will gain valuable insight into regulatory expectations for a scientific and risk-based EM program.
Atelier6 STERIS
Session 2
14h30
Presentation of the latest generation of endotoxin and glucan analysis software from Cape Cod associates: Pyros eXpress
Yohann CAHON & Christine CURAT
The use of suitable software (21 CFR part 11) is essential for verifying and securing your data. Associates of Cape Cod, Inc. Introduces Latest Generation of Endotoxin and Glucan Detection Software Providing Integrated Solutions for Testing, Reporting, Trends and Data Management for Quantitative Detection Endotoxins and glucan.
Atelier7 CAPE COD
Innovation in the detection of mycoplasmas in bioproduction and cell therapy products and processes
Sylvanie CASSARD-GUILLOUX & Christophe ARLIAUD
BIOFIRE mycoplasma is an innovative, fully automated solution from sample to result, which can detect mycoplasma in 1 hour. This unique solution is based on an instrument, a veritable miniaturized molecular biology laboratory, and on a device containing all the reagents and controls for carrying out a test. The simplification of these analyzes allows personnel not specialized in the detection of mycoplasmas to do the tests, and does not require a change in the organization of the laboratory. During this workshop we will present this new solution, its simplicity of use by making the method of choice for an implementation at all stages of the process and of the finished product control.
Atelier8 BIOMERIEUX
Establishing an end to end contamination control solution for your bioprocessing facility
Guy TURNER
Evaluating the suitability of different disinfection technologies and methods for various steps in a biomanufacturing process. Considerations are made around efficacy, budget, validation labor usage and processing time.
Atelier9 BIOQUELL
Comparison of different endotoxin assay methods on the market (LAL, Recombinant) for pharmaceutical waters. A failure in quality control can change everything!
We will discuss during this session the importance of the different factors of the LAL enzymatic cascade in the context of endotoxin detection specification and signal amplification during the assay, and will then discuss the structural diversity of natural endotoxins. We will then see how the various methods on the market (LAL, recombinant) are capable of detecting samples of naturally contaminated water by presenting the results of an international study carried out on samples from dozens of pharmaceutical industries. We will finish this workshop with a practical session of comparison of the different stages of a recombinant method Vs a validated LAL method by cartridges (Cartridge = 95% less reagent Vs traditional LAL method). All workshops are in French or with simultaneous French translation
Atelier10 CHARLES RIVER
Data integrity and paperless
Ysabelle ADOLPHE & Peter GRAVIL
Currently, data traceability is one of the major concerns of pharmaceutical companies, as much as to electronically transpose everything that is done via paper. To do this, Lonza offers several solutions already recognized to its customers, through the WinKQCL software, the automation of endotoxin tests or the paperless system within QC microbiology by the MODA system.
Atelier11 LONZA
The Role of Personnel in Cleanroom Contamination - Aseptic Practices, Knowledge, & Behaviors
Jim POLARINE
It is widely accepted that people are the greatest source of microbial contamination in manned cleanroom manufacturing environments. Working in cleanroom environments is unlike any other task, it requires specialized training and knowledge for personnel to be successful. One of the greatest challenges for companies is that new hires are inexperienced or don't possess a deep understanding of the principles of contamination control. It is critical, as well as a regulatory expectation, that cleanroom personnel receive focused training in microbiology, aseptic practices, cleanroom behaviors and principles of contamination control. The goal of this presentation is to present three (3) key principles of contamination control that cleanroom staff must understand and embrace in order to minimize their impact on the microbiological quality of their working environments. Through discussion, hands-on demonstrations and visual aids, attendees will gain a better understanding of how cleanrooms work and how employees can prevent, rather than react to, contamination events.
Atelier12 STERIS
Session 3
15h30
Detection of endotoxins with recombinant reagents. Update on the current situation, regulatory impact and future solution from Associates of Cape Cod
Yohann CAHON & Christine CURAT
We will update the official texts in progress and to come, concerning the techniques using the recombinant factor. We will present the positioning and the solution provided by Associates of Cape Cod.
Atelier13 CAPE COD
Innovation in the detection of mycoplasmas in bioproduction and cell therapy products and processes
Sylvanie CASSARD-GUILLOUX & Christophe ARLIAUD
BIOFIRE mycoplasma is an innovative, fully automated solution from sample to result, which can detect mycoplasma in 1 hour. This unique solution is based on an instrument, a veritable miniaturized molecular biology laboratory, and on a device containing all the reagents and controls for carrying out a test. The simplification of these analyzes allows personnel not specialized in the detection of mycoplasmas to do the tests, and does not require a change in the organization of the laboratory. During this workshop we will present this new solution, its simplicity of use by making the method of choice for an implementation at all stages of the process and of the finished product control.
Atelier14 BIOMERIEUX
Non-compliant results of microbiological samples, after manual cleaning within a production area. Validation of an emergency decontamination protocol for a quick and secure resumption of production
Jules BOULICOT
In the same way as a preventive cleaning and disinfection protocol carried out after seasonal outages, the study and validation of an emergency cleaning and disinfection protocol in the event of non-conforming results of microbiological samples, can make it possible to reduce significantly disrupting the pace of production. What are the differences between preventive and curative treatments?
Atelier15 BIOQUELL
Risk management and Data integrity thanks to the power of an online endotoxin control (PTS) combined with real-time trend monitoring (Cortex)
During this session, we will talk about validated methods of rapid at-line endotoxin checks in 15 minutes (PTS system), by addressing in particular practical applications of this technology allowing tracking of biofilms and a reduction in pressure related to sampling and transport of samples in process. We will discuss concrete cases of manufacturers who have successfully implemented this at-line control of endotoxins in their production strategy. We will end this workshop with manipulations of PTS systems and a live demonstration of a real-time endotoxin trend monitoring tool. All workshops are in French or with simultaneous French translation
Atelier16 CHARLES RIVER
Endotoxin tests, from LAL to rFC: how does it work, what to choose, validation and specific interference?
Ysabelle ADOLPHE
In order to measure endotoxins, there are various legally possible LAL tests, and now also recombinant factor C or RFC. How to choose the most suitable test and how to execute it? How do you know if the validation of a particular technique is complete? How do you know if the result provided is representative of the initial sample? It is up to us to help you answer all your questions.
Atelier17 LONZA
Optimization of cleaning and disinfection of clean rooms with the VESTASYDE SQ RTU
Sylvie REBOUL
Fungal and bacterial spores in controlled areas can sometimes represent major challenges in controlling contamination in controlled areas. During this presentation, we will show you the many advantages of using a quaternary ammonium type detergent-disinfectant with a very broad spectrum of microbiological efficiency: Vestasyde SQ RTU. STERIS offers you an effective and secure strategy to simplify your schedule for using disinfection products in sterile and non-sterile areas.
Atelier18 STERIS
End of workshops
16h30

Thursday March 19

Session 4
10h30
Presentation of the latest generation of endotoxin and glucan analysis software from Cape Cod associates: Pyros eXpress
Yohann CAHON & Christine CURAT
The use of suitable software (21 CFR part 11) is essential for verifying and securing your data. Associates of Cape Cod, Inc. Introduces Latest Generation of Endotoxin and Glucan Detection Software Providing Integrated Solutions for Testing, Reporting, Trends and Data Management for Quantitative Detection Endotoxins and glucan.
Atelier19 CAPE COD
How can innovation focused on the design of Petri dishes improve the response to the constraints of "DATA INTEGRITY" via its integration into software dedicated to environmental monitoring?
Christophe ARLIAUD, Aniss EL AMRANI, Christophe EMONARD, Jean-Louis JOUVE & Arnaud VANDENBERGHE
In this workshop we will present the evolutions of our culture environments in terms of ergonomics and their integration in a traceability solution for environmental monitoring. This solution to guarantee full traceability of the data from the sample until the end of the incubation. We will then open a round table to discuss current practices and possible improvements to the challenges of traceability.
Atelier20 BIOMERIEUX
Non-compliant results of microbiological samples, after manual cleaning within a production area. Validation of an emergency decontamination protocol for a quick and secure resumption of production
Jules BOULICOT
In the same way as a preventive cleaning and disinfection protocol carried out after seasonal outages, the study and validation of an emergency cleaning and disinfection protocol in the event of non-conforming results of microbiological samples, can make it possible to reduce significantly disrupting the pace of production. What are the differences between preventive and curative treatments?
Atelier21 BIOQUELL
Comparison of different endotoxin assay methods on the market (LAL, Recombinant) for pharmaceutical waters. A failure in quality control can change everything!
We will discuss during this session the importance of the different factors of the LAL enzyme cascade in the context of specificity of endotoxin detection and signal amplification during the assay, and will then discuss the structural diversity of natural endotoxins. We will then see how the different methods on the market (LAL, recombinant) are capable of detecting samples of naturally contaminated water by presenting the results of an international study carried out on samples from dozens of pharmaceutical industries. We will end this workshop with a practical session to compare the different stages of a recombinant method Vs a validated LAL method by cartridges (Cartridge = 95% less reagent Vs traditional LAL method) All workshops are in French or with simultaneous translation in French.
Atelier22 CHARLES RIVER
Automatic Sampling of WFI Water Supplies for Production Sites
Jens POSCHET
The sampling of WFI water system in production sites is a time consuming and costly process, which can be fraud with sampling errors and the risk of contamination the system. The Modular Automated Sampling Technology [MASTTM] from Lonza is a proven technology used for the aseptic collection of samples from up to 10 Bioreactors and subsequent delivery to up to four different analytical pieces of equipment such as bioanalysers, HPLC, UPLC or LC / MS. Here we will discuss how MAST technology can be employed to deliver WFI samples form online collection to testing laboratories or sample collection locations
Atelier23 LONZA
Environmental Monitoring (EM) Programs - Risk Based Development, Qualification and Investigations
Jim POLARINE
The goal of this presentation is to support manufacturers in understanding the regulatory requirements and expectations for a Risk-Based EM Program. Topics discussed will include basic attributes for a compliant EM program including test methods, rationales for site selection and sample frequency, EM data trending, root cause (RC) investigations of excursions and appropriate corrective-preventive actions (CAPA). The discussion will also address shutdown recovery; suitable response plans to planned and un-planned loss of contamination control in cleanroom manufacturing facilities. Case studies will be presented to highlight “best practices” as well as pitfalls to avoid in evaluating EM data for trends and excursion investigations. Attendees will gain valuable insight into regulatory expectations for a scientific and risk-based EM program.
Atelier24 STERIS
Session 5
11h30
Detection of endotoxins with recombinant reagents: update on the current situation, the regulatory impact and the future solution of Associates of Cape Cod
Yohann CAHON & Christine CURAT
We will update the official texts in progress and to come, concerning the techniques using the recombinant factor. We will present the positioning and the solution provided by Associates of Cape Cod.
Atelier25 CAPE COD
How can innovation focused on the design of Petri dishes improve the response to the constraints of "DATA INTEGRITY" via its integration into software dedicated to environmental monitoring?
Christophe ARLIAUD, Aniss EL AMRANI, Christophe EMONARD, Jean-Louis JOUVE & Arnaud VANDENBERGHE
In this workshop we will present the evolutions of our culture environments in terms of ergonomics and their integration in a traceability solution for environmental monitoring. This solution to guarantee full traceability of the data from the sample until the end of the incubation. We will then open a round table to discuss current practices and possible improvements to the challenges of traceability.
Atelier26 BIOMERIEUX
Biological Indicators used within Aseptic Processing Environments: Manufacture, Regulations, Rogues & Validation
John CHEWINS
Providing an overview of the manufacturing process of a biological indicator and how that contributes to its resistance profile. The presentation will explore the regulations surrounding BI's in relation to aseptic processing and will provide guidance on the use of biological indicators in the validation of automated disinfection systems for aseptic processing environments
Atelier27 BIOQUELL
Regulatory requirements don't get simpler over time, but your quality control process can be made easier! Tools to validate an alternative sterility test.
We will approach during this workshop the approach to validate an alternative microbiological method and the tools proposed by Charles River to simplify your procedures with an example of validation pack (detection limit, specificity, equivalence). We will focus on applications for sterility tests and talk about concrete cases at the industrial level. We will end this session with a demonstration of an amplified ATP technology (Celsis method). All workshops are in French or with simultaneous translation into French.
Atelier28 CHARLES RIVER
Automatic Sampling of WFI Water Supplies for Production Sites
Jens POSCHET
The sampling of WFI water system in production sites is a time consuming and costly process, which can be fraud with sampling errors and the risk of contamination the system. The Modular Automated Sampling Technology [MASTTM] from Lonza is a proven technology used for the aseptic collection of samples from up to 10 Bioreactors and subsequent delivery to up to four different analytical pieces of equipment such as bioanalysers, HPLC, UPLC or LC / MS. Here we will discuss how MAST technology can be employed to deliver WFI samples form online collection to testing laboratories or sample collection locations.
Atelier29 LONZA
The Role of Personnel in Cleanroom Contamination - Aseptic Practices, Knowledge, & Behaviors
Jim POLARINE
It is widely accepted that people are the greatest source of microbial contamination in manned cleanroom manufacturing environments. Working in cleanroom environments is unlike any other task, it requires specialized training and knowledge for personnel to be successful. One of the greatest challenges for companies is that new hires are inexperienced or don't possess a deep understanding of the principles of contamination control. It is critical, as well as a regulatory expectation, that cleanroom personnel receive focused training in microbiology, aseptic practices, cleanroom behaviors and principles of contamination control. The goal of this presentation is to present three (3) key principles of contamination control that cleanroom staff must understand and embrace in order to minimize their impact on the microbiological quality of their working environments. Through discussion, hands-on demonstrations and visual aids, attendees will gain a better understanding of how cleanrooms work and how employees can prevent, rather than react to, contamination events.
Atelier30 STERIS
Workshops' end
12h30

Plan of the exhibition

CompanyNo. StandCompanyNo. Stand
BIOMERIEUX1 Albhades18
BIOQUELL2 SYMBIOSE ENVIRONMENT19
GREINER BIO-ONE3 BRUKER FRANCE SAS20
FUJIFILM WAKO CHEMICALS USA4 CARSO-LSEHL21
INTERSCIENCE5 BWT22
EUROFINS BIOPHARMA PRODUCT TESTING6 CORNING BV23
Sartorius7 STERIS24
SGS LIFE SERVICES8 ACM PHARMA25
SKAN AG9 CHARLES RIVER26
10 ORGANIC ALLIANCE EXPERTISE27
11 LONZA28
ASC INSTRUMENT12 Rapid Micro Biosystems29
13 BD LIFE SCIENCES30
14 ASSOCIATES OF CAPE COD31
CONFARMA FRANCE1532
16 BiiON33
17

Services included with the stand

  • A dedicated exhibition space on which you can install your communication products and tools: umbrella stand, roll-up, display ... delimited by a structure with partitions
  • A basic equipment comprising a table 180 x 80 cm, 2 chairs and 1 electrical connection without protective 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)
  • Registration

  • Participant information

  • Billing information

  • A3P Communications / Receive our communications

  • Terms and conditions

  • This field is only used for validation purposes and should remain unchanged.

Contact

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

Phone: CALL US : 04 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

Mercure Tours Center ***
29, rue Edouard Vaillant
37000 Tours
Phone: + 33 (0) 2 47 60 40 60
Email: H3475@accor.com

The Grand Hotel ****
9, place of General Leclerc
(Marshal Leclerc for some GPS)
37000 Tours
Phone: + 33 (0) 2 47 05 35 31
Email: contact@legrandhoteltours.com

Ibis Tours Centre ***
1, rue Maurice Genest (ex rue Georges Claude)
37000 Tours
Phone: + 33 (0) 2 47 70 35 35
Email: h1431@accor.com

Adagio Access ***
41, rue Edouard Vaillant
37000 Tours
Phone: + 33 (0) 2 474 740 00
Email: h8409@adagio-city.com