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The Latest RBD 3000 Applications Advanced Analytical User’s Meeting November 30, 2006 Chicago, IL

The Latest RBD 3000 Applications Advanced Analytical User’s Meeting November 30, 2006 Chicago, IL. Overview. Contamination Level Test For materials that contain low-level bio-burden Determines that material meets microbial specification Utilizes the Most Probable Number (MPN) protocol

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The Latest RBD 3000 Applications Advanced Analytical User’s Meeting November 30, 2006 Chicago, IL

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  1. The Latest RBD 3000 ApplicationsAdvanced Analytical User’s MeetingNovember 30, 2006Chicago, IL

  2. Overview • Contamination Level Test • For materials that contain low-level bio-burden • Determines that material meets microbial specification • Utilizes the Most Probable Number (MPN) protocol • Useful for complex matrices • Antimicrobial Effectiveness Test • Rapidly screens candidate preservative systems • Tracks an increase in dead cell count

  3. Contamination Level Test – Feasible in a Variety of Complex Matrices Company A – In-process pharmaceutical product Company B – Various nutraceutical finished products • Juice, Body Butter, Fiber Company C – Liquid nutraceutical finished product Company D – Various alcoholic beverages

  4. CLT – Protocol for <100cfu/g specification

  5. CLT – Results Company A In-process Product: Specification <1000cfu/g Spiked Below Specification Product contains >100cfu/g and <1000cfu/g; product is within specification Actual spike was 559 cfu Ps. aeruginosa/g product Spiked Above Specification Product contains >1000cfu/g; product fails Actual spike was 3920 cfu Ps. aeruginosa/g product

  6. CLT – Results Company B Body Butter & Juice Products: Specification <100cfu/g or mL Body Butter: Spiked Below Specification Product contains >10cfu/g and <100cfu/g; product is within specification Actual spike was 35 cfu C. albicans/g body butter Juice: Spiked Above Specification Product contains >100cfu/g; product fails Actual spike was 110cfu C. albicans/mL juice Taken fromposter presentation at ASM 2006 A Rapid Most Probable Number Test for Yeast in Nutraceutical Products, K.A. Molitor and A.M. Steger, Advanced Analytical Technologies, Inc., Ames, IA 50010 and D. Wright and M. Roblin, Morinda, Inc., Orem, UT 84604

  7. Contamination Level Test – Benefits • 18-24hr time-to-result • Detects lower levels of potential microbial contamination than the traditional plate count method in complex/opaque matrices • Results are confirmed by the “Most Probable Total Count by Multiple-Tube Method” in USP Chapter <61>, Microbial Limits Test

  8. Antimicrobial Effectiveness Test

  9. Antimicrobial Effectiveness Test • Used to screen candidate preservatives for liquid products • Pharmaceutical and Cosmetic Industries routinely perform • New & reformulated products • Problems with the current method: • Compendial method takes 35 days • Requires significant labor & materials • Not all types &/or formulations of antimicrobials are screened due to time & labor constraints • Delays development of suitable preservative systems • Delays product time to market

  10. Antimicrobial Effectiveness Test – Solution • Use the RBD 3000 to rapidly screen candidate preservative systems • Benefits: • Shorter time to result • Significant labor and materials savings • Evaluate more types/formulations of antimicrobials • Develop better preservative systems • Speed product time to market

  11. Antimicrobial Effectiveness Test – Protocol • Challenge 0.01% (w/v) Benzoic Acid with 105 – 106 cfu/mL • Perform challenge studies with Ps. aeruginosa, S. aureus, and C. albicans • Use RBD 3000 to determine titer of inoculum • Sample at 0, 2hr, 4hr, 6hr, 8hr & 24hr post-inoculation • Dilute samples 1:10 in phosphate buffer for RBD 3000 Biomass & Dead Cell counts using the Biomass and Dead Cell Test Kits • Dilute samples in phosphate buffer + 4% Tween 20 for TSA plate count comparison

  12. 0.01% Benzoic Acid Challenged with Ps. aeruginosa – Test 1

  13. 0.01% Benzoic Acid Challenged with Ps. aeruginosa – Test 2

  14. 0.01% Benzoic Acid Challenged with S. aureus

  15. 0.01% Benzoic Acid Challenged with C. albicans

  16. Antimicrobial Effectiveness Test – Action Items • Test other preservative systems • Determine utility in various liquid product formulations • Demonstrate feasibility with A. niger spores

  17. Summary • Contamination Level Test • Provides a rapid & sensitive detection method for determining if materials meet particular microbial specifications • Antimicrobial Effectiveness Test • Provides a rapid method for screening candidate preservative systems

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