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M-b-344: Alfa Laval Uniq-PMO Sanitary Mix-Proof Valve (Sizes 2", 2 1/2", 3",and 4")

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HHS:PHS:FDA:CFSAN:OC:DCP:MSB

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-b-344

December 11, 2003

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

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Alfa Laval Uniq-PMO Sanitary Mix-Proof Valve (Sizes 2", 2 1/2", 3",and 4")

In accordance with M-I-00-2, Milk and Milk Product Equipment-A Guideline for Evaluating Construction, FDA's Central Region Milk Specialists and CFSAN's Milk Safety Team have evaluated this piece of equipment and have validated the technical information reviewed and submitted by the Atlantic-Midwest Dairy Equipment Review Committee (AMDERC) addressing the Alfa Laval Uniq-PMO Sanitary Mix-Proof Valve. 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) when used to separate cleaning product solution and milk and milk products.

Alfa Laval Uniq-PMO Sanitary Mix-Proof Valve is a single-bodied double seat valve designed to comply with Item 15p. PROTECTION FROM CONTAMINATION, 15p.(B) of the PMO. The valve may be used as part of a fail-safe system to separate milk and milk products from tanks or circuits containing cleaning and/or sanitizing solution.

Compliance with the PMO is based upon construction, installation, and operation as described in the Manufacturer's Manual (#EPM00041ENUS 0304), Instruction Manual (#9612 5789 53) ThinkTop Digital 8-30 VDC PNP/NPN and the following provisions:

Chapter 1 An infrared remote controller can be used to program the ThinkTop Digital 8-30 VDC PNP/NPN without removal of the cover. If the valve is equipped with this option, this option may be required to be disabled and secured or locked out as directed by the Regulatory Agency to prevent unauthorized changes. 2. If the valve is programmed in the field, the procedures outlined in Instruction Manual (#9612 5789 53) ThinkTop Digital 8-30 VDC PNP/NPN, effective date 5/1/2003, must be followed.

The technical information that was reviewed addressing the Alfa Laval Uniq-PMO Sanitary Mix-Proof Valve is on file with AMDERC. The Engineering Design and Technical Construction File (EDTCF) is the property of the manufacturer and may be shown at their discretion. The Table of Contents for this file is attached. For additional information regarding this equipment and to request copies of the documents, please contact:

Roger Ashton
Alfa Laval Inc.
P.O. Box 581909
8201 104th Street
Pleasant Prairie, WI 53158-0909
Phone: (262) 947-4700
Fax: (262) 947-4725
 

FDA's review of this piece of equipment and their validation that it complies with applicable construction criteria of the PMO does not constitute FDA endorsement or approval of the equipment. 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 in your region. This memorandum should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web site at http://www.cfsan.fda.gov at a later date.

/s/

James N. Rench
FDA Regional Dairy Specialist
 

/s/

Jonathan M. Gardner

Sr. Milk Sanitation Officer

Attachments:

Valve Picture
Table of Contents
Test Procedures
Proximity Switches Adjustment Procedures

Engineering Design and Technical Construction File (EDTCF)

Table of Contents

Alfa Laval Uniq-PMO Sanitary Mixproof Valve
(Sizes 2", 2 1/2" 3" and 4")

Alfa Laval Inc.
P.O. Box 581909
8201 104th Street
Pleasant Prairie, WI 53158-0909
Phone: (262)947-3709 Fax: (262)947-4725

Chapter 1 - Instruction Manual

  1. Introductions
  2. Safety
  3. Installation
  4. Technical Specifications
  5. Pneumatic Connections
  6. Electrical Connections and Instructions
  7. Cleaning Procedures
  8. Valve Seat Position Indication
  9. Maintenance
  10. Parts List

Chapter 2 - Detailed Drawings of Valve

  1. 091503-01 Complete Section View
  2. 9613-0085 Lip Seal
  3. 9613-0086 Axial Seal Ring
  4. 9613-0087 Single Lip Seal
  5. 9613-0188 Upper Sealing Element
  6. 9613-0089 Radial Seal
  7. 9613-0243 Lower Sealing Element
  8. 9613-0702 Upper Plug with Balance
  9. 9613-0706 Lower Plug with Balance
  10. 9613-0710 Valve Body
  11. 9613-0726 Welding of Upper Plug
  12. 9613-0728 Welding of Balanced Lower Plug
  13. 9613-0731 Pipe Stub Specifications
  14. 9613-0735 Valve Body Cast
  15. 9613-0736 Valve Body with Hole
  16. 9613-0737 Valve Body with Welded Pipe Stub
  17. 9613-0746 Lower Stem for Lower Plug
  18. 9613-0749 Balance Plug Lower Part
  19. 9613-0751 Machined Head for Lower Plug

Chapter 3 - Essential Requirements of the 3-A Sanitary Standards and Other Associated Certifications

  1. 3-A Certificate Authorization No. 34A, Dated November 18, 2002
  2. FDA Certifications on Rubber Compounds
  3. HNBR 5405.MA Dated 2/13/01
  4. FPM 7221.PA Dated 6/11/02
  5. NBR 5030.25 Dated 6/11/02
  6. EPDM 7351.DA Dated 6/11/02
  7. Statement of Compliance for O-Ring Materials
  8. Certificate for Testing for Compliance from EHEDG
  9. Assessment of In-Place Cleanability Document from Biotechnological Institute
  10. Statement of Continuity for Differing Valve Sizes