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Jack Rowe Certified Laboratories, Inc.

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Presentation on theme: "Jack Rowe Certified Laboratories, Inc."— Presentation transcript:

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


3 Manufacturer’s Validation
AOAC Performance Tested Method (RI) AOAC Official Methods of Analysis

4 AOAC Performance Tested Method (RI): Origins
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 AOAC Performance Tested Method (RI)
Matrix Study One laboratory 1-4 Foods or Surface Inclusivity, Exclusivity, Robustness, Stability and Lot to Lot Variation

6 AOAC Official Methods of Analysis
Pre-Collaborative Study and Collaborative Study Harmonization Collaborative Study

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

8 Harmonization Collaborative Study
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

9 Method compared to Reference Method

10 VIDAS Salmonella (SLM) Easy Salmonella
Official Methods of Analysis 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 Domestic Imports U.S. food import volume, by food group Food group
Food group 1999 2012 Volume of U.S. food imports 1/ Live meat animals (1000) 2/ 6,058.4 7,908.0 Meats 1,439.0 1,335.8 Fish and shellfish 1,677.8 2,354.2 Dairy 242.5 209.8 Vegetables 4,767.5 8,545.0 Fruits 3/ 8,193.8 11,569.6 Nuts 272.0 443.0 Coffee and tea 1,709.4 2,093.8 Cereals and bakery 6,687.6 10,184.4 Vegetable oils 2,320.8 5,178.1 Sugar and candy 322.1 3,730.6 Cocoa and chocolate 923.7 1,237.4 Other edible products 705.9 1,447.3 Beverages (1000 KL) 4/ 2,854.9 5,820.1

13 Method Verification In House
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 Was it Validated? Amaranth Coconut Cumin Egg Cracklet Hing Powder
Tahina/Sesame Seeds Octopus

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

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

17 Spike Calculation Count plates after incubation per BAM Example
Dilution Dilution Dilution Dilution / 2 = 119 cfu/ml

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

19 Verification Set Up 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 Verification 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 Verification 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 Final Package 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

23 Questions

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