Table of Contents - General...

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Sanitary Design and Fabrication Guideline Design Guideline 01 35 27.01 013527.01 - Sanitary Design and Fabrication Guideline May 2017 1 This document gives general requirements for the fabrication or modification of equipment used for processing of food. The engineer is expected to utilize this document in a collaborative effort with the project team, vender, contractor, and/or fabricator to design or modify the equipment to meet the specific project requirements. This document provides detail information intended to enable compliance with GMI food safety standard 3.4 for equipment. Table of Contents 1. Summary 1 2. Contacts 2 3. Definitions 2 4. Materials of Fabrication 2 5. Fabrication Techniques 5 6. Weldment Techniques and Finishes 10 7. Access 15 8. Fasteners 18 9. Drive Units, Bearings, Seals, Lubricants 21 10. References 24 11. Revision Summaries 25 1. Summary This document gives general guidelines for the fabrication or modification of equipment used for processing of food. The basis for recommendations is economic, food safety, personnel safety, sanitation, and equipment life considerations. When a vendor is hired, the vendor is expected to utilize this document, bid specifications, SOCs, drawings and then act in a collaborative way with the project team to design and fabricate or modify the equipment to meet the specific project requirements. Alternate materials and methods of construction, which do not compromise food safety or personnel safety, may be used with prior approval of General Mills Engineering. The prior General Mills Engineering approval for alternate materials and methods allows each project team to customize the equipment for the project requirements (cost, lifecycle, operating schedule, local sanitation practices, etc.). See Specification: 01 33 00 Submittal Procedures, 01 41 00 Regulatory Requirements, 01 45 00 Quality Control, and 01 23 00 Alternates for details on typical procedures to use. This document is intended to reflect sanitary technical guidelines only. Design specifications and purchase orders should include requirements for items such as spare parts, vendor on-site support, performance specifications, operator training, shop

Transcript of Table of Contents - General...

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Sanitary Design and Fabrication Guideline Design Guideline

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013527.01 - Sanitary Design and Fabrication Guideline – May 2017 1

This document gives general

requirements for the fabrication or

modification of equipment used for

processing of food.

The engineer is expected to utilize this

document in a collaborative effort with the

project team, vender, contractor, and/or

fabricator to design or modify the

equipment to meet the specific project

requirements.

This document provides detail information

intended to enable compliance with GMI

food safety standard 3.4 for equipment.

Table of Contents 1. Summary 1

2. Contacts 2

3. Definitions 2

4. Materials of Fabrication 2

5. Fabrication Techniques 5

6. Weldment Techniques and Finishes 10

7. Access 15

8. Fasteners 18

9. Drive Units, Bearings, Seals, Lubricants 21

10. References 24

11. Revision Summaries 25

1. Summary This document gives general guidelines for the fabrication or modification of equipment used for processing of food. The basis for recommendations is economic, food safety, personnel safety, sanitation, and equipment life considerations. When a vendor is hired, the vendor is expected to utilize this document, bid specifications, SOCs, drawings and then act in a collaborative way with the project team to design and fabricate or modify the equipment to meet the specific project requirements. Alternate materials and methods of construction, which do not compromise food safety or personnel safety, may be used with prior approval of General Mills Engineering. The prior General Mills Engineering approval for alternate materials and methods allows each project team to customize the equipment for the project requirements (cost, lifecycle, operating schedule, local sanitation practices, etc.). See Specification: 01 33 00 Submittal Procedures, 01 41 00 Regulatory Requirements, 01 45 00 Quality Control, and 01 23 00 Alternates for details on typical procedures to use. This document is intended to reflect sanitary technical guidelines only. Design specifications and purchase orders should include requirements for items such as spare parts, vendor on-site support, performance specifications, operator training, shop

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drawings, verification for functionality and sanitation at the vendor site before shipping, etc. This document is intended to meet food safety requirements. Local regulation, equipment acceptance by regulatory agencies etc. may vary by region and shall be met in addition to these fabrication guidelines. This document shall apply to equipment used in the processing of food in General Mills plants. It shall include equipment used for refeed, rework, offal, certa, regrinds, recoup, etc. since these are technically classified as food. This document shall not apply to the installation of the equipment or auxiliary pieces (i.e. wiring trays, platforms, pneumatic lines, air handling ductwork, piping hangers, bulk liquid lines, etc.).

2. Contacts

Equipment Technology and Innovation Group Manager Scott Tolson (763) 293 4930 (Owner)

3. Definitions The word "shall" indicates compliance while the word "should" indicates a recommended practice that should be complied with unless approved by the General Mills Lead Engineer or designated representative in writing as having equivalent performance or otherwise acceptable for business reasons for the intended.

4. Materials of Fabrication

Acceptable Materials for Product Contact and Near Product Contact Areas:

Materials and surface coatings shall meet local regulatory requirements. USDA/FDA approvals or letters from vendors certifying that materials comply with CFR title 21 is generally acceptable. Materials for the European Union are defined by regulation EC 1935/2004 “Materials intended to come in contact with food”. Series 300 Stainless Steel - Should be types 18-8 (fasteners only), 304, 304L, 316 or 316L, depending upon the application. The application should be reviewed with GMI to determine the proper grade of stainless steel. The

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application may dictate the use of a specific grade of stainless steel due to salt content, sanitation chemicals, etc. Type 303 stainless steel should not be used in wet wash-down areas due to poor corrosion characteristics, even though it has lower machining and welding costs than 304 and 316. Series 400 Stainless Steel - Can be used in dry applications for nuts, bolts, metal screens, scrapers, knives, etc., due to the inherent strength and magnetic properties. Series 400 is less corrosion resistant than 300 series stainless. Series 17-4 and 15-5 Precipitation Hardened Stainless Steel - Should be used for specific applications. Tempered Spring Steel - Can be used for blades and scrapers due to elastic properties. Hot Rolled Annealed and Pickled (HRAP) stainless steel - Should be surface finished to meet the product contact requirements for Roughness (For Ra in Microinch refer to section 5). Mild steel - Shall only be used on dry ingredient applications with prior GMI approval. Painted mild steel is also permitted for structural supports where wash down duty is not required. The surface shall be free of blowholes, sand impressions, and be no rougher than ANSI 70 micro-inches Ra. Titanium, Inconel, AL6XN, Hastelloy C - Shall only be used for specific applications with prior GMI approval. Nickel - Shall only be electro-less plating and used with prior GMI approval after evaluation of the application needs. Aluminum - Can be used as virgin material in product contact with prior approval from the Food Safety Action Team based upon the product and application. Sanitation chemicals frequently attack uncoated aluminum, so use should be limited to dry clean areas. Teflon impregnated hardcoat anodized aluminum can also be used in product contact areas as long as the hardcoat process complies with CFR title 21. Anodizing should conform to MIL-A-8625 Type III or be subject to GMI approval. Plastic and rubber compounds (including gaskets) - Shall be FDA-approved for product contact and the environment (temperature, abrasion, moisture, chemicals, etc.). The compounds shall be non-porous, non-absorbent, non-toxic, and non-reactive. Sponge and open-celled foam rubber are not acceptable. Polycarbonate, UHMW-PE (virgin), HDPE, TFE (Teflon), Rulon 641, and Delrin are preferred for plastic compounds. Neoprene, Buna-N (Nitrile), EPDM, polyurethane, silicone rubber, and Viton are preferred for rubber compounds. The color of the compounds shall be approved by the individual project needs.

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Nylon shall be used in limited areas with prior GMI approval such as seals, socks, scrapers, screens, etc. Caulking materials - Shall not be used in food contact areas. Caulking used close to food processing areas shall be FDA-approved and used only with prior GMI approval. Depending upon the application, especially baking, silicone-based caulking can negatively affect the product. The color of the caulking shall be approved by the individual project needs. Flexible joints or hoses used for expansion, flexure or vibration isolation - Shall be of sanitary design and made from FDA approved materials in the food contact areas. Smooth inner surfaces shall be used. Smooth outer surfaces should be used. Cloth - Should only be used in dry areas and be accessible for inspection. The material seams shall be folded, stitched, and trimmed to eliminate loose threads and edges. The usage areas will be specific to the application (bag house socks, breather vents, boots, etc.) Paint - Shall comply with GMI specifications 09 91 00.61 Painting, 09 91 00.71 Surface Prep for painting and be FDA-approved epoxy on or near product contact surfaces. The surface prep, primer coat, and final coat details are identified in the specification document.

Unacceptable Materials for Product Contact or Near Product Contact Areas:

Any material that is toxic, imparts taste, discolors or contributes to the adulteration of a product by being splinter-able, "rusting" or flaking off shall not be used. Brushes should not be used in or close to food product zones, unless specific to the application and with prior GMI approval. Metals that are not acceptable include: Cadmium (including coatings on fasteners, nuts, washers, etc.), Antimony, Alloys exceeding 5% lead. Copper / Bronze / Brass - Should only be used in utility lines or machine elements outside food contact areas. Copper alloys shall not be used in fat or oil contact applications. Chromium - Shall not be used due to the danger of flaking, unless specific to the application and with prior GMI approval. Galvanized iron - Should be limited to utility ductwork and conduit only, but may be used in dry applications with prior GMI approval.

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Unfinished cast steel should not be used without any additional machining or finishing.

Enamelware. Porcelain/Ceramics - Shall not be used, unless specific to the application and with prior GMI approval. Glass shall not be used (including glass for sight glasses, gauge faces, lubrication reservoirs, etc.). Brittle plastic such as Plexiglas should only be used with approval of the sanitation center of excellence. Typically, materials with higher impact resistance such as polycarbonate should be substituted. Fiberglass filters, fiberglass insulation. Wood - Shall not be used, unless specific to the application and with prior GMI approval. Asbestos.

5. Fabrication Techniques

All surfaces shall be designed for ease of cleaning and should be free of open seams,

gaps, pockets, crevices, and inaccessible spaces where product, dust, or liquids may

collect.

All surfaces shall be free from loose and adhering metal fragments including burrs, wire edges, welding wire stubs, weld splatter, flash, chips, grinding dust, and other fragments. All surfaces should be evaluated for compatibility with the application and any subsequent treatment or exposure (i.e. sanitation chemicals, infestation heat-ups, salts in the formula, etc.). All edges and corners shall be deburred and rounded smooth unless specifically indicated to be sharp on engineering drawings. Wherever possible the fabricator should minimize welds and use material bends.

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Fabricated frames and structures shall be smooth and designed to minimize flat horizontal surfaces, avoiding ledges, voids, dead-ends and open joints. See figures 1 and 2. Butt joints and lap seams shall be continuously welded. Wherever possible, butt welds should be used rather than fillet welds, because butt welds are easier to access and thus less expensive to finish. See Section 6: Weldments for more information. All open ends of tubing shall be closed with a continuously welded cap.

Figure 1: Orientation of Framework Members

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Drilling through a single wall of enclosed tubing shall not be permitted. All through-holes in tubing shall be sleeved to isolate the tubing interior from any material. See figure 3. Framing should use round, tubular shapes to minimize flat surfaces. If square tubing is necessary, rotate the tubing 45 degrees to create a slanted surface versus flat surface. See figure 1. Angle may be used in the horizontal with the heel pointing up. See figure 1. Completed stainless components should be passivated to remove and carbon contamination from metal finishing processes and ensure a positive corrosion resistant barrier is present per 05 08 00.61 Passivation. Legs should be designed to minimize dead spots or internal corners. Mounting feet should be constructed to individual plant specifications. Standard details EQ-2 and EQ-3 are examples that can be found in the adept document management system. Related specification: 45 15 10 Installation of Food Manufacturing Equipment, note installation is not in the scope of this document, but the installation technique may affect the design of the equipment. Caster selection shall conform to FDA and/or USDA requirements, depending upon the application.

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Flat ledges in product contact areas where product can accumulate shall be eliminated. Interior reinforcing of bins, vessels, hoppers, etc. should be avoided. If necessary, it shall be designed without any flat ledges and all joints shall be continuously welded. Interior corners of bins, vessels, hoppers, spouting, etc. should be rounded with a ½” radius or greater depending upon the application. Glass bead blasting shall not be used without prior GMI discussions and approval on techniques and materials.

Figure 2: Plate Stiffeners

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Sandblasting shall not be used without prior GMI approval and should not be used on stainless steel surfaces. Sandblasted surfaces are permitted on carbon steel surfaces with prior GMI approval as a means of preparing the surface for painting or coating. Product contact surfaces, excluding welds, which are not subject to any subsequent finishing, shall meet a maximum roughness of 32 micro-inches Ra (typical 2B stainless steel sheet has a 20-30 micro-inch Ra range). A smoother finish may be required depending upon the regulatory or application needs.

Flanges for dry material handling transitions should be of the same size and shape at the connection points to avoid ledges or dead spots. This includes trimming the gasket to the proper size so as not to protrude into or be recessed in the product contact area. Conduit or other ancillary piping should be attached to the equipment with adequate spacing to reduce product accumulation. Refer to the attachment techniques shown in figure 3 for best practices in attachments.

Figure 3: Tubing Attachment methods

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Screw conveyors for dry applications can be constructed with mild steel screw flights and shafts and stainless steel troughs and end plates. Hanger bearings should be avoided. Screw conveyors for wet applications (including wet wash down) shall use all stainless steel construction, clear span design (no hanger bearings), seamless trough construction, and all product contact seams continuously welded. A complete standard of construction for belt conveyors is available in GMI-SOC-EQ-01-CONVEYOR.docx. This SOC can be found in the adept document management system. A manufacturer nameplate shall be mounted on all equipment. Nameplates shall list manufacturer name, equipment model and/or serial number, and date of fabrication. It is recommended that the nameplates also list gross weight and purchase order information. Nameplates shall be constructed of Series 300 stainless steel; laser engraved or stamped with a minimum of 3/16” high characters, and continuously welded in a readily accessible area. Adhesive labels shall not be used in or above any product contact area. Labels specifically related to safety or equipment operation may be used away from product contact areas. Non-informational labels, such as “Made in the USA” shall not be attached to the equipment.

6. Weldment Techniques and Finishes

Equipment vendors should understand the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) regulations for sanitary design and fabrication. Equipment vendors should understand, apply, and comply with related 3-A sanitary standards and finish criteria for all equipment used in wet-processing areas. Equipment used in wet-processing areas which does not meet 3-A design criteria and standards may be used with prior GMI approval. Tungsten inert gas (TIG) welding, also called gas tungsten arc welding (GTAW) shall be used as the welding technique for all product contact surfaces and should be used in non-product contact areas. This technique produces a smoother weld that can eliminate or greatly reduce finishing compared to other welding techniques. Non-TIG welding for product contact surfaces must have prior GMI approval. Non-TIG techniques

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can be more economical on certain applications (i.e. welding thick plate using inert gas wire-feed). The weld joint shall be designed so that the finishing operation does not weaken the integrity of the weld and the weld profile shall conform to acceptable weld profiles as noted in (AWS) American Welding Standards D1.1 Acceptable and Unacceptable Weld Profiles. See “Weld Profiles per AWS D1.1:2000” All welds should be designed so that they are accessible to finishing operations. All welds in product contact areas shall be free from defects and conform to regulatory standards, or application needs. Defects include:

Poor weld profile Excessive undercut Porosity Slag inclusions / splatter Tungsten inclusions Non-conformance to welding symbols and notes Cracks or voids Unacceptable weld joint finish Poor blending of weld bead starts and stops Poor blending and tying the ends of welds around corners

All weld joints shall be prepared and finished according to weld symbols, approved drawings, written notes, or directions. Spot or stitch welds shall not be used above or in product contact areas and should be avoided in non-product contact areas. Prior GMI approval shall be obtained before using non-continuous welds. If non-continuous welds are approved, the crack or crevice between each stitch shall be filled with an appropriately chosen and applied sealant. Fusion welds shall not be ground to remove base material that will lessen the integrity of the weld joint. All welds shall meet the requirements of one of the three operating environment zones listed below. The resulting weld requirements are described in each zone. Dry Production Environments

Equipment in this environment must be dry cleaned. This entails the physical removal of material by manual means. Use of water or detergents is not permitted. Acceptable methods of dry cleaning include the following: brushing, scraping, vacuuming, low moisture sanitizing wipes, and minimal compressed air (by exception ONLY). In some cases, painted equipment may be used with prior approval from GMI.

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All welds must be smooth and continuous. Unless otherwise noted, all welds should be unfinished. Unfinished welds are designed for the removal of heat tint using the proper abrasives. For product contact surfaces, the final weld surface finish should be equivalent to 52 µin Rα or better. Butt welds must be flush and must match the higher of the two adjoining surface finishes. Weld profiles shall conform to AWS D1.1 Workmanship & Acceptable Weld Profile Standards. Welds shall have a uniform and continuous ripple and shall connect to intersecting welds to form a continuous appearance. No undercut or under fill shall exceed 0.030”.

Wet Production Environments

These environments include locations that have either wet product in contact with the surface of the equipment, or use wet wash sanitation procedures to clean and sanitize the equipment at the end of the run. This entails the physical removal of material and subsequent sanitizing with the aid of chemicals (cleaners and sanitizers) and water. Acceptable methods include the following: bucket and brush, foaming, CIP, COP, and automated washers. All welds must be smooth and continuous. Unless otherwise noted, all welds should be finished. Finished welds are designed to accept finishing operations, and are then ground and polished to the specific degree of finish. For product contact surfaces, the final weld surface finish should be equivalent to 42 µin Rα or better. Butt welds must be flush and must match the higher of the two adjoining surface finishes.

Sensitive Production Environments

Sensitive environments are subsets of “Wet Production Environments” but differ in that equipment in these areas experience unusually high risk of microbiological growth. If not cleaned properly, the end result may include consumer food poisoning. These environment zones are often designated for production systems involving allergens, but also apply to meat, dairy, and unbaked snack bars. All welds must be smooth and continuous. Unless otherwise noted, all welds should be finished. Finished welds are designed to accept finishing operations, and are then ground and polished to the specific degree of finish. For product contact surfaces, the final weld surface finish should be equivalent to 32 µin Rα or better. Butt welds must be flush and must match the higher of the two adjoining surface finishes.

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Figure 4: Surface Finish Cross Reference Chart

Grit # USA

Finish #

Common

Name

Ra

Microinch

Ra

Micron

ISO # Description

60 #1 Mill Plate 250 6.3 N9 Rough dull finish that results from hot rolling, annealing and descaling.

125 3.2 N8

80 #2 Satin Sheet 40-65 (D) Dull cold rolled finish, anneal, descale, and final pass through unpolished rolls. (B) Bright cold rolled finish with same process as 2D, except sheet receives another pass through polishing rolls.

62 1.6 N7

60-120 #3 52 Intermediate polished surface obtained by finishing with a 100 grit abrasive. This finish is generally used where a semi-polished surface is required.

120 #4 Commercial 40-60 Polished surface obtained by finishing with a 120 grit abrasive. This is a general purpose bright finish with a visible "grain" that prevents a mirror-like reflection.

150 #4 3A Sanitary 42 max

#4 ANSI #4 32 0.8 N6

180 #4 Sanitary

Finish

30 max

200 #4 Biotech 25 max

240 #6 15-20

16 0.4 N5

320 #7 12 max Reflective surface obtained by buffing a polished surface, but not to the extent of removing the visible "grain" or scratch pattern.

8 0.2 N4

400 #8 Mirror 4-8 Highly reflective surface obtained by extensively buffing a polished surface until all scratch patterns are removed to create a mirror-like finish.

500 #8 Super

Mirror

<4 0.1 N3

2 0.05 N2

1 0.025 N1

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Figure 5: Acceptable Weld Profiles

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7. Access

Doors and Panels

Product contact surfaces other than piping shall be visible for inspection and cleaning purposes. Access doors and panels should not require the use of tools to gain entry, however, all guards and access points must comply with OSHA or local safety requirements. Access doors need to be as large as possible to accommodate cleaning, maintenance, and inspection activity. The specific size and shape of the access door will be dictated by vessel size/integrity, entrance frequency, function being performed, need for rescue procedures, etc. Access doors shall be installed in the clean air plenums of bag houses / product re-claimers / air & product separators. Access lids and drop-bottoms should be installed on dry-application screw conveyors. Access doors into hoppers and bins should have the ledges sloped to avoid product accumulation. See GMI Drawings EQ-19 & EQ-20. These can be found in the adept document management system. Hinges should be the take-apart type for cleaning. Piano hinges shall not be used.

Covers

Covers should minimize the use of tools for removal, but the removal method shall comply with local safety standards. All vendor-supplied covers over open product areas shall be cleanable and protect the product from overhead contamination. Where necessary, the covers shall be designed to relieve excess vapor that might result in condensation or mold accumulations against the underside of the cover. Cover edges shall extend beyond the open product area far enough to prevent contaminants from falling or being blown onto the product.

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Clearance and Draining

All wet wash equipment, including piping, shall be designed for drainage. The preference shall be for self-draining designs, but tool-free access shall be provided if self-draining is not feasible (i.e. clamp at the low spot in piping, drain plug at the low end of an incline screw conveyor). The vendor shall comply with the specific plant preference for piping/tubing fitting types, sizes, and access points. For example, Plant XYZ prefers 1.5” S-line fittings with at least one clamp on each elbow. Equipment should be designed to be installed with a free clearance of at least 6” above the floor. This should also account for any utility piping that may violate the 6” clearance. Large equipment such as dryers, toasters, coolers, belts, tanks, etc. that occupy substantial floor space should be designed to be installed with a clearance of at least 24” above the floor.

Figure 6: Access Door

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Figure 7: Bin Access

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8. Fasteners

Acceptable materials for fasteners:

Series 300 stainless steel Excellent corrosion resistance; use in severe wash-down areas Poor strength properties

Series 400 stainless steel Magnetic properties Less corrosion resistance than Series 300; use in dry areas Better strength properties than Series 300

18-8 stainless steel (Series 300 family) More economical than 304 or 316 Less corrosion resistance than 304 or 316

Electro-less zinc plated carbon steel Magnetic properties Zinc provides good corrosion resistance; use in dry areas Good strength properties

Non-plated plain carbon steel (Grade 8) Magnetic properties Poor corrosion resistance; use in dry areas Excellent strength properties Use in hot and/or high torque applications

Cadmium-plated fasteners shall not be used. Captive fasteners, hardware, alignment pins, etc. should be used wherever possible to avoid product contamination. Where non-captive fasteners are required near product zones, locking mechanisms such as Loctite thread locking compound, deformed thread locknuts, Nordlock washers, or Spiralock nuts shall be used. Sheet metal screws, self-tapping screws, staples, and rivets shall not be used in product zones. Threads or bolts shall not project into a product contact area, unless specific to the design (i.e. gudgeon bolts for shafts and hanger bearings).

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Threaded fasteners used on tubing shall be installed to prevent contaminants from entering the tubing interior. See figure 3. Hex head bolts are preferred to socket head cap screws for sanitary reasons. Food grade Anti-seize compounds such as Never-Seez should be used on bolt threads before torqueing either stainless steel or carbon steel fasteners. This will prevent galling, ensure proper bolt tension, and aid in the disassembly. See Figure 8 for proper torque specifications.

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Figure 8: Fastener Torque Table

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9. Drive Units, Bearings, Seals, Lubricants Motors, Gearboxes, & Guards Motors, gearboxes, and guards shall not be located above or in product contact areas. If located near product contact areas, the motors, gearboxes, and guards should be protected with a drip pan to capture any leaks or spills. Drip pan drains shall not be located over a product zone. Guards shall comply with local safety standards and should have semi-open bottoms. Expanded sheet metal should not be used for semi-open bottoms. Further design and fabrication information is available in 01 35 23.01 Machine Safety Guarding Design Guideline. Drive belts should be utilized wherever possible instead of using drive chains. Motors and gearboxes should be raised off their adjustment bases with a minimum of 2” spacer blocks to provide for cleaning and still meet the required vibration standards. Adjustment bases for motors and gearboxes should be designed for easy cleaning and drainage. Coupling guards should provide a minimum of 1” clearance off the support base, if in compliance with local safety codes. Bearings Bearings should be located away from the product contact areas. If required near the product contact area, the materials shall be FDA-approved. Hanger bearings in product contact areas shall only be used with prior GMI approval. If approved, bearing housing materials shall be constructed from Series 300 stainless steel and the bearing insert material shall be FDA-approved and application dependent. Seals Shaft seals in product contact areas shall be nonabsorbent, nontoxic, non-exuding, and odorless. Mechanical seals are preferred. Lubricants The General Mills Toxicology Department has established a chemical approval process that is to be used in all General Mills locations. The process divides lubricants and chemicals into three classes, the classes are Green, Yellow, and Red. It is the expectation within the GMI Lubrication Management System that Green Class lubricants are used in all applications related to the processing, packaging, and transport of ingredients and finished product unless it is not feasible. All lubricants and

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chemicals must also be evaluated for any allergen content. Contact the corporate Toxicologist for additional information about chemical classifications. The following is a summarization of the full toxicology standard.

Green Classified Lubricants & Chemicals (Food Grade) When incidental food contact is probable by a lubricant because of equipment design or by lubricant location, then a "food grade" lubricant must be used. Lubricants in this application must be formulated in compliance with Federal regulations, specifically 21 CFR 178.3570, "Lubricants with Incidental Food Contact". They also may be components, which are "Generally Recognized as Safe" (GRAS).

Yellow Classified Lubricants & Chemicals (Non-Toxic Non-Food Grade) Non-Toxic Non-Food Grade Lubricants included in this section must have an oral LD50 of 5g/kg or greater and cannot contain levels of components known to produce chronic toxic effects. These lubricants are considered contaminants and from the Food and Drug standpoint and carry a zero tolerance in food products. A food product containing these lubricants is considered adulterated.

Red Classified Lubricants & Chemicals (Toxic Non-Food Grade) These lubricants have an oral LD50 of 5g/Kg or less, and/or they contain substances such as heavy metals, chlorinated solvents, petroleum distillate and other compounds in forms or at levels which may produce acute or chronic toxic effects. Lubricants containing such substances must, therefore, be classified as "toxic." Since ingestion of foods accidentally contaminated with "toxic" lubricants could potentially result in poisoning, "TOXIC" LUBRICANTS MUST NOT BE USED IN FOOD PROCESSING, PACKAGING, OR HANDLING EQUIPMENT. Allergen Status As part of the chemical safety review and approval process, we must evaluate the allergen content to ensure compliance with internal food safety policies. As part of this review and approval, the chemical or lubricant should NOT contain any of the following ingredients:

• Milk or milk derived products

• Eggs or egg products

• Soybeans or soybean products,

• Fish or fish products,

• Crustaceans (such as crab, crayfish, lobster, and shrimp),

• Peanuts or peanut products,

• Tree nuts or tree nut products

• Wheat or cereals containing gluten,

• Celery or celery products,

• Mustard or mustard products,

• Sesame or sesame products,

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• Sulphur dioxide and sulphites,

• Mollusks and mollusk products

Large gearboxes (greater than 5 gal.) shall be drained and tagged as being empty prior to shipment. The tag should also indicate the appropriate lubrication for refill. It is the responsibility of the project team to verify that the equipment is properly lubricated prior to operation.

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10. References The following source documents were used as references above. Use this list to

determine which sources to check for updates in the annual review process.

• Engineering for Food Safety and Sanitation, 2nd Ed., Imholte-Tauscher, 1999.

• AWS A3.0: 2001: Standard Welding Terms and Definitions

• AWS D1.1: Workmanship & Acceptable Weld Profile Standards

• “Taking the Mystery Out of Specifying Sanitary Stainless Steel Finishes”,

Reschenberg, Armin: Sanitary Bulk Handling, January 2002

• BISSC (Baking Industry Sanitation Standards Cmte) Standards, Chicago, IL.

• 3-A Sanitary Standards, McLean, VA.

• 01 35 23.01 Machine Safety Guarding Design Guideline

• 09 91 00.61 Painting,

• 09 91 00.71 Surface Prep for painting

• 05 08 00.61 Passivation

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11. Revision Summaries Enter information in these tables to track revisions to the master document.

NOTE: In the Entry column, enter your information between the dashes. The entries

automatically update matching document properties.

Document Property Entry

Master Owner Scott Tolson Increment revision

numbers by one. Master Revision Number H

Master Revision Date 5/12/2017

Revision Number

Revision Date

Revision Owner

Revision Summary (Brief description of major changes)

E 11/1/13 Scott Tolson Updated section VIII. D. 3 and updated

entire document to refer to backup

documentation in Adept document

management system.

F 3/1/2014 Scott Tolson Updated Section V to describe welding

based on production zones rather than weld

type. Added surface cross-reference chart.

G 8/1/2014 Scott Tolson Updated Section III item 10 on use of

Aluminum and 15 on painting of steel.

H 5/12/2017 Scott Tolson Updated to new Guideline format, added

information on anti-seize and bolt torque

tables.