3-A Sanitary Standard For Homogenizers and Reciprocating Pumps, Number 04-05

Copyright© 3-A Sanitary Standards, Inc.
, McLean, VA 04-05
3-A® Sanitary Standard for Homogenizers and

Reciprocating Pumps, Number 04-05
Standards Developing Organizations

3-A Sanitary Standards, Inc. (3-A SSI)
In Collaboration With
United States Public Health Service (USPHS)/
United States Food and Drug Administration (USFDA)
United States Department of Agriculture (USDA)
European Hygienic Engineering & Design Group (EHEDG)
Effective: June 15, 2012
Note: The highlighted text denotes changes to the previous document.

Copyright© 3-A Sanitary Standards, Inc., McLean, VA 04-05
TABLE OF CONTENTS
TITLE .................................................................................................................................i
DISCLAIMERS ................................................................................................................ v
FOREWORD .................................................................................................................... v
A SCOPE .................................................................................................................... 1
B NORMATIVE REFERENCES ............................................................................. 1
C DEFINITIONS ....................................................................................................... 3
C1 Bond ............................................................................................................... 3
C2 Burr ................................................................................................................ 3
C3 Cleaning ......................................................................................................... 3
C3.1 Clean-in-Place (CIP) Cleaning .......................................................... 3
C3.2 Clean-Out-of-Place ............................................................................ 3
C3.3 Manual Cleaning ............................................................................... 3
C4 Cleanable or Cleanability ............................................................................... 3
C4.1 CIPable .............................................................................................. 3
C5 Corrosion Resistant ........................................................................................ 3
C6 Dead End ........................................................................................................ 3
C7 Fittings............................................................................................................ 3
C7.1 CIP Fittings ....................................................................................... 3
C7.2 Manually Cleaned Fittings................................................................. 3
C8 Hot Isostatic Pressing (HIP) ........................................................................... 3
C9 High Velocity Oxyfuel Spray (HVOF) ........................................................... 3
C10 Inlet ................................................................................................................ 4
C11 Inspectable ...................................................................................................... 4
C12 Nontoxic Materials ......................................................................................... 4
C13 Outlet/Product Outlet...................................................................................... 4
C14 Processing Area .............................................................................................. 4
C15 Product ........................................................................................................... 4
C16 Pumps ............................................................................................................. 4
C16.1 Reciprocating Pump .......................................................................... 4
C16.2 Homogenizer ..................................................................................... 4
C17 Readily Accessible ......................................................................................... 4
C18 Readily Removable ........................................................................................ 4
C19 Roughness Average (Ra)................................................................................. 4
C20 Safe Water ...................................................................................................... 4
C21 Sanitizing or Sanitization................................................................................ 4
C22 Simple Hand Tools ......................................................................................... 4
C23 Soil ................................................................................................................. 4
C24 Solution .......................................................................................................... 4
C25 Sterilization .................................................................................................... 4
C26 Substantially Flush ......................................................................................... 4
C27 Surfaces .......................................................................................................... 5
C27.1 Product Contact Surfaces .................................................................. 5
C27.2 Nonproduct Contact Surfaces ............................................................ 5
C27.3 Splash Contact Surfaces .................................................................... 5
ii
C28 Surface Modification ...................................................................................... 5

C28.1 Surface Treatments ............................................................................ 5
C28.2 Coatings, Overlays and Encapsulations ............................................. 5
D MATERIALS ......................................................................................................... 5
D1 Product Contact Surfaces................................................................................ 5
D1.1 Metals ................................................................................................ 5
D1.2 Nonmetals.......................................................................................... 6
D1.3 Lubrication Media ............................................................................. 7
D2 Nonproduct Contact Surfaces ......................................................................... 7
E FABRICATION ..................................................................................................... 7
E1 Product Contact Surfaces................................................................................ 7
E1.1 Surface Texture ................................................................................. 7
E1.2 Permanent Joints................................................................................ 7
E1.4 Coatings............................................................................................. 8
E1.5 Cleaning and Inspectability ............................................................... 8
E1.6 Draining............................................................................................. 8
E1.7 Gaskets, Gasket Retaining Grooves, O-rings and Seals..................... 8
E1.8 Radii .................................................................................................. 9
E1.9 Threads ............................................................................................ 10
E1.10 Coil Springs ..................................................................................... 10
E1.11 High-Temperature Systems ............................................................. 10
E1.12 Pistons or Plungers .......................................................................... 11
E1.13 Bearings or Bushings....................................................................... 11
E1.14 Homogenizing Valves ..................................................................... 11
E1.15 Safety Relief Valves ........................................................................ 11
E2 Nonproduct Contact Surfaces ....................................................................... 11
E2.1 Surfaces ........................................................................................... 11
E2.2 Joints ............................................................................................... 11
E2.3 Name and Information Plates .......................................................... 12
E2.4 Coatings........................................................................................... 12
E2.5 Cleaning and Inspectability ............................................................. 12
E2.6 Draining........................................................................................... 12
E2.7 Threads ............................................................................................ 12
E2.8 Service Piping and Lines ................................................................. 13
E2.9 Panels, Doors, or Access Ports ........................................................ 13
E2.10 Guards and Other Safety Devices .................................................... 13
E2.11 Supports........................................................................................... 14
E2.12 Special Considerations .................................................................... 14
APPENDIX
F STAINLESS STEEL AND EQUIVALENT MATERIALS ............................. 15
G PRODUCT CONTACT SURFACE FINISH .................................................... 20
H ELECTROLESS NICKEL ALLOY .................................................................. 20
I STERILIZING TIME/TEMPERATURE .......................................................... 20
J ENGINEERING DESIGN AND TECHNICAL CONSTRUCTION FILE .... 20
K INSTRUCTION HANDBOOK, MAINTENANCE, AND CLEANING ......... 22
iii
Disclaimers
3-A Sanitary Standards, Inc. (3-A SSI) and collaborating organizations do not assume or undertake to discharge all or
any responsibilities of manufacturers or any other user of 3-A Sanitary Standards or 3-A Accepted Practices. 3-A SSI is
not responsible to any individual, organization or entity for the use of 3-A Standards and 3-A Accepted Practices. It is
the science-based opinions, professional findings of volunteer experts and consensus that provides the sanitary
(hygienic) criteria included in 3-A documents.
3-A Standards and 3-A Practices do not include provisions for mechanical and electrical safety. Mechanical and
electrical safety criteria are established by government regulations and other standards development organizations
(SDOs). Other SDO standards may be referenced.
3-A Sanitary Standards, Inc., its employees and its volunteer committees shall not incur any obligation or liability for
damages, including consequential damages, arising out of or in connection with the development, use, interpretation of,
and reliance upon this 3-A Standard.
Drawings and illustrations contained herein are to assist in understanding the criteria in this 3-A Standard. Drawings
and illustrations are not intended to show all variations of the equipment or system nor are they to exclude alternate
methods meeting this standard. Drawings and illustrations are non-normative.
Foreword
This 3-A Standard is to establish minimum sanitary (hygienic) requirements for Homogenizers and Reciprocating
Pumps. Standard English is the official language of 3-A Sanitary Standards and 3-A Accepted Practices.
This 3-A Standard is for voluntary use by directly and materially affected organizations such as equipment and
machinery fabricators, processors, regulatory agencies and by 3-A Sanitary Standards, Inc. to assure adequate public
health protection exist for the devices and covered products. 3-A Sanitary Standards, Inc. use these documents as the
source for sanitary criteria as part of 3-A Symbol authorization.
This 3-A Standard was developed jointly by 3-A Sanitary Standards, Inc. (3-A SSI), the United States Public Health
Service (USPHS), United States Food and Drug Administration (USFDA), the United States Department of Agriculture
– Dairy Programs (USDA), and the European Hygienic Engineering & Design Group (EHEDG).
It is our purpose to encourage inventive genius and provide a forum to discuss new developments. Suggestions for
improvement and new technology are welcome any time for consideration by the 3-A Sanitary Standards Committees.
Please forward comments to 3-A SSI, 6888 Elm Street, Suite 2D, McLean, VA 22101-3829 USA. By fax: 703-761-
6284. By e-mail to: 3-ainfo@3-a.org.
iv
A SCOPE
A1 This 3-A Sanitary Standard covers the sanitary aspects of homogenizers and reciprocating pumps, and their integral
ancillary components, for milk, milk products and other liquid food products. Product enters the homogenizer or
reciprocating pump at the product inlet and exits at the product outlet.
A2 This 3-A Sanitary Standard does not include drum-type pumps.
A3 In order to conform to this 3-A Sanitary Standard, homogenizers and reciprocating pumps shall conform to the following
criteria for design, materials of construction, fabrication techniques and installation, as appropriate, and the current
revisions or editions of all referenced documents cited herein.
B NORMATIVE REFERENCES
B1 The following listed 3-A Sanitary Standards, 3-A Accepted Practices and other documents shall be considered as
Normative References and the provisions of the referenced documents shall apply to this Standard without further reference
in this document unless necessary to describe special considerations.
B2 3-A Sanitary Standards
Doc. No. Title (3-A Sanitary Standards for:)
18- Multiple-Use Rubber and Rubber-Like Materials

20- Multiple-Use Plastic Materials
33- Metal Tubing
42- In-Line Strainers
53- Compression-Type Valves
63- Sanitary Fittings
74- Sensors and Sensor Fittings and Connections Used on Equipment
82- Pulsation Dampening Devices
88- Machine Leveling Feet and Supports
B3 3-A Accepted Practices
Doc. No. Title (3-A Accepted Practice for:)

603- Sanitary Construction, Installation, Testing, and Operation of High-Temperature Short-Time and Higher-
Heat Shorter-Time Pasteurizer Systems
604- Supplying Air Under Pressure in Contact with Product or Product Contact Surfaces
609- Method of Producing Steam of Culinary Quality
B4 Other References and Standards
Ref. No. Title

1. American Society of Mechanical Engineers (ASME) B46.1 - Surface Texture Waviness and Lay.
Available from the American Society of Mechanical Engineers, Three Park Ave., New York, NY 10016-
5990, Phone: (212) 705-7722 or at http://www.asme.org
2. National Primary Drinking Water Regulation of the Environmental Protection Agency (EPA), The Code
of Federal Regulations (CFR), Title 40, Parts 141, 142, and 143. For sale by the Superintendent of
Documents, U.S. Government Printing Office, Washington, D.C. 20402, Phone: (202) 512-1800 or the
EPA web site at: http://water.epa.gov/drink/contaminants/index.cfm
1
3. Grade “A” Pasteurized Milk Ordinance, available from:

www.fda.gov/food/foodsafety/product-specificinformation/milksafety/default.htm
4. AWS/ANSI D18.1 – Specification for Welding of Austenitic Stainless Steel Tube and Pipe Systems in
Sanitary (Hygienic) Applications.
AWS D18.2 – Guide to Weld Discoloration Levels on Inside of Austenitic Stainless Steel Tube (ANSI
Approved)
AWS D18.3/D18.3M – Specification for Welding of Tanks, Vessels, and Other Equipment in Sanitary
(Hygienic) Applications (ANSI Approved)
Published by American Welding Society, 550 N.W. LeJeune Rd., Miami FL, Phone: (800) 443-3953,
www.aws.org
5. Advanced Materials and Processes, Volume 137(1), “Coatings and Coating Practices” by H. Herman,
“Surface Modification” by F. A. Smidt. ASM International, Materials Park, OH 44073, Phone: (216)
338-5151, Internet http://asminternational.org
6. AMS-S-13165, Shot Peening of Metal Parts. SAE International, 400 Commonwealth Dr., Warrendale,
PA 15096-0001, Internet: http://www.sae.org
7. SAE AMS 2406, Chromium Plating (Electrodeposited). SAE-AMS QQ-N-290A, Nickel Plating
(Electrodeposited). SAE International, 400 Commonwealth Dr., Warrendale, PA 15096-0001,
Internet: http://www.sae.org
8. AIST Stainless Steels: A Steel Products Manual, Association for Iron & Steel Technology, 186
Thorn Hill Road, Warrendale, PA 15086, Phone: (724) 814 3000, Internet: www.aist.org
9. Steel Casting Handbook, Supplement 2, Steel Founders Society of America, 780 McArdle Dr., Unit
G, Crystal Lake, IL 60014, Phone: (815) 455-8240, Fax: (815) 455-8241, Internet: www.sfsa.org
10. MIL-C-26074E. Military Specification: Coatings, Electroless Nickel Requirements For.

Standardization, Document Automation & Production Service (Department of Navy), 700 Robbins
Avenue, Building 4, Section D, Philadelphia, PA 19111-5094, Phone: (215) 697-2179, Fax: (215)
697-1462.
11. The Code of Federal Regulations (CFR), Title 21, Parts 175 – Indirect Food Additives: Adhesives
and Components of Coatings. For sale by the Superintendent of Documents, U.S. Government
Printing Office, Washington, D.C. 20402, Phone: (202) 512-1800, Internet:
http://www.gpoaccess.gov/cfr/index.html
12. Machinery's Handbook, published by Industrial Press Inc., 200 Madison Avenue, New York, NY
10157, Phone: (888) 528-7852, Internet: http://new.industrialpress.com
13. Aerospace Standard (AS) 568, Aerospace Size Standards for O-rings, published by SAE, 400
Commonwealth Drive, Warrendale, PA 15086, Phone: (724)-776-4841, Internet: http://www.sae.org
14. ISO 3601-1:2002: Fluid Power Systems, Sealing Devices – O-Rings – Part 1: Inside diameters,
cross-sections, tolerances and size identification code, The International Organization for
Standardization (ISO), 1 ch. de la Voie-Creuse, Postale 56, CH -1211, Geneva 20, Switzerland,
Phone: +41-22-749-01-11, Internet: www.iso.org
2
15. ASTM specifications for Cast Grades A351/A351M, A743/A743M and A744/A744M. Available
from ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, Phone: (610) 832-9500.
www.astm.org/standard/index.shtml
C DEFINITIONS
C1 Bond: The adhesive or cohesive forces holding materials together. This definition excludes press and shrink fits.
C2 Burr: A thin ridge or sharp area remaining after cutting, drilling, or punching a material.
C3 Cleaning
C3.1 Clean-in-Place (CIP) Cleaning: The removal of soil from product contact surfaces in their process position by circulating,
spraying, or flowing chemical solutions and water rinses onto and over the surfaces to be cleaned. Components of the
equipment, which are not designed to be cleaned in place, are removed from the equipment to be COP or manually cleaned.
C3.2 Clean-Out-of-Place (COP): Removal of soil when the equipment is partially or totally disassembled. Soil removal is
effected by circulating chemical solutions and water rinses in a wash tank, which may be fitted with circulating pump(s).
C3.3 Manual Cleaning: Removal of soil when the equipment is partially or totally disassembled. Soil removal is effected with
chemical solutions and water rinses with the assistance of one or a combination of brushes, nonmetallic scouring pads and
scrapers, and high or low pressure hoses, with cleaning aids manipulated by hand.
C4 Cleanable or Cleanability: The suitability of materials of construction, design and fabrication required to assure that the
equipment can be freed from soil.
C4.1 CIPable: The design and fabrication of equipment which allows the equipment surfaces to be cleaned by CIP methods for
a prescribed time and at a prescribed concentration, flow rate, pressure, and temperature demonstrated to be effective.
C5 Corrosion Resistant: A surface or material which has the property to retain its original surface characteristics for its
predicted service period, when exposed to the conditions encountered in the environment of intended use, including contact
with product, cleaning and sanitizing chemicals, steam, or sterilization compounds or solutions.
C6 Dead End: An area or space wherein a product, ingredient, cleaning or sanitizing agent, or other extraneous matter may be
trapped, retained, or not completely displaced during operational or cleaning procedures.
C7 Fittings
C7.1 CIP Fittings: Fittings designed to be cleaned while fully assembled. If such a fitting has a removable joint, the joint is
self-centering, employs a gasket, and the resulting gasketed joint forms a substantially flush interior surface.
C7.2 Manually Cleaned Fittings: Removable joint fittings of which the design requires dismantling for manual cleaning.
C8 Hot Isostatic Pressing (HIP): The application of high pressure and temperatures through the medium of a pressuring
gas (usually argon or nitrogen), during the precision casting of near net shapes of solid parts and the layering of
coatings on substrates, to remove internal porosity and voids, via diffusion bonding, both at the surface and within the
casting and coating.
C9 High Velocity Oxyfuel Spray (HVOF): A thermal spray dry process that produces a dense non-porous metal coating
from metal powder (usually of a composition inclusive of nickel, nichrome, inconel, chrome oxide and ceramics-
tungsten carbide) using a fuel (usually propylene, hydrogen, propane, kerosene/oxygen) which heats the powder to a
molten state during the high-velocity delivery at the part to be coated using a propellant gas.
C10 Inlet: An opening that allows product, solutions, steam, or air to enter the equipment.
3
C11 Inspectable: Designed, fabricated and installed to make product contact surfaces available for close visual observation.
C12 Nontoxic Materials: Substances, which under the conditions of their use, are in compliance with applicable requirements
of the FDA.
C13 Outlet/Product Outlet: An opening that allows product or solutions to exit the equipment.
C14 Processing Area: A room or area suitable for the manufacturing and packaging of products.
C15 Product: Milk, milk products or other liquid food products.
C16 Pumps:
C16.1 Reciprocating Pump: A positive displacement pump that moves product by reciprocating motion of a plunger(s) or a
piston(s) operating in a cylinder(s).
C16.2 Homogenizer: A reciprocating pump which employs a specially designed homogenizing valve(s) for the purpose of
reducing particle size and creating an even dispersion and uniform product emulsion. The homogenizing valve(s) may be
installed at the homogenizer and/or at a downstream location by means of a suitable high-pressure resistant connection.
C17 Readily Accessible: A location that can be safely reached by personnel from the floor, other permanent work area or stable
platform (permanent or moveable).
C18 Readily Removable: Designed, fabricated, and installed to be quickly separated from the equipment with or without the use
of simple hand tools.
C19 Roughness Average (Ra): An arithmetical mean of the absolute values of the surface profile departure within a sampling
length. (Refer to B4, Reference No. 1.)
C20 Safe Water: Water from a supply properly located, protected, and operated, and shall be of a safe, sanitary quality. The
water shall meet the standards as described in the National Primary Drinking Water Regulation of the Environmental
Protection Agency (EPA) (Refer to B4, Reference No. 2) or Category I Reclaimed Process Water as described in Appendix
D of the PMO. (Refer to B4, Reference No. 3.)
C21 Sanitizing or Sanitization: A process applied to a clean surface which is capable of reducing the numbers of the most
resistant human pathogens by at least 5 log10 reductions (99.999%) to 7 log10 reductions (99.99999%) by applying hot
water, hot air, or steam, or by applying an EPA-registered sanitizer according to label directions. Sanitizing may be
effected by mechanical or manual methods.
C22 Simple Hand Tools: A screwdriver, wrench, mallet, or readily available dedicated tool(s) normally used by operating and
cleaning personnel.
C23 Soil: Unwanted organic residue or inorganic matter.
C24 Solution: Water or any mixture of cleaning agents, sanitizers and water used for flushing, cleaning, rinsing, or sanitizing.
C25 Sterilization: A process effected by heat, chemicals, or other mechanical means that destroys all vegetative bacteria and
inactivates relevant bacterial spores of public health concern.
C26 Substantially Flush: Mating surfaces or other juxtaposed surfaces that are not more than 1/32 in. (0.80 mm) off-set from
each other, except for pipeline and tubular piping welds which must meet AWS/ANSI D18.1. (Refer to B4, Reference No.
4.)
4
C27 Surfaces
C27.1 Product Contact Surfaces: All surfaces which are exposed to the product and surfaces from which splashed product,
liquids or material may drain, drop, or be drawn into the product or onto product contact surfaces under normal conditions
of use.
C27.2 Nonproduct Contact Surfaces: All exposed surfaces from which splashed product, liquids, or other materials cannot drain,
drop or be drawn into the product or onto product contact surfaces under normal conditions of use.
C27.3 Splash Contact Surfaces: Nonproduct contact surfaces that during normal use are subject to accumulation of soil and
which require routine cleaning and from which the accumulated soil cannot drain, drop, or be drawn into the product or
product contact surfaces.
C28 Surface Modification (Refer to B4, Reference 5)
C28.1 Surface Treatments: Processes where chemical composition or mechanical properties of the existing surface are altered.
There is no appreciable build-up of new material or removal of existing material.
C28.1.1 Surface treatments include:
1. Mechanical (grinding, shot peening, polishing) (Refer to B4, Reference 6)

2. Thermal (surface hardening laser, electron beam)
3. Diffusion (carburizing, nitriding, HIP)
4. Chemical (etching, oxidation, passivation)
5. Ion implantation
6. Electropolishing
C28.2 Coatings, Overlays and Escapsulations: Processes where a different material is deposited onto a defined base material or
substrate to create a product contact surface. There is a build-up of new material. The coating, overlay or encapsulation
material does not alter the physical properties of the substrate.
C28.2.1 Coating processes include:
1. Chemical (conversion coatings, except anodizing)

2. Electrodeposition, engineering plating (Refer to B4, Reference 7)
3. Thermo spraying (flame, plasma, arc spray, HVOF)
4. Physical vapor deposition
5. Chemical vapor deposition
D MATERIALS
D1 Product Contact Surfaces
All materials having product contact surfaces shall be of such composition as to retain their surface and conformational
characteristics when exposed to the conditions encountered in the environment of intended use including cleaning and
sanitization treatment or sterilization.
D1.1 Metals
D1.1.1 Product contact surfaces shall be of stainless steel of the Association for American Iron and Steel Technology (AIST ) 300
Series, excluding 301, 302 (except as noted in D1.1.1.4) and 303 (Refer to B4, Reference No. 8) or corresponding Alloy
Cast Institute (ACI) types (Refer to B4, Reference No. 9) or metal, inclusive of powdered metals, which under conditions
of intended use is at least as corrosion resistant as 304 stainless steel, and is nontoxic and impermeable. (Refer to
Appendix, Section F) except that:
5
D1.1.1.1 Homogenizing valves, plungers, pistons, cylinders, suction and discharge valves, guides, seats, and their associated
components made of the materials provided for in D1.1.1 may have their product contact surfaces modified by surface
treatment or coating(s).
D1.1.1.2 Homogenizing valves, plunger, pistons, cylinders, suction and discharge valves, guides, seats, and their associated
components may also be made of other nontoxic structurally suitable metal(s) that have their product contact surfaces
modified by surface treatment or coating(s), provided that the resulting surfaces are as corrosion resistant as the materials
provided for in Section D1.1.1.
D1.1.1.3 Homogenizing valves, plungers, pistons, cylinders, suction and discharge valves, guides, seats, and their associated
components may also be made of stainless steel of the AIST 400 Series that is made as corrosion resistant as AIST 304
Series by surface treatment or coating(s), or made of nontoxic, nonabsorbent metal that is as corrosion resistant, under the
conditions of intended use, as stainless steel of the AIST 304 Series.
D1.1.1.4 Coil springs may also be made of stainless steel AIST 302 material.
D1.1.1.5 Where welding is involved, the carbon content of the stainless steel shall not exceed 0.08%.
D1.1.1.6 Alloys containing lead, leachable copper, or other toxic metals shall not be used.
D1.1.2 Homogenizing valves, plungers, pistons, cylinders, suction and discharge valves, guides, seats, and their associated
components may be covered by a coating of electroless nickel alloy. (Refer to B4, Reference Number 10 and Appendix,
Section H.)
D1.1.3 Solder, when used, shall be silver bearing solder and shall be corrosion resistant, free of cadmium, lead, and antimony,
nonabsorbent, and shall not impart any toxic substance to the product when exposed to the conditions encountered in the
environment of intended use and in cleaning and bactericidal treatment or sterilization.
D1.2 Nonmetals
D1.2.1 Rubber and rubber-like materials (elastomers) may be used for gaskets, seals, O-rings and when used for the specified
application(s), shall conform to the applicable provisions of 3-A Sanitary Standard, Number 18-.
D1.2.2 Plastic materials may be used for gaskets, seals, O-rings, bushings, guides, coatings, and when used for the above-specified
application(s), shall conform to the applicable provisions of 3-A Sanitary Standard, Number 20-.
D1.2.3 Adhesives used for bonding rubber and rubber-like materials, bonding plastic materials, and bonding of carbon or ceramic
seal components shall be nontoxic. Adhesives shall comply with Title 21 CFR 175 - Indirect Food Additives: Adhesives
and Components of Coatings (Refer to B4, Reference No.11).
D1.2.4 Carbon and ceramic materials (including tungsten carbide) may be used for plungers, pistons, pump valve parts,
homogenizing valves, cylinders and their associated parts, and when used, shall be inert, nontoxic, nonabsorbent, insoluble,
and resistant to scratching, scoring, and distortion when exposed to the conditions encountered in the environment of
intended use, including cleaning and sanitizing treatment and sterilization.
D1.2.5 Composite materials of nitrile, cotton, polyester, PTFE, aramid, and HNBR (hydrogenated nitrile rubber), which are fully
coated with elastomers and/or polymers conforming to the applicable provisions of 3-A Sanitary Standard, Number 18- for
elastomers and 3-A Sanitary Standard, Number 20- for polymers, may be used for plunger or piston seals.
6
D1.3 Lubrication Media
D1.3.1 When required, either safe water or condensed culinary steam shall be used in a single pass configuration for lubrication of
the pistons (Refer to B4 , Reference Number 2 and B3, Reference Number 609-), except that:
D1.3.1.1 For aseptic and other applications, media heat recovery components may be arranged in series with the lubrication media
delivery components and shall be designed to maintain the sanitary (hygienic) integrity of the lubrication media before the
media is discharged to atmosphere. The media shall not be re-used. The point of media discharge may serve as a leak
detector for the piston or plunger seals.
D2 Nonproduct Contact Surfaces
D2.1 All nonproduct contact surfaces shall be of corrosion-resistant material or material that is rendered corrosion resistant. If
the surfaces are coated, including painted surfaces, the coating shall adhere. All nonproduct contact surfaces shall be
relatively nonabsorbent, durable, and cleanable. Parts removable for cleaning having both product contact and nonproduct
contact surfaces shall not be painted.
E FABRICATION
E1 Product Contact Surfaces
E1.1 Surface Texture
Surfaces, including fabricated, welded and soldered joints, shall be at least as smooth as a 32 in. (0.8 m) Ra finish and
shall be free of pits, folds, crevices, cracks, and misalignments in the final fabricated form. (Refer to Appendix, Section
G.)
E1.2 Permanent Joints
E1.2.1 All permanent joints in metallic surfaces shall be continuously welded, except that:
E1.2.1.1 Press-fits, force-fits or shrink-fits may be used to produce crevice-free permanent joints only when neither welding nor
soldering is practical. Joints of these types may only be used to assemble metallic parts having circular cross sections, free
of shoulders or relieved areas. Press-fitting, force-fitting or shrink-fitting may be used for valve seats and homogenizing
valves. (Refer to B4, Reference No.12.) (See the following illustrations of acceptable press-fits, force-fits, or shrink-fits:)
E1.3 Silver-bearing solder may be used for flushing joints of suction and discharge valve seats and filling voids and surface
porosity of head block castings.
7
E1.4 Coatings
E1.4.1 Coatings, when used, shall be free of delamination, pitting, flaking, spalling, blistering, or distortion when exposed to the
conditions encountered in the environment of intended use, including cleaning and sanitizing treatment or sterilization.
E1.5 Cleaning and Inspectibility
E1.5.1 Equipment intended for COP or manual cleaning shall be designed and fabricated so all product contact surfaces are
readily accessible and inspectable either when in an installed position or when removed. Junctures between components
may or may not be gasketed or sealed. All demountable appurtances shall be readily removable with simple hand tools.
E1.5.2 Equipment intended for CIP cleaning shall be designed and fabricated so all product contact surfaces, including all non-
removed appurtenances, can be CIP cleaned. Junctures between components shall be sealed or designed for manual or
COP cleaning. (See Appendix K.)
E1.5.2.1 All CIP cleaned surfaces, including all non-removed appurtenances, shall be readily accessible and inspectable. All
demountable appurtenances shall be readily removable.
E1.5.3 Ports for instrumentation and pressure safety relief devices on high pressure pumps and homogenizers designed to operate
at over 250 psig (1724 kPa) may have dead end passages of 10 port diameters, or less, but not to exceed 5 in. (127 mm)
when assembled, provided the passages are readily accessible for manual cleaning and inspection when disassembled.
E1.6 Draining
E1.6.1 When disassembled, all product contact surfaces shall be self-draining except for typical clingage or adherence.
E1.7 Gaskets, Gasket Retaining Grooves, O-rings and Seals
E1.7.1 All gaskets shall be removable or bonded.
E1.7.2 Grooves in gaskets shall be no deeper than their width unless the gasket is readily removable and reversible for cleaning.
E1.7.3 Gasket retaining grooves for removable gaskets shall not exceed 1/4 in. (6.35 mm) in depth or be less than 1/4 in. (6.35
mm) wide, except those for O-rings with cross-section dimensions 1/4 in. (6.35 mm) or smaller, and those provided for in
the 3-A Sanitary Standards referenced in Section B, Normative References.
E1.7.4 Gaskets between flat sealing surfaces shall be substantially flush with the product contact surfaces. The juncture shall
create a crevice free joint, without any unsupported gasket material.
E1.7.5 Surfaces with two or more O-rings or seals in series on a shaft except for plunger or piston seals, shall have a self-draining
leak-detection port between them that is open to the atmosphere and visible to the operator, unless this area is designed for
manual or COP cleaning, or unless this area is flushed by suitable flushing medium (e.g. safe water, sterile condensate).
The leak-detection port shall be a minimum of 1/8 in. (3.18 mm) in diameter.
E1.7.6 Gasketed joints employing recessed O-rings or seals which are intended for CIP shall be substantially flush so that some of
the O-ring or seal surface will be partially exposed to cleaning solutions (See following illustrations of examples).
8
E1.8 Radii
E1.8.1 All angles of less than 135 shall have radii of at least, 1/4 in. (6.35 mm), except that:
E1.8.1.1 Smaller radii may be used for valves, valve seats, seals, and pistons. Such radii shall be at least 1/32 in. (0.794 mm)
except that:
E1.8.1.1.1 No minimum radius is required for homogenizing valve(s) and impact ring(s) due to essential functional reasons of
homogenizing efficiency and performance.
E1.8.1.2 The radii in grooves in gaskets or in retaining grooves for removable gaskets shall be a minimum of 1/8 in. (3.18 mm),
except for retaining grooves for O-rings with a cross section dimension 1/4 in. (6.35 mm) or smaller, and those
provided for in the 3-A Sanitary Standards referenced in Section B, Normative References.
E1.8.1.3 Radii in retaining grooves for standard circular cross section O-rings shall be as specified in the Table below (Refer to
B4, Reference No. 13 and B4, Reference No. 14).
9
O-Ring O-Ring O-Ring Minimum

Cross Cross Cross Groove
Section, Section Actual Section Actual Radius
Nominal (AS 568) (ISO 3601-1)
(AS 568)
0.0160 in.
1/16 in. 0.073 in. 1.85 mm (0.406 mm)
0.0310 in.
3/32 in. 0.106 in. 2.69 mm (0.787 mm)
0.0310 in.
1/8 in. 0.143 in. 3.63 mm (0.787 mm)
0.0620 in.
3/16 in. 0.215 in. 5.46 mm (1.575 mm)
0.0940 in.
1/4 in. 0.281 in. 7.14 mm (2.39 mm)
E1.8.1.4 Radii in gasket retaining grooves and seats for seals with a nonstandard circular, square, rectangular, or other shaped
cross section O-ring with the shorter dimension 1/4 in. (6.35 mm) and smaller shall be those radii closest to the standard
circular cross section O-ring as specified in E1.8.1.3. To determine minimum radius in the retaining groove for a
nonstandard O-ring, compare its cross-section dimension with those shown in column 2 of the table above, determine
which is closest, and use the applicable minimum groove radius. For a square O-ring, use the flat-to-flat side dimension
for comparison. For a rectangular or other shaped O-ring, use the dimension that will fit into the retaining groove.
E1.8.1.5 There are no minimum radii requirements for soldered joints or for the product contact junctures of press or shrink fits.
E1.8.1.6 There are no minimum radii requirements for the product contact junctures of flat sealing surfaces.
E1.9 Threads
E1.9.1 There shall be no exposed or enclosed threads on product contact surfaces.
E1.10 Coil Springs
E1.10.1 Coil springs shall be made of round cross-section stock or wire.
E1.10.2 Coil profiles of springs intended for CIP shall not be modified to produce a flat mounting surface except that:
E1.10.2.1 Springs, when used with piston or plunger seals and suction and discharge valves, may have flat ends incurred from the
spring wire cutting operation and may be modified to include point contact at the coil ends and at the intermediate coils
with cylinders, valve ports and retainer rings, as required for maintaining spring alignment.
E1.10.3 When used, modified coil ends terminating with ears or tabs, shall not be modified to produce square or rectangular
shaped ears or tabs.
E1.10.4 Coil springs shall have at least 3/32 in. (2.38 mm) spacing between coils, including end coils, when the spring is in the
relaxed state.
E1.11 High Temperature Systems
E1.11.1 Equipment designed for use in a processing system to be sterilized by heat at a temperature of 250F (121C) or higher
shall conform to the following:
10
E1.11.2 The design and fabrication shall be such that all surfaces can be:
1. Sterilized by saturated steam or water under pressure (at least 15.3 psig or 106 kPa) at a temperature of at least 250F
(121C (See Appendix I), and
2. Operated at the temperature and pressure required for processing of the product.
E1.11.3 The steam or other sterilizing medium chamber(s) shall be constructed so the interior surfaces are inspectable.
E1.11.4 Seal(s) of sanitary design shall be provided between the product contact surface(s) and the steam or other sterilizing
medium chamber.
E1.12 Pistons or Plungers
E1.12.1 The portion of the pistons or plungers traveling in and out of the product shall be sealed with a seal arrangement of
individual gaskets of sanitary design that are removable, cleanable and inspectable. The gaskets shall be installed using a
mechanical force to compress the gaskets in the operating condition. This force can be applied by a coil spring and
locking/carrier nut plus product pressure to provide adequate tightness to eliminate open spaces between the individual
gaskets. When used, the lubricating media shall be directed onto the pistons or plungers on the non-product contact side of
the seal and directed to drain. The leakage path to the drain shall not be obstructed. (See Appendix K.)
E1.12.2 Lubrication media used for the pistons or plungers shall be delivered to the pistons or plungers in a single pass
configuration.
E1.13 Bearings or Bushings
E1.13.1 Bearings or bushings having a product contact surface shall be of a non-lubricated or product-lubricated type.
E14 Homogenizing Valves
E14.1 The product contact surfaces of homogenizing valves shall meet the requirements of these standards, except for those single
service valves which are intended to be discarded after each day’s use.
E1.15 Safety Relief Valves
E1.15.1 Safety relief valves, when provided, may be of the compression-type conforming to 3-A Sanitary Standard for
Compression-Type Valves, Number 53- (Reference: B2), or shall be of suitable types conforming to the applicable
provisions of this standard and shall be cleanable and inspectable.
E2 Nonproduct Contact Surfaces
E2.1 Surfaces
E2.1.1 Exposed surfaces shall have relatively smooth finishes and be relatively free of pockets and crevices.
E2.1.2 Knurled surfaces shall not be used.
E2.1.3 All surfaces of motors are not considered exposed surfaces and are exempt from this standard. Motors shall be located in a
manner to prevent cooling fan airflow from blowing directly onto exposed products or product contact surfaces.
E2.2 Joints
E2.2.1 Permanent joints subject to product residue shall be continuously welded. Welded junctures do not require grinding or
polishing, except that:
11
E2.2.1.1 Where welding is not possible for functional or safety reasons, inclusive of joints not intended for routine disassembly,
bolted joints may be used.
E2.2.1.2 Recessed socket head bolts shall not be used, except that:
E2.2.1.2.1 Recessed socket head bolts may be used, provided they are away from any product or splash contact surfaces, are
shielded from any product residues or mounted so they do not retain soil.
E2.2.1.3 Rivets shall not be used, except on gear reducers, pneumatic cylinders, hydraulic cylinders and nameplates on equipment.
E2.3 Name and Information Plates
E2.3.1 Name and information plates, when used, shall be continuously welded or effectively sealed to the equipment, except on
components listed in Section E2.2.1.3, where rivets are allowed.
E2.3.2 Non-metallic, adhesive-backed name and information plates are also acceptable.
E2.3.3 An information plate shall be attached juxtaposition to the nameplate stating:
1. Maximum pressure at which the equipment can be operated.
2. To prevent corrosion or damage, the recommendations of the manufacturer shall be followed with respect to time,
temperature, and the concentration of specific cleaning solutions and chemical bactericide.
3. “This equipment * designed for sterilization.”

* Insert one of the following:
(a) “is”
(b) “is not”
E2.4 Coatings
E2.4.1 If the framework and exterior panels of the equipment are not made of corrosion-resistant metal, they shall be painted or
coated. When coatings are used, they shall be free from delamination, pitting, flaking, spalling, blistering, or distortion
when exposed to the conditions encountered in the environment of intended use, including cleaning and sanitizing.
E2.5 Cleaning and Inspectability
E2.5.1 Surfaces shall be designed and fabricated to facilitate cleaning and inspectability and shall be relatively free of areas
where liquids or product residues can accumulate and not be cleaned out.
E2.6 Draining
E2.6.1 Surfaces shall be designed to minimize the pooling of liquids and to insure that liquids cannot drain into the product or
onto product contact surfaces.
E2.7 Threads
E2.7.1 Exposed threads shall be minimized. Exposed threads shall not exceed one half (½) the nominal diameter of the thread,
except that:
E2.7.1.1 Threads that are subject to routine product splash during processing and cleaning shall be covered by an enclosed nut.
12
E2.8 Service Piping and Lines
E2.8.1 Exposed braided coverings of cables or hoses shall not be used except that:
E2.8.1.1 Hoses that have overbraided surfaces, when necessary for high pressure and/or temperature applications, shall be coated
with a material to produce relatively smooth exterior surfaces and to create a seal sufficient to prevent ingress of liquids
into the braiding.
E2.8.2 Electrical and utility connections shall be as remote as practical from the product contact areas of the equipment.
E2.8.3 Components using machinery fluids (e.g. lubricating, hydraulic and signal transfer fluids) shall be installed to prevent fluid
ingress into the product or onto product contact surfaces.
E2.8.3.1 Hydraulic fluids, when used for homogenizing valve actuators, shall be food grade.
E2.8.4 Hose clamps of the worm gear type shall not be used.
E2.9 Panels, Doors, or Access Ports
E2.9.1 Panels, doors or access ports may include soundproof enclosures and alcoves.
E2.9.2 Panels, doors, or access ports shall be provided to allow access to the interior of the equipment.
E2.9.3 Panels, doors, or access ports shall be constructed in a manner that will prevent the entrance of contaminants.
E2.9.4 Panels and doors having both product contact and nonproduct contact surfaces shall meet the fabrication criteria for
product contact surfaces.
E2.9.5 The use of hinges, wing nuts, latches, and similar easy-opening fastening devices are recommended to allow easy access
without special tools, except when required for safety reasons to avoid easy access to moving parts causing potential health
and safety risk for operators.
E2.9.6 Any hinges, wing nuts, latches, and similar easy-opening fastening devices used shall be attached so as to minimize the use
of fasteners and the creation of cracks and crevices.
E2.9.7 Hinges shall be of a sanitary design that can be readily disassembled. Continuous or piano-type hinges shall not be used on
the equipment or its control cabinets, unless such hinges are located at least 18 in. (457 mm) from any product or splash
contact surface.
E2.9.8 When braces, supports or frames made from hollow stock are used, the integrity of these structures shall not be
compromised by drilling into the hollow interiors. If bolting is required, welded studs to the exterior or fully welded
sleeves shall be employed or gaskets shall be used to effectively seal the hollow stock.
E2.9.9 When external lap joints for sheathing over insulated areas are used, they shall be overlapped downward and overlapped
joints shall be effectively sealed between the mating surfaces with suitable sealants.
E2.10 Guards and Other Safety Devices

E2.10.1 Guards required by personnel safety standards shall be removable for cleaning and inspection of the equipment. Guards
and channels, when used, shall be designed to minimize the accumulation of debris and liquids, with use of appropriate
self-draining ports or openings.
13
E2.11 Supports
E2.11.1 The means of supporting homogenizers and reciprocating pumps shall conform with the applicable provisions of 3-A
Sanitary Standard for Machine Leveling Feet and Supports Number 88- (See Reference B2) except that:
E2.11.2 When a homogenizer or reciprocating pump is designed to be installed with product contact surfaces in the process area
and other nonproduct contact surfaces are to be located outside the process area, they shall be separated by an alcove.
E2.11.3.1 The alcove shall be constructed of corrosion-resistant stainless steel, designed so that:
1. It can be sealed to the process area wall.

2. All interior alcove surfaces are free draining to the process area.
E2.11.3.2 The alcove shall be located so that any leakage from the product contact surfaces shall be detectable from the processing
area.
E2.11.4 Casters, when provided, shall be of sufficient size to provide a clearance between the lowest part of the base and the
floor of at least 4 in. (102 mm). Casters shall be easily cleanable, durable under conditions of intended use, including
cleaning and sanitizing and of a size that will permit easy movement of the equipment.
E2.12 Special Considerations
E2.12.1 Accessibility
E2.12.1.1 The space between the cylinder(s) and the drive shall be readily accessible for cleaning, self-draining and protected so that
liquids will not enter the drive. This space shall be provided with a cover or shield. The cover may be designed to
permit observation without removing it from the homogenizer or reciprocating pump.
E2.12.2 Homogenizers or reciprocating pumps to be used as the timing device in a pasteurizing system shall be provided with an
easily accessible or externally visible means of sealing to prevent the operation of the homogenizer or reciprocating
pump at a greater flow rate than that which gives legal holding time without breaking the seal.
E2.12.3 When a homogenizer or reciprocating pump is provided with an attached or free-standing sound suppression enclosure,
the enclosure shall be designed and constructed so that there is easy access for cleaning and inspection of all product
contact parts of the homogenizer or reciprocating pump and to any part which may require sealing by a regulatory
authority. All external surfaces of such an enclosure shall be smooth, durable, free of pockets and crevices, and be
readily cleanable and those to be coated shall be effectively prepared for coating. Sound suppressing materials, when
used, shall be impermeable, smooth, durable and crack or crevice-free or shall be fully encapsulated in metal or smooth
plastic jackets which are totally enclosed and are moisture and vermin proof. Adhesives and sealants, when used, for
joining of insulated panels and sound suppressing materials shall be non-toxic and effectively seal against liquid
penetration of the joint between the sound suppressing material and backing/support panel material to which it is
attached.
14
APPENDIX
F STAINLESS STEEL AND EQUIVALENT MATERIALS
F1 Stainless steel conforming to the applicable composition ranges established by AIST for wrought products, or by ACI for
cast products, should be considered in conformance to the requirements of Section D1.1 herein. The first reference cited in
D1.1.1 sets forth the chemical ranges and limits of acceptable stainless steel of the 300 Series. Cast grades of stainless steel
corresponding to types, 304, and 316 are designated, CF-8, and CF-8M, respectively. The chemical compositions of these
cast grades are covered by ASTM specifications A351/A351M, A743/A743M and A744/A744M (Refer to B4, Reference
Number 7).
Fabrication of stainless steel equipment and components, including cutting, grinding, and finishing, should be performed
with materials and tools properly segregated for such purposes and not previously used on other metals. This is to prevent
cross-contamination of the stainless steel with other metal contaminants.
F2 TABLE 1 (Refer to B4, Reference No. 14 and B4. Reference No. 8.)
WROUGHT PRODUCTS TYPICALLY USED

ASTM
UNS # Material AIST/SAE Properties ASTM
Grade Designation Standard Grade Grade Designation
Pub. No. Designation
A276
S30400 304 Austenitic S.S. 304
A666
A276 Low Carbon
S30403 304L 304L
A666 Austenitic S.S.
A276 Austenitic S.S.
S31600 316 316
A666 plus Mo*
A276 Low Carbon
S31603 A666 316L Austenitic S.S. 316L
plus Mo*
*Molybdenum
15
TABLE 2
CAST PRODUCTS
UNS # ACI
ASTM Common
Grade Designation Grade
Material Standard Pub. No. Names
Designation
A351
J92500 A743 CF-3 Cast 304L
A744
A351
J92800 A743 CF-3M Cast 316L
A744
A351
J92600 A743 CF-8 Cast 304
A744
A351
J92900 A743 CF-8M Cast 316
A744
J92180 A747 Nb7 Cu – 1 Cast 17-4 PH
J92110 A747 Nb7 Cu –2 Cast 15-5 PH
N26055 A494 CY5Sn BiM Alloy 88
Free Machining
J92701 A743 CF-16F
Austenitic S.S.
16
TABLE 3 - OPTIONAL METAL ALLOYS
Optional metal alloys having the following compositions are examples considered in compliance with Section D1.1.1 herein.
(Percentages are maximums unless range is given.)
UNS UNS UNS UNS UNS UNS UNS UNS UNS UNS
N08367 S21800 S20161 N26055 N26455 S17400 S15500 S32750 R20500 R50400
ASTM ASTM ASTM ASTM ASTM ASTM ASTM ASTM ASTM
A743 A743 A494 A494 A747 A747 A479 A560 B67
Mat’l Std Mat’l Std Mat’l Std Mat’l Std Mat’l Std Mat’l Std Mat’l Std Mat’l Std Mat’l Std
CN-3MN CF-10 CY5SnBi CW-2M Nb7Cu-1 Nb7Cu-2 CrNiMo 50Cr- C-2
SMnN M N 25-7-4 50Ni
Common Nitronic- Gall- Hastelloy-
AL-6XN® Alloy 88 17-4 PH 15-5 PH Duplex 50/50 Titanium
Name 60 Tough C®
C 0.03 0.10 0.15 0.05 0.02 0.07 0.07 0.03 0.10 0.10
Mn 2.00 7.00-9.00 4.00-6.00 1.50 1.00 0.70 0.70 1.20 0.30
Si 1.00 3.50-4.50 3.00-4.00 0.50 0.80 1.00 1.00 0.80 1.00
P 0.04 0.04 0.04 0.03 0.03 0.035 0.035 0.035 0.02
S 0.01 0.03 0.04 0.03 0.03 0.03 0.03 0.015 0.02
Cr 20.0-22.0 16.0-18.0 15.0-18.0 11.0-14.0 15.0-17.5 15.5-17.5 14.0- 25.0 48.0-52.0
15.50
Ni 23.5-25.5 8.00-9.00 4.00-6.00 Balance Balance 3.60-4.60 3.50-5.50 7.0 Balance
Mo 6.0-7.0 2.0-3.5 15.0-17.5 4.0
Nb 0.15-0.35 0.15-0.35
Cu 0.75 2.50-3.20 2.50-3.20 0.50
N 0.18-0.26 0.08-0.18 0.08-0.20 0.05 0.05 0.30 0.30 0.03
Fe Balance Balance Balance 2.00 2.00 Balance Balance Balance 1.00 0.30
Sn 3.0-5.0
Bi 3.0-5.0
W 1.0
Ti 0.50 Balance
Al 0.25
Other H = 0.015
O = 0.25
* Percentage is maximum unless range is given.
17
TABLE 3 - OPTIONAL METAL ALLOYS (Cont.)
Industry Name 2205 2205 329 904L 254SMO Stellite 6 Stellite 12 Stellite 20 Stellite 21
AMS 5385
UNS UNS UNS UNS UNS UNS AWS ASTM A732
Specification: S32205 S31803 S32900 N08904 S31254 30006 RCoCr-B
None
Gr. 21
Mil-C-13358
Element Type: Duplex Duplex Duplex
Stainless Stainless
Stainless Stainless Stainless Cobalt Alloy Cobalt Alloy Cobalt Alloy Cobalt Alloy
Steel Steel
Steel Steel Steel
min 0 0 0.9 1.7 2 0.2
C
max 0.030 0.030 0.200 0.020 0.020 1.4 2 2.45 0.35
min 0 0 0 0 0 0 0
Mn
max 2.00 2.00 1.00 2.00 1.00 1 1
min 0 0 0 0 0 0 0
Si
max 1.00 1.00 0.75 1.00 0.80 1.1 1
min 0 0 0 0 0
P
max 0.03 0.03 0.04 0.045 0.03
min 0 0
S
max 0.02 0.02 0.03 0.035 0.01
min 21.0 22 23 19 19.5 27 27 28 26
Cr
max 23.0 23 28 23 20.5 32 32 33 29
min 2.5 3 1 4 6 0 4.5
Mo
max 3.5 3.5 2 5 6.5 1.5 6
min 4.5 4.5 2.5 23 17.5 0 0 2
Ni
max 6.5 6.5 5 28 18.5 3 2.5 3
min 0.08 0.14 0.18
N
max 0.20 0.2 0.22
min 4 7.5 15.5
W
max 6 9.5 17.5
min
Co Balance Balance Balance Balance
max
min
Fe Balance Balance Balance Balance
max 2.5 2.5 2.5 3
min 1 0.5
Cu
max 2 1
min
Al
max
18
TABLE 3 - OPTIONAL METAL ALLOYS (Cont.)
Industry Name Rexalloy ®™ 33 Rexalloy ®™ 44

UNS R30001
MIL-R01731-MILRCoCr-C
Specification: None
(low tungsten)
Element Type: Cobalt Alloy Cobalt Alloy

min 2.10 1.70
C
max 2.40 2.00
min .80 .60
Mn
max 1.20 1.20
min .35 .35
Si
max .65 .65
min .00 .00
P
max .04 .04
min .15 .00
B
max .30 .15
min 32.00 32.00
Cr
max 33.50 33.50
min .00 .40
Mo
max 0.50 .70
min .00 .00
Ni
max 1.00 1.00
min .00 .00
N
max 0.030 .030
min 17.50 8.25
W
max 18.50 9.25
Balance Balance
Co
min .00 .00
Fe
max 2.00 2.00
min .00 .40
V
max .10 .60
min N/A N/A
Al
max N/A N/A
F3 Metal alloys or metals or like materials other than the above may be as corrosion resistant as 300 Series Stainless Steel.
This may be shown when metal alloys or metals are tested in accordance with ASTM G31 Laboratory Immersion
Corrosion Testing of Metals and have a corrosion rate of less than 10.0 mil per year. The test parameters, including the
type of chemical(s), their concentration(s), and temperature(s), should be representative of cleaning and sanitizing
conditions used in equipment.
19
G PRODUCT CONTACT SURFACE FINISH
G1 Surface finish, obtained by mechanical polishing with 150 grit or better silicon carbide (aluminum oxide or other standard
approved abrasives) properly applied on stainless steel sheets, is considered in conformance to the requirements of Section
E1.1 herein. Representative areas of the finished surfaces should be tested to verify that the end finish is at least as smooth
as Ra 32 in. (0.8 m).
G2 Surface finish on sheets (less than 3/16 in. (4.76 mm) thickness) of 2B (cold rolled) stainless steel, inspected and selected
to be free of pits, folds and crevices are generally found to be as smooth as or smoother than stainless steel sheets with an
Ra  32 in. ( 0.8 m) finish and are acceptable for the fabrication of equipment if free of imperfections.
H ELECTROLESS NICKEL ALLOY
An electroless nickel alloy coating having the following composition is deemed to be in compliance with D1.1.2 herein:
Nickel - 90% minimum,

Phosphorous - 6% minimum and 10% maximum as a supersaturated solution of nickel phosphide in nickel,
Trace amounts of carbon, oxygen, hydrogen, and nitrogen,
No other elements allowed.
I STERILIZING TIME/TEMPERATURE
The minimum temperature of 250 deg. F (121 deg. C) for sterilizing equipment should be maintained for a least 30 minutes
or equivalent time/temperature treatment.
J ENGINEERING DESIGN AND TECHNICAL CONSTRUCTION FILE

The following is an example of an Engineering Design and Technical Construction File (EDTCF) to be maintained by the
fabricator as evidence of conforming to 3-A Sanitary Standards or 3-A Accepted Practices. (The file may contain more or
less information as applicable to the equipment or system.)
The maintenance of this file is required for an application for Authorization to Display the 3-A Symbol and will be
evaluated during the required Third Party Verification (TPV) evaluation of the equipment.
J1 Purpose
J1.1 To establish and document the material, fabrication, and installation (where appropriate) requirements for the engineering
design and technical construction files for all products, assemblies, and sub-assemblies supplied by the manufacturer
thereof to be in conformance to the sanitary criteria found in 3-A Sanitary Standards or 3-A Accepted Practices.
J2 Scope
J2.1 This EDTCF applies to equipment specified by:
J2.1.1 3-A Sanitary Standards for Homogenizers and Reciprocating Pumps, Number 04- .
J2.1.2 List all applicable 3-A Sanitary Standards and 3-A Accepted Practices.
J3 Responsibilities
J3.1 The EDTCF is maintained by {Name and Title of Responsible Official} who is responsible for maintaining, publishing,
and distributing the EDTCF.
J3.2 Implementation: All divisions, specifically development engineering, standards engineering, sales engineering, and product
departments are responsible for implementing the EDTCF.
20
J4 Applicability
J4.1 The 3-A Sanitary Standards and 3-A Accepted Practices are voluntarily applied as suitable sanitary criteria for dairy and
food processing equipment. 3-A Sanitary Standards are referenced in the Grade A PMO, which provides that equipment
manufactured in conformity to 3-A Sanitary Standards complies with the sanitary design and construction standards of this
Ordinance, and 21 CFR 58 Subpart B-- General Specifications for Dairy Plants Approved for USDA Inspection and
Grading Service.
J5 References
J5.1 List any additional regulations that apply to the equipment or system covered by this EDTCF.
J5.2 The date of conformity or 3-A Symbol Authorization and certificate number, if authorized.
J6 EDTCF
J6.1 The Engineering Design and Technical Construction File may consist of the following:
a. an overall drawing of the subject equipment;
b. full detailed drawings, accompanied by any calculations, notes, test results, etc. required to check the conformity of the
equipment to the 3-A Sanitary Standard or 3-A Accepted Practice;
c. a list of:
(1) the essential requirements of the standards or practices;
(2) other technical specifications, which were used when the equipment was designed;
d. a description of methods adopted;
e. if essential, any technical report or certificate obtained from a competent testing body or laboratory;
f. any technical report giving the results of tests carried out internally by Engineering or others;
g. documentation and test reports on any research or tests on components, assemblies and/or the complete product to
determine and demonstrate that by its design and construction the product is capable of being installed, put into
service, and operated in a sanitary manner (optional);
h. a determination of the foreseeable lifetime of the product (optional);
i. a copy of the instructions for the product (Instruction Manuals/Instruction Books);
j. for serial manufacturing, the internal measures that will be implemented to insure that the equipment will continue to
be manufactured in conformity to the provisions of the 3-A Sanitary Standards or 3-A Accepted Practices;
k. engineering reports;
l. laboratory reports;
m. bills of material;
n. wiring diagrams, if applicable;
o. purchase order engineering files;
p. hazard evaluation committee reports, if executed;
q. change records;
r. customer specifications;
s. any notified body technical reports and certification tests;
t. copy of the 3-A Symbol authorization, if applicable.
J6.2 The EDTCF file does not have to include detailed plans or any other specific information regarding the sub-assemblies,
tooling, or fixtures used for the manufacture of the product unless knowledge of them is essential for the verification of
conformity to the basic sanitary requirements found in 3-A documents.
J6.3 The documentation referred to in J6.1, above, need not permanently exist in a material manner in the EDTCF, but it must
be possible to assemble them and make them available within a period of time commensurate with its importance (one
week is considered reasonable time). As a minimum, each product EDTCF must physically contain an index of the
applicable document of J6.1, above.
J6.4 The EDTCF may be in hard copy or software form.
21
J7 Confidentiality
J7.1 The EDTCF is the property of the manufacturer and is shown at their discretion, except that all or part of this file will be
available to 3-A SSI or a regulatory agency for cause and upon request.
J8 File Location
J8.1 The EDTCF is maintained at {Location} the premises of the manufacturer of the equipment.
J9 File Retention
J9.1 The EDTCF (including all documentation referred to in J6.1) shall be retained and kept available for 12 years following the
date of placing the equipment in use or from the last unit produced in the case of series manufacture.
Nickel - 90% minimum,
Phosphorous - 6% minimum and 10% maximum as a supersaturated solution of nickel phosphide in nickel,
Trace amounts of carbon, oxygen, hydrogen, and nitrogen,
No other elements allowed.
K INSTRUCTION HANDBOOK, MAINTENANCE, AND CLEANING

K1 Instruction Handbook
The instruction handbook includes the following items:
K1.1 Installation of the Equipment and Associated Equipment
Information is provided so that, after the equipment is installed, it maintains its hygienic integrity (e.g., drainability and
inspectability). Recommendations should be provided as to the lubrication media delivery system to the pistons or plungers
to include aseptic processing applications and, when used, the heat recovery of cooling media to maintain the sanitary
(hygienic) integrity of the lubrication media. The drainage system for the lubrication media may be used for leak detection.
K1.2 Instructions for Use
Measures are described on the use of the equipment so that when used correctly the product is not exposed to factors
that can lead to contamination.
K2 Maintenance and Cleaning
K2.1 Maintenance
Guidance for inspection, monitoring and replacement of expendable parts should be given to ensure that the hygienic
integrity of the equipment is maintained during its intended lifetime. This information should include specific gasket,
plunger or piston seals or O-ring materials where they are used because of product characteristics (e.g., high fat or high
acid) or operational characteristics (e.g., pressure or steam applications or when used to create a tight seal between product
contact surfaces, and non-sanitary threads).
K2.2 Cleaning
The instructions specify typical routine procedures for cleaning, sanitizing, rinsing, and inspection for cleanliness and,
where appropriate, sterilization. Recommended cleaning and sanitizing procedures, materials, implements, and agents
should be specified. Recommended cleaning and sanitizing procedures, materials, implements, and agents shall be
compatible with the materials of construction. Where dismantling is required, specific instructions should be provided.
22

3-A Sanitary Standard For Homogenizers and Reciprocating Pumps, Number 04-05

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3-A Sanitary Standard For Homogenizers and Reciprocating Pumps, Number 04-05

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Copyright© 3-A Sanitary Standards, Inc.

3-A® Sanitary Standard for Homogenizers and

Standards Developing Organizations

Effective: June 15, 2012

Note: The highlighted text denotes changes to the previous document.

B NORMATIVE REFERENCES ............................................................................. 1

C28 Surface Modification ...................................................................................... 5

A2 This 3-A Sanitary Standard does not include drum-type pumps.

B2 3-A Sanitary Standards

Doc. No. Title (3-A Sanitary Standards for:)

18- Multiple-Use Rubber and Rubber-Like Materials

B3 3-A Accepted Practices

Doc. No. Title (3-A Accepted Practice for:)

B4 Other References and Standards

Ref. No. Title

3. Grade “A” Pasteurized Milk Ordinance, available from:

10. MIL-C-26074E. Military Specification: Coatings, Electroless Nickel Requirements For.

C15 Product: Milk, milk products or other liquid food products.

C23 Soil: Unwanted organic residue or inorganic matter.

C28 Surface Modification (Refer to B4, Reference 5)

C28.1.1 Surface treatments include:

1. Mechanical (grinding, shot peening, polishing) (Refer to B4, Reference 6)

C28.2.1 Coating processes include:

1. Chemical (conversion coatings, except anodizing)

D1 Product Contact Surfaces

D1.3 Lubrication Media

D2 Nonproduct Contact Surfaces

E1 Product Contact Surfaces

E1.1 Surface Texture

E1.2 Permanent Joints

E1.5 Cleaning and Inspectibility

E1.7 Gaskets, Gasket Retaining Grooves, O-rings and Seals

E1.7.1 All gaskets shall be removable or bonded.

O-Ring O-Ring O-Ring Minimum

E1.9.1 There shall be no exposed or enclosed threads on product contact surfaces.

E1.10 Coil Springs

E1.10.1 Coil springs shall be made of round cross-section stock or wire.

E1.11 High Temperature Systems

E1.12 Pistons or Plungers

E1.13 Bearings or Bushings

E14 Homogenizing Valves

E1.15 Safety Relief Valves

E2 Nonproduct Contact Surfaces

E2.1.2 Knurled surfaces shall not be used.

E2.3 Name and Information Plates

E2.3.3 An information plate shall be attached juxtaposition to the nameplate stating:

1. Maximum pressure at which the equipment can be operated.

3. “This equipment * designed for sterilization.”

E2.5 Cleaning and Inspectability

E2.8 Service Piping and Lines

E2.9 Panels, Doors, or Access Ports

E2.10 Guards and Other Safety Devices

1. It can be sealed to the process area wall.

E2.12 Special Considerations

F STAINLESS STEEL AND EQUIVALENT MATERIALS

WROUGHT PRODUCTS TYPICALLY USED

TABLE 3 - OPTIONAL METAL ALLOYS

TABLE 3 - OPTIONAL METAL ALLOYS (Cont.)

TABLE 3 - OPTIONAL METAL ALLOYS (Cont.)

Industry Name Rexalloy ®™ 33 Rexalloy ®™ 44

Element Type: Cobalt Alloy Cobalt Alloy

G PRODUCT CONTACT SURFACE FINISH

H ELECTROLESS NICKEL ALLOY