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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

Nearby Hotels

Mercure Tours Centre ***

29, rue Edouard Vaillant
T. 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)
T. 02 47 70 35 35


Adagio Access ***

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