Presentation is loading. Please wait.

Presentation is loading. Please wait.

Jack Rowe Jack Rowe Certified Laboratories, Inc. Bridging Science with Service Since 1926.

Similar presentations

Presentation on theme: "Jack Rowe Jack Rowe Certified Laboratories, Inc. Bridging Science with Service Since 1926."— Presentation transcript:

1 Jack Rowe Jack Rowe Certified Laboratories, Inc. Bridging Science with Service Since 1926


3 AOAC Performance Tested Method (RI) AOAC Official Methods of Analysis

4 Rapid increase in Proprietary Methods Speed to market critical AOAC OMA Higher Cost, More Time Performance Tested Methods Kicked off in 1991 Opportunity to achieve some level of validation in less time Often serves as a pre-collaborative until full OMA is completed

5 Matrix Study One laboratory 1-4 Foods or Surface Inclusivity, Exclusivity, Robustness, Stability and Lot to Lot Variation

6 Pre-Collaborative Study and Collaborative Study Harmonization Collaborative Study

7 Selection of matrices associated with pathogen Natural vs. Artificial contamination Strain types Competing flora Fractional results

8 Quantitative 8 laboratories minimum, 1-6 matrices 4 inoculation levels/matrix 2 test portions per level per matrix per method Qualitative 10 laboratories minimum, 1-6 matrices, 3 inoculation levels per matrix, 6 test portions per level per matrix per method Method compared to Reference Method


10 Official Methods of Analysis 2011.03 Salmonella in a Variety of Food

11 Foods/Eggs and Egg Products, Eggs and Egg Products/Liquid Eggs, Eggs and Egg Products/Eggs, Dairy Products/Ice Cream, Vegetables/Spinach, Spinach/Fresh Spinach, Fish/Shrimp, Nuts and Nut Products/Peanut Butter, Peanuts/Peanut Butter, Meat and Meat Products/Turkey, Meat and Meat Products/Pork, Meat and Meat Products/Roast Beef, Meat and Meat Products/Pork Sausage, Meat and Meat Products/Chicken, Dairy Products/Milk, Milk/Whole Milk, Foods/Fish, Nuts and Nut Products/Pecans, Baked Goods/Cake Mix, Grains/Dry Pasta, Spices and Condiments/Black Pepper, Milk/Dried Milk, Eggs and Egg Products/Dried Egg Yolks, Cacao Bean and Its Products/Chocolate, Foods/Fruits and Fruit Products, Fruit Juices/Orange Juice, Pet Foods, Water : Validated Matrices

12 U.S. food import volume, by food group Food group 19992012 Volume of U.S. food imports 1/ Live meat animals (1000) 2/6,058.47,908.0 Meats1,439.01,335.8 Fish and shellfish1,677.82,354.2 Dairy242.5209.8 Vegetables4,767.58,545.0 Fruits 3/8,193.811,569.6 Nuts272.0443.0 Coffee and tea1,709.42,093.8 Cereals and bakery6,687.610,184.4 Vegetable oils2,320.85,178.1 Sugar and candy322.13,730.6 Cocoa and chocolate923.71,237.4 Other edible products705.91,447.3 Beverages (1000 KL) 4/2,854.95,820.1 Domestic Imports

13 FDA will accept all matrices validated by the manufacturer for the AOAC study Other matrices must be verified by laboratory to determine if the method is suitable for the matrix

14 Amaranth Coconut Cumin Egg Cracklet Hing Powder Tahina/Sesame Seeds Octopus

15 Spike level must not exceed 30 cells (25 gram sample) Seven successful validations must occur (No false negatives or positives)

16 Salmonella culture Atypical or Typical Serial dilution in Phosphate Buffer Plated in Duplicate 1ml and 0.1ml Selective Agar Hektoen or XLD

17 Count plates after incubation per BAM Example Dilution 4 125 Dilution 5 14 Dilution 4 113 Dilution 5 12 125 + 113 / 2 = 119 cfu/ml

18 Dilution 4 tube contains 119 cfu/ml X ml x 119 cfu/ml = 30 cfu 30 cfu/119 cfu/ml = X ml X = 0.252 or 250 ul

19 Prepare sample per BAM (or BioMerieux) instructions Weigh out 25 gram sample and spike with calculated volume Plate the calculated spike volume in duplicate on selective agar

20 Incubate per normal protocol Confirm counts from spike volume do not exceed 30 cells Control sample must produce a negative result. If the sample is presumptive positive it contains an unspecified amount of Salmonella and demonstration of < 30 cfu/ 25 gram sample is not possible Abandon Verification

21 All controls must give appropriate reactions Positive Cultural Control Negative Cultural Control Diluent Blank The Presumptive Positive spike must be confirmed following reference method

22 Biochemical Identification of Spike, Negative and Positive Control Media preparation logs for all media used Autoclave Sterilization Records for all media Media Sterility records for all media used Balance Calibration Check Records Temperature Records for all Appliances Water Quality Records Confirmation serves as Document of Productivity


Download ppt "Jack Rowe Jack Rowe Certified Laboratories, Inc. Bridging Science with Service Since 1926."

Similar presentations

Ads by Google