HHS: PHS: FDA: CFSAN:OFP: DCP: MSB
 
      5100 Paint Branch Parkway
 College Park, MD 20740-3835
 
                  M-b-336
 
      September 16, 2002
 
 
TO:  		All Regional Food and Drug Directors
      Attn:  Regional Milk Specialists
 
FROM:  	Milk Safety Branch (HFS-626)
 
SUBJECT:  	Bardiani ZL Mix-Proof Valve
 
 
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 Bardiani ZL 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).
 
The Bardiani ZL Mix-Proof Valve is a 2-inch, 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.
 
The technical information that was reviewed addressing the Bardiani ZL Mix-Proof
Valve constitutes the PRDERC's Engineering Design and Technical Construction
File (EDTCF) PR-01-02.  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:
 
				Bardiani Valvole USA/ProTherm
				4203 W. Alamos
				Fresno, California 93722
				Attn: Milos Cikara
				Phone: (559) 271-2150
				Fax: (559) 271-2151
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 http://www.cfsan.fda.gov and may be widely distributed to
representatives of the dairy industry and other interested parties.
 
 
 
 
 
 
Randy Elsberry					Steven T. Sims
FDA Regional Dairy Specialist			FDA/MSB Milk Sanitation Officer
 
 
 
 
 
 
 
Attachments:
 
 
 

EDTCF
PMO Mix-Proof Valve
Table of Contents
 
Section #1             PMO Mix-Proof Valve
(   Overall Drawing of the PMO Mix-Proof Valve
 
 
Section #2             Detailed Drawings
  PMO Mix-Proof Valve Overall Dimension For 21' Size (dwg. P200)
   Assembly of:
(  Ports
(  Body
(  Actuator
(  Control Top
 
  Dimensional Drawings
(  Body (dwg. 2839)
(  Ports sizes (dwg. 2847)
(  Yoke (dwg. 2832)
(  Upper Stem (dwg. 2834)
(  Lower Stem (dwg. 2840)
(  O-Ring Position #60, #126 (dwg. 2924)
(  O-Ring Position #62 (dwg. 134)
(  Seal Position #69, #70 (dwg. X52)
(  O-Ring Position #78 (dwg. 2926)
(  D-Ring Position #94 (dwg. 2646)
 
 
Section #3-#4        Essential Requirements of the 3-A Sanitary Standards
 3-A Sanitary Standards For Compression-Type Valves For Milk And Milk Products,
  Number 53-01
 
 3-A Symbol Certification
(  PMO Mix-Proof Model ZL 2" Size
 
 
Section #5              Verification of Other Standards
(      ASME -SA-182 Grade F 316L
(      ASTM A-182.
 
 
Section #6             Instruction Manual
  Foreword, Safety, Warranty
  Introduction
  Installation
  Operation
  Maintenance
  Parts List
  Manufacture Standards
 
 
 
Section #7             Internal Quality Control
 Quality Control Inspection Form
(  Material of Construction
(  Dimension
(  Drawing
(  Hydrostatic Test
(  Pneumatic Test
(  Electric Test
(  Visual Check
 
 
Section #8- #9     Engineering and Laboratory Reports
 Photographs of Outside and Inside Construction of the Valve
 Technical Data Sheet on ZL 211 Size
 
 
Section #10          Appropriate Materials Needed to Verify Compliance
 Finishing SS Surface Report
(  Taylor Hudson Limited Lab. Report RA 0.18 micron
 
 Metals Stainless Steel Certificate
(  Sandwik Lab Report On:
? Chemical Composition
? Tensile Test
? Hardness Test
? Heat Treatment
 
 Orobica Laboratory Report On:
 Gasket Certificate EPDM And Viton Meeting CFR 21 Ch. I Requirements
(  Hardness
(  Tensile Strength
(  Elongation
(  Tear Resistance
(  Specific Gravity
(  Compression
 
 Cerise Laboratory Report On Elastomer
 
 
 
Section # 11          Wiring Diagrams
 
 Proximity Switches Drawing
 Control Top Wiring Configuration
 Proximity Switches Specifications
 
 
 
Section #12            Additional Documentation for Verification Compliance
 A Letter From USDA /AMS/Dairy Division
(  Confirmation Of Acceptance From Mr. Rocklyn R. Bates for ZP Valve
     (Compression Valve)
(  Facility & Equipment Review Specialist
 
 
 
 
Section #13              Documentation and Test Reports
 Per P57 15p(B) of Grade "All Pasteurized Milk Ordinance
 PMO Mix-Proof Valve Stems Positioning Verification Test
(  Test #1 Upper Stem - Closing Position
(   Test #2 Upper Stem - Opening Position
(   Test #3 Lower Stem - Positioning
(   Proximity Switches Adjustment Test
(    Proximity Switches Adjustment Procedure
 
 
 
 
Section #14    	Verification of How All Safeguards are Met
 Quality Control Test
? Valve Type Identification
? Material of Construction
? Dimension
? Drawing
? Hydrostatic Test
? Pneumatic Test
? Electric Test
? Visual Check
 
 Use and Maintenance Manual
(  Proper Installation (P.11-13)
(  Proper Operation (P. 14-18)
(  Safety Chapter Section #l Manual
    Warning Signs (P. 4 - 8)
    Caution Signs (P. 7)
 
 
 
Section #15                PMO Testing Procedure and Engineering Drawings
 PMO Mix-Proof Valve Stems Positioning Verification Test
( Test #1 Upper Stem - Closing Position
( Test 42 Upper Stem - Opening Position
( Test Oi3 Lower Stem - Positioning
( Proximity Switches Adjustment Test
( Proximity Switches Adjustment Procedure
 
 PMO Mix -Proof Overall Dimension For 211 Size
(   Control Top
(  Port Sizes
(  Body
(  Actuator
(  Height
(  Stems
 
 Dimensional Drawings PMO Mix-Proof Valve 211 Size
(   Ports Sizes
(   Yoke Valve
(   Body With
(   Radii
(   Upper Stem
(   Lower Stem
 
 
 O-Rings in contact with Product
(  O-Ring Position #60, #120    (dwg. 2924)
(  O-Ring Position #62 (dwg. 134)
(  Seal Position #69, #70 (dwg. X52)
(  O-Ring Position #78 (dwg. 2926)
(  O-Ring Position #94 (dwg. 2646)
 
 Disassembly Drawing
 
 Parts Identification Drawing PMO Mix-Proof Model ZL
 
 Parts List
 
 Product Contact Surface Finnish Specifications
 
 Welds And Permanent Joints Specifications
 
 
 
1
 
 
 
 
M-b-336	1	September 16, 2002