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M-b-343: Bardiani Valvole USA/Pro Therm ZP-FD Flow Diversion Device

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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.

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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.

/s/

Randy Elsberry
FDA Regional Dairy Specialist

/s/

Jonathan M. Gardner
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

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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

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* 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

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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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