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

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

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

The Rapid Microbiology Company Finished productsRaw MaterialsIn-Process Testing Risk-Based Analysis: Impact of Microbial Contamination 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

The Rapid Microbiology Company Finished productsRaw MaterialsIn-Process Testing QA Challenges 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

The Rapid Microbiology Company  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 Need: Faster Results from the Micro Lab Copyright AES- Chemunex 2008 Pascal Yvon, Pharm.D., MBA

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

The Rapid Microbiology Company 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

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

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

The Rapid Microbiology Company AES-Chemunex: Labeling Technology CRITERIA OF VIABILITY  Enzyme activity  Membrane integrity Enzyme Viability substrate Free fluorochrome Microorganism 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 DIRECT LABELING

The Rapid Microbiology Company AES Chemunex Detection Technology: Flow Cytometry Detecto r 1 Detecto r 2 Waste Las er 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  Microorganism cells are counted directly one by one Copyright AES- Chemunex 2008 Pascal Yvon, Pharm.D., MBA DIRECT DETECTION & ENUMERATION

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

The Rapid Microbiology Company Direct Count Test & Presence-Absence Test Raw materials Non-sterile products Process water Sensitivity: 100+ cells per ml* Time: Result available 15 min after sampling for a single sample * application dependent DIRECT COUNT METHOD Final-product testing Sterile products PRESENCE/ABSENCE METHOD Sensitivity: 1 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

The Rapid Microbiology Company - fully automated analyzer - up to 350 samples per working shift - throughput 50 samples/h (application dependent) - capacity samples per batch - fully automated analyzer - 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 AES-Chemunex: Rapid Microbiology Systems D-Count BactiFlow ALS BactiFlow Copyright AES- Chemunex 2008 Pascal Yvon, Pharm.D., MBA

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

The Rapid Microbiology Company 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

The Rapid Microbiology Company 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

The Rapid Microbiology Company Companies Using Rapid Microbiology Copyright AES- Chemunex 2008 Pascal Yvon, Pharm.D., MBA 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

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