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:
 
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.
 
 
 
	/ss/								/ss/
 
James N. Rench					       	Jonathan M. Gardner
FDA Regional Dairy Specialist				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
 
a) Introductions
b) Safety
c) Installation
d) Technical Specifications
e) Pneumatic Connections
f) Electrical Connections and Instructions
g) Cleaning Procedures
h) Valve Seat Position Indication
i) Maintenance
j) Parts List
 
Chapter 2 - Detailed Drawings of Valve
 
a) 091503-01 Complete Section View
b) 9613-0085 Lip Seal
c) 9613-0086 Axial Seal Ring
d) 9613-0087 Single Lip Seal
e) 9613-0188 Upper Sealing Element
f) 9613-0089 Radial Seal
g) 9613-0243 Lower Sealing Element
h) 9613-0702 Upper Plug with Balance
i) 9613-0706 Lower Plug with Balance
j) 9613-0710 Valve Body
k) 9613-0726 Welding of Upper Plug
l) 9613-0728 Welding of Balanced Lower Plug
m) 9613-0731 Pipe Stub Specifications
n) 9613-0735 Valve Body Cast
o) 9613-0736 Valve Body with Hole
p) 9613-0737 Valve Body with Welded Pipe Stub
q) 9613-0746 Lower Stem for Lower Plug
r) 9613-0749 Balance Plug Lower Part
s) 9613-0751 Machined Head for Lower Plug
 
Chapter 3 - Essential Requirements of the 3-A Sanitary Standards and Other
Associated Certifications
 
a) 3-A Certificate Authorization No. 34A, Dated November 18, 2002
b) FDA Certifications on Rubber Compounds 	
1) HNBR 5405.MA Dated 2/13/01
2) FPM 7221.PA Dated 6/11/02
3) NBR 5030.25 Dated 6/11/02
4) EPDM 7351.DA Dated 6/11/02
c) Statement of Compliance for O-Ring Materials
d) Certificate for Testing for Compliance from EHEDG
e) Assessment of In-Place Cleanability Document from Biotechnological Institute
f) Statement of Continuity for Differing Valve Sizes
 

 
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M-b-344	1	December 11, 2003