HHS:PHS:FDA:CFSAN:OC:DCP:MSB
 
                                                 5100 Paint Branch Parkway
                                                 College Park, MD 20740-3835
 
                                                 M-b-343
 
                                                 December 10, 2003
 
 
TO:  		All Regional Food and Drug Directors
      Attn:  Regional Milk Specialists
 
FROM:  	Milk Safety Branch (HFS-626)
 
SUBJECT:  	Bardiani Valvole USA/Pro Therm ZP-FD Flow Diversion Device
 
 
In accordance with M-I-00-2, Milk and Milk Product Equipment-A Guideline for
Evaluating Construction, FDA's Pacific Region Dairy Products Team and CFSAN's
Milk Safety Team have evaluated this piece of equipment and have validated the
technical information reviewed and submitted by the Pacific Region Dairy
Equipment Review Committee addressing the Bardiani Valvole USA/Pro Therm ZP-FD
Flow Diversion Device (FDD).  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 Valvole USA/Pro Therm ZP-FD FDD is a dual stem FDD, which has been
designed to comply with Item 16p(B) of the PMO. The technical designs reviewed
were for 1" (25.4cm), 2" (50.8cm), 2.5" (63.5cm), 3" (76.2), and 4" (101.6cm),
FDDs. The FDD has been shown to operate properly with two (2) different control
systems: Cam timer and Micro-Logix 1000.
 
Compliance is based upon installation and operation in accordance with the
Bardiani Valvole USA/Pro Therm ZP-FD Use and Maintenance Manual for the Flow
Diversion Device Revision #3-September 29, 2003 and the following provisions.
 
1. The installation shall comply with applicable tests in Appendix I. of the
PMO.
2. Easy access to the valve and panel is necessary for the HTST operator and
Regulatory Agency testing; therefore, an appropriate fixed platform may be
required for testing and maintenance of the valve and/or panel.
3. Appendix I., Test 5.4, Device Assembly of the PMO, shall be conducted in
accordance with the testing procedures in the installation and operation manual
provided by the manufacturer. The manufacturer shall provide a gap gauge to
facilitate conducting this test in the required manner.
4. After installation and determination of compliance by PMO testing, regulatory
seals shall be applied through the handle of the manual air shut-off valves and
around the valve body. The seal shall be sufficiently tight to assure the manual
shut-off valve cannot be closed without breaking the seal.
 
All technical information that was reviewed addressing the Bardiani Valvole USA/
Pro Therm Model ZP-FD FDD is on file with the Pacific Region Dairy Equipment
Review Committee (PR-00-03). 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:
				
				Milos Cikara
				Bardiani Valvole USA
				Pro Therm Engineering Company Inc.
				4203 W. Alamos
				Fresno, California 93722
				Phone: (559) 271-2150
				Fax: (559) 271-2151
 
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. 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/
 
 
Randy Elsberry					Jonathan M. Gardner
FDA Regional Dairy Specialist			MSB/Sr.  Milk Sanitation Officer
 
 
 
 
Attachments:
	Valve Literature
	Valve Test Procedure
	Table of Contents of Technical Data Review
 
 

   Engineering Design and Technical Construction File
                       EDTCF
 
   Bardiani Valvole USA/ Pro Therm ZP-FD Flow Diversion Device
                       FDD
                 Table of Contents
 
 
 
 
 Section #1   Flow Diversion Device Overall Drawing
 
    * Flow Diversion Device Drawing
                                Supply Port
                                Divert Port
    			        Leak Detect Port Forward Flow Port
                                Air Connection
    			        Control Wire Connection
                                Control Top
    	 		        Valve B Divert Valve
    			        Valve A Leak Detect Valve
    * Overall Valves Dimensions Drawing
    			        Sizes 1" Through 4"
 
 Section #2   Detailed Drawings ZP Valves
 
    * Divert Valve Dimension For Sizes 1" Through 4"
    				Port Sizes 			
    				Body
    				Actuator
    				Height
    				Center Line
    				Tri-Clamp
 
    * Enlarged Drawings
    			Divert Valve Sizes 1" Through 2.5" (#A 112)
    			Divert Valve Sizes 3" And 4" (A 113)
    			View of Yoke and Stem
 
    * Dimensional Drawings
    			Lower Body Valve Sizes 1" Through 4"
    			Upper Body Valve Sizes 1" Through 4"
    			Yoke Valve Sizes Valve Sizes 1" Through 4" 						
                        0' Rings Valve Sizes 1" Through 4"
                        Gaskets Valve Sizes 1" Through 4"
 
 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
    			ZP Series On-Off (used in ZP-FDD)
    			Valve Sizes 1" through 4"
    			Body Configurations L, T, TL, LT, LL
 
 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
    * Lab Reports On Maximum Seal Pressure And Air Consumption
    * Graphs Reports On Pressure Drop Through Valve Sizes 1" To 4"
 
 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
    * Gasket Certificate EPDM And Viton Meeting CFR Requirements CFR 21 Ch. 1
    			Cerise Laboratory Report On:
    			Hardness
    			Tensile Strength
    			Elongation
    			Tear Resistance
    			Specific Gravity
    			Compression
    * Technical Data
    			Temperature for Sterility Up To 140C (284 F)
    			Ra 2.6 through 0.2 Microns Available
 
 Section #11  Wiring Diagrams
 
    * Control Top With Solenoid Drawing
    * Micro-Switches Adjustment Drawing
    * Micro-Switches Installation Drawing
    * Micro-Switches Drawing
    * Solenoid Drawing
    * Enlarged Micros-Switches Dimensional Drawing
    * Conformity Certificate
 
 
 Section #12    Additional Documentation for Verification Compliance
 
              A Letter from USDA /AMS/Dairy Division
                Confirmation of Acceptance from Mr. Rocklyn R. Bates  (USDA)
                Facility & Equipment Review Specialist
 
 Section #13  Documentation and Test Reports
 
    			A Testing Place Will Be Determined
                           HTST Application with Approved PLC Systems for Milk and Milk Products
    			A Testing Procedure Will Be Written
                           Per P. 340 "Milk Pasteurization Controls and Test" Manual
    			A Test Documentation Will Be Prepared
    			   Per P. 342 "Milk Pasteurization Controls and Test" Manual
    			A Schedule Date Will Be Determined
    			A 10 Day Notice Will Be Given To DERC to Attend the Test
    			A 2 to 3hr Test Will Be Performed On Water and Documented
                           As Prescribed P.105 -110 "Milk Pasteurization Controls and Test" Manual
    			   And per P. 208 -213 of "Grade A PMO" Manual
    			
 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. 13 -17)
    			Proper Operation (P. 18 -26)
    			Safety Section #1 Manual
    			Warning Signs (P. 4 -8)
    			Caution Signs (P. 7)
 
 
 Section #15  PMO Testing Procedure & Engineering Drawings
 
    * PMO Test Procedure
 
    			Test #1 Checking the Assembly
    			Test #2 Timing Pump Time Delay Interlock
    			Test #3 CIP Time Delay Relay
 
    * Divert Valve Overall Dimension for Sizes 1" Through 4'.'
    			Control Top
    			Port Sizes
    			Body
    			Actuator
    			Height
    			Stem
    			Tri-Clamp
 
    * Enlarged Drawings
    			View of Yoke and Stem
    * Dimensional Drawings
    			Yoke Valve Sizes 1 ", 1.5", 2", 2.5", 3", 4"
    			Body Valve Sizes with Radii for 1", 1.5", 2", 2.5", 3", 4"
    * Design Of Flanges, Gasket Joints, And O-Rings
    * Disassembling Drawing Valve 1" Through 4"
    * Parts Identification Drawing ZP Valve Sizes 1 "Through 2.5"
    * Parts Identification Drawing ZP Valve Sizes 3" And 4"
    * Parts List
    * Product Contact Surface Finish Specifications
    * Welds And Permanents Joints Specifications
 
 
 
 
 
 
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M-b-343	1	 December 10, 2003