Copyright© 3-A Sanitary Standards, Inc.

, McLean, VA 101-00

3-A® Sanitary Standard for Pipeline Product Recovery

Equipment Using Projectiles,
Number 101-00

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: August 21, 2012

Copyright© 3-A Sanitary Standards, Inc., McLean, VA 101-00

TABLE OF CONTENTS
TITLE ..................................................................................................................................i
DISCLAIMERS ................................................................................................................iv
FOREWORD ....................................................................................................................iv
A SCOPE ...................................................................................................................... 1
B NORMATIVE REFERENCES .............................................................................. 1
C DEFINITIONS ......................................................................................................... 3
C1 Bond ................................................................................................................. 3
C2 Cleaning ........................................................................................................... 3
C2.1 Clean-in-Place (CIP) Cleaning ............................................................ 3
C2.2 Clean-Out-of-Place (COP) ................................................................... 3
C2.3 Manual Cleaning .................................................................................. 3
C3 Cleanable or Cleanability................................................................................. 3
C3.1 CIPable ................................................................................................... 3
C4 Chamber ........................................................................................................... 3
C5 Corrosion Resistant .......................................................................................... 3
C6 Essential Functional Reason ............................................................................ 3
C7 Inlet .................................................................................................................. 3
C8 Inspectable ....................................................................................................... 3
C9 Nontoxic Materials .......................................................................................... 3
C10 Opening............................................................................................................ 3
C11 Outlet/Product Outlet ....................................................................................... 3
C12 Processing Area ............................................................................................... 3
C13 Product ............................................................................................................. 3
C14 Propellant Medium .......................................................................................... 3
C15 Readily Removable .......................................................................................... 4
C16 Regulatory Agency .......................................................................................... 4
C17 Roughness Average (Ra) .................................................................................. 4
C18 Safe Water ....................................................................................................... 4
C19 Sanitizing or Sanitization ................................................................................. 4
C20 Sealed ............................................................................................................... 4
C21 Simple Hand Tools .......................................................................................... 4
C22 Soil ................................................................................................................... 4
C23 Solution ............................................................................................................ 4
C24 Sterilization ...................................................................................................... 4
C25 Substantially Flush........................................................................................... 4
C26 Surfaces............................................................................................................ 4
C26.1 Product Contact Surfaces ..................................................................... 4
C26.2 Solution Contact Surfaces .................................................................... 4
C26.3 Nonproduct Contact Surfaces ............................................................... 4
C27 Surface Modification ....................................................................................... 5
C27.1 Surface Treatments ............................................................................... 5
C27.2 Coatings, Overlays and Encapsulations ............................................... 5
C28 Unitized ........................................................................................................ 5
C29 Launching Mechanism ................................................................................. 5
C30 Projectile ....................................................................................................... 5
C31 Propellant System ......................................................................................... 5
C32 ReceivingMechanism ................................................................................... 5
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D MATERIALS ........................................................................................................... 5
D1 Product Contact Surfaces ................................................................................. 5
D1.1 Metals ............................................................................................... 5
D1.2 Nonmetals ......................................................................................... 6
D2 Magnets or Other Materials Embedded in Projectiles ..................................... 6
D3 Non-Product Contact Surfaces......................................................................... 6
E FABRICATION ....................................................................................................... 6
E1 Product Contact Services ................................................................................. 6
E1.1 Surface Texture ................................................................................ 6
E1.2 Permanent Joints............................................................................... 6
E1.3 Bonded Materials.............................................................................. 6
E1.4 Coatings ............................................................................................ 7
E1.5 Cleaning and Inspectability .............................................................. 7
E1.6 Draining ............................................................................................ 7
E1.7 Gaskets, Gasket Retaining Grooves, O-Rings & Seals .................... 7
E1.8 Radii ................................................................................................. 8
E1.9 Threads ............................................................................................. 9
E1.10 Sterilizing Chambers ........................................................................ 9
E1.11 Shafts ................................................................................................ 9
E2 Nonproduct Contact Surfaces ........................................................................ 10
E2.1 Surfaces .......................................................................................... 10
E2.2 Joints............................................................................................... 10
E2.3 Cleaning & Inspectability ............................................................... 10
E2.4 Draining .......................................................................................... 10
E2.5 Threads ........................................................................................... 10
E2.6 Service Piping & Lines................................................................... 10
E2.7 Panels, Doors, or Access Ports ....................................................... 10
E2.8 Guards & Other Safety Devices ..................................................... 11
E2.9 Supports .......................................................................................... 11
E2.10 Name and Information Plates ........................................................ 11
F SPECIAL CONSIDERATIONS........................................................................... 11
F1 Projectile Handling ........................................................................................ 11
F2 Projectile Inspection and Cleaning ................................................................ 12
F3 Introduction and Evacuation of Propellant Medium ...................................... 12
F4 Installation .................................................................................................... 12
APPENDIX
1 STAINLESS STEEL AND EQUIVALENT MATERIALS ............................... 12
2 PRODUCT CONTACT SURFACE FINISH ...................................................... 17
3 CIP CLEANING.................................................................................................... 17
4 SUGGESTED CLEANING PROCEDURES ...................................................... 17
5 ENGINEERING DESIGN AND TECHNICAL CONSTRUCTION FILE ..... 17
6 INSTRUCTION HANDBOOK FOR INSTALLATION,
MAINTENANCE, AND CLEANING ................................................................. 19

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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 of Pipeline Product Recovery
Equipment using Projectiles. 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: [email protected].

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A SCOPE

A1 This 3-A Sanitary Standard applies to the sanitary aspects of pipeline product recovery equipment using projectiles
in process pipelines that transfer dairy or food products. The equipment includes the launching mechanism,
receiving mechanism, and projectile.

A2 To conform to this 3-A Sanitary Standard, pipeline product recovery equipment using projectiles 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
51- Plug-Type Valves
53- Compression-Type Valves
62- Hose Assemblies
63- Sanitary Fittings
68- Ball-Type Valves
74- Sensors and Sensor Fittings and Connections Used on Equipment
88- Machine Leveling Feet and Supports

B3 3-A Accepted Practices

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

604- Supplying Air Under Pressure for Contact with Product or Product Contact Surfaces
605- Permanently Installed Product and Solution Pipelines and Cleaning Systems

B4 Other References and Standards

Ref. No. Title
1. Grade “A” Pasteurized Milk Ordinance, available from:
www.fda.gov/food/foodsafety/product-specificinformation/milksafety/default.htm

2. 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
3. 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

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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. 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
7. ASTM A959, Specifying Harmonized Standard Grade Compositions for Wrought Stainless Steels,
Standard Guide for: Available from ASTM 100 Barr Harbor Drive, West Conshohocken, Pa
19428-2959, Phone: (610) 832 9500, Internet: www.astm.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. 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
11. EHEDG Doc. 9 – Welding Stainless Steel to Meet Hygienic Requirements. European Hygienic
Engineering & Design Group. Published by EHEDG, www.ehedg.org
12. 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
13. 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
14. 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 or at http://www.astm.org

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C DEFINITIONS

C1 Bond: The adhesive or cohesive forces holding materials together. This definition excludes press and shrink fits.

C2 Cleaning

C2.1 Clean-in-Place Cleaning: (CIP): 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. Product contact surfaces to be CIP cleaned are inspectable.

C.2.2 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).

C2.3 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.

C3 Cleanable or Cleanability: The suitability of materials of construction, design and fabrication required to assure that
the equipment can be freed from soil.

C3.1 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.

C4 Chamber: An enclosed area between two seals. Not inclusive of the seals.

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 Essential Functional Reason: A condition or feature of design or fabrication that cannot be modified and is required
for the proper operation of the equipment.

C7 Inlet: An opening that allows product, solutions, steam, or air to enter the equipment.

C8 Inspectable: Designed, fabricated and installed to make product contact surfaces available for close visual
observation.

C9 Nontoxic Materials: Substances, which under the conditions of their use, are in compliance with applicable
requirements of the FDA.

C10 Opening: A hole through the product contact surface of equipment that is unsealed and is connected to external
piping or is open to atmosphere.

C11 Outlet/Product Outlet: An opening that allows product or solutions to exit the equipment.

C12 Processing Area: A room or area suitable for the manufacturing and packaging of products.

C13 Product: Milk, milk products or other related products.

C14 Propellant Medium: A liquid, vapor, or gas suitable for its intended use and is compatible with all materials in
contact with the medium.
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C15 Readily Removable: Designed, fabricated, and installed to be quickly separated from the equipment with or without
the use of simple hand tools.

C16 Regulatory Agency: The state or local agency having regulatory jurisdiction, or the validation for compliance
(testing, timing and sealing) with legal pasteurization criteria as set forth in the PMO. (Refer to B4, Reference No.
1.)

C17 Roughness Average (Ra): An arithmetical mean of the absolute values of the surface profile departure within a
sampling length. (Refer to B4, Reference No. 2.)

C18 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. 3) or Category I Reclaimed Process Water as
described in Appendix D of the PMO. (Refer to B4, Reference No. 1.)

C19 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.

C20 Sealed: Closed to the penetration of fluids by the application of one or more continuous welds, coatings, overlays,
encapsulations, solders, adhesives, rubber, rubber-like or plastic gasket under compression, mechanical force seals,
or press-fits or shrink-fits.

C21 Simple Hand Tools: A screwdriver, wrench, mallet, or readily available dedicated tool(s) normally used by
operating and cleaning personnel.

C22 Soil: Unwanted organic residue or inorganic matter.

C23 Solution: Water or any mixture of cleaning agents, sanitizers and water used for flushing, cleaning, rinsing, or
sanitizing.

C24 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.

C25 Substantially Flush: Mating surfaces or other juxtaposed surfaces that are not more than 1/32 in. (0.794 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.)

C26 Surfaces

C26.1 Product Contact Surfaces: All surfaces which are exposed to the product and surfaces from which splashed product,
liquids or material may drain, drop, diffuse or be drawn into the product or onto product contact surfaces.

C26.2 Solution Contact Surfaces: All interior surfaces of the equipment or system, including associated piping, that are
used for supplying and recirculating cleaning and/or sanitizing solutions, except those used to supply concentrated
cleaning and sanitizing chemicals from bulk storage to the point of chemical addition.

C26.3 Nonproduct Contact Surfaces: All exposed surfaces from which splashed product, liquids, or other materials cannot
drain, drop, diffuse or be drawn into or onto the product, product contact surfaces, open packages, or the product
contact surfaces of package components.

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C27 Surface Modification (Refer to B4, Reference No. 5)

C27.1 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.

C27.1.1 Surface treatments include:

1. Mechanical (grinding, polishing)

2. Chemical (etching, oxidation, passivation)
3. Electropolishing

C27.2 Coatings, Overlays and Encapsulations: A process where a different material is deposited 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.

C27.2.1 Coating processes include:

1. Chemical (conversion coatings except anodizing)

2. Engineering plating (e.g., electrodeposition (Refer to B4, Reference No. 6, gold plating)
3. Thermal spraying (e.g., flame, plasma, arc spray)
4. Physical vapor deposition
5. Chemical vapor deposition

C28 Unitized: The connection, assembly, or attachment of functional sub-units to form a complete machine.

C29 Launching Mechanism: Equipment required to insert projectile(s) into a product pipeline.

C30 Projectile: Device propelled through a pipeline.

C31 Propellant System: Equipment and medium used to move a projectile in a pipeline.

C32 Receiving Mechanism: Equipment required to remove, stop, or redirect projectiles; or to position projectiles for
cleaning in a product pipeline.

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 sanitizing treatment or sterilization.

D1.1 Metals

D1.1.1 Product contact surfaces shall be of stainless steel conforming to the applicable composition ranges established by
ASTM A 959 or AIST Stainless Steels: A Steel Products Manual for 304/304L and 316/316L (Refer to B4,
References No. 7 and No. 8) or corresponding Alloy Casting Institute (ACI) types (Refer to B4, Reference No. 9) or
metal (Refer to Appendix, Section 1) which under conditions of intended use is at least as corrosion resistant as 304
stainless steel, and is non-porous. Alloys containing lead, leachable copper, or other toxic materials shall not be
used. Where welding is involved, the carbon content of the stainless steel shall not exceed 0.08%.

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D1.2 Nonmetals

D1.2.1 Rubber and rubber-like materials may be used for projectiles, projectile coatings, gaskets and seals 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 projectiles, projectile coatings, gaskets and seals 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, and bonding plastic materials, shall be nontoxic.
Adhesives shall comply with 21 CFR 175 - Indirect Food Additives: Adhesives and Components of Coatings (Refer
to B4, Reference No. 10).

D1.2.4 Ceramic materials (including tungsten carbide) may be used for imbedded magnets and when used, shall be inert,
nonporous, nontoxic, nonabsorbent, insoluble, resistant to scratching, scoring, and distortion when exposed to the
conditions encountered in the environment of intended use, including cleaning, sanitizing or sterilization treatment.

D2 Magnets or Other Materials Embedded in Projectiles

D2.1 Magnets or other materials, including those not conforming to section D1.1.1, which are completely embedded in
projectiles, shall be nontoxic.

D3 Non-product Contact Surfaces

D3.1 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 (Refer to Appendix 2)

E1.1.1 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, and cracks in the final fabricated form. (Refer to Appendix 2), except that:

E1.1.1.1 Sanitary tubing joints, welded in accordance with E1.2.2, shall be free of pits, folds, crevices, and cracks, and
misalignments, and may have an as-welded interior surface finish.

E1.2 Permanent Joints

E1.2.1 All permanent joints in metallic surfaces shall be continuously welded.

E1.2.2 Permanent joints in sanitary tubing shall be welded in accordance with either AWS/ANSI D18.1 (Refer to B4,
Reference No. 4) or EHEDG Doc. 9 (Refer to B4, Reference No. 11).

E1.3 Bonded Materials

E1.3.1 Rubber and rubber-like materials, plastic materials, and carbon or ceramic seal component materials may be bonded.
The bond shall be continuous and mechanically sound. The rubber and rubber-like material, the plastic material,
and carbon or ceramic seal component materials shall not separate from the base material to which it is bonded when
exposed to the conditions encountered in the environment of intended use, including cleaning and sanitizing
treatment or sterilization.

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E1.4 Coatings

E1.4.1 Coatings, when used, shall be continuous and free of delamination, pitting, flaking, spalling, blistering, or distortion
when exposed to the conditions encountered in the environment of intended use, including cleaning, sanitizing, or
sterilization treatment.

E1.5 Cleaning and Inspectability

E1.5.1 Equipment intended for COP or manual cleaning shall be designed and fabricated so all product contact surfaces can
be visually inspected either when in an installed position or when removed. Junctures between components may or
may not be gasketed or sealed. All demountable appurtenances shall be readily removable.

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.

E1.6 Draining

E1.6.1 Pipelines, the launching mechanism chamber, and receiving mechanism shall be drainable or self-draining and
pitched to drain points.

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

E1.7.1 Gaskets shall be removable or bonded.

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 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).

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E1.7.6 The surfaces behind removable gaskets under compression shall be easily cleanable and inspectable.

E1.8 Radii

E1.8.1 All angles of less than 135 shall have radii of at least ¼ in. (6.35 mm), except that:

E1.8.1.1 Smaller radii may be used for projectiles. Such radii shall be at least 1/16 in. (1.59 mm).

E1.8.1.2 Radii in retaining grooves for standard circular cross section O-rings shall be as specified in the Table below (Refer
to B4, Reference No. 12 and B4, Reference No. 13).

O-Ring O-Ring O-Ring Minimum

Cross Cross Cross Groove
Section, Section, Section, Radius
Nominal Nominal Nominal
(AS 568) (AS 568) (ISO 3601-1)
0.016 in.
1/16 in. 0.070 in. 1.80 mm (0.41 mm)

2.65 mm 0.031 in.

3/32 in. 0.103 in. (0.79 mm)
change to 0.031 in.
1/8 in. 0.139 in. 3.55 mm c (0.79 mm)
o
0.062 in.
3/16 in. 0.210 in. 5.30 mm r (1.58 mm)
r
0.094 in.
1/4 in. 0.275 in. 7.00 mm e (2.39 mm)
c
t
E1.8.1.3 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
c mm) and smaller shall be those radii closest
to the standard circular cross section O-ring as specified in oE1.8.1.1. To determine minimum radius in the
retaining groove for a nonstandard O-ring, compare its cross-section
n dimension with those shown in column 2
of the Table above, determine which is closest, and use the applicable
v minimum groove radius. For a square O-
ring, use the flat-to-flat side dimension for comparison. Fore a rectangular or other shaped O-ring, use the
dimension that will fit into the retaining groove. r
s
E1.8.1.4 There are no minimum radii requirements for the product icontact junctures of flat sealing surfaces. (See
following illustrations of examples.) o
n
8 s
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Product Side

Non-Product
Non-Product

Non-Product Product Side Product Side Non-Product

E1.9 Threads

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

E1.10 Sterilizing Chambers

E1.10.1 Sterilizing chamber(s), which utilize steam or other sterilizing media, shall be constructed so the interior surfaces are
inspectable.

E1.10.2 Seal(s) of sanitary design shall be provided between the product contact surface(s) and the steam or other sterilizing
medium chamber.

E1.11 Shafts

E1.11.1 Shafts that pass through a product contact surface below the product level shall have a packless-type seal of sanitary
design that is readily accessible and inspectable.

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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.

E2.2 Joints

E2.2.1 Permanent joints subject to product residue shall be continuously welded. Welded junctures do not require grinding
or polishing.

E2.2.2 Recessed socket head bolts shall not be used.

E2.2.3 Rivets shall not be used.

E2.3 Cleaning and Inspectability

E2.3.1 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 cannot be cleaned out.

E2.4 Draining

E2.4.1 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.

E2.5 Threads

E2.5.1 Exposed threads shall be minimized. The exposed threads shall not exceed one half (½) the nominal diameter of the
thread, except that:

E2.5.1.1 Threads that are subject to routine product splash during processing and cleaning shall be covered by an enclosed
nut.

E2.6 Service Piping and Lines

E2.6.1 Exposed braided coverings of cables or hoses shall not be used.

E2.6.2 Electrical and utility connections shall be as remote as practical from the product contact areas of the equipment.

E2.6.3 Exhaust air from pneumatic equipment shall be piped away from product contact surfaces.

E2.6.4 Hose clamps of the worm gear type shall not be used.

E2.7 Panels, Doors, or Access Ports

E2.7.1 Panels and doors having both a product contact surface and a nonproduct contact surface shall meet the fabrication
criteria of a product contact surface.

E2.7.2 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.

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E2.7.3 Hinges shall be of a 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.

E2.8 Guards and Other Safety Devices

E2.8.1 Guards required by personnel safety standards shall be removable for cleaning and inspection of the equipment.
Guards shall be designed to minimize the accumulation of debris and liquids.

E2.9 Supports

E2.9.1 If mounted directly on a wall or column, the area of attachment of the equipment to its mounting surface shall be
designed for sealing to the wall or column. If the design of the equipment is to be mounted offset from a wall or
column, it shall provide at least a 4 in. (102 mm) clearance between the outside of the equipment and the wall or
column.

E2.10 Name and Information Plates

E2.10.1 Name and information plates, when used, shall be continuously welded or effectively sealed to the equipment.

E2.10.2 Name and information may be applied to the equipment by acid, electro-chemical etching, laser, or pin stamping.
Non-metallic, adhesive-backed, name and information plates are also acceptable.

E2.10.3 An information plate, when necessary to convey special information, shall be attached in juxtaposition to the
nameplate. Alternatively, the information may appear on the nameplate:
1. Maximum temperature and pressure at which the equipment can be operated.

2. A statement that, 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 steam sterilization.”

* Insert one of the following:

(a) “is”
(b) “is not"

4. This equipment requires manual cleaning in accordance with the manufacturer’s recommendations.

5. “This equipment * designed for CIP cleaning. Clean in accordance with the manufacturer’s recommendation”.

* Insert one of the following:

(a) “is”
(b) “is not”

F SPECIAL CONSIDERATIONS

F1 Projectile Handling

F1.1 No tools or devices shall be required to handle projectiles, except those specifically supplied by the manufacturer.

F1.1.1 Where specific tools or devices are required, the manufacturer shall supply these tools or devices with explicit
instruction for their intended and correct use. These tools or devices shall be considered product contact surfaces
and shall be constructed with appropriate materials, using proper fabrication techniques.

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F2 Projectile Inspection and Cleaning

F2.1 Projectiles shall be supplied with explicit instructions for inspection. Instructions shall include:
1. Recommended frequency of inspection.
2. Description of any special conditions or events that would require inspection.
3. Method(s) for inspection.
4. Criteria for inspection to confirm projectile complies with section D1 and D2.

F2.2 Projectiles designed to be cleaned out of place shall be supplied with permanent unique identification and explicit
instructions for cleaning in compliance with section E2.10.3.

F2.3 Projectiles designed to be cleaned-in-place shall be supplied with a certificate indicating the required CIP limitations
for:
1. Flow minimum and maximum.
2. Temperature minimum and maximum.

F3 Introduction and Evacuation of Propellant Medium

F3.1 Seal(s) of sanitary design, cleanable and inspectable per section E1.5.2, shall be provided between the product
contact surface(s) and the propellant medium chamber immediately adjacent to the product contact surface.

F3.2 A check valve is required to prevent ingress of any material from the product contact area beyond the medium
chamber.

F3.3 The propellant medium chamber(s) immediately adjacent to the product contact surface shall be constructed so the
interior surfaces are compatible with product contact surfaces and shall be cleanable, inspectable and drainable.

F4 Installation

F4.1 Information shall be supplied to provide instruction for the proper installation of all equipment (See Appendix 6).

APPENDIX

1 STAINLESS STEEL AND EQUIVALENT MATERIALS

1.1 Stainless steel conforming to the applicable composition ranges established by ASTM A 959 or AIST Stainless
Steels: A Steel Products Manual for wrought products, or by ACI for cast products, should be considered in
conformance to the requirements of Section D1.1 herein. These references cited in D1.1.1 set 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
14). Table 1 and Tables 2 through 7, Discretionary Metal Alloys, provides the nominal composition of these most
commonly used wrought and cast alloys.

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.

1.2 Table 1 provides the nominal composition of the most commonly used wrought and cast alloys. Tables 2 – 7 provide
the nominal composition of discretionary wrought and cast alloys.

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Table 1
Wrought and Cast Stainless Steel Alloys Most Commonly Used(A)

Nominal Composition
Typical Comparable UNS No. Carbon Cr Ni Fe Mo
Wrought Castings
Type ASTM
ASTM A 351,
A 240 & A 743
A 270 A 744
304 S30400 0.08 Max 18.2 8.2 Bal.
CF8 J92600 0.08 Max 18.2 8.2 Bal.
304L S30403 0.03 Max 18.2 8.2 Bal.
CF3 J92500 0.03 Max 17.2 8.2 Bal.
316 S31600 0.08 Max 16.7 11.2 Bal. 2.2
CF8M J92900 0.08 Max 18.2 9.2 Bal. 2.2
316L S31603 0.03 Max 16.7 11.2 Bal. 2.2
CF3M J92800 0.03 Max 17.2 9.2 Bal. 2.2

(A) The most commonly used stainless steels for 3-A Sanitary Standards are Types 304 and 316 or the low carbon
versions of 304L and 316L with a maximum of 0.03 % carbon. The major difference between the Type 304 and 316
grades is the addition of 2.0 to 3.0 % molybdenum. Molybdenum provides increased resistance to pitting and crevice
corrosion such as may be encountered in higher levels of chlorides or strong cleaning solutions.

(B) The maximum sulfur content of wrought alloys 304/304L and 316/316L is 0.03%. Sulfur content can have an
effect in autogenous orbital welding ASTM A 270 tubing. For this application the preferred sulfur range is 0.003 to
0.010%.

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Table 2
Discretionary Wrought and Cast Wear and Galling Resistant Stainless Steels(A)

Nominal Composition
Wrought Comparable UNS No. Carbon Cr Ni Fe Mn Si Others
Common Casting
Name
Nitronic S21800 0.10 17 8.5 Bal. 8 4
60 Max
ASTM J92972 0.10 17 8.5 Bal. 8 4
A743 Max
CF10SMnN
Gall- S20161 0.15 16.5 5 Bal. 5 3.5
Tough Max
Alloy 88 N25055 0.05 12.5 Bal. 1 1 0.25 Sn 4
ASTM Max Bi 4
A494 Mo 3
CY5SnBiM

(A) These stainless steels have excellent wear and galling resistance compared to the standard austenitic stainless
steels. They have been shown to be capable of providing satisfactory performance in many service and cleaning
environments found in the dairy industry. However, in aggressive environments some of these grades may not be as
corrosion resistant as type 304 stainless steel and it is the responsibility of the fabricator to determine compatibility
with the proposed environment.

Table 3
Discretionary Wrought and Cast Duplex Stainless Steels(A)

Nominal Composition
Wrought Comparable UNS Carbon Cr Ni Fe Mo N Other
Type Casting No.
2205 S32205 0.03 Max 22.5 5.5 Bal. 3 0.14 –
ASTM 0.20
A240
ASTM J92205 22.5 22.5 5.5 Bal. 3 0/10 –
A995 0.30
CD3MN

(A) The duplex stainless steels have a crystalline structure that is approximately half austenite and half ferrite and
have superior mechanical properties than the austenitic stainless steels. Type 2205 is the most common and widely
used of the duplex stainless steels. The corrosion resistance of 2205 grade is better than Type 316 in most media.
Nitrogen is a critical element for weldability and corrosion resistance in the duplex stainless steels. There are a
number of leaner (lower alloyed) duplex grades and higher alloyed (superduplex) grades that may be appropriate for
3-A Sanitary applications.

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Table 4
Discretionary Wrought and Cast Precipitation-Hardenable Stainless Steels(A)

Nominal Composition
Wrought Comparable UNS Carbon Cr Ni Fe Cb Cu
Type ASTM A693 Casting No.
ASTM A747
Alloy 17-4PH S17400 0.07 16.5 4 Bal. 0.3 4
Max
CB7Cu-1 J92180 0.07 16.5 4.1 Bal. 0.25 2.8
Max
Alloy 15-5 S15500 0.07 14.7 4.5 Bal. 0.3 3.5
Max
CB7Cu-2 J92110 0.07 14.8 4.8 Bal. 0.25 2.8
Max

(A) The precipitation-hardenable stainless steels can be heat treated to develop exceptionally high tensile strengths.
They are welded and fabricated using procedures typically used for other stainless steels. These stainless steels have
been shown to be capable of providing satisfactory performance in many service and cleaning environments found
in the dairy industry. However, in aggressive environments some of these grades may not be as corrosion resistant as
type 304 stainless steel and it is the responsibility of the fabricator to determine compatibility with the proposed
environment.

Table 5
Discretionary Wrought and Cast Superaustenitic Stainless Steels(A)

Nominal Composition
Wrought Casting UNS Carbon Cr Ni Fe Mo N Other
Type ASTM ASTM A743 No.
A240
Alloy N08367 0.03 21 24.5 Bal. 6.5 0.18 –
AL-6XN Max 0.25
CN3MN J94651 0.03 21 24.5 Bal. 6.5 0.18 –
Max 0.26
Alloy 254 S31254 0.02 20 18 Bal. 6.2 0.18 - Cu
SMO Max 0.22 0.75
CK3MCuN J93254 0.025 20 18.5 Bal. 6.5 0.18 – Cu
Max 0.24 0.75
Alloys 25- N08926 0.02 20 25 Bal. 6.5 0.15 –
6Mo & Max 0.25
1925 hMo
CN3MN J94651 0.03 21 24.5 Bal. 6.5 0.18 –
Max 0.25

(A) The superaustenitic stainless steels have excellent resistance to pitting and crevice corrosion in chloride-
containing environments. Also their resistance to stress corrosion cracking is superior to that of the common
stainless steels. These alloys are readily welded and fabricated using the conventional processes used for other
grades of stainless steels. For maximum corrosion resistance of the welds, the filler metals should be one of the Ni-
Cr-Mo filler metals such as alloy 625 or alloy C-22/622 or the welds should be solution annealed after welding.

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Table 6
Discretionary Wrought and Cast Nickel-Chromium-Molybdenum Alloys(A)

Nominal Composition
Wrought Casting UNS Carbon Cr Ni Mo Fe Other
Type ASTM A494 No.
ASTM B443 & B575
Alloy 625 N06625 0.10 21.5 Bal. 9 5.0 Cb
Max Max 3.6
CW6MC N26625 0.06 21.5 Bal. 9 5.0 Cb
Max Max 3.8
Alloy C-22 & 622 N06022 0.015 21.2 Bal. 13.5 4 W
Max 3
CX2MW N26022 0.02 21.2 Bal. 13.5 4 W
Max 3
Alloy C276 N10276 0.02 15.5 Bal. 16 5.5 W
Max 3.8
CW2M N26455 0.02 16.2 Bal. 16.2 2.0 W
Max Max 1.0 Max

(A) The nickel-chromium-molybdenum alloys have a considerably higher level of corrosion resistance than the
superaustenitic stainless steels in highly corrosive environments, particularly high chloride environments. In such
environments, the corrosion resistance increases with increasing molybdenum content, therefore the order of
increasing resistance of the above three alloys is alloy 625 least resistant and alloy C-276 most resistant in high
chloride environments.

Table 7
Discretionary Wrought Titanium Alloy(A)

Nominal Composition
Alloy UNS Carbon Cr Ni Fe Ti Other
No.
Titanium Grade 2 R50400 0.10 0.30 Bal.
(unalloyed) Max Max

(A) Titanium may be useful in special food applications involving high chlorides and highly acidic conditions.

1.3 Alloys or metals other than the above may be as corrosion resistant as 304 Series Stainless Steel. This may be
shown by corrosion testing the candidate grades in test solutions that are representative of the service conditions
used for the equipment. The test parameters, including the type of chemical(s), their concentration(s), and
temperature(s), should be representative of cleaning and sanitizing conditions used for equipment. Testing shall be
in accordance with ASTM G 31 and the measured unifier corrosion rate shall be less than 10 MPY and with no pit
depth of 1 mil or greater.

1.4 The minimum criteria for metals in section D1.1 are based on experience with the processing of milk and
conventional dairy products. More corrosion-resistant metals may be appropriate when the equipment is used to
process modified dairy products or other non-dairy food products, especially those containing salts or having high
acidity/low pH or both, and processed at high temperatures. The corrosive effect of galvanic currents should also be
considered when choosing suitable materials, particularly when different metals are used in the same system.

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2 PRODUCT CONTACT SURFACE FINISH

2.1 Surface finish, obtained by mechanical polishing with 150 grit or finer silicon carbide (aluminum oxide or other
standard approved abrasives) properly applied on stainless steel sheets, is considered in conformance to the
requirements of Section E1.1.1 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).

3 CIP CLEANING
Product recovery systems intended for CIP cleaning should be designed so that solution is applied to all product
contact surfaces, except those areas requiring manual cleaning. When being cleaned, the equipment should have a
minimum flow rate of 5 feet per second (1.52 meters per second) across all product contact surfaces. The slope
should be a minimum of 1/4 in. per ft. (20.0 mm per m).

4 SUGGESTED CLEANING PROCEDURES

Instructions for proper cleaning should be supplied by the manufacturer in the installation or operations manual.

5 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.

5.1 Purpose
5.1.1 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.

5.2 Scope
5.2.1 This EDTCF applies to equipment specified by:

5.2.1.1 3-A Sanitary Standards for Pipeline Product Recovery Equipment Using Projectiles, Number 101-00.

5.2.1.2 List all applicable 3-A Sanitary Standards and 3-A Accepted Practices.

5.3 Responsibilities
5.3.1 The EDTCF is maintained by {Name and Title of Responsible Official} who is responsible for maintaining,
publishing, and distributing the EDTCF.

5.3.2 Implementation: All divisions, specifically development engineering, standards engineering, sales engineering, and
product departments are responsible for implementing the EDTCF.

5.4 Applicability
5.4.1 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. The 3-A Sanitary Standards and Accepted Practices are also referenced in
7 CFR 58 Subpart B — General Specifications for Dairy Plants Approved for USDA Inspection and Grading
Service. This subpart requires all new, replacement or modified equipment and all processing systems, cleaning

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systems, utensils, or replacement parts to comply with the most current, appropriate 3-A Sanitary Standards or 3-A
Accepted Practices.

5.5 References
5.5.1 List any additional regulations that apply to the equipment or system covered by this EDTCF.

5.5.2 The date of conformity or 3-A Symbol Authorization and certificate number, if authorized.

5.6 EDTCF
5.6.1 The Engineering Design and Technical Construction File contents:

5.6.1.1 The Engineering Design and Technical Construction File shall contain the following items:
a. Table of Contents (listing all documents within the EDTCF or the locations where the items may be found);
b. A copy of the 3-A Sanitary Standard to be applied to the subject equipment;
c. An overall drawing or general arrangement drawing of the subject equipment;
d. 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;
e. If essential, any technical report or certificate obtained from a competent testing body or laboratory;
f. Instructions for cleaning of the subject equipment or item referenced by the standard (including a listing, as may
be applicable, for all manually cleaned components or appurtenances and the procedures for cleaning of these
items. (Example: silo tank door gasket);
g. Material certifications for all materials of construction included in the equipment;
h. 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;
i. Change records; and
j. Copy of the 3-A Symbol authorization, if applicable.

5.6.1.2 The Engineering Design and Technical Construction File may further optionally contain the following:
a. A list of the essential requirements of the standards or practices;
b. Other technical specifications, which were used when the equipment was designed;
c. A copy of the instructions for the product (instruction manuals/instruction books);
d. A description of methods adopted;
e. Any technical report giving the results of tests carried out internally by Engineering or others;
f. 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);
g. A determination of the foreseeable lifetime of the product (optional);
h. Engineering reports;
i. Laboratory reports;
j. Bills of material;
k. Wiring diagrams, if applicable;
l. Purchase order engineering files;
m. Hazard evaluation committee reports, if executed;
n. Customer specifications; and
o. Any notified body technical reports and certification tests.

5.6.2 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.

5.6.3 The documentation referred to in 5.6.1, 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
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importance (one week is considered reasonable time). As a minimum, each product EDTCF must physically contain
an index of the applicable document of 5.6.1, above.

5.6.4 The EDTCF may be in hard copy or digital form.

5.7 Confidentiality
5.7.1 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 the 3-A SSI or a regulatory agency for cause and upon request.

5.8 File Location

5.8.1 The EDTCF is maintained at {Location}.

5.9 File Retention

5.9.1 The EDTCF (including all documentation referred to in 5.6.1) 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.

6 INSTRUCTION HANDBOOK FOR INSTALLATION, MAINTENANCE, AND CLEANING

The instruction handbook includes the following items:

6.1 Installation of the Equipment and Associated Equipment

6.1.2 If equipment is to be mounted on a slab or island, information is provided about its construction. The slab or island
should be of sufficient height so that the bottoms of all product connections are at least 4 in. (102 mm) above the
floor. The mounting surface of the slab or island should be coated with a suitable layer of waterproof mastic
material, which will harden without cracking. The junction of the equipment base and the slab or island should be
sealed.

6.1.3 Information is provided so that, after the equipment is installed, it maintains its hygienic integrity (e.g., drainability
and inspectability).

6.2 Instructions for Use

6.2.1 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.

6.2.2 Guidance is given to warn of any known propellant medium or other operational concerns that could lead to a
premature failure or are a safety concern.

6.3 Maintenance
6.3.1 A system of measures is recommended to ensure that the hygienic integrity of the equipment is maintained during
the intended lifetime. This information should include specific gasket, seal or O-ring materials where they are used
because of product characteristics (e.g. high fat or high acid) or operational characteristics (e.g. vacuum or steam
applications or when used to create a bacterial tight seal between product contact surfaces and non-sanitary threads).

6.4 Cleaning
6.4.1 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.

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