M-b-337: Definox VDCI PMO Mix-Proof Valve (2", 2 1/2", 3", 4" and 6")

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5100 Paint Branch Parkway
College Park, MD 20740-3835


September 16, 2002

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Definox VDCI PMO Mix-Proof Valve (2", 2 1/2", 3", 4" and 6")

In accordance with M-I-00-2, Milk and Milk Product Equipment-A Guideline for Evaluating Construction, the Pacific Region Dairy Products Team (DPT) has evaluated this piece of equipment and has validated the technical information reviewed and submitted by the Pacific Region Dairy Equipment Review Committee (PRDERC) addressing the Definox VDCI PMO Mix-Proof Valve (2", 2 1/2", 3", 4" and 6"). When constructed, installed and operated as described in this memorandum, this piece of equipment has been found to meet the applicable provisions of the Grade "A" Pasteurized Milk Ordinance (PMO).

The Definox VDCI PMO Mix-Proof Valve (2", 2 1/2", 3", 4" and 6") is a single-bodied double-seat valve designed to comply with Item 15p(B) of the PMO. The valve may be used to separate milk and milk products from tanks or circuits containing cleaning and/or sanitizing solutions. This valve may not be used to separate raw products (dairy, non-dairy or water) from pasteurized milk or milk products.

NOTE: In order to test the valve operation, the valve is equipped with an adjusting screw to test the lower valve seat. To test the upper valve seat, a u-shaped precision spacer will be provided with the valve.

The technical information that was reviewed, addressing the Definox VDCI PMO Mix-Proof Valve, constitutes the PRDERC's Engineering Design and Technical Construction File (EDTCF) PR-00-04. The Table of Contents for this file is attached and the EDTCF is on file with the PRDERC.

The material in the EDTCF is the property of the manufacturer and may be shown at their discretion. Technical information regarding this equipment may be obtained from:

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Defontaine of America, Inc.
Dept. Definox
16720 W. Victor Road
New Berlin, WI 53151
Attn: Bill Stern
Phone: (262) 797-5730
Fax: (262) 797-5735

FDA's review and acceptance of this piece of equipment does not constitute agency endorsement or approval. Any representation on a label or in printed literature citing or indicating as, "FDA Approved", is false and misleading.

Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies and State Milk Sanitation Rating Officers. This memorandum will also be available at a later date on the FDA Web site at and may be widely distributed to representatives of the dairy industry and other interested parties.

Randy Elsberry
FDA Regional Dairy Specialist

Steven T. Sims
FDA/MSB Milk Sanitation Officer


Engineering Design and Technical Construction File (EDTCF)

Table of Contents

16720 W. Victor Road
New Berlin, Wisconsin 53151
Phone: (262) 797-5730 Fax: (262) 797-5735

Chapter 1- Technical Presentation

  1. General Characteristics
  2. Description of Use
  3. Valve Identification
  4. Schematic Diagram
  5. Features of the VDCI
  6. Options
  7. Opening/Closing Times
  8. Air Consumption
  9. Valve Weight
  10. Valve Resistance to Expansion (body thickness, deformation test)
  11. Cv Coefficient and Pressure Drop

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Chapter 2- Detailed Drawings, Calculations and Tests for the Conformity of the Equipment

  1. Pressure Test
  2. Detailed Drawing: Valve Closed Position (IT-TDFX-0771-062 Revision 1, May 2000)
  3. Detailed Drawing: Raising the Upper Plug Allows the Chamber and Seal to be Cleaned (IT-TDFX-0771-062 Revision 1, May 2000)
  4. Detailed Drawing: Full Flow Design (IT-TDFX-0771-062 Revision 1, May 2000)
  5. Detailed Drawing: Raising the Lower Plug Allows Chamber and Seal to be Cleaned (IT-TDFX-0771-062 Revision 1, May 2000)

Chapter 3- Essential Requirements of the 3-A Sanitary Standards and Accepted Practices

  1. 3-A Certificate, Authorization No. 376, dated January 25, 1983
  2. Detailed Drawing: Spool Spacer Scraper VDCI 2000 (CE74837B, 06/07/00)
  3. Detailed Drawing: Scraper Upper Clack Valve (CE74837C, 05/07/00)
  4. Detailed Drawing: Scraper Lower Clack Valve (CE74837D, 05/07/00)
  5. Detailed Drawing: Spool Spacer Vapor VDCI 2000 (CE74837E, 06/07/00)
  6. Detailed Drawing: Balancing Stem Protector Vapor (CE74837F, 06/07/00)
  7. Detailed Drawing: Body X VDCI 2000 (CE71929A, 05/07/00)
  8. Detailed Drawing: Lower Clack Valve N-1 VDCI 2000 (CE71929B, 05/07/00)
  9. Detailed Drawing: Lower Clack Valve N-2 VDCI 2000 (CE71929C, 05/07/00)
  10. Detailed Drawing: Upper Clack Valve N-1 VDCI 2000 (CE71929D, 06/07/00)
  11. Detailed Drawing: Spool Spacer VDCI 2000 (CE71929E, 06/07/00)

Chapter 4- Maintenance and Fitting Instructions

  1. Installation Instructions (IT.DFX.091 Indice= November 2000)
  2. Maintenance Instructions (IT-DFX-090 Indice 1; October 2000)

Chapter 5- The Internal Measures Implemented to Insure that the Equipment will Continue to be Manufactured in Conformity

  1. ISO 9001 Certificate
  2. Application of the Instructions for the Processing of Characteristics of Regulation
  3. Detailed Drawing: Body X Scraper VDCI 2000 (CE74837A, 05/07/00)
  4. Definox Control Plan and Detailed Diagram Number PT714549

Chapter 6- Engineering and Laboratory Reports

  1. ASEPT-Validation of the In-Place Cleanability of the Double Glove Valve VDCI SP DN 50 of Defontaine SA, Definox according to the EHEDG Test Procedure
  2. European Hygienic Equipment Design Group (EHEDG)- A Method for Assessment of In-Place Cleanability of Food Processing Equipment

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Chapter 7- Description and Documentation on Detection

  1. Test Detector Procedure VDCI PMO
    1. Evolution Management
    2. Tightness Stroke
    3. Upper Plug Detector
    4. Lower Plug Detector
    5. Calculation of Security Stroke
    6. Drawing about the Security detection of the VDCI PMO (IT-DFX-098 Index 1, April 2001)
  2. Detector Certificates
  3. AS-i Electronic Unit for PMO Valve (IT-TDFX-089 GB rev 1, October 2000)

Chapter 8- Appropriate Materials

  1. Conformity Certificate
    1. Section 21 CFR 177.2600
    2. Section 21 CFR 177.1550
    3. Directive 89/109 (C.E.E.)
    4. European Norms relating to the Security and Health
  2. Conformity Certificate
    1. AISI 316 L

Addendum 1- Engineering Design & Technical Construction File (EDTCF)

  1. Revised Technical Drawings (ITDFX.087-Rev 2 and CE719529 Rev 2)
  2. Revised Description of Use
  3. Detailed Information on Drainage Port
  4. Detailed Description of Diagram Number PT7141549
  5. Detailed Valve Identification (ITDFX.087-Rev 2)
  6. Test Detector Procedure (ITDFX 098GB index 1)
  7. Detailed Description of CIP Spay Connection

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