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FDA Field Survey of Powdered Formula Manufacturing

FDA Field Survey of Powdered Formula Manufacturing. Don L. Zink, Ph.D. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Plant and Dairy Foods and Beverages. Presentation Objectives. To describe the manufacturing practices used in the plants surveyed

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FDA Field Survey of Powdered Formula Manufacturing

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  1. FDA Field Survey of Powdered Formula Manufacturing Don L. Zink, Ph.D. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Plant and Dairy Foods and Beverages DEOP #02-18

  2. Presentation Objectives • To describe the manufacturing practices used in the plants surveyed • To summarize the microbiological criteria applied to powdered infant formula • To review the results of FDA’s survey of finished product and raw materials DEOP #02-18

  3. Powdered Formula Manufacturing Processes • Dry Blending • Minimizes the use of water in the processing area • Vulnerable to contamination of ingredients • Difficult to use lot testing as a means of ensuring the microbiological quality of ingredients • Wet Mixing – Spray Drying • Ingredients are hydrated and pasteurized to destroy the vegetative cells of harmful bacteria • Requires frequent wet cleaning of large equipment items • The use of water promotes the growth of bacteria in the plant environment DEOP #02-18

  4. Typical Wet Mixing-Spray Drying Process Protein Minerals Pasteurization Cooling 170 – 260°F Oils Heat Sensitive Nutrients Corn Syrup Wet Mixing Preheater Holding Tank Homogenizer 160 – 200°F Approx. 170 °F Can Filling Line Sifter Fluidized Bed Totes or Bags DEOP #02-18

  5. Typical Wet Mixing-Spray Drying and Dry Blending Combined Process Dry Raw Materials Pasteurization Cooling 170 – 260°F Oils Wet Mixing Preheater Holding Tank Homogenizer 160 – 200°F Approx. 170 °F Dry Raw Materials Spray Dryer Sifter Sifter Can Filling Line Fluidized Bed Drums, Totes or Bags DEOP #02-18 Ribbon Blender

  6. Spray Dryer Detail Spray Dryer Tower Lower section of a Niro Spray Dryer Fluidized Bed Sifter Photo and diagram from Niro, Inc. DEOP #02-18

  7. Box Dryer Detail Interior of Box Dryer Product Inlet Powder Removal Images from Rabin Worldwide and from Marriott-Walker Corporation DEOP #02-18

  8. Fluidized Bed Detail Exterior View Interior View Images from Rabin Worldwide DEOP #02-18

  9. Microbiological Standards • CODEX Standards (limit per gram) • Aerobic Plate Count - n=5, c=2, m=103, M=104 • Coliforms - n=5, c=1, m<3*, M=20 • Salmonella - n=60, c=0, m=0 *<3 means no positive tube in a 3-tube MPN From “Recommended International Code of Hygienic Practice for Foods for Infants and Children, CAC/RCP-21” (1979) DEOP #02-18

  10. Microbiological Standards • Canadian Standards (limit per gram) • Aerobic Plate Count - n= 5, c=2, m=103, M=104 • Escherichia coli - n=10, c=1, m<1.8, M=101 • Salmonella - n=20, c=0, m=0 • Staph. aureus - n=10, c=1, m=101, M=102 • Bacillus cereus - n=10, c=1, m=102, M=104 • Cl. perfringens - n=10, c=1, m=102, M=103 From “Health Products and Food Branch Standards and Guidelines for Microbiological Safety of Food, Interpretive Summary”, Jan. 2003 DEOP #02-18

  11. Microbiological Standards • China (GB10767-1997) • Aerobic Plate Count - <30,000 / gm • Coliforms - < 40 / 100 gm • “Pathogens” - none detectable • Yeasts & Molds - < 50 / gm DEOP #02-18

  12. Microbiological Standards • FDA (proposed in 1996 ANPR) • Aerobic Plate Count - < 10,000 / gm • Coliforms - < 3.05 MPN / gm • Fecal Coliforms - < 3.05 MPN / gm • Salmonella - n=60, c=0, m=0 • L. monocytogenes - negative • S. aureus - < 3.05 MPN / gm • Bacillus cereus - < 100 / gm DEOP #02-18

  13. Domestic Infant Formula Plants (Including Contractors) DEOP #02-18

  14. FDA Field Survey of Powdered Infant Formula • Objectives: • To collect an official sample of selected powdered infant formulas and raw materials in order to assess the prevalence and numbers of E. sakazakii in these samples • To conduct an inspection at each major domestic powdered infant formula producer in order to understand any possible relationship between industry practices and the prevalence of E. sakazakii. DEOP #02-18

  15. Sample Profile(by Plant)

  16. Finished Product Sample Profile (by Product Type) DEOP #02-18

  17. Finished Product Sampling Procedure MPN Analysis of Each Composite Using the 3 – Tube Method Composite (4 X 500 gm) 20 cans (> 8 oz.) 4 x 3 x 100 gm 4 x 3 x 10 gm 4 x 3 x 1 gm 1,332 gm cultured Theoretical limit of detection = 1 in 1,332 grams Minimum limit of quantitation = 0.31 MPN / 100 grams* * 95% CI = .015 MPN / 100 gm - 1.04 MPN / 100 gm DEOP #02-18

  18. FDA Field Survey Results DEOP #02-18

  19. FDA Field Survey Results DEOP #02-18

  20. FDA Field Survey Results • All positive finished product samples were at the lowest limit of quantitation (0.36 MPN / 100 gm) • There was no correlation between test results and manufacturing practices (e.g., wet mixing-spray drying vs. dry blending) • There was no apparent relationship between test results and product type (soy vs. milk) DEOP #02-18

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