1. Rapid Microbiology Results Challenges and Solutions
For FOOD Products
Challenges and Solutions
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

2. Production Process: From Farm to Finished Products
From Farms Factories Finished Products TO TO
Manage Your Quality During
the Whole Production Process
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

3. Critical Control Points (CCPs) In the Production Process
Testing of
Raw Materials
& Water
In-Process Testing
(Blending, Filling,
Pasteurization, etc.)
& Cleaning Validation
Testing & Release of
Finished Products
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

4. Risk-Based Analysis: Impact of Microbial Contamination
Raw Materials
In-Process Testing
Finished products
Unloading contaminated trucks
Low quality of raw materials
Contamination of storage tanks
Formation of biofilms
High sanitization costs
Plant downtime
Loss of in-process products
High cost of re-treatment
Contamination of tanks
Plant downtime
High cost of cleaning
Loss of contaminated batches
Back orders
Loss of business
Recalls
Damage to company image
Waste of Time / Loss of Money
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

5. Proactive Actions in QA to Save Time & Money
QA Challenges
Raw Materials
In-Process Testing
Finished products
Real -time control of raw materials before unloading
Real-time control of water
Fast analysis of bulk products before filling
Optimize pasteurization conditions according to microbial content
Fast detection, localization & correction of contamination
Decrease warehouse costs
Increase production flexibility
Decrease product losses
Minimize production disruption
Protection of company image
Improved delivery time
Proactive Actions in QA to Save Time & Money
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

6. Need: Faster Results from the Micro Lab
Traditional microbiology results are based on plate-count methods, which can take 3 to 7+ days until results are available
Slow results
Retrospective to production schedules
Results vary with microbial population, media & conditions
Spores & stressed cells require extended growth periods
Products need to be kept in quarantine until micro results are available
Raw materials can not be used until micro lab delivers results
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

7. Advantage: Rapid Results Within 24 or 48 Hours
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

8. Solution: Real-Time Microbiology Testing
Minimize contamination risks
Control raw materials before use
Implement just-in-time production
Remediate problems in real-time
Minimize holding time
Release products earlier
Reduce cost for product storage
Minimize losses
Guarantee product quality
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

9. Benefits of Rapid Microbiology
Raw Materials
In-Process Testing
Finished products
Direct count raw material within 20min
Direct count water within 20min
Save 2 to 4 Days
Direct count surface within 20min
Presence/Absence TVC 24h
Save 2 to 4 Days
Presence/Absence TVC 24h
Save 2 to 4 Days
Total Time Savings over the Entire Production Cycle:
6 TO 12 DAYS
Save Time & Money with Total QA
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

10. AES-CHEMUNEX: Unique Solutions
Rapid Microbiology Testing
Using Ultra-sensitive
Flow-cytometers
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

11. AES-Chemunex: Labeling Technology
Enzyme
Viability substrate
Free fluorochrome
DIRECT
LABELING
Microorganism
CRITERIA OF VIABILITY
Enzyme activity
Membrane integrity
APPLICABLE FOR
Total Viable Count
Yeast & Molds
Enterobacteriaceae (selective enrichment)
Salmonella (selective enrichment and immunologic labeling)
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA 11

12. AES Chemunex Detection Technology: Flow Cytometry
DIRECT DETECTION
& ENUMERATION
Detector 1
Detector 2
Waste
Laser
Sample
Designed for industrial
microbiology testing
Sample passes flowcell
in a linear fluid stream
Microorganism cells are
illuminated by 488 nm
laser beam
Emmitted fluorescence
is collected by sensitive
detectors
counted directly one by one
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

13. Results Directly In Microbial Cell Counts
No Calibration
No Interpretation
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

14. Direct Count Test & Presence-Absence Test
Raw materials
Non-sterile products
Process water
Final-product testing
Sterile products
DIRECT COUNT METHOD
PRESENCE/ABSENCE METHOD
Sensitivity: cells per ml*
Time: Result available 15 min
after sampling for a
single sample
* application dependent
Sensitivity: microorganism per pack*
Time: Result available 15 min
after pre-incubation and sampling (single sample)
Pre-incubation: hours in pack*
* application dependent
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

15. AES-Chemunex: Rapid Microbiology Systems
D-Count
- fully automated analyzer
- up to 350 samples per working shift
- throughput 50 samples/h (application dependent)
- capacity samples per batch
- up to 150 samples per day
- throughput 20 samples/h (application dependent)
- capacity 1-25 samples per batch
- semi-automatic analyzer
- up to 50 samples per day
- 1 to 10 samples per batch
BactiFlow ALS
BactiFlow
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

16. Applications Dairy Beverages Salad, meat, etc. Water
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

17. AES-Chemunex: Combining Speed with Sensitivity
Easy-to-use systems, designed for industrial microbial use
Rapid results
Direct Count results within a few minutes after sampling
Presence / Absence test for sterile samples with typically hours pre-incubation of sample
Direct Counting and Presence/Absence Test
Quantitative Direct Count Method: counting cell by cell
No calibration curve required, no data interpretation
Direct correlation with traditional plate count, easy to validate
High Sensitivity
Large Linear Counting: up to 500,000 microorganisms/ml labeled solution
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

18. Rapid Microbiology: Benefits
SENSITIVITY TO ONE CELL, ACCURACY & SPEED
DIRECT COUNTING OF MICROBIAL CELLS
HIGH CAPACITY & THROUGHPUT, MINIMUM OPERATOR TIME, NO INTERPRETATION
Get results in hours
Test raw materials, in-process & final products in real time
Release final products in hours, not days
Extend product shelf life by days
Reduce warehousing space & costs
Reduce production downtimes & contamination risks
Detect & respond to contamination risks immediately
Increase production flexibility & productivity
Increase profitability
Safeguard product quality, reputation & customer satisfaction
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

19. Companies Using Rapid Microbiology
Antartic
BINA Bischofszell
Cadbury Schweppes
Coca Cola
Cott
Dannon
Délifruits
Del Monte
Eckes Granini
Emig Gerber
Frutarom
Fruchtquell-Gerolsteiner
Hassia Mineralbrunnen
Hochwald Sprudel
Joker
Kerry Aptunion
Pfanner
Rauch Fruchsäfte
Rivella
Dr. Siemer Getränke
Sill
Wesergold
Wild, Wild Flavors
Zuegg
Copyright AES-Chemunex 2008
Pascal Yvon, Pharm.D., MBA

20. CEO of AES-Chemunex, Inc.
Contact: Pascal Yvon
Tel
AES – Chemunex, Inc.
301 N. Harrison Street, Suite 109
Princeton, NJ 08540
Fax
Pascal Yvon, PharmD, MBA
CEO of AES-Chemunex, Inc.
Princeton, NJ
Copyright AES-Chemunex
Pascal Yvon, Pharm.D., MBA, 2008