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U.S. Department of Health and Human Services

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M-b-336: Bardiani ZL Mix-Proof Valve

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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.

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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.fda.gov and may be widely distributed to representatives of the dairy industry and other interested parties.

Randy Elsberry
FDA Regional Dairy Specialist

Steven T. Sims
FDA/MSB Milk Sanitation Officer

Attachments:

Diagram of Bardiani ZL Mix-Proof Valve

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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.

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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

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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 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

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