Copsright® 3-4 Sanitary Standard, Ine McLean, VA 604-05 3-A° Accepted Practices for Supplying Air Under Pressure in Contact With Milk, Milk Products and Product Contact Surfaces, Number 604-05 Standard Developer 3-A Sanitary Standards, Inc, (3-A SSD) In Collaboration With United States Public Health Service (USPHS)/ United States Food and Drug Administration (USFDA) United States Department of Agriculture ~ Dairy Programs (USDA) European Hygienic Engineering & Design Group (EHEDG) Adopted: November 21, 2004‘Copyright® 3.4 Sanitary Standards, Ine, MeLean, VA 604-05 Disclaimers 3-A Sanitary Standards, Inc. (3-A SSI) and collaborating organizations do not assume or undertake to discharge all or any responsibilities of manufacturers or any other user of 3-A Sanitary Standards or 3-A Accepted Practices. 3-A SSI is not responsible to any individual, organization or entity for the use of 3-A Sanitary Standards and 3-A Accepted Practices. It is the science-based opinions, professional findings of voluntecr experts and consensus that provides the sanitary (hygienic) criteria included in 3-A documents. 3-A Sanitary Standards and 3-A Accepted Practices do not include provisions for mechanical and electrical safety. Mechanical and electrical safety criteria are established by government regulations and other standards development organizations (SDOs). Other SDO standards may be referenced. 3-A Sanitary Standards, Inc., its employees and its volunteer committees shall not incur any obligation or liability for damages, including consequential damages, arising out of or in connection with the development, Use, interpretation of, and reliance upon this 3-A Accepted Practice. Drawings and illustrations contained herein are to assist in understanding the eriteria in this 3-A Accepted Practice, Drawings and illustrations are not intended to show all variations of the equipment or system nor are. they (it) to exelude alternate methods meeting this standard. Drawings and illustrations are non-normative Foreword ‘This 3-A Accepted Practice is to establish minimum sanitary (hygienic) requirements for Supplying Air Under Pressure in Contact With Milk, Milk Products and Product Contact Surfaces. Standard English is the official language of 3-A Sanitary Standards and 3-A Accepted Practices. ‘This 3-A Accepted Practice is for voluntary use by directly and materially affected organizations such as equipment and machinery fabricators, processors, regulatory agencies and by 3-A SSI to assure adequate public health protection exist for the devices and covered products, 3-A Sanitary Standards, Inc. use these documents as the source for sanitary criteria as part of 3-A Symbol authorization, This 3-A Accepted Practice was developed jointly by 3-A SSI. the United States Public Health Service (USPHS)/United States Food and Drug Administration (USFDA), the United States Department of Agriculture — Dairy Programs (USDA), and the European Hysienic Engineering & Design Group (EHEDG). Icis our purpose to encourage inventive genius and provide a forum to discuss new developments. Suggestions for improvement and new technology are welcome any time for consideration by the 3-A Sanitary Standards Committees. Please forward comments to the 3-A SSI, 1451 Dolley Madison Boulevard, Suite 210, McLean, VA 22101-3850, USA. By fax: 703-761-6284. By e-mail to: 3-ainfo@3-a org.Copyrlght® 3-4 Saottary Standards, Inc, MeL Al AS SCOPE, 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, ther comestibles, product contact surfaces, and solution contact surfaces. ‘The system shall begin with the ait intake filter and end at point(s) of application, In order 10 conform to these 3-A Accepted Practices, equipment for the supplying of air as defined herein shall conform tthe following design, material, fabrication and installation criteria and the applicable special requirement Normative References Doc. No. Title (3-A Sanitary Standards for:) 18. 20- 33 58 63 Maltiple-use Rubber and Rubber-Like Materials Used as Product Contact Surfaces Maltiple-use Plastic Materials Polished Metal Tubing Vacuum Breakers and Check Valves Sanitary Fittings Doc. No. Title (3-A Accepted Practices for:) 605- Permanently Installed Product and Solution BI BL Pipelines and Cleaning Systems. DEFINITIONS Air Under Pressure: Shall mean air, the pressure of which has been increased by ‘mechanical means to exceed atmospheric pressure, and which is in contact with products or other comestibles, and solution contact surfaces, the awomatic opening of containers, the “drying of product contact surfaces, “and for other purposes where specifically directed at a product contact surface. Low Pressure Air: Shall mean air that has been pressurized to less than 15 psig (1 bar) by mechanical means utilizing a fan or blower. Compressed Air: Shall mean sir that has been compressed by mechanical means to 15 psig (bar) or above, " Use eurent evsios or etons of normative dovuments cite. B2 Ba B3.1 B32 BS BT Br B72 604-05 Bond: Shall mean the adhesive or cohesive forces holding materials together. This definition excludes press and shrink fis Air Contact Surfaces Processing Air Contact Surfaces: Sball mean all surfaces in contact with filtered air prior «0 coming in contact with the product, commencing at the frame of the final ai filter ‘and ending at the first downstream procluct ‘contact surface. Exhaust Air Contact Surfaces: Shall mean the surfaces of the air ducts, plenum chambers) (if provided), and appurtenances from the final product contact surface through the exhaust system, systems categories Central System: Shall mean those whieh furnish air 1 more than one piece of equipment. (See Figure 1.) Suet systems usually require the use of an ir storage tank, Individual Sysiom: Shall mean those whieh furnish air to one piece of equipment, and Which may be an integral part of a given piece of equipment. (See Figures 2, 3, 4 and 5.) Produet: Shall mean food, food products or ‘other comestibles. Solutions: Shall mean water, homogenous mixtures of cleaning agents, sanitizers, and ‘combinations of these. Surfaces Product Contact Surfaces: Shall mean all surfaces which are exposed to the product and surfuces from which liquids (materials) may rain, drop, diffise or be drawn into the product or into the container, and surfaces that ouch the product contact surfaces of the container. Solution Contact Surfaces: Shall mean the nerior surfaces of the system which are used exclusively for supply and recirculation of cleaning and/or sanitizing solutions, except those used to supply concentrated cleaning and/or sanitizing chemicals to the point ofopera B73 BS Bo BIO BI BI BI 364 Sanitary Standards, Ie MeLcan, VA, Nonproduct Contact Surfaces: Shall mean all other exposed surfaces. Corrosion Resistant: Shall mean the surface hhas_ the property to maintain its original surface characteristics for its intended service period when exposed 1 the conditions encountered in the environment of intended use, including expected contact with product and cleaning, sanitizing treatment, or sterilization compounds or solutions. Easity or Readily Accessible: Shall mean a location which can be safely reached by personnel from a floor, platform (fixed or ‘moveable), or other permanent work area, Easily or Readily Removable: Shall mean Quickly separated from the equipment with the use of simple hand tools. Nontoxic Materials: shall those substances which under the conditions of their use are in compliance with applicable requirements of the Food and Drug Simple Hand Tools: Shall mean implements, normally used by operating and cleaning personnel, such as a screwdriver, wrench, or mallet Sanitizing or Sanitization: Shall mean a process applied to a cleaned surface which is capable of reducing the numbers of the most resistant human pathogens by at least 5 logo reductions (99.999%) to 7 logy reductions (99.99999%) by applying accumulated hot ‘water, hot air, or steam, of by applying an EPA-registered sanitizer according to label dircetions. Sanitizing may be cffccted by ‘mechanical or manual methods. cu 023 23.1.1 C24 Table 604-05 MATERIALS Metals Prodict contact surfaces shall be of stainless steel of the American Iron and Steel Insiute {AIS} 300 Sexes" (excluding 301 and 302) or corresponding Alloy Cast Insitute? (ACI) types or metal which under conditions of intended use is atleast as corosion-esstant as stainless steel of the foregoing types, and is nontoxic and nonsbsorbent, (See Appendix, Section G2) Nonmetals Rubber and rubber-like materials may be used for gaskets, flexible tubing, connectors, and parts having the same functional purposes, Rubber and rubber-like materials when used for the above-specified application(s) shall conform to the applicable provisions of the = A Sanitary Standard, Number 18: Plastic materials may be used for gaskets, and parts having the same functional purposes, Plastic materials when used for the above- specified application(s) shall conform to the applicable provisions of the 3-A Sanitary Standard, Number 20-, except that Plastic materials may be used for flexible tubing or fiuings. Tubing and fiuings as referenced in D7.5.1 shall be constructed of materials meeting Title 21, Part 170-199 of the Code of Federal Regulations or otherwise accepted by the Food and Drug ‘Administration for food contact. Rubber and rubher-like materials and plastic ‘materials having product contact surfaces shall be of such composition as to retain their surface and conformational characteristics when exposed to the conditions encountered in the environment of intended use and in cleaning and sanitization AUS! Stat Procts Manacl, Stainless & Heat Resisting Steck 1._ Available fom the American Ion and Stel Soci 156 Hil Road, Waren, PA 15086 * stot Founders Society of America, Cast Metal Federation Building. 455 State Stet, Des Pines 60016Copyright® 3.4 Sanitary Standards, Ine MeL, VA C3 Pressurized Air Filters and Filter Media 3.1 All filers shall consist of materials which, under the conditions of intended use, are rontoxie, nonmedia releasing, and do not release toxic volatiles or other contaminants, including those which may impart any favor ‘or odor to the product of to the C32 Bonding materials’ in the media, if used, shall be nontoxic, nonvolatile and insoluble under all conditions of use. C33. The adhesive’, if used, for bonding rubber and rubber-like materials and bonding plastic materials shall be nontoxic, D FABRICATION DI Surface Texture D1.1 All product contact surfaces shall have a texture at least as smooth as 32 win, oF 0.8 pm. R, finish on stainless steel sheets and be free ‘of imperfections such as pits, folds and crevices in the final fabricated form, (See Appendix, Section I.) D2 Permanent Joints D21 All permanent joints in metallic product ‘contact surfaces shall be continuously welded. 2.2 All metal tubing shall conform to the applicable provisions for welded sanitary product pipelines found in the 3-A Accepted Practices, Number 605-. D3 Fittings D3... All sanitary fiwings and connections shall ‘conform to the applicable provisions of 3-8 Standard, Number 63- D4 Air Supply Equipment 4.1 Air supply shall be taken from a clean space ‘or from relatively clean outer air and shall pass through filter upstream from the compressing equipment, This filter shall be Tocated and constructed so that it is easily Adhesives shall comply with 21 CFR 17S — Indirect Food ‘Adiines: Adhesives and Components of Coaings. Documents taille for sale by the Superintendent of Documents, US (Government Prating Oc, Washington. DC. 20402. Da2.3 Ds Ds.t D6.1 p62 D63 604-05 accessible for examination, and the filter media are easily removable for cleaning or replacement, The filter shall be protected from weather, drainage, water, product spillage and physical damage Air under pressure shall be oil free. Oil free air may be produced by one of the following ‘methods, or their equivalent: Use of carbon or teflon ring piston, or diaphragm type, or water Tubricated compressors, ‘Use of lubricated compressors with effective provisions for removal of all oil) by condensation and coalescing or absorption. Water lubricated or nonlubricated blowers, Air Under Pressure Air under pressure systems in excess of 15 psig (1 bar) shall he provided with methods of ‘moisture removal. The removal of moisture may be achieved by condensation and coalescing filtration or absorption, or equivalent, to prevent free water in the system Filters Filters shall be constructed and installed so as to assure effective passage of air through the filter media only. Intake air filter efficiency shall be at least 98% SAE J726, June 1987 using AC coarse test dust. The coalescin, fier and any (raps as referenced in D4.2.2 and DS, when used, shall bbe located in the ait pipeline downstream from the compressing equipment, and from the air tank, if one is used (See Figures 1, 3 and 5.). The filter shall be readily accessible for examination, cleaning, and for replacing the filter media. The moisture trap shall be equipped with a petcock or other means for draining accumulated water * ‘Sociaty of Automotive Enginsors, 400 Commonwealth Drive ‘Warendals, PA 1S 0001 (413) 776-4881Copyriah D6 D66.1 6.6.2 bi Dat DI2 DI3 ‘MiL-stD.2 364 Sanitary Standards, Ie MeLcan, VA, When coalescing filters are used, a means shall be provided 10 measure the differential pressure across the filter, The differential pressure device is required 10 indicate the nocd for filter media replacement All coalescing filter housings shall be provided with a means of removing the condensed liguid from the filtration device. This can be accomplished by an automatic oF ‘manual drain installed on the base of the filter housing ‘The final filter media shall be disposable. The fier media shall be located in the airline upstream from, and as elose as possible 10, the point of application (See Figures 1, 2, 3 and 5) except that a final filler shall not be required where the compressing equipment is of a fan or blower type and operating at a pressure of less than 1S psig (1 bar). (See Figure 4.) Electronic air cleaners utilizing electrostatic precipitation principles to collect particulate ‘matter may be used. Final filter efficiency shall be at least 99% as measured by the Dioctylphthalate Fog Method (DOP) test.” When commercially stetile air is required, dhe final fier efficiency shall be at least 9.999% as measured by the DOP test. Disposable filter medi and reused, shall not be cleaned Air Piping ‘The requirements of D7 which follow do not apply to low-pressure air where the compressing equipment is of the fan or blower type. ‘The air piping from the compressing equipment to the filter and moisture trap described under D6.3 shall be readily drainable, ‘A product cheek valve which conforms to the applicable criteria of the 3A Sanitary Miliary Stndied 282° Method 1029.1 Dioeiiphthalets Fog Mothed (DOP). Standardization, Document Order Desk (Deparment of Navy) “100. Robbins Avenue, Bulking Sostion D,Phladlphi, PA I9LLL-SOD4 D731 bia Dis bis. EI Ba 604-05 ‘Standard, Number 58- shall be installed in the air piping downstream from the final filer described in D6.5 tw prevent backflow of product into the ar pipeline, except that ‘A check valve shall not be required if the air iping enters the product zone from a point higher than the product overflow level which is open to atmosphere ot is for dry product applications or for other dry application where Tiquids are not present. Air distribution piping and fittings afler the final filter shall be of corrosion-resistant materials ‘Air distribution piping, fiwings and gaskets between the discharge of the sanitary check valve to the processing equipment shall conform to the 3-A Sanitary Standard, Number 63 and to 3-A Sanitary Standard, ‘Number 33-, except that: ‘Where a check valve is not required (see D7.3 and 7.3.1), plastic oF rubber of rubber-like tubing and suitable compatible fiuings and connections made of plastic or stainless steel ‘may be used between the final filter and the point of application, SPECIAL REQUIREMENTS — OF AGITATION BY AIR Tubing used to introduee air into the produet and/or product zone shall be stainless steel and shall conform to the 3-A Sanitary Standard, Number 33- ‘There shall be no threads on product contact surfaces, When drilled or perforated pipe is used, internal drilling burrs shall be removed and the orifiees shall be chamfered on the outer surface of the pipe. If the volume of the air from the compressing equipment is in excess of that required for satisfactory agitation, suitable means shall be ‘employed to eliminate the excess volume. If the produet to be agitated is in an enclosed tank, adequate means shall be provided to allow the air used for agitation to escape.Copyright® 3-4 Sanitary Stan Fl FB SPECIAL REQUIREMENTS FOR AIR DIRECTED AT —_ CONTAINERS, CLOSURES AND SUPPLEMENTARY FITMENTS When air under pressure is directed at product contact surfuees of containers, closures and supplementary fitments, the air passage from the final filter to the point of application shall be made of a nontoxic, relatively ‘nonabsorbent material, Cheek valves are not requiced, The final filter shall be located as close as practical «0 the point of application, (See Figures 1, 2, 3, and 5.) APPENDIX STAINLESS STEEL MATERIALS, Stainless steel conforming to the applicable composition ranges established by AISI for wrought products, or by ACT for cast products, should be considered to be in conformance to the requirements of Section CI herein. Where welding is involved, the carbon content of the stainless steel should not exceed 0.08%. The first reference cited in CAL sels forth the chemical ranges and limits of acceptable stainless steel of the 300 Series. Cast grades of stainless steel corresponding to types 303, 304, and 316 are designated Ci 16F, CF-8, and CF-8M, respectively. The chemical compositions of these cast grades are covered by ASTM’ specifications ASSVA3SIM, — ATAW/ATA3M— and ATM/ATAIM, 7 ASIM, 101 Bare Harbor Drive, West Conshobosken, PA 19428 2859, G2 TABLEL 604-05 WROUGHT PRODUCTS TYPICALLY USED UNS# | ASTM”) AISV | Properties sae . ce Free: Machining saos00 | asez | aos | Bee Machining Rate | a ssoio0 | S27 | 304 | Austenitic Ss. A276 Tow Carbon S50403 | n.665 | AE | Ausceitie SS. A276 ‘ustenitie SS. 831600 | 's-666 | 316 _| ptus Mor A2T6 Low Carbon s31603 | A:666 | 3161. | Austenitic 8. plus Mo® "Molybdenunr G3 TABLE2 UNS ‘Common Names AaST soson | A743 Cast 3041 A744 ‘AiST yors00 | 4-743 | CF3M Cast 316L A744 ABST yor600 | A-743, crs Cast 304 A744 An351 yozs00 | A743 | CSM Cast 316 A744 Toni80_|_A7a7_| CB7Cu1 |_ Cast 17-3 PL ya |_A747_| CB7Cu-2 | Cast 15-5 PH N26055_| A494 | CYSSnBIM | __ Alloy 88. somo | A703 | croor | WeeMachainsCopyright® 3-4 Sanitary Standards 604-05 Gt ‘TABLE 3 OPTIONAL METAL ALLOYS. Optional metal alloys having the following compositions are examples considered in compliance with Section C herein, (Percentages are maxi TRS TS TNS UNS Tas] UNS] UNS UNS NosS67 samer | _szouss | Nzmiss sisso_| ss900 | r20sve | Re0%00 7ST ast | —ASTaT 7ST aM | AST ATA ad sass Ava ‘A560 B67 Grade Grade | Grade Grade Grade | Grade cn. cvssapat | want Norcu2 socr. ca aMN ‘SONI a oH ta TOF Tar a 70) oro 010 Ma [20 | ro0o00 | soneo0 is Tor a om 700 [ a0 S| tor 3s0350_| soto 7 oa To THO Ts Too P| aan] an] aa Tar Tor oa] aes | oon | a S| 00] 000 | oa Tos coy Tas ws 0080 | 00 G | 200 | tear sors0 | thoran | ismars | isstrs | aotsso | axoa80 | axosan zo | i009 ae Wo | 07H Tas ans THOR Nb Tasos | GSO a T0320] 250520 os a Tis or 730 Fe Baance | Bataee | —Balanoe 300 Ton [Balance | Balance | atmee [100 050 a 30s, Ti Tos w 77 Tt ‘50 | —Batense ar 1s Other T= 00 G5 Metal alloys or metals other than the above may be as corvosion resistant as 300 Series Stainless steel. This may be shown when metal alloys or metals are tested in accordanee with ASTM G31 Laboratory Immersion Corrosion Testing of Metals and have a corrosion rate of less than 10.0 mil per year. The test parameters such as the type of chemical(s), theit concentration(s), and temperature(s) should be representative of cleaning and saniti leachable copper, or other toxic metals should not be used. conditions used in dairy equipment Alloys containing lead,Copyright® 3-A Sanitary Standard * American Society of Mechanical En ‘New Vork, NY 10017-2392, DOP Test (Dioctytphihalate) is a standard rest developed by the military to challenge filter media With the most difficult: particle to capture. Dioctylphthalate is oil that is aerosolized into 0.2 to 03 micron sized panicles. By measuring the particle concentration both upstream and downstream of the filter media, the filter media retention efficiency can be determined. Retention efficiency is gencrally represented by % removal of the DOP aerosol PRODUCT — CONTACT — SURFACE, FINISH Surface finish equivalent to 150 grit or bewer as obtained with silicon carbide, properly ‘applied on stainless steel sheets, is considered in compliance with the requirements of Section D.1 herein, A maximum Ra of 32 tin (0.8 im) when measured according to the recommendations in ANSVASME’ B46. Surjaces Texture, Waviness and Lay is considered to be equivalent to a No.4 finish, ers, MS East 47 Stet J 604-05 FILTER REPLACEMENT ‘The final filter should be provided with method to indicate the need for filler replacement by using established empirical techniques, differential pressure or other integral west methods, DIAGRAMS These diagrams are intended to demonstrate {general principles only, and are not intended to limit individual ingenuity. The design used should conform to the sanitary requirements set forth in these 3A Accepted Practices The following examples are inelucled in this Appendix: DRAWING | HGURE | A DRAWING NAME. No. NO. Centeal Sytem TEA 602.05-01 Tadividual Systems| > A 604. 05-02 Individual Systems | 3 | A. 604.05.05, Individual System | 4 | 3. 608-05-08, ‘Rotating Mandrel [3 | A 603-05405, ‘Assemblc- MeLean, WA, 604-05 FIGURE L 2 CENTRAL SYS1 eM. COMPRESSING EQUIPMENT INTAKE AIR FILTER AFTERCOOLER SANITARY RELIEF VAL! AIR PIPE LINE COALESCING PRESSURE GAUGE (OPTIONAL) DRYER (WHEN USED) SANITARY PIPING DOWNSTREAM FROM THIS POINT K VALVE (WHERE REQUIRED) TER AND MOISTURE TRAP. ‘T OF APPLICATION LVE, MOISTURE LEG OR TRAP AIR STORAGE TANK, AIR GAP TRAP AND DRAIN VALVE, CONDENSATE PIPE.604-05 ‘S) AT —* =< xX 9) MV (40 FIGURE 2: INDIVIDUAL SYSTEM COMPRESSING EQUIPMENT DRAIN VALVE AFTERCOOLER (WHEN USED) PRESSURE. GAUGE (OPTIONAL) DRYER (WHEN USED) AIR PIPE LINE COALESCING FILTER AND MOISTURE TRAP FINAL FILTER PRODUCT CHECK VALVE (WHERE REQUIRED) SANITARY PIPING DOWNSTREAM FROM THIS POINT TO POINT OF APPLICATION INTAKE AIR FILTERJs Inc, McLean, VA 604-05 Copyright® 3-4 Sanitary Stan FIGURE 3: INDIVIDUAL SYSTEM, 1 BLOWER OR FAN (S-15PSI) 2. AIR LINE OR DUC 3. PRESSURE GAUGE (WHEN USED) 4 || TO POINT OF APPLICATION | FINAL FILTER (WHEN USED) 6. INTAKE AIR FILTERCopyright® 3-4 Sanitary Stan Js Inc, McLean, VA 604-05 , FIGURE 4: INDIVIDUAL SYSTEM 1, BLOWER OR FAN (BELOW SPS1) 2. INTAKE AIR FILTER 3. TO POINT OF APPLICATIONPRESSURE AIR PIPELINE COALESCING FILTER AND MOISTURE TRAP DRAIN VALVE DRYER (WHEN USED) FINAL FILTER, INTAKE AIR FILTER FIXED AIR PASSAGE, ROTATING MANDREL ASSEMBLY 604-05