# Presentation: 451785

## 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

**Notes:**
Frequently, presenters must deliver material of a technical nature to an audience unfamiliar with the topic or vocabulary.  The material may be complex or heavy with detail.  To present technical material effectively, use the following guidelines from Dale Carnegie Training®.

Consider the amount of time available and prepare to organize your material.  Narrow your topic.  Divide your presentation into clear segments. Follow a logical progression. Maintain your focus throughout. Close the presentation with a summary, repetition of the key steps, or a logical conclusion.

Keep your audience in mind at all times.  For example, be sure data is clear and information is relevant.  Keep the level of detail and vocabulary appropriate for the audience.  Use visuals to support key points or steps.  Keep alert to the needs of your listeners, and you will have a more receptive audience.

## 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

## 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

## Typical Wet Mixing-Spray Drying Process

- Protein

- Oils

- Corn Syrup

- Wet Mixing

- Pasteurization

- Cooling

- Heat Sensitive Nutrients

- Homogenizer

- Holding Tank

- Preheater

- Fluidized Bed

- Sifter

- Totes or Bags

- Can Filling
- Line

- 170 – 260°F

- Approx. 170 °F

- 160 – 200°F

- Minerals

- DEOP #02-18

## Typical Wet Mixing-Spray Drying and Dry Blending Combined Process

- Dry
- Raw Materials

- Wet Mixing

- Oils

- Pasteurization

- Cooling

- Homogenizer

- Holding Tank

- Preheater

- Spray Dryer

- Sifter

- Drums, Totes or Bags

- Dry
- Raw Materials

- Ribbon Blender

- Sifter

- Can Filling
- Line

- 170 – 260°F

- 160 – 200°F

- Approx. 170 °F

- Fluidized Bed

- DEOP #02-18

## Spray Dryer Detail

- Spray Dryer
- Tower

- Fluidized
- Bed

- Sifter

- Lower section of a Niro
- Spray Dryer

- Photo and diagram from Niro, Inc.

- DEOP #02-18

## Box Dryer Detail

- Interior of Box Dryer

- Powder Removal

- Product Inlet

- Images from Rabin Worldwide and from Marriott-Walker Corporation

- DEOP #02-18

## Fluidized Bed Detail

- Exterior View

- Interior View

- Images from Rabin Worldwide

- DEOP #02-18

## 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

## 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

## 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

## 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

## Domestic Infant Formula Plants (Including Contractors)

- DEOP #02-18

**Notes:**
Includes only firms producing finished product.  Does not include corporate headquarters, premix manufacturers, or firms producing formulas for export only.

## 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

**Notes:**
In your opening, establish the relevancy of the topic to the audience.  Give a brief preview of the presentation and establish value for the listeners.  Take into account your audience’s interest and expertise in the topic when choosing your vocabulary, examples, and illustrations.  Focus on the importance of the topic to your audience, and  you will have more attentive listeners.

## Sample Profile (by Plant)

| Plant | TotalSamples | Finished Product | Carbohydrate | Fat | Protein |
| --- | --- | --- | --- | --- | --- |
| 1 | 38 | 7 | 15 | 0 | 16 |
| 2 | 12 | 2 | 7 | 0 | 3 |
| 3 | 3 | 1 | 1 | 0 | 1 |
| 4 | 12 | 4 | 4 | 0 | 4 |
| 5 | 6 | 2 | 2 | 0 | 2 |
| 6 | 9 | 2 | 4 | 0 | 3 |
| 7 | 6 | 3 | 3 | 0 | 0 |
| 8 | 2 | 1 | 1 | 0 | 0 |
| 9 | 1 | 0 | 0 | 0 | 1 |
| 10 | 3 | 0 | 1 | 1 | 1 |
| Totals | 92 | 22 | 38 | 1 | 31 |

**Notes:**
Note: No Powdered fat components were sampled because none were used to manufacture the final products sampled.

## Finished Product Sample Profile (by Product Type)

| Total Sampled | 22 |
| --- | --- |
| Full-Term Formulas | 14 |
| Pre-Term Formulas | 4 |
| Metabolic formulas | 2 |
| Hydrolysates | 2 |

- DEOP #02-18

## Finished Product Sampling Procedure

- 20 cans
- (_>_ 8 oz.)

- Composite
- (4 X 500 gm)

- MPN Analysis of Each Composite
- Using the 3 – Tube Method

- 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

- * 95% CI = .015 MPN / 100 gm  - 1.04 MPN / 100 gm

- Minimum limit of quantitation = 0.31 MPN / 100 grams*

- DEOP #02-18

## FDA Field Survey Results

| Sample
Type | No. of Positive Samples (%) | Test Result | Total Samples
Tested |
| --- | --- | --- | --- |
| Finished Product | 5  (22.7%) | 0.36 MPN/
100 grams | 22 |
| Carbohydrate | 1  (2.6%) | Positive | 38 |
| Protein | 1  (3.2%) | Positive | 31 |
| Fat | 0  (0 %) | Negative | 1 |

- DEOP #02-18

## FDA Field Survey Results

| Product Type | Test Result
 No. positive / No. tested (%) |
| --- | --- |
| Full-Term Formulas | 4 of 14 (28.5%) |
| Pre-Term Formulas | 1 of 4 (25%) |
| Metabolic formulas | 0 of 2 |
| Hydrolysates
 | 0 of 2 |

- DEOP #02-18

## 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