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

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

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

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

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

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

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

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

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

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

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

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

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

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: 100+ cells per ml* Time: Result available 15 min after sampling for a single sample * application dependent Sensitivity: 1 microorganism per pack* Time: Result available 15 min after pre-incubation and sampling (single sample) Pre-incubation: 24 - 72 hours in pack* * application dependent Copyright AES-Chemunex 2008 Pascal Yvon, Pharm.D., MBA

AES-Chemunex: Rapid Microbiology Systems D-Count - fully automated analyzer - up to 350 samples per working shift - throughput 50 samples/h (application dependent) - capacity 1 - 50 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

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

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 24-48 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

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

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

CEO of AES-Chemunex, Inc. Contact: Pascal Yvon Tel. 609 497 0166 p.yvon@us.aeschemunex.com AES – Chemunex, Inc. 301 N. Harrison Street, Suite 109 Princeton, NJ 08540 Fax 609 497 7307 www.aeschemunex.com Pascal Yvon, PharmD, MBA CEO of AES-Chemunex, Inc. Princeton, NJ Copyright AES-Chemunex Pascal Yvon, Pharm.D., MBA, 2008