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A3P Microbiology Meetings
2016, March 15th and 16th in Tours
  sterility tests, identification,
Bioburden, Cosmetics

The A3P Microbiology meetings is a professional event held every two years.
Conducted by experts who agreed to share their knowledge, experiences and opinions, it is a major meeting of companies concerned directly or indirectly by the contamination.
Scheduled every two years, this professional and unique event draws its wealth and success from exchanges, debates and confrontations of ideas on current topics organized around three activities : lectures, workshops and exhibition.




  PROGRAM - A3P Microbiology Meetings
    
      
VINCI Convention Center
Boulevard Heurteloup 26 - 37000 TOURS


    microbio banner2 2016
   
Booking
EXHIBITOR

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Exhibitors list

Registration
PARTICIPANT

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Tuesday March 15th
  8h30     Participants registration and coffee
  8h45 A3P Introduction
  9h00 - Microbiological safety of cosmetic products “News and trends”
Alain Crozier - Cle@nCosmeticConsulting
  9h40 - Recent advances in microbiological decontamination technologies dedidated to cosmetic raw material
Adrien AGOULON - AGROHALL
  10h00  Break and exhibition visit
  10h30
Interactive Workshops (Session I)

You have the opportunity to attend interactive workshops all these days. These interactive workshops organized by Partners, are an opportunity to attend demonstrations, to find out about existing technologies, innovations in preview and share experiences and comments. You can participate to 3 sessions : Tuesday, March 15 10h30 (1 hour) and 16h00 (2 hours) and Wednesday March 16 10h30 (1 hours)
 
biomerieux logo Identification: what's new since the advent of identification technologies?
abstract here
charles river logo Workshop on detection:
Amplified-ATP bioluminescence assay for microbial detection in 24h and sterility testing in 4/7 days: highlight on hard-to-test product types (non-filterable, non-soluble, oil, opaque or highly pigmented…).
abstract here
lonza logo Low Endotoxin Recover - Where does the industry stand?
abstract here
merck logo Exchanges of experience on microbiological monitoring of aseptic production lines RABS or isolator
We will share visions of the pharmaceutical industry.
abstract here
logo mettler No microorganism will escape you! Presentation of the new microbial control system in real time for pharmaceutical water
abstract here
thermo logo A renewed offer from Thermo Fisher Scientific
abstract here
  11h30 - "L'Oréal testimony": Validation and Suitability of the detection method using flow cytometry and "Change control" approach
Coralie AUSSUDRE - L'OREAL
  12h00 - Bioburden control : current situation, problems and solutions
Sylvie GUYOMARD DEVANLAY - μBIOPHARMA
  12h30 Lunch
  14h30 - Alternative sterility test in Pharmaceutical Industry
Thierry BONNEVAY - SANOFI PASTEUR
  15h00 - Implementation and validation of a rapid and polyvalent alternative method in the laboratory
Philippe TAILLIEZ - ACM PHARMA
  15h30  Break and exhibition visit
  16h00
interactive workshops (Session II)

   
biomerieux logo Environment: Environmental Controls, news and perspectives
abstract here
charles river logo Workshop on identification :
Improvement of your environmental monitoring program with a polyphasic approach and trending analysis
abstract here
lonza logo Low Endotoxin Recover - Where does the industry stand?
abstract here
merck logo Development and validation of a rapid sterility test: Company Experience Back CONFARMA France, quality control expert.
abstract here
logo mettler No microorganism will escape you! Presentation of the new microbial control system in real time for pharmaceutical water
abstract here
thermo logo Microbiological control of isolators and clean rooms – how to validate the use of a new plate… an a new innovative contact plate applicator ?
abstract here
  18h00 End of Day
  20h00      Dinner at the Hangar
   
 
Wednesday March 16th
  8h30     Participants registration and coffee
  9h00 - EM test automation - What is possible today ?
Lucile PLOURDE OWOBI - SANOFI PASTEUR
  9h30 - Strategy of the microbiological control in the process of cell and gene therapy
Stephanie Bucher - CELL FOR CURE LFB Group
  10h00  Break and exhibition visit
  10h30
interactive workshops (Session II)

   
biomerieux logo

Environment: Monitoring of physical parameters to control laboratory
abstract here

charles river logo Workshop on identification :
Improvement of your environmental monitoring program with a polyphasic approach and trending analysis
abstract here
lonza logo Low Endotoxin Recover - Where does the industry stand?
abstract here
merck logo Exchanges of experience on microbiological monitoring of aseptic production lines RABS or isolator
We will share visions of the pharmaceutical industry.
abstract here
logo mettler No microorganism will escape you! Presentation of the new microbial control system in real time for pharmaceutical water
abstract here
thermo logo MicroSEQ® Identification system for routine environmental monitoring
abstract here
  11h30 - Micro-organism's identification
Arnaud CARLOTTI - Eurofins
  12h00 - Multicentric study on incubation temperatures for environmental monitoring and aseptic process simulations
Roland GUINET - RGMP Compliance
  12h30 Lunch
  14h30

Round table:
- Environmental Controls developments and strategies
- Changes in Annex I
Roland GUINET - RGMP Compliance

  16h30   Conference Closing

 

microbio banner 2016

 

biomerieux logo hd

1 WORKSHOP - Part 1

Identification: what's new since the advent of identification technologies?

Whatever your identification system, we offer a "update your knowledge" in microbial identification.
A fun and interactive workshop to discover or rediscover the history of microbiology and an update on the latest advances and technological taxonomic
Finally an update that does not require exchange control or requalification test, enjoy ...!

charles river logo hd

2 WORKSHOP - Part 1

Workshop detection: ATPmétrie Technology for enhanced microbial detection 24h and a sterility test in 4 / 7 days: focus on complex products (non-filterable, opaque, oily ...)

Initiatives such as the PAT are created to help the industry to pharmaceuticals to market faster without sacrificing quality and security.
Adenosine triphosphate (ATP) is the basic energy molecule found in all living cells, methods of ATP bioluminescence, have become a standard for rapid microbial detection.
During the workshop we discuss the determination of ATP by bioluminescence using an enzymatic reaction (complex luciferin / luciferase) releasing energy in the form of light measured using a luminometer. The ATP technology is amplified to 25 50% faster than standard ATP test and quickly delivers accurate and reliable results for microbial limits testing (MLT) and sterility. The absence of microorganisms was confirmed in 24h for MLT or to 4 7 days for sterility testing.
We then discuss the implementation of ease of this nondestructive technology that offers flexibility and protocols for the treatment of complex samples (non-filterable, non-soluble, oily, opaque ...).
This technology allows the use of a similar approach or improved your conventional method, both in terms of environments that incubation and seeding.
Finally, we'll talk about Celsis approach in the validation of rapid methods for detecting microbial and sterility in accordance with the regulations in force:

  • PDA Technical Report 33 - Evaluation, Validation and Implementation of New Microbiological Testing Methods
  • Ph EUR 5.1.6. - Alternative Methods for Control of Microbiological Quality
  • USP Chapter <1223> - Validation of Alternative Microbiological Methods



 

Amplified ATP bioluminescence assay for microbial detection in 24h and sterility testing in 4 / 7 days: highlight on hard-to-test product type (non-filterable, non-soluble, oil, opaque or highly pigmented ...).

PAT --other and initiatives are designed to help companies get Their pharmaceutical products out the door more Quickly without Sacrificing safety.
All living organisms contenir adenosine triphosphate (ATP)
ATP bioluminescence assays are now the industry standard for rapid microbial detection.
During this workshop We Will review the standard ATP bioluminescence assay using the enzyme luciferase to catalyze the consumption of microbial ATP qui Produces light Measured by a luminometer.
Amplified ATP technology is to 25 50% faster than the standard ATP assay and Generates reliable and accurate results Quickly for microbial limits (MLT) and sterility testing.
Negative growth is confirmed 24 Within hours MLT for gold, for sterility testing, in 4 7 days to for sterility testing (less than half the time of traditional methods).
Then We Will address the easy implementation process of this non-destructive technology, protocol Offering flexibility and management of hard-to-test product type (non-filterable, non-soluble, oil, opaque or highly pigmented ...).
This technology Provides a similar or more effective approach to your classical microbial testing in terms of media, incubation and seeding.
Finally, we'll approach the Chat the Celsis Within The validation of rapid microbial detection method in compliance with current règlements texts:

  • PDA Technical Report 33 - Evaluation, Validation and Implementation of New Microbiological Testing Methods
  • Ph EUR 5.1.6. - Alternative Methods for Control of Microbiological Quality
  • USP Chapter <1223> - Validation of Alternative Microbiological Methods

lonza logo hd

3 WORKSHOP
Low Endotoxin Recovery - Where does the industry stand?

Low Endotoxin Recovery (LER) Also Known As low Lipopolysaccharide Recovery (LLR) has-been a controversial topic circulating endotoxin testing Throughout The community for Nearly three years. There is some evidence to show LER That is an irreversible masking effect Brought about the combination of some surfactants (Polysorbate) and chelators (Citrate Phosphate) That are used in over 70% of drug formulations, PARTICULARLY biologics.
Although Some-have Suggested "demasking" as a means clustering to Overcome LER and comply-with the US Food and Drug Administration's request for hold-time studies in Biologics License Applications (BLA), Many Are still try trying to Understand whether thesis processes are Actually Necessary. The argument remains que la LER phenomenon is something That Actually HAS-been around for years, and Does not pose a public health risk. While others still questions whether There Is a missing link entre les unrecoverable endotoxin and Its potential to Become active in the human body.
Like most manufacturers endotoxin test, Lonza HAS aussi beens Following The LER movement and is working diligently to find a solution to assist drug manufacturers In Their product investigations. This presentation Will walk through the current status of LER, From Both the user and Regulatory Perspective. We Will give insight as to what regulators are looking to see in the BLA Regarding hold-time studies, as well as Provide insight into what the industry is doing to "unmask" the endotoxin That May be lurking in drug products.

Merck logo hd


Part 4 2 WORKSHOP
Exchange of experiences on microbiological monitoring of aseptic production lines RABS or isolator. We will share visions of the pharmaceutical industry.

The following topics will be covered:

  • The demonstration of "Isobag" insulator, introduction of new technology "All in One" environmental agar Merck ready-to save space and time
  • Monitoring of airborne microorganisms, key to monitoring a RABS or isolator production: interest of the qualification of new air sampling systems using suitable culture media, examples of mobile devices (personal sampling points) or multi remote heads in the controlled area (several samples simultaneously, pump and electronics for out of area space and time gain), programming modes of taking, secure management of the decontamination cycle of equipment, quality control agar .
  • Optimization of sampling surfaces and gloves: how to prevent the risk of false negatives and secondary contaminations difficult to critical access points, ...?
  • Questions answers

mettler hd logo
5 WORKSHOP
No organisms will escape you!

METTLER TOLEDO Thornton Reveals New microbial control system in real time for pharmaceutical waters.

Discover the 7000RMS first online analyzer for continuous monitoring of microbial load.

Detection of microbial contamination in real time a real need

"For several years, the pharmaceutical industry wants a system for real-time measurement of the microbial load," says Anthony Bevilacqua, Director of R & D department at METTLER TOLEDO Thornton.
"This technology will be invaluable and will help pharmaceutical companies to validate their real-time water distribution systems, reduce costs related to sampling and offline to eliminate false positives," says Jim Cannon , head of the pharmaceutical market in Thornton.

The 7000RMS allows continuous analysis of microbial contamination and inert particles both in the water distribution system at a point of use.

This compact unit not only provides real-time assessment of bioburden levels in the water, but it also reduces the cost of labor (limited sampling and tests) and energy consumption through a better management of sanitation cycles while leading to a better understanding of the process and increased product safety.

Revolution in microbial detection

Unlike other modern techniques to measure microorganisms in water, the laser-induced fluorescence technology (LIF) integrated in 7000RMS requires no coloring or reagent, which is therefore a real time saver.

The integration of LIF technology in the analyzer associated with the Mie theory and sophisticated algorithms to measure and determine whether they are microorganisms or inert particles.

The analyzer is ideal for use online or "at-line" and for laboratory sampling measurements.

With a touch user interface with multiple data transfer options, it is equipped with SCADA connectivity with ModBus TCP, several analog outputs and can work with Wi-Fi.


thermo logo hd
Part 6 1 WORKSHOP
The offer renewed Thermo Fisher Scientific

The purpose of this workshop is to present the complete range of Thermo Fisher Scientific group for microbiology pharmaceutical and related industry which now includes the Life Technologies solutions. We want to review our historical ranges and news.

1) media for Media Fill Test: the use of dehydrated media to use formulations of ready-packaged PCB innovative containers.

2) The Cultiloops and Quanticult strains for control of fertile environments and control of identification automata

3) The new triple bagged TWIP boxes Thermo Scientific for environmental control isolator or clean room.

4) The offer dedicated to the cosmetic industry

5) The Sensititre range for the determination of minimum inhibitory concentrations.

6) MicroSeq identification system for environmental control by DNA sequencing 16S for bacteria and fungi to D2 gene.

7) Contaminants cell culture: Detection of mycoplasma, virus and murine Vesivirus by real-time PCR.



A Renewed offer from Thermo Fisher Scientific

The goal of this workshop is to present the broad offer for the pharma microbiology Proposed by Thermo Fisher Scientific group. Solutions from Life Technologies are now integrated. We will review our hand products ranges and the latest releases In Particular.

1) Broths for Media Fill Tests: from dehydrated formats to the use of innovative solutions of ready Prepared broths in Bio Process Containers.

2) Collection strains Cultiloops Quanticult and for the control of culture media and vending of identification.

3) New triple wrapped flat TWIP Thermo Scientific for environment control in isolator and clean room.

4) Range of products dedicated to the cosmetic industry.

5) Sensititre automat for the determination of minimum inhibitory concentrations.

6) MicroSEQ® Identification system for routine environmental monitoring: microbial detection based on the 16S rRNA gene for a specific bacteria or genomic area of ​​the wide subunit for fungi

7) Contaminants of pharmaceutical products. Detection of Mycoplasma, Vesivirus and Mouse Minute Virus. Replaced your cultivation method by real time PCR!



biomerieux logo hd

1 WORKSHOP - Part 2
Environment: Environmental Controls, news and perspectives

Based on current practices and expectations of the pharmaceutical industry, we offer a round table to debate on topics as diverse as expiration, neutralization, security of supply, automation, performance, sequences incubation and ease of implementation in everyday life.


charles river logo hd



2 WORKSHOP - Part 2

Identification workshop: MPROVING your environmental monitoring with the identification polyphasic approach and monitoring trends


Precise identification of microorganisms in industrial settings is a critical element of the environmental monitoring program (EM).

All methods whether phenotypic, genotypic or proteotypic have strengths and weaknesses. The objective of the workshop will be to describe the multiphase approach, the best compromise to have the most reliable method for identifying the most profitable and financially.

An expert will intervene to describe the MALDI-TOF mass first method chosen for this polyphasic approach. Then we will detail the sequencing used in back-up, historical premium method offering the most extensive databases.

The combination of both techniques can improve the identification rate (98%) and reduce the error rate (2%).

We then describe the Charles River approach for more efficient management of the production environment based on reliable identification combined with regular monitoring of trends.

This monitoring through the platform "Tracking & Trending" allows the detection of the emergence of indicator organisms and rapid and precise highlight any deviation from the normal operating conditions. It provides manufacturers with the information needed to respond to alerts and deviations that may occur in their facilities.



Workshop Identification: Improvement of your environmental monitoring program with a polyphasic approach and trending analysis

Accurate identification of unknown bacterial isolates is an essential first step in understanding the impact and Improving industry environmental monitoring program (EM).
All methods, phenotypic, genotypic and Strengths and Weaknesses proteotypic-have. The goal of this workshop is to describe the multiphase approach; The Most confidant, fast and cost-effective option for accurate microbial identification.
A Mass Spectrometry Expert Will detail the MALDI-TOF, the primary method Chosen for this polyphasic approach. We Will Then describe the sequencing method Supporting the proteotypic one; it is the gold standard for classification with the Widest library.
Combination of the two technical Allows to Improve the identification rate extendible up to 98% and to Decrease the error rate to 2%.
Then We Will present the Charles River to Improve comprehensive approach based environmental monitoring is accurate identification combined with regular tracking analysis.
The Tracking and Trending IT solution equip factories with the Necessary data to detect the emergence of changes in the microflora, to tour and responds to alerts in your facility.

lonza logo hd

3 WORKSHOP
Low Endotoxin Recovery - Where does the industry stand?

Low Endotoxin Recovery (LER) Also Known As low Lipopolysaccharide Recovery (LLR) has-been a controversial topic circulating endotoxin testing Throughout The community for Nearly three years. There is some evidence to show LER That is an irreversible masking effect Brought about the combination of some surfactants (Polysorbate) and chelators (Citrate Phosphate) That are used in over 70% of drug formulations, PARTICULARLY biologics.
Although Some-have Suggested "demasking" as a means clustering to Overcome LER and comply-with the US Food and Drug Administration's request for hold-time studies in Biologics License Applications (BLA), Many Are still try trying to Understand whether thesis processes are Actually Necessary. The argument remains que la LER phenomenon is something That Actually HAS-been around for years, and Does not pose a public health risk. While others still questions whether There Is a missing link entre les unrecoverable endotoxin and Its potential to Become active in the human body.
Like most manufacturers endotoxin test, Lonza HAS aussi beens Following The LER movement and is working diligently to find a solution to assist drug manufacturers In Their product investigations. This presentation Will walk through the current status of LER, From Both the user and Regulatory Perspective. We Will give insight as to what regulators are looking to see in the BLA Regarding hold-time studies, as well as Provide insight into what the industry is doing to "unmask" the endotoxin That May be lurking in drug products.


Merck logo hd

Part 4 1 WORKSHOP
Development and validation of a rapid sterility test: Company Experience Back CONFARMA France, quality control expert.

The implementation of alternative methods to control microbiological quality is an investment project that affects more and more of the world of health industries. The validation of an alternative system for this sterility test challenges as verification of the applicability of a product on a new technology. Several issues can be encountered during the validation phase:

  • product compatibility with the technical
  • Generating results "false positives"
  • Neutralization of the antimicrobial activity on innovative technology
  • Interference with the product technology
  • Comparability of the alternative method with the traditional method

This workshop will address these issues from the perspective of CONFARMA France, who will provide feedback on the technology Milliflex® Rapid using examples encountered during validations on its customers' products.

mettler hd logo
5 WORKSHOP
No organisms will escape you!

METTLER TOLEDO Thornton Reveals New microbial control system in real time for pharmaceutical waters.

Discover the 7000RMS first online analyzer for continuous monitoring of microbial load.

Detection of microbial contamination in real time a real need

"For several years, the pharmaceutical industry wants a system for real-time measurement of the microbial load," says Anthony Bevilacqua, Director of R & D department at METTLER TOLEDO Thornton.
"This technology will be invaluable and will help pharmaceutical companies to validate their real-time water distribution systems, reduce costs related to sampling and offline to eliminate false positives," says Jim Cannon , head of the pharmaceutical market in Thornton.

The 7000RMS allows continuous analysis of microbial contamination and inert particles both in the water distribution system at a point of use.

This compact unit not only provides real-time assessment of bioburden levels in the water, but it also reduces the cost of labor (limited sampling and tests) and energy consumption through a better management of sanitation cycles while leading to a better understanding of the process and increased product safety.

Revolution in microbial detection

Unlike other modern techniques to measure microorganisms in water, the laser-induced fluorescence technology (LIF) integrated in 7000RMS requires no coloring or reagent, which is therefore a real time saver.

The integration of LIF technology in the analyzer associated with the Mie theory and sophisticated algorithms to measure and determine whether they are microorganisms or inert particles.

The analyzer is ideal for use online or "at-line" and for laboratory sampling measurements.

With a touch user interface with multiple data transfer options, it is equipped with SCADA connectivity with ModBus TCP, several analog outputs and can work with Wi-Fi.


thermo logo hd
Part 6 2 WORKSHOP
Microbiological environmental monitoring in the cleanroom or isolator ... how to validate a new range of backgrounds ... and a new applicator innovative contact boxes?

The purpose of this workshop is to provide guidance and technical advice to achieve an in situ validation boxes in media (TSA Sabouraud) for environmental control (air and surfaces). Will be reviewed including the validation of neutralizing properties, cultural performance, the ability to sterilize packaging peroxide permeability, resistance to desiccation ... An example of evaluation protocol will be provided to each part of the process qualification.

The presentation will be illustrated by taking the example of the new triple bagged and irradiated boxes offered by Thermo Scientific and its applicator. They have an innovative technology for enhanced security ...



Microbiological control of isolators and clean rooms - how to validate the use of a new year ... flat has new innovative touch flat applicator?

The purpose of this workshop is to Provide Some technical guidelines and tips to perform a validation of website settle flat or flat contact for environment control. Will be Discussed the assessment of medium neutralization Ability, medium fertility, sterilization Ability of packages, peroxide permeability, resistance to desiccation ... An example of test protocol Will Be Provided For Each share of the qualification process.

The presentation will be illustrated with the new triple wrapped and irradiated flat from Thermo Scientific and Their applicator. This fully validated solution Provide innovative technical features for a safer approach ...

biomerieux logo hd1 WORKSHOP - Part 3

Environment: Monitoring of physical parameters in the laboratory control.

Labguard3D is a highly automated solution for monitoring thermostatic chambers of laboratory and production areas. This innovative solution consists of radio transmitters fitted with sensors capable sensors and transmit information by radio frequency to a receiver Ethernet. All monitoring is so centralized in a secure software on the company server. The result is a valuable human time saving for monitoring thermostatic chambers in comparison to surveys conducted empirically manuals. An alert manager informs Quality responsible for any malfunctions at all times by automatically sending SMS, emails or phone calls. The new generation of Labguard3D transmitters is very high capacity: 4 thermostatic chambers can be controlled simultaneously by a single issuer. The transmitter is also multi LABGUARD; it is possible to monitor different physical parameters on the same transmitter. These exclusive 2 points constitutes a technological first, cause a reduction in the cost of installation to -25% compared to traditional monitoring stations. The Labguard3D issuers also have an alarm system 3D color and a GUI. For 1ere time, Labguard3D temperature sensors feature a smart memory for recording the measurement parameters of the probes.

 

 

charles river logo hd



2 WORKSHOP - Part 2

Identification workshop: MPROVING your environmental monitoring with the identification polyphasic approach and monitoring trends


Precise identification of microorganisms in industrial settings is a critical element of the environmental monitoring program (EM).

All methods whether phenotypic, genotypic or proteotypic have strengths and weaknesses. The objective of the workshop will be to describe the multiphase approach, the best compromise to have the most reliable method for identifying the most profitable and financially.

An expert will intervene to describe the MALDI-TOF mass first method chosen for this polyphasic approach. Then we will detail the sequencing used in back-up, historical premium method offering the most extensive databases.

The combination of both techniques can improve the identification rate (98%) and reduce the error rate (2%).

We then describe the Charles River approach for more efficient management of the production environment based on reliable identification combined with regular monitoring of trends.

This monitoring through the platform "Tracking & Trending" allows the detection of the emergence of indicator organisms and rapid and precise highlight any deviation from the normal operating conditions. It provides manufacturers with the information needed to respond to alerts and deviations that may occur in their facilities.



Workshop Identification: Improvement of your environmental monitoring program with a polyphasic approach and trending analysis

Accurate identification of unknown bacterial isolates is an essential first step in understanding the impact and Improving industry environmental monitoring program (EM).
All methods, phenotypic, genotypic and Strengths and Weaknesses proteotypic-have. The goal of this workshop is to describe the multiphase approach; The Most confidant, fast and cost-effective option for accurate microbial identification.
A Mass Spectrometry Expert Will detail the MALDI-TOF, the primary method Chosen for this polyphasic approach. We Will Then describe the sequencing method Supporting the proteotypic one; it is the gold standard for classification with the Widest library.
Combination of the two technical Allows to Improve the identification rate extendible up to 98% and to Decrease the error rate to 2%.
Then We Will present the Charles River to Improve comprehensive approach based environmental monitoring is accurate identification combined with regular tracking analysis.
The Tracking and Trending IT solution equip factories with the Necessary data to detect the emergence of changes in the microflora, to tour and responds to alerts in your facility.

lonza logo hd

3 WORKSHOP
Low Endotoxin Recovery - Where does the industry stand?

Low Endotoxin Recovery (LER) Also Known As low Lipopolysaccharide Recovery (LLR) has-been a controversial topic circulating endotoxin testing Throughout The community for Nearly three years. There is some evidence to show LER That is an irreversible masking effect Brought about the combination of some surfactants (Polysorbate) and chelators (Citrate Phosphate) That are used in over 70% of drug formulations, PARTICULARLY biologics.
Although Some-have Suggested "demasking" as a means clustering to Overcome LER and comply-with the US Food and Drug Administration's request for hold-time studies in Biologics License Applications (BLA), Many Are still try trying to Understand whether thesis processes are Actually Necessary. The argument remains que la LER phenomenon is something That Actually HAS-been around for years, and Does not pose a public health risk. While others still questions whether There Is a missing link entre les unrecoverable endotoxin and Its potential to Become active in the human body.
Like most manufacturers endotoxin test, Lonza HAS aussi beens Following The LER movement and is working diligently to find a solution to assist drug manufacturers In Their product investigations. This presentation Will walk through the current status of LER, From Both the user and Regulatory Perspective. We Will give insight as to what regulators are looking to see in the BLA Regarding hold-time studies, as well as Provide insight into what the industry is doing to "unmask" the endotoxin That May be lurking in drug products.

Merck logo hd


Part 4 2 WORKSHOP
Exchange of experiences on microbiological monitoring of aseptic production lines RABS or isolator. We will share visions of the pharmaceutical industry.

The following topics will be covered:

  • The demonstration of "Isobag" insulator, introduction of new technology "All in One" environmental agar Merck ready-to save space and time
  • Monitoring of airborne microorganisms, key to monitoring a RABS or isolator production: interest of the qualification of new air sampling systems using suitable culture media, examples of mobile devices (personal sampling points) or multi remote heads in the controlled area (several samples simultaneously, pump and electronics for out of area space and time gain), programming modes of taking, secure management of the decontamination cycle of equipment, quality control agar .
  • Optimization of sampling surfaces and gloves: how to prevent the risk of false negatives and secondary contaminations difficult to critical access points, ...?
  • Questions answers

mettler hd logo
5 WORKSHOP
No organisms will escape you!

METTLER TOLEDO Thornton Reveals New microbial control system in real time for pharmaceutical waters.

Discover the 7000RMS first online analyzer for continuous monitoring of microbial load.

Detection of microbial contamination in real time a real need

"For several years, the pharmaceutical industry wants a system for real-time measurement of the microbial load," says Anthony Bevilacqua, Director of R & D department at METTLER TOLEDO Thornton.
"This technology will be invaluable and will help pharmaceutical companies to validate their real-time water distribution systems, reduce costs related to sampling and offline to eliminate false positives," says Jim Cannon , head of the pharmaceutical market in Thornton.

The 7000RMS allows continuous analysis of microbial contamination and inert particles both in the water distribution system at a point of use.

This compact unit not only provides real-time assessment of bioburden levels in the water, but it also reduces the cost of labor (limited sampling and tests) and energy consumption through a better management of sanitation cycles while leading to a better understanding of the process and increased product safety.

Revolution in microbial detection

Unlike other modern techniques to measure microorganisms in water, the laser-induced fluorescence technology (LIF) integrated in 7000RMS requires no coloring or reagent, which is therefore a real time saver.

The integration of LIF technology in the analyzer associated with the Mie theory and sophisticated algorithms to measure and determine whether they are microorganisms or inert particles.

The analyzer is ideal for use online or "at-line" and for laboratory sampling measurements.

With a touch user interface with multiple data transfer options, it is equipped with SCADA connectivity with ModBus TCP, several analog outputs and can work with Wi-Fi.


thermo logo hd
Part 6 3 WORKSHOP
MicroSEQ® Identification system for routine environmental monitoring

  • An easy to use platform
  • MSID v3.0: self-identification results
  • Increasing the ability to identify with the library "MicroSEQ® ID 16S 500 bp Supplemental Library"

Ion 16S ™ Solution Metagenomics typing of microorganisms by massive sequencing of semiconductor, potential technological breakthroughs of tomorrow.



MicroSEQ® identification system for routine environmental monitoring

  • A simplified platform for microbial identification
  • MSID v3.0: A single user software with Auto-ID interface
  • Expanding the Ability of identification through MicroSEQ® ID 16S 500 bp Supplemental Library

Ion ™ 16S Metagenomics Solution: Rapid identification of polybacterial research samples using Ion Torrent Sequencing Systems

Hotels in the vicinity

Mercure Tours Centre ***

29, rue Edouard Vaillant
Such. 02 47 60 40 60


The Grand Hotel ***

9, place du Maréchal Leclerc

Offer Dating A3P Microbiology
Single bb classic 74.00 euros
Single bb comfort 84.00 euros
Single bb upper 99.00 euros
Tourist tax: EUR 1.10


Ibis Tours Centre ***

1, rue Maurice Genest (ex rue Georges Claude)
Such. 02 47 70 35 35


Adagio Access ***

41, rue Edouard Vaillant
Such. 02 47 47 40 00