3 A Sanitary Standards Quick Reference Guide

3-A Sanitary Standards
Quick Reference of the

3-A Sanitary Standards & Accepted Practices

List Date: January 4, 2013

3-A Std & Practices List with Document Scopes Page 1 of 98 J anuary 4,2013

IMPORTANT NOTES & DISCLAIMER

Disclaimer

This list has been created as a quick guide reference of the current 3-A Sanitary
Standards and Accepted Practices. It is not intended to replace, override or contradict the
actual copyrighted standards and accepted practices. Though an effort has been made to
ensure the accuracy of this reference list, it is not guaranteed, and should always be
verified with the latest 3-A Sanitary Standards and Accepted Practices.

Notes

This reference list was created J anuary 4, 2013, using the 3-A Sanitary Standards
and Accepted Practices as they were currently published in December 2012. The
Pharmaceutical P3-A standards are also included.
References for each standard include the cross reference 3-A Standards &
Accepted Practices
Other references may also be referenced in the Standards and Accepted Practices
but are not listed in this quick guide in all cases. Please verify all the references in
the applicable Standards and Accepted Practices.
3-A Sanitary Standards & Accepted Practices are copyrighted and cannot be
distributed without authorization. See www.3-a.org


Contents

Disclaimer ........................................................................................................................... 2
Notes ................................................................................................................................... 2
01-08 Storage Tanks ........................................................................................................... 7
02-11 Centrifugal and Positive Rotary Pumps.................................................................... 8
04-05 Homogenizers and Reciprocating Pumps ................................................................. 8
05-15 Stainless Steel Automotive Transportation Tanks for Bulk Delivery and Farm
Pick-Up Service ................................................................................................................ 11
10-04 Filters Using Single Service Filter Media .............................................................. 12
11-09 Plate Type Heat Exchangers ................................................................................... 12
12-07 Tubular Heat Exchangers ....................................................................................... 14
13-11 Farm Milk Cooling and Holding Tanks ................................................................. 15
16-05 Milk and Milk Products Evaporators and Vacuum Pans ........................................ 16
17-11 Formers, Fillers, and Sealers of Containers for Fluid Milk and Fluid Milk Products
........................................................................................................................................... 17
18-03 Multiple-Use Rubber and Rubber-Like Materials Used as Product Contact Surfaces
in Dairy Equipment ........................................................................................................... 18
19-07 Batch and Continuous Freezers for Ice Cream, Ices and Similarly Frozen Dairy
Foods ................................................................................................................................. 19
20-27 Multiple-Use Plastic Materials ............................................................................... 21
21-01 Centrifugal Separators and Clarifiers ..................................................................... 22
22-08 Silo-Type Storage Tanks for Milk and Milk Products ........................................... 23
23-06 Equipment for Packaging Viscous Product ............................................................ 24
24-03 Non-Coil Type Batch Pasteurizers for Milk and Milk Products ............................ 26
25-03 Non-Coil Type Batch Processors ........................................................................... 27
26-05 Sifters for Dry Products ......................................................................................... 28
27-06 Equipment for Packaging Dry Milk and Dry Milk Products ................................ 29
28-04 Flow Meters for Milk and Milk Products ............................................................... 30
29-03 Air Eliminators ...................................................................................................... 30

30-01 Farm Milk Storage Tanks ...................................................................................... 32
31-06 Scraped Surface Heat Exchangers ......................................................................... 33
32-02 Uninsulated Tanks for Milk and Milk Products .................................................... 33
33-02 Polished Metal Tubing for Milk and Milk Products ............................................... 35
34-02 Portable Bins for Dry Milk and Dry Milk Products .............................................. 35
35-04 Blending Equipment .............................................................................................. 36
36-01 Inline Rotor-Stator Mixers..................................................................................... 37
38-00 Cottage Cheese Vats .............................................................................................. 37
39-01 Pneumatic Conveyors for Dry Milk and Dry Milk Products ................................ 38
40-04 Bag Collectors ....................................................................................................... 39
41-03 Mechanical Conveyors for Dry Products ............................................................... 41
42-01 In-Line Strainers for Milk and Milk Products, Number ......................................... 41
44-03 Diaphragm Pumps ................................................................................................. 42
45-02 Crossflow Membrane Modules ............................................................................. 43
46-03 Refractometers and Energy Absorbing Optical Sensors for Milk and Milk
Products............................................................................................................................. 43
49-01 Air Driven Sonic Horns for Dry Products ............................................................. 44
50-01 Level Sensing Devices for Dry Products ................................................................ 45
51-01 Plug-Type Valves for Milk and Milk Products ..................................................... 45
52-02 Plastic Plug-Type Valves for Milk and Milk Products.......................................... 46
53-06 Compression-Type Valves .................................................................................... 47
54-02 Diaphragm-Type Valves for Milk and Milk Products........................................... 47
55-02 Boot Seal Type Valves .......................................................................................... 48
56-00 Inlet and Outlet Leak-Protector Plug-Type Valves for Milk and Milk Products .. 50
57-02 Disc-Type Valves .................................................................................................. 51
58-01 Vacuum Breakers and Check Valves for Milk and Milk Products ....................... 52
59-00 Automatic Positive Displacement Samplers for Fluid Milk and Fluid Milk
Products............................................................................................................................. 53
60-00 Milk and Milk Products Rupture Discs ................................................................. 54
61-01 Steam Injection Heaters for Milk and Milk Products ............................................ 54
62-02 Hose Assemblies for Milk and Milk Products........................................................ 55

63-03 Sanitary Fittings ..................................................................................................... 57
64-00 Pressure Reducing and Back Pressure Regulating Valves for Milk and Milk
Products............................................................................................................................. 58
65-01 Sight and/or Light Windows and Sight Indicators in Contact with Product ......... 58
68-00 Ball-Type Valves for Milk and Milk Products ...................................................... 60
70-01 Italian-Type Pasta Filata Style Cheese Cookers .................................................... 60
71-01 Italian-Type Pasta Filata Style Cheese Moulders ................................................. 61
72-01 Italian-Type Pasta Filata Style Moulded Cheese Chillers ..................................... 62
73-01 Shear Mixers, Mixers, and Agitators ..................................................................... 63
74-05 Sensors and Sensor Fittings and Connections ....................................................... 64
75-01 Belt-Type Feeders.................................................................................................. 66
78-01 Spray Cleaning Devices Intended to Remain in Place ........................................... 68
81-00 Auger-Type Feeders .............................................................................................. 69
82-00 Pulsation Dampening Devices ............................................................................... 70
83-00 Enclosed Cheese Vats and Tables ......................................................................... 70
84-02 Personnel Access Ports for Wet Applications ....................................................... 71
85-02 Double-Seat Mixproof Valves ............................................................................... 72
87-00 Mechanical Strainers .............................................................................................. 72
88-00 Machine Leveling Feet and Supports .................................................................... 73
95-00 Transportation Tank Vents .................................................................................... 74
101-00 Pipeline Product Recovery Equipment ................................................................ 76
603-07 Sanitary Construction, Installation, Testing and Operation of High-Temperature
Short-Time and Higher-Heat Shorter-Time Pasteurizer Systems ..................................... 80
604-05 Supplying Air Under Pressure in Contact With Milk, Milk Products and Product
Contact Surfaces ............................................................................................................... 81
605-04 Permanently Installed Product and Solution Pipelines and Cleaning Systems
Used in Milk and Milk Product Processing Plants ........................................................... 82
606-05 Design, Fabrication, and Installation of Milking and Milk Handling Equipment 83
607-05 Spray Drying Systems .......................................................................................... 84
608-02 Instantizing Systems ............................................................................................ 86
609-03 A Method of Producing Culinary Steam ............................................................. 87

610-02 Sanitary Construction, Installation, and Cleaning of Cross Flow Membrane
Processing Systems ........................................................................................................... 87
611-00 Farm Milk Cooling and Storage Systems ............................................................ 90
612-00 Plant Environmental Air Quality ......................................................................... 91
E-600 Egg Breaking and Separating Machines ............................................................... 92
E-1500 Shell Egg Washers .............................................................................................. 93
P3-A-001 Pharmaceutical General Glossary .................................................................... 93
P3-A-002 Materials for Use in Process Equipment and Systems ..................................... 94


01-08 Storage Tanks

Title: 3-ASanitary Standards for Storage Tanks, Number 01-08

Date: Effective November 20, 2001.

Scope: A1 These standards cover the sanitary aspects of storage tanks for milk
and milk products.

A2 In order to conform to these 3-A Sanitary Standards, storage tanks
shall comply with the following design, material, and fabrication
criteria.

References: 3-A Sanitary Standard for:
18- Multiple-Use Rubber and Rubber-Like Materials Used as Product
Contact Surfaces in Dairy Equipment
20- Multiple-Use Plastic Materials
51- Plug-Type Valves for Milk and Milk Products
52- Plastic Plug-Type Valves for Milk and Milk Products
53- Compression-Type Valves
54- Diaphragm-Type Valves for Milk and Milk Products
56- Inlet and Outlet Leak-Protector Plug-Type Valves for Milk and
Milk Products
57- Disc-Type Valves
58- Vacuum Breakers and Check Valves for Milk and Milk Products
59- Automatic Positive Displacement Samplers for Fluid Milk and
Fluid Milk Products
63- Sanitary Fittings
74- Sensors and Sensor Fittings and Connections
73- Shear Mixers, Mixers, and Agitators
65- Sight and/or Light Windows and Sight Indicators in Contact with
Product
33- Polished Metal Tubing for Milk and Milk Products
85- Double-Seat Mixproof Valves

3-A Accepted Practice for:
604- Supplying Air Under Pressure in Contact With Milk, Milk
Products and Product Contact Surfaces


02-11 Centrifugal and Positi ve Rotary Pumps

Title: 3-A Sanitary Standards for Centrifugal and Positive Rotary Pumps,
Number 02-11

Date: Effective J uly 14, 2012

Scope: A1 These standards cover the sanitary aspects of centrifugal and
positive rotary pumps for milk and milk products.

A2 In order to conform to these 3 A Sanitary Standards, centrifugal
and positive rotary pumps shall comply with the following design,
materials, and fabrication criteria


04-05 Homogenizers and Reciprocating Pumps

Title: 3-ASanitary Standards for Homogenizers and Reciprocating Pumps,
Number 04-05

Date: Effective J une 15, 2012

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.

18- Multiple-Use Rubber and Rubber-Like Materials

33- Metal Tubing
42- In-Line Strainers
74- Sensors and Sensor Fittings and Connections Used on Equipment
82- Pulsation Dampening Devices
88- Machine Leveling Feet and Supports
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

External
References:
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

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. LeJ eune 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

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

05-15 Stainless Steel Automotive Transportation Tanks
for Bulk Deli very and Farm Pick-Up Service

Title: 3-ASanitary Standards for Stainless Steel Automotive Transportation
Tanks for Bulk Delivery and Farm Pick-Up Service, Number 05-15

Date: Effective November 24, 2002

Scope: A1 These standards cover the sanitary aspects of automotive
transportation tanks for milk, fluid milk products, and other liquid
comestible products.

A2 In order to conform to these 3-A Sanitary Standards, transportation
tanks shall comply with the following design, material and
fabrication criteria

02- Centrifugal and Positive Rotary Pumps
62- Hose Assemblies for Milk and Milk Products
68- Ball-Type Valves for Milk and Milk Products

605- Permanently Installed Product and Solution Pipelines and Cleaning
Systems Used in Milk and Milk Product Processing Plants

3-A Sanitary Standards referenced which have been discontinued
55- Boot Seal-Type Valves for Milk and Milk Products
66- Caged-Ball Valves for Milk and Milk Products

10-04 Filters Using Single Service Filter Media

Title: 3-ASanitary Standards for Filters Using Single Service Filter Media,
Number 10-04


Scope: A1 These standards cover sanitary aspects of enclosed filtration
equipment that uses single service filter media for filtering milk
and milk products.

A2 In order to conform to these 3-A Sanitary Standards, filters shall
comply with the following design, material, and fabrication
criteria.


11-09 Plate Type Heat Exchangers

Title: 3-ASanitary Standards for Plate Type Heat Exchangers, Number 11-08

Date: Effective: August 1, 2010
Scope: A1. This standard covers the sanitary aspects of plate type heat
exchangers beginning with the inlet fittings for product(s) and for
heat exchange media and ending with the outlet fittings for
product(s) and for heat exchange media. This standard include the
frame and/or support components for holding the heat exchange
plates and the means for manual or mechanical opening and
closing of the plate pack assembly.

A2 In order to conform to this 3-A Sanitary Standard, plate heat
exchangers 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 in Section B.
18- Multiple-Use Rubber and Rubber-like Materials
33- Metal Tubing
External
References:
1. AIST Steel Products Manual, Stainless & Heat Resisting Steels,
Table 2-1. Association for Iron & Steel Technology (AIST), 410
Commonwealth Drive, Warrendale, PA 15086, Phone: (412) 776-
1535. www.AIST.org

2. Steel Casting Handbook, Supplement 2, 1999. Available from
Steel Founders Society of America, 780 McArdle Dr., Unit G,
Crystal Lake, IL 60014, Phone: (815) 455-8240, Fax: (815) 455-
8241, www.sfsa.org.

Building 4, Section D, Philadelphia, PA 19111-5094, Phone:
(215)697-2179, Fax: (215) 697-1462.

and A744/A744M. Available from ASTM, 100 Barr Harbor
Drive, West Conshohocken, PA 19428-1959, Phone: (610) 832-
9500. www.astm.org/standard/index.shtml

5. ASTM specifications for Wrought Grades A276, A582, and A666.
Available from ASTM, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959, Phone: (610) 832-9500.
www.astm.org/standard/index.shtml

6. (ANSI)/American Society of Mechanical Engineers (ASME)
B46.1 Surface Texture Waviness and Lay. Available from the
American Society of Mechanical Engineers, 345 East 47th Street,
New York, NY 10017-2392, Phone: (212) 705-7722.

7. EHEDG Doc. 35 Welding of Stainless Steel Tubing in the Food
Industry. European Hygienic Engineering & Design Group.
Published by EHEDG. www.ehedg.org


Printing Office, Washington, D.C. 20402, Phone: (202) 512-1800
or at http://gpoacess.gov/cfr/index.html.

9. GAR C-9 Cast Microfinish Comparator. Available from Gar
Electroforming Division, Electroformers Inc., 11 Augusta Drive,
Commerce Park, PO Box 340, Danbury, CT 06813-0340, Phone:
(203) 744-4300.

(216) 338-5151.

12-07 Tubular Heat Exchangers

Title: 3-ASanitary Standards for Tubular Heat Exchangers, Number 12-07

Date: Adopted November 16, 2003

Scope: A1 These standards cover the sanitary aspects of tubular heat
exchangers without agitators. Tubular heat exchangers may have
tube cross-sectional profile modifications or removable devices for
promotion of desired flow characteristics. The standards do not
cover high-pressure (greater than 250 psig or 1724 kPa product
pressure) tubular heat exchangers which require special tubing
and/or fittings.

A2 In order to conform to these 3-A Sanitary Standards, tubular heat
exchangers shall conform to the following design, material, and
fabrication criteria.




13-11 Farm Milk Cooling and Holding Tanks

Title: 3-ASanitary Standards for Farm Milk Cooling and Holding Tanks,
Number 13-11

Date: Effective: J uly 23, 2012

Scope: A1 This standard covers the sanitary aspects of tanks in which bulk
milk is cooled and stored on dairy farms.

A2 Tanks made in conformance to these standards shall provide a
means for cooling the milk.

A3 The milk tank will consist of the following components: Lining,
jacket and rail, personnel access openings and covers, outlet valve,
vent, agitation, refrigeration, measuring device and internal
solution piping.

A3.1 Other components may include: external solution piping, cleaning
controls, temperature indication thermometer, recording
thermometer, and weather protective cover and sanitary seals for
agitator.

A4 In order to conform to these 3-A Sanitary Standards, farm milk
cooling and holding tanks shall conform to the following design,
material, fabrication, and cooling criteria.

78- Spray Cleaning Devices Intended to Remain in Place
73- Shear Mixers, Mixers and Agitators
Product


16-05 Milk and Milk Products Evaporators and Vacuum
Pans

Title: 3-ASanitary Standards for Milk and Milk Products Evaporators and
Vacuum Pans, Number 16-05

Date: Reaffirmed August 24, 1997

Scope: A1 These standards cover the sanitary aspects of evaporators and
vacuum pans used for milk and milk products.

A2 In order to conform to these 3-A Sanitary Standards, evaporators
and vacuum pans shall comply with the following design, material,
and fabrication criteria.

11- Plate Type Heat Exchangers
12- Tubular Heat Exchangers
31- Scraped Surface Heat Exchangers
Fluid Milk Products

603- Sanitary Construction, Installation, Testing, and Operation of
High-Temperature Short-Time and Higher-Heat Shorter-Time
Pasteurizer Systems



17-11 Formers, Fillers, and Sealers of Containers for
Fluid Milk and Fluid Milk Products

Title: 3-ASanitary Standards for Formers, Fillers, and Sealers of Containers
for Fluid Milk and Fluid Milk Products, Number 17-11


Scope: A1 These standards cover the sanitary aspects of unitized equipment for
forming, filling, and sealing containers for fluid milk and fluid
milk products. The equipment shall perform one or more of the
following functions: 1) forming the container, 2) applying and
sealing a supplementary fitment or device, 3) filling the container
and 4) sealing, including capping if part of the unitized equipment,
the container. The equipment shall start at the points where the
product, utilities (air, water, steam, cleaning chemicals, etc.),
container, container blank, or container material first enters the
unitized equipment. The equipment shall end where the formed,
filled, and/or sealed container exits the equipment.

A2 These standards do not pertain to the container, to free-standing
container forming equipment or to other equipment such as
labelers, printers, daters, cappers, applicators of supplementary
fitments or devices or wrappers not furnished as part of the
unitized equipment, nor shall it apply to fillers of viscous products,
such as frozen desserts, cottage cheese, cultured yogurt, sour
cream, whipped butter, cream cheese, and other similar viscous
dairy products.

A3 In order to conform to these 3-A Sanitary Standards, formers,
fillers, and sealers of containers shall comply with the following
design, material, and fabrication criteria.

28- Flow Meters for Milk and Milk Products
04- Homogenizers and Reciprocating Pumps
44- Diaphragm Pumps

Fluid Milk Products
60- Milk and Milk Products Rupture Discs
64- Pressure Reducing and Back Pressure Regulating Valves for Milk
and Milk Products
Product

609- A Method of Producing Culinary Steam


18-03 Multiple-Use Rubber and Rubber-Like Materials
Used as Product Contact Surfaces in Dairy Equipment

Title: 3-A Sanitary Standards for Multiple-Use Rubber and Rubber-Like
Materials Used as Product Contact Surfaces in Dairy Equipment, Number
18-03

Date: Effective August 21, 1999

Scope: A1 These sanitary standards cover the material and serviceability
requirements of rubber and rubber-like materials intended for
multiple-use as product contact surfaces or solution contact
surfaces in the production, processing and handling of milk or milk
products. Test procedures and criteria are also provided for rubber
and rubber-like materials as a means of determining their
acceptance as to their ability to be cleaned and to receive effective
bactericidal treatment or steam sterilization and to maintain their
essential properties in these accelerated use-simulating conditions .
These standards are not meant to cover design and fabrication
criteria for individual rubber or rubber-like components because
such criteria are provided for in other 3-A Sanitary Standards and

3-A Accepted Practices, nor are these standards intended to cover
RTV silicone adhesives or sealants.

A2 In order to conform with these 3-A Standards, multiple-use rubber
and rubber-like materials shall comply with the following material,
original physical properties and serviceability requirements.


19-07 Batch and Continuous Freezers for Ice Cream,
Ices and Similarly Frozen Dairy Foods

Title: 3-A Sanitary Standards for Batch and Continuous Freezers for Ice
Cream, Ices and Similarly Frozen Dairy Foods, Number 19-07

Date: Effective December 1, 2008

Scope: A1 These standards cover the sanitary aspects of batch and continuous
freezers for ice cream, sherbets, sorbets, ices, and other similarly-
frozen foods and equipment integral therewith, including pumps,
equipment for incorporating air or introducing flavoring material
into the product and mix supply tanks attached to and made as a
part of the freezer. These standards do not cover equipment
designed for the freezing of soft-serve type ice cream, ices, and
similarly-frozen products which are served to the consumer
without further hardening.

A2 In order to conform to these 3-A Sanitary Standards, batch and
continuous freezers for ice cream, sherbets, sorbets, ices, and other
similarly frozen foods shall conform to the following design,
material, fabrication criteria and the applicable documents
referenced herein.

28- Flow Meters
33- Polished Metal Tubing
58- Vacuum Breakers and Check Valves


External
References:
Smidt, p. 61. ASM International, Materials Park, OH 44073 (216)
338-5151.

2. AMS-S-13165, Shot Peening of Metal Parts. Society of
Automotive Engineers (AWS), Commonwealth Dr., Warrendale
PA 15096-0001.

3. SAE-AMS-QQ-C-320, Chromium Plating (Electrodeposited).
SAE-AMS QQ-N-290A, Nickel Plating (Electrodeposited). Society
of Automotive Engineers (AWS), 400 Commonwealth Dr.,
Warrendale, PA 15096- 0001.

4. AISI Steel Products Manual, Stainless & Heat Resisting Steels,
November 1990, Table 2-1, pp. 17-20. Available from the
American Iron and Steel Society, 410 Commonwealth Drive,
Warrendale, PA 15086 (412-776-1535).

5. 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 .

and A744/A744M. Available from ASTM, 100 Barr Harbor Drive,
West Conshohocken, PA 19428-2959, Phone: (610) 832-9500.

7. ASTM specifications for Wrought Grades A-276, A-582, and A-
666. Available from ASTM, 100 Barr Harbor Drive, West

B46.1 Surface Texture. Available from ASME, 345 East 47th
Street, New York, NY 10017-2392 (212-705-7722).

Printing Office, Washington, D.C. 20402, (202) 512-1800.


10. ASHRAE test 52.2-1999 method of testing general ventilation air-
cleaning devices for removal efficiency by particle size. Available
from American Society of Heating, Refrigeration and Air
Conditioning Engineers, 1791 Tullie Circle, N.E., Atlanta, GA
30329 Phone: 404-636-8400.

11. ISO 14644-1 designating standard classes of air particulate
cleanliness and specifies methods for verifying air cleanliness
classifications. Available from The International Organization for
Standardization (ISO), 1 Rue de Varembe, Case Postale 58, CH 1
1211, Geneva, Switzerland, Phone: +41-22-734-1240.

12. Machinery's Handbook, published by Industrial Press Inc., 200
Madison Avenue, New York, NY 10157, Phone: (888) 528-7852.

PA 15086. Phone: (412) 776-4970.

Applications. Published by American Welding Society, 550 N.W.
LeJ eune Rd., Miami FL, Phone: (800) 443-3953, www.aws.org.

15. EHEDG Doc. 9 Welding Stainless Steel to Meet Hygienic
Requirements. European Hygienic Engineering & Design Group.
Published by EHEDG, www.ehedg.org

16. ISO 3601-1: The International Organization for Standardization
(ISO), 1 Rue de Varembe, Case Postale 58, CH 1 1211, Geneva,
Switzerland. Phone: +41-22-734-1240.

20-27 Multiple-Use Plastic Materials

Title: 3-ASanitary Standards for Multiple-Use Plastic Materials, Number 20-
27

Date: Effective: J uly 7, 2011

Scope: A1 These sanitary standards cover the material requirements of
plastics for multiple-use as product contact and/or cleaning
solution contact surfaces in equipment for production, processing,
and handling of milk and milk product(s). Test criteria are
provided for plastics as a means of determining their acceptance as

to their ability to be cleaned and to receive effective bactericidal
treatment and to maintain their essential functional properties and
surface finish in accelerated use-simulating tests . These standards
do not apply to plastics for single service application nor plastics
which are of rubber or rubber-like origin resulting from chemical
or thermal vulcanization or curing. These standards are also not
meant to cover design and fabrication criteria for individual plastic
components, because such criteria are provided for in other 3-A
Sanitary Standards and 3-A Accepted Practices.

A2 In order to conform to these 3-A Sanitary Standards, multiple-use
plastics shall comply with the following material, fabrication of
test specimens as described in Section D3 herein, and cleanability
standards.


21-01 Centrifugal Separators and Clarifiers

Title: 3-A Sanitary Standards for Centrifugal Separators and Clarifiers,
Number 21-01

Date: Effective: November 13, 2006

Scope: A1 These Standards cover the sanitary aspects of centrifugal
separators or clarifiers used to separate fractions of milk or milk
products or other liquid food products or to centrifugally remove
dense phase material from products. This machine starts at the
product inlet(s) and terminates at the product outlet(s) and the
nonproduct discharge(s), if included.

These Standards do not cover cyclonic types of separators,
decanters, basket centrifuges and other types of devices and the
spacers (caulks) for separator or clarifier discs and their attachment
to the discs. (See Appendix M.)

A2 In order to conform to these 3-A Sanitary Standards, centrifugal
separators or clarifiers shall comply with the following design,
material, and fabrication criteria and the applicable documents
referenced herein.


Product


22-08 Silo-Type Storage Tanks for Milk and Milk
Products

Title: 3-ASanitary Standards for Silo-Type Storage Tanks for Milk and Milk
Products, Number 22-08

Date: Adopted: November 21, 2004

Scope: A1 These standards cover the sanitary aspects of silo-type storage
tanks for milk and milk products used at dairy processing plants.
These standards are not intended to cover silo-type tanks used on
dairy farms.

A2 In order to conform to these 3-A Sanitary Standards, silo-type
storage tanks shall conform to the following design, material,
fabrication and refrigeration criteria

Milk Products




23-06 Equipment for Packaging Viscous Product

Title: 3-ASanitary Standards for Equipment for Packaging Viscous Products,
Number 23-06


Scope: A1 These standards cover the sanitary aspects of unitized equipment
for holding, opening, forming, dispensing, filling, closing, sealing,
or capping containers for viscous products, or wrapping viscous
products, and all parts essential to these functions. The equipment
shall perform one or more of the following functions:
1. Holding the container preparatory to further processing
2. Opening the container
3. Forming the container
4. Dispensing a preformed container
5. Applying and sealing a supplementary fitment
6. Other processing equipment, as defined herein
7. Filling the container
8. Closing the container
9. Sealing the container
10. Capping the container
11. Wrapping the container
12. Applying a tamper-evident security seal.

The equipment shall start at the point(s) where the product,
container, container blank, container material or wrapping material
first enters the equipment. The equipment shall end where the
packaged product exits the unitized equipment.

A2 These standards do not pertain to the container, to free-standing

container forming equipment or to other equipment such as
labelers, printers, daters, cappers, applicators of supplementary
fitments or devices or wrappers not furnished as part of the
unitized equipment, nor shall it apply to fillers of nonviscous
products.

A3 In order to conform to these 3-A Sanitary Standards, equipment for
packaging viscous products shall conform to the following design,
referenced herein.

Product
46- Refractometers and Energy Absorbing Optical Sensors for Milk
and Milk Products




24-03 Non-Coil Type Batch Pasteurizers for Milk and Milk
Products

Title: 3-ASanitary Standards for Non-Coil Type Batch Pasteurizers for Milk
and Milk Products, Number 24-03

Date: Effective J uly 16, 2010

Scope: A1 This standard covers the sanitary aspect of non-coil type batch
pasteurizers used to pasteurize milk, fluid milk products, or other
fluid food products and includes those appurtenances necessary to
meet pasteurization requirements. This Standard shall be deemed
inclusive of the points where the product enters and exits the
noncoil type batch pasteurizer.

A2 In order to conform to this 3-A Sanitary Standard, non-coil type
batch pasteurizers shall conform to the following criteria for
design, materials of construction, fabrication techniques and

56- Inlet and Outlet Leak-Protector Plug-Type Valves
65- Sight and/or Light Windows and Sight Indicators
73- Shear Mixers, Mixers and Agitators
78- Spray Devices to Remain in Place
84- Personnel Access Port for Wet Applications

604- Supplying Air Under Pressure in Contact with Product, and
Product Contact Surfaces
609- Accepted Practice for Culinary Steam

External
References:
1535. www.AIST.org


Crystal Lake, IL
60014, Phone: (815) 455-8240, Fax: (815) 455-8241,
Internet: www.sfsa.org


Stainless Steel Tubeand 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.


6. Grade A Pasteurized Milk Ordinance,
http://www.cfsan.fda.gov/~ear/pmo03toc.html.

or at http://www.gpoaccess.gov/cfr/index.html.

PA 15086, Phone: (724)-776-4841.

Switzerland, Phone: +41-22-734-1240.

25-03 Non-Coil Type Batch Processors

Title: 3-ASanitary Standards for Non-Coil Type Batch Processors, Number
25-03


Scope: A1 These standards cover sanitary aspects of non-coil type batch
processors used to heat, cool, or process milk, fluid milk products,
or other fluid comestibles. Batch processors may be either of the
atmospheric or closed type. The latter may be operated at
pressures from below to above that of the atmosphere.

A2 In order to conform to these 3-A Sanitary Standards, non-coil type
batch processors shall conform to the following design, material,
Product
Milk Products


26-05 Sifters for Dry Products

Title: 3-ASanitary Standards for Sifters for Dry Products, Number 26-05

Date: Effective: April 26, 2007

Scope: A1 These standards cover the sanitary aspects of sifters used for
processing dry products beginning at, as appropriate, the inlets for

products, cleaning solutions, processing air and terminating at the
outlets for product, processing air, cleaning solutions or rejected
material.

A2 In order to conform to these 3 A Sanitary Standards, sifting
equipment shall comply with the following design, material, and

Product

27-06 Equipment for Packaging Dry Milk and Dry Milk
Products

Title: 3-ASanitary Standards for Equipment for Packaging Dry Milk and Dry
Milk Products, Number 27-06

Date: Effective May 7, 2010

Scope: A1 These standards cover the sanitary aspects of equipment for
performing the functions of holding, forming, dispensing, filling,
weighing, deaerating, closing, and/or sealing containers, and all
parts which are essential to these functions when they are
performed as an integral part of the packaging operation. These
standards do not pertain to the container nor to a duct(s) which is
not a part of the packaging equipment.

A2 In order to conform to these 3-A Sanitary Standards, equipment for
packaging dry milk and dry milk products shall conform to the
following design, material, and fabrication criteria and the
applicable documents referenced herein.




28-04 Flow Meters for Milk and Milk Products

Title: 3-ASanitary Standards for Flow Meters for Milk and Milk Products,
Number 28-04

Date: Effective J anuary 26, 2009

Scope: A1 These standards cover the sanitary aspects of flow meters for milk
and milk products and include that portion of any device integral
with the meter such as strainers, temperature sensors and density
sensors, which is in contact with the flowing product. It does not
pertain to meters designed to measure the milk from an individual
milking animal.

A2 In order to conform to these 3 A Sanitary Standards, flow meters
criteria


29-03 Air Eliminators

Title: 3-ASanitary Standards for Air Eliminators, Number 29-03


Scope: A1 This 3-A Sanitary Standard covers the sanitary aspects of air
eliminators that vent air removed from product directly to the
atmosphere and does not apply to devices using vacuum to remove
air. Product and air enter the air eliminator at the inlet connection,

product exits at the outlet connection and air exits at the air vent.

A2 In order to conform to this 3-A Sanitary Standard, air eliminators
shall conform to the following criteria for design, materials of
construction, fabrication techniques and installation, as
documents cited herein.

18- Multiple-Use Rubber and Rubber-like Materials
33- Metal Tubing
Product

External
References:
1. (ANSI)/American Society of Mechanical Engineers (ASME) B46.1
- Surface Texture Waviness and Lay. Available from the American
Society of Mechanical Engineers, 345 East 47th Street, New York,
NY 10017-2392, Phone: (212) 705-7722. http://webstore.ansi.org

1535. www.AIST.org

3. Steel Casting Handbook, Supplement 2, 1999, 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

or at http://www.gpoaccess.gov/cfr/index.html

LeJ eune Rd., Miami FL, Phone: (800) 443-3953, www.aws.org



7. Aerospace Standard (AS) 568, published by SAE, 400
4970.

1211, Geneva 20, Switzerland, Phone: +41-22-749-01-11.
www.iso.org



30-01 Farm Milk Storage Tanks

Title: 3-ASanitary Standards for Farm Milk Storage Tanks, Number 30-01

Date: Effective September 9, 1984

Scope: A1 These standards cover the sanitary aspects of tanks in which bulk
milk is stored on dairy farms. They do not pertain to storage tanks
nor to silo type tanks for milk and milk products used in dairy
processing plants nor do they pertain to farm milk cooling and
holding tanks.

A2 Tanks made in conformance to these standards will prevent a
significant increase in the temperature of the milk stored in the
tank by the insulation or by the combination of the insulation and
refrigeration. These tanks will not provide the means for cooling
the milk.

A3 In order to conform with these 3-A Sanitary Standards, farm milk
storage tanks shall comply with the following design, material and




31-06 Scraped Surface Heat Exchangers

Title: 3-ASanitary Standards for Scraped Surface Heat Exchangers, Number
31-06

Date: Effective: September 24, 2010

Scope: A1 These standards cover the sanitary aspects of scraped surface heat
exchangers for adding heat to, or removing heat from products.
These standards do not pertain to freezers for ice cream, ices and
similarly frozen dairy foods nor to batch processors.

A2 In order to conform to these 3-A Sanitary Standards, scraped
surface heat exchangers shall conform to the following design,
material and fabrication criteria

19- Batch and Continuous Freesers for Ice Cream, Ices and Similarly
Frozen Dairy Foods

32-02 Uninsulated Tanks for Milk and Milk Products


Title: 3-A Sanitary Standards for Uninsulated Tanks for Milk and Milk


Scope: A1 These standards cover the sanitary aspects of un-insulated tanks,
both open top and closed types, and both single and multiple
compartment types, that are intended to be used for one of the
following purposes:

A1.1 Mixing of milk and milk products and ingredients.

A1.2 Storage of milk and milk products in uninsulated tanks
intended to be located in a room in which the air
surrounding the tank will maintain the product temperature.

A1.3 Storage of milk and milk products in uninsulated tanks
having heat exchange surfaces to maintain the product
temperature.

A1.4 As a raw product constant level tank in a pasteurizing
system.

A1.5 As a product surge or feed tank within a milk or milk
products processing system, and farm milk handling
equipment.

A2 In order to conform with these 3-A Sanitary Standards, uninsulated
tanks shall comply with the following design, material, and

Milk Products




33-02 Polished Metal Tubing for Milk and Milk Products

Title: 3-ASanitary Standards for Polished Metal Tubing for Milk and Milk


Scope: A1 This standard covers the sanitary aspects of metal tubing used to
convey milk and milk products. This standard does not apply to the
assembly of metal tubing into further fabricated forms or systems.

A2 In order to conform to this 3-A Sanitary Standard, metal tubing
shall conform to the following criteria for materials of
construction, fabrication techniques, and the current revisions or
editions of all referenced documents cited herein.


34-02 Portable Bins for Dry Milk and Dry Milk Products

Title: 3-ASanitary Standards for Portable Bins for Dry Milk and Dry Milk


Scope: A1 These standards cover the sanitary aspects of portable bins for
storage, transportation and handling of dry milk and dry milk
products in bulk. They do not pertain to (1) stationary bins, (2)
bins (tanks) installed on automotive highway equipment, or (3)
piping and appurtenances that are not attached to the bin.

A2 In order to conform with these 3 A Sanitary Standards, dry milk
bins shall comply with the following design, material, and
fabrication criteria, and the applicable documents referenced

herein.


35-04 Blending Equipment

Title: 3-ASanitary Standards for Blending Equipment, Number 35-04


Scope: A1 These standards cover the sanitary aspects of blending equipment
used for combining and/or mixing either wet or dry products and
includes any component equipment which shall conform to their
respective 3-A Sanitary Standards.

A1.1 The blending equipment begins at the entrance to the hopper or
infeed pipe connection(s) and ends at the exit pipe fitting and
includes all equipment in between.

A2 In order to conform to these 3-A Sanitary Standards, blending
equipment shall conform to the following design, material and

References: 3-A Sanitary Standards for:
32- Uninsulated Tanks
36- In-Line Rotor-Stator Mixers
51- Plug-Type Valves
52- Plastic Plug-Type Valves
54- Diaphragm-Type Valves
55- Boot Seal-Type Valves
57- Tank Outlet Valves
62- Hose Assemblies

81- Auger-Type Feeders

3-A Accepted Practices for:
Systems

36-01 Inline Rotor-Stator Mixers

Title: 3-ASanitary Standards for Inline Rotor-Stator Mixers Number 36-01


Scope: A1 These standards cover the sanitary aspects of inline devices which
use a combination of a rotor and a stator to effect mixing and size
reductions for liquids, slurries, and liquid-gas mixtures.

A1.1 The rotor-stator mixer begins at the infeed pipe connection(s) and
ends at the exit pipe fitting and includes all equipment in between.

A2 In order to conform to the 3-A Sanitary Standards, rotor-stator
inline mixers, (Referred hereinafter as inline mixers) shall
conform to the following design, material and fabrication criteria
and the applicable documents referenced herein.


38-00 Cottage Cheese Vats

Title: 3-ASanitary Standards for Cottage Cheese Vats, Number 38-00


Scope: A1 These standards cover the sanitary aspects of open top-type vats

used in the batch production of cottage cheese curd.

A2 In order to conform with these 3-A Sanitary Standards, cottage
cheese vats shall comply with the following design, material and


39-01 Pneumatic Conveyors for Dry Milk and Dry Milk
Products

Title: 3-ASanitary Standards for Pneumatic Conveyors for Dry Milk and Dry
Milk Products, Number 39-01


Scope: A1 These standards cover the sanitary aspects of equipment used in
systems solely for the pneumatic conveying of dry milk, dry milk
products, or other dry comestibles utilizing air flow which is
caused by either a pressure or vacuum differential. These
standards are not intended to cover pneumatic conveying
equipment or systems that are an integral part of a spray drying or
instantizing system unless specifically referenced for that purpose
in the applicable 3-A Sanitary Standard or 3-A Accepted Practice.
The equipment begins at the point at which product enters the
conveyor and ends at the point(s) where product is discharged from
the conveyor. With respect to air, the equipment begins at the
point where conveying air leaves the final filter and ends at the
entrance of the air/product separator equipment. These standards
also include any required product accumulation, conditioning and
metering equipment which are located before product introduction
into the conveying air pipeline and which are provided by the
equipment manufacturer.

These standards do not cover the use of:

1. Air slide type conveyors which convey product using air
flow through a permeable membrane type media or
perforated plate.
2. Wand type pneumatic conveying equipment from open

containers or bags where ambient air can be introduced to
convey product.
3. Product storage bins, hoppers, silos that are part of the
air/product separation equipment.
4. Bag collectors, when used as air/product separators, which
are covered by 3-A Sanitary Standards for Bag Collectors,
No. 40-.

A2 In order to conform to these 3-A Sanitary Standards, pneumatic dry
milk conveyors shall conform to the following design, material and

50- Level Sensing Devices for Dry Products
62- Hose Assemblies
Product
66- Caged-Ball Valves
68- Ball-Type Valves

Systems

40-04 Bag Collectors

Title: 3-ASanitary Standards for Bag Collectors, Number 40-04

Date: Effective: March 16, 2012

Scope: A1 These standards cover the sanitary aspects of bag collectors for the
dry filter entrapment and collection of particulates of dry food
products from air exhausted from spray drying systems,
instantizing systems, or other dry product systems beginning at the
flanges or junctions of the product/air inlets of the bag collector
and terminating at the flanges or junctions of the air exhaust and
product outlets.


With respect to pressurized air, the bag collector starts at the air
inlet to the pressurized air reservoir, or, in the case of an internal
pressurized air receiver, it shall start at the air inlet to the bag
collector.

With respect to processing air, if provided, the bag collector starts
at the flange or junction of the processing air inlet(s).

If the bag collector is designed for mechanical cleaning, these
standards include the cleaning solution pipelines, valves, and
associated components integral to the bag collector.

These standards also include materials and fabrication criteria
appropriate for bag collectors:
a. to be cleaned by a variety of methods and with
different degrees of prior disassembly.
b. which have optional integral fluid bed components.

These standards do not include equipment mounted upstream from
inlet flanges or junctions or downstream from the outlet flanges or
junctions, including but not limited to product outlet valves,
isolation valves, air ducting, fans, and blowers.

A2 In order to conform to these 3-A Sanitary Standards, bag collectors
shall conform to the following design, material, and fabrication
criteria, and the applicable documents referenced herein.

and Milk Products
41- Mechanical Conveyors for Dry Products
Product
49- Air Driven Sonic Horns for Dry Products

Milk Products

607- Spray Drying Systems

41-03 Mechanical Conveyors for Dry Products

Title: 3-ASanitary Standards for Mechanical Conveyors for Dry Products,
Number 41-03

Date: Effective: J anuary 4, 2008

Scope: A1 These standards cover the sanitary aspects of mechanical
equipment used solely for conveying dry milk and dry milk
products except bucket types and are not an integral part of the
dryer, commencing with the point at which the product enters the
conveyor and ending at the point the product is discharged from
the conveyor.

A2 In order to conform to these 3-A Sanitary Standards, mechanical
dry milk conveyors shall conform to the following design,
material, and fabrication criteria.


42-01 In-Line Strainers for Milk and Milk Products,
Number


Title: 3-ASanitary Standards for In-Line Strainers for Milk and Milk Products,
Number 42-01


Scope: A1 These standards cover the sanitary aspects of in-line strainers for
milk and milk products.

Straining devices which employ mechanical action are not covered
by this standard.

A2 In order to conform with these 3-A Sanitary Standards, in-line
strainers shall comply with the following design, material, and


44-03 Diaphragm Pumps

Title: 3-ASanitary Standards for Diaphragm Pumps, Number 44-03


Scope: A1 These standards cover the sanitary aspects of air, hydraulically, or
mechanically driven diaphragm pumps for milk and milk products.

A2 In order to conform to these 3-A Sanitary Standards, diaphragm
pumps shall comply with the following design, material, and



45-02 Crossflow Membrane Modules

Title: 3-ASanitary Standards for Crossflow Membrane Modules, Number 45-
02


Scope: A1 These standards cover the sanitary aspects of crossflow membrane
modules for use with ultrafiltration, diafiltration, microfiltration
and reverse osmosis systems for processing milk and milk
products.

A2 In order to conform to these 3-A Sanitary Standards, membrane
modules shall conform to the following design, material, and


610- Sanitary Construction, Installation, and Cleaning of Cross Flow
Membrane Processing Systems

46-03 Refractometers and Energy Absorbing Optical
Sensors for Milk and Milk Products

Title: 3-A Sanitary Standards for Refractometers and Energy Absorbing
Optical Sensors for Milk and Milk Products, Number 46-03


Scope: A1 These standards cover the sanitary aspects of refractometers and
energy absorbing optical sensors used on milk and milk products
equipment for sensing concentration, turbidity and/or color.

A2 In order to conform with these 3-A Sanitary Standards,
refractometers and energy absorbing optical sensors shall comply
with the following design, material, and fabrication criteria and the

applicable documents referenced herein.


609- Method of Producing Steam of a Culinary Quality


49-01 Air Dri ven Sonic Horns for Dry Products

Title: 3-ASanitary Standards for Air Driven Sonic Horns for Dry Products,
Number 49-01


Scope: A1 These standards cover the sanitary aspects of air-driven sonic horns
that dislodge particulates, enhance atomization, augment
fluidization or are used in other ways to enhance the drying and/or
recovery of dry products. Sonic horns shall begin at the
downstream face of the filter element located at the compressed air
connection of the driver and terminate at the discharge of the
acoustic bell.

A2 In order to conform to these 3-A Sanitary Standards, sonic horns
criteria




50-01 Level Sensing Devices for Dry Products

Title: 3-ASanitary Standards for Level Sensing Devices for Dry Products,
Number 50-01


Scope: A1 These standards cover the sanitary aspects of devices, excluding
load cells, which have product contact surfaces and are used on dry
products, storage vessels or equipment for sensing product level.

A2 In order to conform to these 3-A Sanitary Standards, dry product
level sensing devices shall comply with the following design,
material, and fabrication criteria .



51-01 Plug-Type Valves for Milk and Milk Products

Title: 3-A Sanitary Standards for Plug-Type Valves for Milk and Milk



Scope: A1 These standards cover the sanitary aspects of plug type valves used
on processing equipment and on equipment and lines which hold
or convey milk or milk products. These standards do not pertain to
thermoplastic plug-type valves which are covered by current 3 A
Sanitary Standards for Plastic Plug Type Valves for Milk and Milk
Products, Number 52 .

A2 In order to conform to these 3 A Sanitary Standards, plug type
valves shall comply with the following in design, material and
fabrication criteria and the applicable documents referenced herein


52-02 Plastic Plug-Type Valves for Milk and Milk
Products

Title: 3-ASanitary Standards for Plastic Plug-Type Valves for Milk and Milk


Scope: A1 These standards cover the sanitary aspects of plastic plug-type
valves used on processing equipment for milk or milk products and
on equipment and pipelines which hold or convey milk or milk
products.

A2 In order to conform with these 3 A Sanitary Standards, plastic
plug-type valves shall comply with the following design, material,
and fabrication criteria and the applicable documents referenced
herein


53-06 Compression-Type Val ves

Title: 3-ASanitary Standards for Compression-Type Valves, Number 53-06

Date: Effective: May 22, 2009

Scope: A1 These standards cover the sanitary aspects of compression-type
valves (reference 3-A drawings, number 3-A-100-24 and 3-A-100-
25) used on processing equipment and on equipment and lines
which hold or convey milk or milk products.

A2 In order to conform to these 3-A Sanitary Standards, compression-
type valves shall comply with the following in design, material and


54-02 Diaphragm-Type Val ves for Milk and Milk
Products

Title: 3-ASanitary Standards for Diaphragm-Type Valves for Milk and Milk


Scope: A1 These standards cover the sanitary aspects of diaphragm-type
valves (reference drawing, number 3-A 54-01-01) used on
processing equipment and on equipment and lines which hold or
convey milk or milk products. The valve shall consist of a bonnet
assembly (hand-wheel or power [air] operated), a diaphragm, and a
suitable body.

A2 In order to conform to these 3-A Sanitary Standards, diaphragm-
type valves shall comply with the following design, material, and


33- Polished Metal Tubing for Dairy Products

55-02 Boot Seal Type Val ves

Title: 3-ASanitary Standard for Boot Seal Type Valves, Number 55-02


Scope: A1 This 3-A Sanitary Standard covers the sanitary aspects of boot seal
type valves used as components on processing equipment and
pipelines that hold or convey milk, milk products, and other food
products. The valve assembly includes an actuator moving a piston
rod, a boot seal attached to the piston rod and supported by it, and
a valve housing or body enclosing the boot seal and providing
entry and exit points for the product. Product enters the boot seal
type valve at the inlet connection and exits at the outlet connection.

A2 In order to conform to this 3-A Sanitary Standard, Boot Seal Type
Valves shall conform to the following criteria for design, materials
of construction, fabrication techniques and installation, as
documents cited herein.

33- Metal Tubing
External
References:
1535.

2. Steel Casting Handbook, Supplement 2, 1999, available from Steel
Founders Society of America, 780 McArdle Dr., Unit G, Crystal
Lake, IL 60014, Phone: (815) 455-8240, Fax: (815) 455-8241,

3. ASTM specifications for Cast Grades A351/A351M and

A744/A744M. Available from ASTM, 100 Barr Harbor Drive,


NY 10017-2392, Phone: (212) 705-7722.

PA 15086, Phone: (724) 776-4841.

7. ISO 3601-1:2002 Fluid Power Systems, Sealing Devices O-Rings
Part I: Inside diameters, cross-sections, tolerances, and size
identification code., The International Organization for
Standardization (ISO), 1 Rue de Varembe, Case Postale 58, CH 1
1211, Geneva, Switzerland, Phone: +41-22-734-1240.

Applications and AWS D18.2 Guide to Weld Discoloration
Levels on Inside of Austenitic Stainless Steel Tube (ANSI


10. EHEDG Doc. 35 Welding of Stainless Steel Tubing in the Food
Industry, European Hygienic Engineering & Design Group.


12. The Code of Federal Regulations (CFR), Title 29, Part 1910.147 -
The Control of Hazardous Energy. For sale by the Superintendent
of Documents, U.S. Government Printing Office, Washington, DC

20402, Phone: (202) 512-1800 or at
http://www.gpoaccess.gov/cfr/index.html.

13. The Code of Federal Regulations (CFR), Title 21, Part 177 Indirect
Food Additives: Polymers. For sale by the Superintendent of
Documents, U.S. Government Printing Office, Washington, DC
20402, Phone: (202) 512-1800 or at

14. GAR C-9 Cast Microfinish Comparator. Available from Gar
Electroforming Division, Electroformers Inc., 11 Augusta Drive,
Commerce Park, PO Box 340, Danbury, CT 06813-0340, Phone:
(203) 744-4300.

15. EHEDG Doc. 2 A Method for Assessing the In-Place
Cleanability of Food Processing Equipment, European Hygienic
Engineering & Design Group. Published by EHEDG,
www.ehedg.org

or at http://www.gpoaccess.gov/cfr/index.html .

56-00 Inlet and Outlet Leak-Protector Plug-Type Val ves
for Milk and Milk Products

Title: 3-ASanitary Standards for Inlet and Outlet Leak-Protector Plug-Type
Valves for Milk and Milk Products, Number 56-00

Date: Effective May 22, 1993

Scope: A1 These standards cover the sanitary aspects of inlet and outlet leak-
protector plug valves for batch pasteurizers, hereinafter called
valves, (reference 3-A drawings, numbers 3-A-100 E-1, 3-A-100
E-2, 3-A-100 E-3, 3-A-100 E-4, 3-A-100 E-5, 3-A-100 E-6, 3-
A-100 E-7, and 3-A-100 E-8.)

A2 In order to conform to these 3-A Sanitary Standards, inlet and
outlet leak-protector plug valves shall comply with the following
design, material and fabrication criteria.



57-02 Disc-Type Valves

Title: 3-ASanitary Standards for Disc-Type Valves, Number 57-02

Date: Effective: May 1, 2008

Scope: A1 These standards cover the sanitary aspects of disc-type valves
having a one- or two-piece body and disc with the disc rotating
between the closed and open positions, as used on tanks or vessels
that hold the product or solutions and as installed in product and
solution pipelines. The stem that rotates the disc does not penetrate
the seal face or seal seat insert of the valve. The disc-type valve
begins at the product inlet connection and ends at the product
outlet connection. These Standards do not include butterfly-type
valves which may use two- or three-piece bodies and gaskets as
sandwich seals and seal faces in combination with a disc and in
which the stem penetrates the elastomer seal.

A2 In order to conform to this 3-A Sanitary Standard, disc-type valves
shall conform to the following design, material, and fabrication
criteria, and applicable documents referenced herein.


External
References:
Automotive Engineers (AWS), 400 Commonwealth Dr.,
Warrendale, PA 15096-0001.

Table 2-1. Available from the American Iron and Steel Society,
410 Commonwealth Drive, Warrendale, PA 15086 (412-776-
1535).

3. Steel Founders Society of America, 780 McArdle Dr. Unit G,
Crystal Lake, IL 60014, Phone: (815) 455-8240, Fax: (815)

455-8241, Internet: www.sfa.org.

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.

B46.1 Surface Texture. Available from ASME, 345 East 47th
Street, New York, NY 10017-2392 (212) 705-7722.

6. Machinerys Handbook, published by Industrial Press Inc., 200
Madison Avenue, New York, NY 10157, Phone: 888-528-
7852.

Applications. Published by American Welding Society, 550
N.W. LeJ eune Rd., Miami FL, Phone: (800) 443-3953,
www.aws.org.

Requirements. European Hygienic Engineering & Design
Group. Published by EHEDG, www.ehedg.org.

rings, published by SAE, 400 Commonwealth Drive,
Warrendale, PA 15086, Phone: (412) 776-4970.

10. ISO 3601-1: The International Organization for
Standardization (ISO), 1 Rue de Varembe, Case Postale 58, CH
1 1211, Geneva, Switzerland, Phone: +41-22-734-1240.

11. ASTM, 100 Barr Harbor Drive, West Conshohocken, PA
19428-2959 (610) 832-9500.

58-01 Vacuum Breakers and Check Val ves for Milk and
Milk Products

Title: 3-ASanitary Standards for Vacuum Breakers and Check Valves for Milk
and Milk Products, Number 58-01



Scope: A1 These standards cover the sanitary aspects of vacuum breakers and
check valves used on processing equipment and on equipment and
lines which hold or convey milk or milk products. See Appendix,
Section H for drawings numbered 3-A-100M-1, 3-A-100M-2, 3-A-
100M-3, 3-A-100M-4 and 3-A-100M-5.

A2 In order to conform to these 3-A Sanitary Standards, vacuum
breakers and check valves shall comply with the following design,
material and fabrication criteria.


605- Permanently Installed Product and Solution Pipelines and
Cleaning Systems Used in Milk and Milk Product Processing Plants

59-00 Automatic Positi ve Displacement Samplers for
Fluid Milk and Fluid Milk Products

Title: 3-ASanitary Standards for Automatic Positive Displacement Samplers
for Fluid Milk and Fluid Milk Products, Number 59-00


Scope: A1 These standards cover the sanitary aspects of air operated or
electrically operated automatic positive displacement samplers
(reference revised 3-A drawings, numbers 3-A-100D-1, 3-A-100D-
2, 3-A-100D-3, 3-A100D 1. 3-A-100D-5 and 3-A-100D-6) used on
processing equipment and on equipment and lines which hold or
convey fluid milk or fluid milk products. The sampler assembly
may consist of a body, plunger, head, O-rings, seals, cylinder
valves, diaphragm, springs and an air or electrically operated
mechanism. It shall also include a closure plug or sample discharge
port closure suitable for sealing the sample discharge opening
when the sampler is not in use. These standards shall not cover
automatic positive displacement samples used in aseptic or ultra

pasteurization systems

A2 In order to conform to these 3-A Standards, air operated or
electrically operated positive displacement samplers shall comply
with the following in design, material and fabrication.


60-00 Milk and Milk Products Rupture Discs

Title: 3-ASanitary Standards for Milk and Milk Products Rupture Discs,
Number 60-00


Scope: A1 These standards cover the sanitary aspects of rupture discs
(reference drawing Number 3-A-100-43) used on processing
equipment and on equipment and lines which hold or convey milk
or milk products. The rupture disc assembly shall consist of a disc
holder, top section (if used), seal, a girdle and means for rupturing
the seal.

A2 In order to conform to these 3-A Standards, rupture discs shall
comply with the following in design, material and fabrication

01- Storage Tanks
22- Silo-Type Storage Tanks for Milk and Milk Products

61-01 Steam Injection Heaters for Milk and Milk
Products

Title: 3-ASanitary Standards for Steam Injection Heaters for Milk and Milk


Date: Effective: September 11, 2006

Scope: A1 These standards cover the sanitary aspects of steam injection
heaters used to heat milk or milk products when the heater is on
processing equipment or in the pipelines conveying milk or milk
products.

A2 In order to conform to these 3 A Sanitary Standards, steam
injection heaters shall comply with the following design, material,



62-02 Hose Assemblies for Milk and Milk Products

Title: 3-A Sanitary Standards for Hose Assemblies for Milk and Milk


Scope: A1 This 3-A Sanitary Standard covers the sanitary aspects of hose
assemblies consisting of sanitary couplings permanently attached
to one or both ends of multiple-use smooth-bore hoses in a manner
such that the resultant hose-to-coupling junction is CIPable. The
hose assemblies are intended for the conveying of milk, milk
products, or other comestibles. The hose assemblies covered by
this standard are of three basic types as defined in C5.1.1, C5.1.2
and C5.1.3, and the components described therein are to be
assembled only by their manufacturer, or by an authorized
fabricator/distributor. Also see Appendix F1.

A2 This 3-A Sanitary Standard does not cover the following types of
hose assemblies: Also see Appendix F2 and F3.

A2.1 Hose assemblies which utilize band, strap, or worm-gear type
clamps or manually tightened fitting devices customarily used to
secure removable fittings and which are not designed for CIP

cleaning.

A2.2 Hose assemblies with a convoluted or a corrugated inner surface.
Also see Appendix F4.

A2.3 Hose assemblies with exposed metal overbraid exterior surfaces.
Also see E2.1 and Appendix F5.

A2.4 Hose assemblies with a hose ID of less than 0.75 in. (19.05 mm).

External
References:
1. SAE-AMS-QQ-C-320, Chromium Plating (Electrodeposited).
SAE-AMS QQ-N- 290A, Nickel Plating (Electrodeposited).
Society of Automotive Engineers (AWS), 400 Commonwealth Dr.,

1535. www.AIST.org

3. Steel Casting Handbook, Supplement 2, 1999, 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





666. Available fromASTM, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959, Phone: (610)832-9500.

63-03 Sanitary Fittings

Title: 3-ASanitary Standards for Sanitary Fittings, Number 63-03


Scope: A1 These standards cover the sanitary aspects of fittings and gaskets
for fittings used on processing equipment and pipelines which hold
or convey milk, milk products, or other comestibles. These
standards cover the product contact surfaces of disassemblable
joints on sanitary fittings.

A1.1 Standards for fabricated hose assemblies are found in 3-A Sanitary
Standards for Hose Assemblies for Milk and Milk Products,
Number 62-.

A2 These standards do not cover:

A2.1 Fittings, such as recessed ferrules, which are attached to a pipeline
or equipment by means of soldering.

A2.2 Recessless or rolled on fittings, except as allowed in Section
D2.1.1.

A3 In order to conform to these 3-A Sanitary Standards for Sanitary
Fittings, fittings shall conform to the following design, material,
and fabrication criteria, and the applicable documents referenced
herein.


606- Design, Fabrication, and Installation of Milking and Milk Handling
Equipment


64-00 Pressure Reducing and Back Pressure Regulating
Valves for Milk and Milk Products

Title: 3-A Sanitary Standards for Pressure Reducing and Back Pressure
Regulating Valves for Milk and Milk Products, Number 64-00

Date: Reaffirmed November 15, 1998

Scope: A1 These standards cover the sanitary aspects of pressure reducing and
back pressure regulating valves used on processing equipment and
on equipment and lines which hold or convey milk or milk
products.

A2 In order to conform to these 3-A Sanitary Standards, pressure
reducing and back pressure regulating valves shall comply with the
following design, material and fabrication criteria.


65-01 Sight and/or Light Windows and Sight Indicators
in Contact with Product

Title: 3-A Sanitary Standard for Sight and/or Light Windows and Sight
Indicators in Contact with Product Number 65-01

Date: Effective: J une 12, 2008

Scope: A1 These standards cover the sanitary aspects of sight and/or light
windows, sight and/or light window flushing systems when
provided, and sight indicators, and begin and end at the fitting
connections to the pipeline or equipment or at the flange welded to
the pipeline or equipment. The flushing system begins at the shut
off valve and ends at the delivery nozzle or pipe or tube. These
standards do not cover external direct-reading gauges for tanks.

A2 In order to conform to these 3 A Sanitary Standards, sight and/or
light windows, flushing systems when provided, and sight
indicators shall conform to the following in design, material and



Systems
609- Method of Producing Steam of Culinary Quality

External
References:
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.

Table 2-1, American Iron and Steel Society, 410 Commonwealth
Drive, Warrendale, PA 15086. Phone: (412) 776-1535.

Crystal Lake, IL 60014,Phone:(815)455-8240 Fax:(815)455-8241,

West Conshohocken, PA 19428-2959. Phone: (610) 832-9500.

5. American Society of Mechanical Engineers, 345 East 47th Street,
New York, NY 10017-2392. Phone: (212) 705-7722.

6. Grade A Pasteurized Milk Ordinance http://www.cfsan.fda.gov/-
ear/pmoO3toc.html.




68-00 Ball-Type Valves for Milk and Milk Products

Title: 3-A Sanitary Standards for Ball-Type Valves for Milk and Milk


Scope: A1 These standards cover the sanitary aspects of ball-type valves used
on processing equipment and on equipment and lines which hold
or convey milk or milk products.

A2 In order to conform with these 3 A Sanitary Standards, ball-type
valves shall comply with the following design, material, and


70-01 Italian-Type Pasta Filata Style Cheese Cookers

Title: 3-A Sanitary Standards for Italian-Type Pasta Filata Style Cheese
Cookers, Number 70-01


Scope: A1 The equipment covered by these standards may include unitized
sections that act as receiving reservoirs, pre-heat or cooking
sections (direct or indirect), integral heating media systems,
stretcher sections, discharge reservoir and discharge ports. The
cheese equipment shall begin at the point where cheese curd is
introduced and shall terminate at the point where cooked and
stretched cheese is discharged. With regard to the use of steam,
hot water, or other forms of heating media, the equipment shall
begin and end at the manufacturer's supplied fittings. (Cheese

dicers, mills, cyclones or similar appurtenances attached to the
receiving reservoir are not covered by these standards.)

A2 In order to conform to these 3 A Sanitary Standards, Italian-type
pasta filata style cheese cookers shall conform to the following
design, material, and fabrication criteria

Contact
61- Steam Injection Heaters for Milk and Milk Products



71-01 Italian-Type Pasta Filata Style Cheese Moulders
.
Title: 3-A Sanitary Standards for Italian-Type Pasta Filata Style Cheese
Moulders, Number 71-01


Scope: A1 These standards cover the sanitary aspects of Italian-type pasta
filata style cheese moulders, including but not limited to
mozzarella, string and provolone cheeses. The equipment shall
begin at the point where the cooked and stretched cheese is
introduced and shall terminate at the point where the cheese is
discharged into transfer moulds, discharged from integral moulds,
or discharged through an extruder. The equipment may include
individual or combined equipment sections that act as receiving-
transition units, salt application devices, receiving reservoirs,

integral moulds or extruder pieces. These standards also cover
Italian cheese moulders which cool moulded cheese by indirect
methods.

pasta filata style cheese moulders shall conform to the following
design, material, and fabrication criteria

Contact


72-01 Italian-Type Pasta Filata Style Moulded Cheese
Chillers

Title: 3-A Sanitary Standards for Italian-Type Pasta Filata Style Moulded
Cheese Chillers, Number 72-01


Scope: A1 These standards cover the sanitary aspects of Italian-type pasta
filata style moulded cheese chillers including but not limited to
mozzarella and provolone cheese. The equipment described in
these standards is used to cool the moulded cheese. The equipment
shall begin at the point where the warm moulded cheese enters,
and terminates where the formed-chilled cheese exits the mould.
The equipment may include individual or combined components
such as cheese moulds, conveyors, direct cooling media systems,
and cheese demoulding apparatus. These standards include
methods for direct cooling of the cheese and may include one or
more of the following uses of the cheese cooling media:
immersion, spray, cascade, circulation or recirculation. With
regard to the use of steam, water, or cooling media, the equipment

shall begin and end at the manufacturer's supplied fittings.

pasta filata style moulded cheese chillers shall conform to the
following design, material, and fabrication criteria.

Contact
Product



73-01 Shear Mixers, Mixers, and Agitators

Title: 3-A Sanitary Standards for Shear Mixers, Mixers, and Agitators,
Number 73-01

Date: Effective: October 27, 2005

Scope: A1 These standards cover the sanitary aspects of agitators, mixers and
shear mixers used for combining and/or mixing, either liquids or
liquids with solid products. Specifically included are batch mixers
immersed into the product. Shear mixers, mixers, and agitators
may be of the top, side or bottom entry types. These standards do
not include the vessel in which the agitator, mixer or shear mixer is

used.

A2 In order to conform to these 3 A Sanitary Standards, shear mixers,
mixers, and agitators shall conform to the following design,

Contact

74-05 Sensors and Sensor Fittings and Connections

Title: 3-ASanitary Standards for Sensors and Sensor Fittings and Connections,
Number 74-05


Scope: A1 This 3-A Sanitary Standard applies to the sanitary aspects of sensors
and sensor fittings and connections for equipment which contains
or processes milk and milk products and on pipelines which
convey milk and milk products and to sensors and sensor fittings
and connections within recirculation cleaning systems.

A2 To conform to this 3-A Sanitary Standard, sensors and sensor
fittings and connections shall conform to the following criteria for
design, materials of construction, fabrication techniques and the
current revisions or editions of all referenced documents cited
herein and, in the case of field-installed adaptors or spuds and their
associated sensors, installation criteria.

Contact
33- Metal Tubing

External
References:
1. The Code of Federal Regulations (CFR), Title 21, Part 110.3 (o)
Current good manufacturing practice in manufacturing, packaging,
or holding human food, definitions. (FDAs definition of sanitize
from the GMP regs). The Code of Federal Regulations (CFR),
Title 40, Part 152.500 Pesticide registration and classification
procedures, requirements for devices. The Code of Federal

Regulations (CFR), Title 40, Part 161.640 Data requirements for
registration, product performance data. The Code of Federal
Regulations (CFR), Title 40, Part 180.940 Tolerances and
exemptions from tolerances for pesticide chemicals in food,
tolerance exemptions for active and inert ingredients for use in
antimicrobial formulations (food-contact surface sanitizing
solutions). For sale by the Superintendent of Documents, U.S.
Government Printing Office, Washington, DC 20402, Phone: (202)
512-1800 or at http://www.gpoaccess.gov/cfr/index.html .

QQ-N-290A, Nickel Plating (Electrodeposited). SAE International,
http://www.sae.org


www.sfsa.org



8. EHEDG Guideline 2, A Method for Assessing the In-Place
Cleanability of Food Processing Equipment. European Hygienic
www.ehedg.org


www.iso.org

11. 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

12. 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

75-01 Belt-Type Feeders

Title: 3-ASanitary Standards for Belt-Type Feeders, Number 75-01

Date: Effective J une 4, 2012

Scope: A1 This 3-A Sanitary Standard applies to the sanitary aspects of belt-
type feeders used to convey products at a controlled rate. Product
enters the feeder at the inlet hopper/chute and exits at the head
pulley or enclosure discharge opening.

A2 To conform to this 3-A Sanitary Standard, belt-type feeders shall
comply with the following design, material, and fabrication criteria
and the current revisions of applicable documents cited herein.

33- Metal Tubing

External
References:

http://www.sae.org

2. (American Society of Mechanical Engineers (ASME) B46.1 -


http://www.sae.org


www.sfsa.org

Building 4, Section D, Philadelphia, PA 19111-5094, Phone: (215)
697-2179, Fax: (215) 697-1462.



10. EHEDG Guideline 2, A Method for Assessing the In-Place
Cleanability of Food Processing Equipment. European Hygienic
www.ehedg.org


Published by EHEDG, www.ehedg.org.


www.iso.org


78-01 Spray Cleaning Devices Intended to Remain in
Place
.
Title: 3-ASanitary Standards for Spray Cleaning Devices Intended to Remain
in Place, Number 78-01


Scope: A1 These standards cover the sanitary aspects of spray cleaning
devices attached to stainless steel solution supply tubes intended to
remain in place during processing operations and used on storage
and processing equipment and machinery for milk, milk products,
or other comestibles. These standards do not cover spray cleaning
devices which are removed prior to processing operations.

A2 In order to conform to these 3-A Sanitary Standards, spray
cleaning devices shall conform to the following design, material,

herein.

Contact


81-00 Auger-Type Feeders

Title: 3-ASanitary Standards for Auger-Type Feeders, Number 81-00


Scope: A1 These standards cover the sanitary aspects of auger-type feeders
used to convey, at a controlled rate, dry milk, dry milk products
and dry milk products and associated ingredients. Product enters
the auger-type feeder hopper and exits at the auger output via a
discharge tube assembly.

A2 In order to conform to these 3-A Sanitary Standards, auger-type
feeders shall comply with the following design, material, and
.

and Milk Products
Product


82-00 Pulsation Dampening Devices

Title: 3-ASanitary Standards for Pulsation Dampening Devices, Number 82-
00


Scope: A1 These standards cover the sanitary requirements for pulsation
dampening devices used in hygienic and aseptic processing
systems for fluid dairy products and other fluid comestibles.

A2 In order to conform to these 3-A Sanitary Standards, pulsation
dampening devices shall comply with the following design,
referenced herein.


83-00 Enclosed Cheese Vats and Tables

Title: 3-ASanitary Standards for Enclosed Cheese Vats and Tables, Number
83-00


Scope: A1 These standards cover the sanitary aspects of enclosed cheese vats
and tables used in the batch production of cheese curd and open
vats that are covered during mechanical cleaning. This standard
does not include equipment with capabilities for pressing of curd.

A2 In order to conform to these 3-A Sanitary Standards, enclosed
cheese vats and tables shall conform to the following design,
material and fabrication criteria.


Product


84-02 Personnel Access Ports for Wet Applications

Title: 3-ASanitary Standards for Personnel Access Ports for Wet Applications,
Number 84-02

Date: Effective: J une 1, 2007

Scope: A1 These standards cover the sanitary aspects of atmospheric or
pressure-type personnel access ports and associated covers for wet
applications. They may include the mounting flanges, hinges,
covers, dust covers and may be of the inside swing, outside swing,
sliding, or removable types. These standards do not include
installation criteria.

A2 In order to conform to these 3 A Sanitary Standards personnel
access ports shall conform to the following in design, material and

55- Boot Seal-Type Valves
59- Automatic Positive Displacement Samplers for Fluid Products
Product

Systems

85-02 Double-Seat Mixproof Valves

Title: 3 ASanitary Standards for Double-Seat Mixproof Valves, Number 85-
02

Date: Adopted: March 17, 2011

Scope: A1 These standards cover the sanitary aspects of double-seat mixproof
valves used on processing equipment and on equipment and lines
which hold or convey milk, milk products, and other comestibles.

A2 These valves cannot be used to separate raw milk and milk
products from pasteurized milk, milk products, and other
comestibles.

A3 In order to conform to these 3-A Sanitary Standards, double-seat
mixproof valves shall conform to the following in design, material
herein.


87-00 Mechanical Strainers

Title: 3-ASanitary Standards for Mechanical Strainers, Number 87-00


Scope: Al This 3-A Sanitary Standard covers the sanitary aspects of
mechanical strainers used for processing a mixture of liquid milk,
milk products, and other liquid comestibles containing particulates.
The equipment receives the product into a chamber (i.e., housing)

which contains the components used for mechanically separating
the product into two or more streams. The equipment shall start at
the point where the product in-feed piping is connected to the
mechanical strainer and ends at the points where the streams exit
the mechanical strainer.

A2 This standard does not apply to vibratory screeners, belt-type
screeners, centrifugal separators or decanters.

A3 In order to conform to these 3-A Sanitary Standards, mechanical
straining equipment shall comply with the following design,


88-00 Machine Leveling Feet and Supports

Title: 3-ASanitary Standard for Machine Leveling Feet and Supports, Number
88-00

Date: Effective: December 1, 2006

Scope: A1 This standard covers the sanitary aspects of machine leveling feet
and supports used on equipment in a wet processing area of dairy,
food and other comestible products plants, including dry
processing areas cleaned with water. These feet or supports attach
to the equipment and support the equipment from the floor. The
feet or supports begin at the point where the feet or supports attach
to the leg(s) or the body of the equipment and end at the support
point on the floor. This standard does not include supports that
attach to a wall or ceiling.

These feet and supports are not product contact surfaces but have a
hygienic significance because they may become a harborage of soil
and create a source of secondary contamination to the products.

This standard does not cover Casters.


This standard does not cover mounting to a Slab or Island.

A2 In order to conform to this 3-A Sanitary Standard, machine
leveling feet or supports shall conform to the following criteria for
design, material of construction, fabrication techniques and

References: B NORMATIVE REFERENCES

Ref. No. Title
(216) 338-5151.

Automotive Engineers (AWS), 400 Commonwealth Dr.,

or at: http://www.gpoaccess.gov/cfr/index.html .

Table 2-1. American Iron and Steel Society, 410 Commonwealth
Drive, Warrendale, PA 15086, Phone: (412) 776-1535.

5. Steel Founders Society of America, Cast Metal Federation
Building, 455 State Street, Des Plaines, IL 60016, Phone: (708)
299-9160.

95-00 Transportation Tank Vents

Title: 3-ASanitary Standard for Transportation Tank Vents, Number 95-00

Date: Effective: October 22, 2012

Scope: A1 This 3-A Sanitary Standard covers the sanitary aspects of pressure
vents, vacuum vents, surge valves and atmospheric vents used on
transportation tanks. The vent begins at the fitting where the vent
attaches to the tank and ends where air or pressure is expelled to

the atmosphere or taken into the transportation tank from the
atmosphere.

A2 In order to conform to this 3-A Sanitary Standard, pressure vents,
vacuum vents, surge valve and atmospheric vents 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.

33- Metal Tubing

External
References:
1. American Society of Mechanical Engineers (ASME) B46.1 -
10016- 5990, Phone: (212) 705-7722 or at http://www.asme.org



http://www.sae.org

http://www.sae.org



www.sfsa.org


9. EHEDG Guideline 9 Welding Stainless Steel to Meet Hygienic


Rings Part 1: Inside diameters, crosssections, tolerances and size
identification code, The International Organization for
1211, Geneva 20, Switzerland, Phone: +41-22-749-01- 11,
Internet: www.iso.org


13. ASTM Specifications for Wrought Grades A-276, A-582, and A-
666. Available from ASTM, 100 Barr

101-00 Pipeline Product Recovery Equipment

Title: 3 ASanitary Standard for Pipeline Product Recovery Equipment Using
Projectiles, Number 101-00


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

33- Metal Tubing
51- Plug-Type Valves
62- Hose Assemblies
68- Ball-Type Valves

604- Supplying Air Under Pressure for Contact with Product or Product
Contact Surfaces
Systems
External
References:
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 -

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

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


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


www.sfsa.org





www.iso.org

West Conshohocken, PA 19428-2959, Phone: (610) 832-9500 or at
http://www.astm.org


603-07 Sanitary Construction, Installation, Testing and
Operation of High-Temperature Short-Time and Higher-
Heat Shorter-Time Pasteurizer Systems

Title: 3-A Accepted Practices for the Sanitary Construction, Installation,
Testing and Operation of High-Temperature Short-Time and Higher-Heat
Shorter-Time Pasteurizer Systems, Number 603-07


Scope: A1 These 3-A Accepted Practices shall pertain to high-temperature
short-time (HTST) and higher-heat shorter-time (HHST)
pasteurization equipment, appurtenances, and controls used in a
complete pasteurization system for milk and milk products. In
addition to pasteurization, such systems may include flavor
control, vacuum treatment, homogenization, clarification,
separation, or other processes, which if included, are to be installed
so that they do not influence required time, temperature, flow and
pressure relationships.

A2 In order to conform to these 3-A Accepted Practices, HTST or
HHST pasteurizer systems shall conform to the following design,
material, fabrication and installation criteria.1

A3 An Appendix is also included covering Application to Install,
Operation, Determination of Holding time and Pressure
Relationships, Stainless Steel Materials, Product Contact Surface
Finish and a list of 3-A Sanitary Standards and Accepted Practices
referred to in the text. (NOTE: Numbered end notes and references
are assembled in Appendix, Section R, on pages ___ to ___.)

01- Storage Tanks
10- Filters Using Single Service Filter Media
13- Farm Milk Cooling and Holding Tanks
16- Milk and Milk Products Evaporators and Vacuum Pans
Products
25- Non-Coil Type Batch Processors

31- Scraped Surface Heat Exchangers
32- Uninsulated Tanks for Milk and Milk Products
35- Blending Equipment
42- In-Line Strainers for Milk and Milk Products, Number
Fluid Milk Products
Product

607- Spray Drying Systems
608- Instantizing Systems

37- Pressure and Level Sensing Devices

604-05 Suppl ying Air Under Pressure in Contact With
Milk, Milk Products and Product Contact Surfaces

Title: 3-AAccepted Practices for Supplying Air Under Pressure in Contact
With Milk, Milk Products and Product Contact Surfaces, Number 604-05


Scope: A1 These 3-A Accepted Practices shall pertain to the sanitary aspects
of the equipment and filters used in the supplying of air under
pressure for contact with food, food products, other comestibles,
product contact surfaces, and solution contact surfaces. The
system shall begin with the air intake filter and end at point(s) of
application.


A2 In order to conform to these 3-A Accepted Practices, equipment for
the supplying of air as defined herein shall conform to the
following design, material, fabrication and installation criteria and
the applicable special requirements,

18- Multiple-use Rubber and Rubber-Like Materials Used as Product
Contact Surfaces
20- Multiple-use Plastic Materials

Systems

605-04 Permanentl y Installed Product and Solution
Pipelines and Cleaning Systems Used in Milk and Milk
Product Processing Plants

Title: 3-AAccepted Practices for Permanently Installed Product and Solution
Pipelines and Cleaning Systems Used in Milk and Milk Product
Processing Plants, Number 605-04


Scope: Al These 3 A Accepted Practices provide for the installation and
mechanical cleaning and sanitizing of rigid pipelines used for milk
and milk processing systems in which the connections are welded
or are provided with permanently installed CIP fittings. These 3 A
Accepted Practices also specify materials, fabrication and other
requirements for the rigid cleaning solution lines and for the
mechanical cleaning (CIP) unit which circulates the pre rinse,
rinse, cleaning solutions and post rinse liquids used for cleaning
and sanitizing the product pipelines and process equipment. The
mechanical cleaning and sanitizing of individual items of
equipment may be found in the 3 A Sanitary Standards covering
the specific equipment. This practice does not pertain to cleaning
systems used on dairy farms, nor to large diameter piping used for
conveying dry product in milk drying or instantizing systems. (See
Appendix, Section P for an example of a mechanical (CIP)
cleaning unit.)



606-05 Design, Fabrication, and Installation of Milking
and Milk Handling Equipment

Title: 3-AAccepted Practices for the Design, Fabrication, and Installation of
Milking and Milk Handling Equipment, Number 606-05


Scope: A1 These 3-A Accepted Practices shall pertain to equipment used in a
milking system that begins with the equipment applied to the cow
to extract milk and continues to all components in the system
exclusive of the container in which the raw milk is stored or from
which the milk is removed from the dairy farm.

A2 In order to conform to these 3 A Accepted Practices, milking and
milk handling equipment shall conform to the following design,
material, fabrication, and installation criteria.

10- Filters Using Single Service Filter Media
30- Farm Milk Storage Tanks
32- Uninsulated Tanks for Milk and Milk Products



607-05 Spray Drying Systems

Title: 3-AAccepted Practices for Spray Drying Systems, Number 607-05


of equipment for spray drying milk and milk products, and include
all equipment necessary for spray drying milk and milk products
beginning with the discharge of the final pump which delivers the
liquid product to the atomizers and terminates at the point the
finished product leaves the system for conveying either to the
packaging system or to bulk storage. The drying system may
include but shall not be limited to the equipment used for moving
and cleaning air, heating and/or cooling air, fluid product handling,
fluid product heating, fluid product atomizing, gas injection into
the product, atomized product dispersion into the heated air, dry
ingredient introduction into the process air or product, product
reintroduction, agglomeration, dry or partially dry product
retention, additional product drying, separating dry product from
the air, exhausting the air, dry product cooling and/or conveying,
dry product sifting and classifying, dry product particle size
reduction, metallic particle detection and separation, internal
vibration, air locks, fire suppression appurtenances, pressure relief
(explosion venting), product sampling, heat recovery, permanently
installed mechanical cleaning devices, instrument sensor fittings,
observation ports and any other equipment that may become a part
of the spray drying system for handling processing air or product.

A2 Pneumatic and/or mechanical conveyors which are an integral part
of a spray drying system are subject to the same material,
fabrication, design, and processing air requirements of 3-A
Sanitary Standards for Pneumatic Conveyors for Dry Milk and Dry
Milk Products, Number 39- and 3-A Sanitary Standards for
Mechanical Conveyors for Dry Milk and Dry Milk Products,
Number 41- both of which apply to such conveyors that are not an

integral part of a dryer system.

A3 In order to conform to these 3-A Accepted Practices, spray drying
system components shall conform to the following criteria for
design, material, fabrication, air supply and the applicable
documents referenced herein.

26- Sifters for Dry Products
39- Pneumatic Conveyors for Dry Milk and Dry Milk Products
40- Bag Collectors
49- Air Driven Sonic Horns for Dry Products
Product
61- Steam Injection Heaters for Milk and Milk Products

608- Instantizing Systems


43- Wet Collectors for Dry Milk & Dry Milk Products

608-02 Instantizing Systems

Title: 3-AAccepted Practices for Instantizing Systems, Number 608-02

of equipment in instantizing systems and include all equipment
necessary for instantizing dry milk and dry milk products
beginning with the equipment which receives the product to be
instantized and terminating at the point the product is discharged to
either the packaging system or storage. The instantizing systems
include equipment used for moving and cleaning the air, heating
and/or cooling air, conveying the product, moistening the product,
additional drying of the product, removing the instantized product
from the air and cooling the product.

A2 In order to conform to these 3-A Accepted Practices, equipment in
instantizing systems shall comply with the following criteria for
design, material, fabrication, processing air and moistening
medium .

39- Pneumatic Conveyors for Dry Milk and Dry Milk Products
40- Bag Collectors

603- Sanitary Construction, Installation, Testing and Operation of High-
Temperature Short-Time and Higher-Heat Shorter-Time
Pasteurizer Systems


609-03 A Method of Producing Culinary Steam

Title: 3-AAccepted Practices for A Method of Producing Culinary Steam,
Number 609-03


Scope: A1 This 3-A Accepted Practice shall pertain to the sanitary aspects of
the equipment and filters used in the supplying of steam of culinary
quality which comes in direct contact with food products, other
comestibles, or product contact surfaces. The system shall begin
with the steam inlet of the entrainment separator and terminate at
the steam inlet of the process equipment.

A2 In order to conform to this 3 A Accepted Practice, equipment for
supplying steam of culinary quality, as defined herein, shall
conform to the following design, material, fabrication, and
installation criteria.

Contact Surfaces
64- Pressure Reducing and Back Pressure Regulating Valves

Systems

610-02 Sanitary Construction, Installation, and Cleaning
of Cross Flow Membrane Processing Systems

Title: 3-AAccepted Practices for the Sanitary Construction, Installation, and
Cleaning of Cross Flow Membrane Processing Systems, Number 610-02

Date: Adopted J uly 31, 2009

Scope: A1 This 3-A Accepted Practice pertains to the sanitary aspects of

equipment necessary for crossflow membrane processing of milk,
milk products, and their fractions. These processes include
ultrafiltration, diafiltration, microfiltration, nanofiltration and
reverse osmosis. The system begins at the product inlet to the
supply tank which delivers the liquid product to the membrane
equipment and, if diafiltration is used, at the outlet of the nearest
valve which delivers water for diafiltration. The system terminates
at the connections on the membrane equipment where concentrate
and permeate leave the membrane equipment for storage or further
processing. This 3-A Accepted Practice does not cover materials
and fabrication of membrane modules. Membrane modules are
covered under 3-A Sanitary Standard, Number 45-.

A2 In order to conform to this 3-A Accepted Practice, membrane
process systems shall conform to the following criteria for design,
materials of construction, fabrication techniques and installation, as
appropriate, and applicable provisions of current revisions or
editions of all referenced documents cited herein.

References: Doc. No. Title (3-A Sanitary Standards for:)
11- Plate-Type Heat Exchangers
28- Flow Meters
32- Uninsulated Tanks
45- Crossflow Membrane Modules
54- Diaphragm-Type Valves
61- Steam Injection Heaters

Doc. No. Title (3-A Sanitary Standards for:)
62- Hose Assemblies
65- Sight and/or Light Windows and Sight Indicators in Contact With
Product
82- Pulsation Dampening Devices
87- Mechanical Strainers

External
References
Table 2-1. American Iron and Steel Society, 410 Commonwealth
Drive, Warrendale, PA 15086 (412) 776-1535.

2. Steel Casting Handbook, Supplement 2, 1999. Available from 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.

West Conshohocken, PA 19428-2959. Phone: (610) 832-9500.

Conshohocken, PA 19428-2959. Phone: (610) 832-9500.

PA 15086 (412-776-4970).

Switzerland (41-22-734-1240).

7. The Code of Federal Regulations (CFR), Title 21, Part 175
Printing Office, Washington, D.C. 20402, (202) 512-1800 or at

8. FDA GRADE A PASTEURIZED MILK ORDINANCE (PMO).
Available from: Milk Safety Branch, HFS-626, Div. Of
Cooperative Programs, Food and Drug Administration, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, or at
http://www.cfsan.fda.gov/~ear/pmo03toc.html.

9. The Code of Federal Regulations (CFR), Title 21, part 177-179
Indirect Food Additives. For sale by the Superintendent of
20402, (202) 512-1800 or at

10. GAR C-9 Cast Microfinish Comparator. Can be obtained from
GAR Electroforming Division, Box 340, Danbury, CT 06813-

0340, (203) 744-4300.

Coating Practices by H. Herman, Surface Modification by
F.A.Smidt, p. 61. ASM International, Materials Park, OH 44073
(216) 338-5151.

NY 10017-2392, Phone: (212) 705-7722.

Title 40, Parts 141, 142, and 143. For sale by the Superintendent of
20402, Phone: (202) 512-1800 or the EPA web site at:
http://www.epa.gov/OGWD/ .)

LeJ eune Rd., Miami FL, Phone: (800) 443-3953, www.aws.org .

Published by EHEDG, www.ehedg.org .

611-00 Farm Milk Cooling and Storage Systems

Title: 3-AAccepted Practices for Farm Milk Cooling and Storage Systems,
Number 611-00


Scope: A1 These 3-A Accepted Practices shall pertain to equipment used for
farm milk cooling and storage systems. These systems shall begin
at the inlet of the heat exchanger and end with the milk storage
vessel from which the raw milk is removed from the dairy farm.

A2 In order to conform with these 3 A Accepted Practices, farm milk
cooling and storage systems shall comply with the following
design, material, fabrication, cooling and installation criteria.


30- Farm Milk Storage Tanks
01- Storage Tanks


612-00 Plant Environmental Air Quality

Title: 3-AAccepted Practice for Plant Environmental Air Quality, Number
612-00

Date: Effective December 30, 2011

Scope: A1 This 3-A Accepted Practice covers the materials, design, fabrication
and installation of equipment used to produce and handle plant
environmental air in processing, packaging, and storage areas.

A2 This 3-A Accepted Practice also provides guidance for the air
quality to be maintained in food processing, packaging, and storage
areas. These conditions are considered necessary to minimize
contamination of product, product contact surfaces, and open
containers.

A3 This 3-A Accepted Practice applies to HVAC systems installed in
new building construction and does not apply to existing HVAC
systems or minor renovation work.

A4 This 3-A Accepted Practice does not apply to warehouse areas,
receiving areas, coolers and freezers.

External
References:
1. The Code of Federal Regulations (CFR), Title 21, Part 175


2. The Code of Federal Regulations (CFR), Title 21, Part 110.40,
Current Good Manufacturing Practice in Manufacturing,
Packaging, or Holding Human Food, Equipment and Utensils. For
sale by the Superintendent of Documents, U.S. Government

3. ANSI/ASHRAE 52.2-2007, Method of Testing General Ventilation
Air-Cleaning Devices for Removal Efficiency by Particle Size.
Obtainable from American Society of Heating, Refrigeration and
Air Conditioning Engineers, USA web site: www.ashrae.org

4. ISO 14644-1: 1999, Cleanrooms and associated controlled
environments Part 1: Classification of air cleanliness. This
document designates standard classes of air particulate cleanliness
and specifies methods for verifying air cleanliness classifications.
Obtainable from International Standards Organization, Switzerland
web site: www.iso.ch

E-600 Egg Breaking and Separating Machines

Title: E-3-ASanitary Standards for Egg Breaking and Separating Machines,
Number E-0600


Scope: A1 These E-3-A Sanitary Standards cover the sanitary aspect of egg
breaking and separating machines including processing air sources.
They do not cover associated egg washers or conveyors used for the
purpose of delivering eggs to the machine nor to equipment used
beyond the point the product and the egg shell are discharged form
the machine.

A2 In order to conform to these E-3-A Sanitary Standards, egg
breaking and separating machines shall comply with the following
design, material and fabrication criteria.




E-1500 Shell Egg Washers

Title: E-3-ASanitary Standards for Shell Egg Washers, Number E-1500


Scope: Al These E-3-A Sanitary Standards cover the sanitary aspects for
washers of shell eggs. They do not pertain to any device used in
moving the product from a flat to the washer rollers or washer in
feed system such as hand or vacuum lifters, trays, wire fingers or
similar
devices nor do they pertain to fixed transfer devices between components
nor to an oiling device which is used with a washer in a shell egg
cartoning operation.

A2 In order to conform with these E-3-A Sanitary Standards, shell egg
washers shall comply with the following design, material and


P3-A-001 Pharmaceutical General Glossary

Title: General Glossary of Terminology Used In Pharmaceutical 3-A
Standards P3-A 001

Date: Effective April 1, 2008

Scope: A1 This standard shall provide users of Pharmaceutical 3-A (P3-A)
Standards and Accepted Practices with definitions of acronyms and
terms widely used in these documents.

References:

P3-A-002 Materials for Use in Process Equipment and
Systems

Title: Pharmaceutical 3-A Sanitary/Hygienic Standards for Materials for Use
in Process Equipment and Systems P3-A 002
Date: Effective April 1, 2008

Scope: A1 These sanitary/hygienic standards provide minimum materials and
surface property requirements, including minimum fabrication
related materials and surface property requirements for equipment
and components utilized in the pharmaceutical manufacturing
environment whereby those material and surface properties may
directly, indirectly, or incidentally impact the strength, identity,
safety, purity or quality of the active pharmaceutical ingredient,
excipient, or drug product.
A2 Subject materials include metals, non-metals (i.e. polymerics,
plastics, elastomers, ceramics, glass, lubricants, sealants, and
adhesives), and their processed forms intended for single or
multiple-use as direct, indirect, or incidental product contact and/or
cleaning solution (aqueous and/or non-aqueous) contact surfaces in
equipment for production, processing, and handling of the active
pharmaceutical ingredient, excipient, or drug product.
A3 This standard shall apply to new equipment.
A4 See Appendix A for those manufacturing steps for which this
standard intended to apply.

References: Normative References:

21 CFR 210 cGMP Practice in Mfg, Processing, Packaging, or Holding of
Drugs.

21 CFR 211 cGMP for Finished Pharmaceuticals.

21 CFR 175 Indirect Food Additives: Adhesives and Components of
Coatings.

21 CFR 176 Indirect Food Additives: Paper and Paperboard Components.

21 CFR 177 Indirect Food Additives: Polymers.

21 CFR 178 Indirect Food Additives: Adjuvants, Production Aids, and

Sanitizers.

21 CFR 820 Quality System Regulation.

ISO 2743 Vitreous and porcelain enamels - Determination of resistance to
condensing hydrochloric acid vapor.

ISO 13807 Vitreous and porcelain enamels - Determination of crack
formation temperature in the thermal shock testing of enamels for the
chemical industry.

ISO 2723 Vitreous and porcelain enamels for sheet steel - Production of
specimens for testing

ISO 2733 Vitreous and porcelain enamels - Apparatus for testing with acid
and neutral liquids and their vapors.

ISO 2734 Vitreous and porcelain enamels - Apparatus for testing with
alkaline liquids.

ISO 2745 Vitreous and porcelain enamels - Determination of resistance to
hot sodium hydroxide.

ISO 3601-1 Fluid power systems - O-rings - Part 1: Inside diameters,
cross-sections, tolerances and size identification code.

ICH Q7 Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients.

ICH Q1A Stability Testing of New Drug Substances and Products.
United States Pharmacopoeia (current Edition).

ASTM A380 Standard Practice for Cleaning, Descaling, and Passivation
of Stainless Steel Parts, Equipment, and Systems.

ASTM D395 Compression Set Rubber.

ASTM B912 Standard Specification for Passivation of Stainless Steels
Using Electropolishing.

ASTM D2240 Rubber Property Durometer Hardness.

ASTM G31 Laboratory Immersion Corrosion Testing of Metals.

ASME B46.1 Surface Texture.


AWS D18.1 Specification for Welding of Austenitic Stainless Steel Tube
and Pipe Systems in Sanitary (Hygienic) Applications.

Steel Products Manual: Stainless Steels Iron & Steel Society ISBN: 1-
886362-34-3.

NSF White Book - Lubricant Reference.

P3-A 001 General Glossary of Terminology Used In Pharmaceutical 3-
AStandards.
Machinery's Handbook, 27th Edition, Industrial Press Inc., New York, NY

P3-A-003 End Suction Centrifugal Pumps

Title: Pharmaceutical 3-ASanitary/Hygienic Standards for End
Suction Centrifugal Pumps for Active Pharmaceutical Ingredients
P3-A-003:2012

Date: Effective February 1, 2012

Scope: A1 These standards cover the sanitary design requirements of
mechanically sealed end-suction centrifugal pumps, conforming to
ANSI/ASME B73.1, pertinent to active pharmaceutical ingredient
(API) manufacturing in order to maintain product integrity.

A2 In order to conform to these P3-A Standards, mechanically sealed
end-suction centrifugal pumps shall comply with the following
design, materials, and fabrication criteria. (Refer to Appendix D
(Non-normative) for a typical diagram of a pump and a seal.)

References: Normative References:

B1. The Code of Federal Regulations (CFR), Title 21,\ Parts 175

B2 The Code of Federal Regulations (CFR), Title 21, Part 177 Indirect
Food Additives: Polymers. For sale by the Superintendent of
Documents, U.S. Government Printing Office, Washington, DC
20402, Phone: (202) 512-1800 or at

B3 American Society of Mechanical Engineers (ASME) ANSI/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,
http://www.asme.org.

B4 Aerospace Standard (AS) 568, Aerospace Size Standards for O-
PA 15086, Phone: (724)-776-4841, http://standards.sae.org/as568c.

B5 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
1211, Geneva 20, Switzerland, Phone: +41-22-749-01-11.
http://www.iso.org .

B6 American Society of Mechanical Engineers American Society of
Mechanical Engineers (ASME) ANSI/ASME B73.1
Specification for Horizontal End Suction Centrifugal Pumps for
Chemical Process. Available from the American Society of
Mechanical Engineers, Three Park Ave., New York, NY 10016-
5990, Phone: (212) 705-7722, http://www.asme.org.

B7 Pharmaceutical 3-A (P3-A) ANSI/3-A P3-A-001- 2008 Standard
Terminology Relating to Equipment Used in the Manufacture of
Active Pharmaceutical Ingredients. Available from 3-A Sanitary
Standards, Inc. 6888 Elm Street, Suite 2D, McLean, VA 22101,
Phone (703) 790-0295, http://www.3-a.org.

B8 Pharmaceutical 3-A (P3-A) ANSI/3-A P3-A-002-2 2008
Sanitary/Hygienic Standards for Materials for Use in Process
Equipment and Systems. Available from 3-A Sanitary Standards,
Inc. 6888 Elm Street, Suite 2D, McLean, VA 22101, Phone (703)
790-0295, http://www.3-a.org.

B9 American Petroleum Institute (API) ANSI/API 682, Pumps Shaft
Sealing Systems for Centrifugal and Rotary Pumps, Available from
The American Petroleum Institute, 1220 L Street NW,
Washington, D.C. 20005-4070, Phone (202) 682-8000,
http://www.api.org.

B10 ISO 21049:2004: Pumps Shaft Sealing Systems for Centrifugal
and Rotary Pumps, Available from 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.
http://www.iso.org.

B11 Aerospace Standard (AS) 568, published by SAE, 400
Commonwealth Drive, Warrendale, PA 15086, Phone (412-776-
4970).

B12 ISO 3601-1: 1988 (E), published by the International Organization
for Standardization (ISO), 1 Rue de Varembe, Case Postale 58, CH
1 1211, Geneva, Switzerland (41-22-734-1240).


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