1、 *0!.*0%+*(0* . %)!.%*0%+*(0* . %! 0* . NSF/ANSI $2 “%“ materials classified as hazardous substances (such as carcinogens, mutagens and teratogens); asbestos and asbestos containing materials; wood; enamelware; porcelain; leather; uncoated aluminum and aluminum alloys; and uncoated anodized aluminum
2、 and aluminum alloys.4.2 Product contact surfacesIn addition to the general requirements (see 4.1), materials used for product contact surfaces shall: be corrosion resistant to both product and cleaning/sanitization materials; be non-toxic; not contaminate or otherwise have any adverse effect on the
3、 product; be non-absorbent (except where technically or functionally unavoidable); and be temperature resistant to processing and heat treatments where necessary (e.g., freezing, heat-sterilization). 2015 NSF NSF/ANSI/3-A SSI 14159-1 201454.2.1 Metals4.2.1.1 Product contact surfaces shall be: AISI 3
4、00 series stainless steel; or of stainless steel of a type appropriate for the application; or when necessary, stainless steel that has been hardened by heat treatment or precipitation hardening, including martensitic stainless steel; or other alloys that can be shown to be as corrosion resistant as
5、 austenitic stainless steel and are non-absorbent and non-toxic (see chart in Annex D); or other metals and metal alloys (including solder) suitable for the conditions of intended use; or carbon steel when used for cutting surfaces; or black iron pipe when used for the processing, storage, and trans
6、portation of fully rendered vegetable and animal fats.4.2.1.2 Copper and copper alloys, bronze, brass, and zinc galvanizing shall not be used for product contact surfaces. These materials may be used in supply air and supply water lines or for gears and bushings used in non-product contact surfaces.
7、 Brass is acceptable for potable water systems.4.2.1.3 Surface coatings and platings may be used if the base material is non-toxic. Coatings shall meet the requirements of 4.2.2.4.2.2 Non-metalsProduct contact surfaces shall be manufactured from or composed of substances that: may not reasonably be
8、expected to result, directly or indirectly, in their becoming a component of food or otherwise affecting the characteristics of food, including the imparting of a color, taste, or odor to food; or are generally recognized as safe or have received prior sanction for their intended use; or are regulat
9、ed as indirect food additives under the provisions of 21 CFR, parts 174-189; or are exempt from regulation as food additives under the provisions of the 21 CFR, part 170.39; or can be demonstrated to be safe for the intended use, subject to the Food, Drug, and Cosmetic Act, Section 409(h)(1) 21 U.S.
10、C. 348(h)(1), Premarket Notification.4.2.2.1 Elastomers and polymers 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 sanitizati
11、on or sterilization.4.2.2.2 Adhesives and the bonds created by their use shall be compatible with the surfaces, products, and cleaning/sanitizing materials in which they are in contact. All bonds shall be continuous and mechanically sound so that the adhesives do not separate from the base materials
12、 to which they are bonded.4.2.2.3 Where materials having certain inherent functional purposes are required for specific application, product contact surfaces may be made of these materials (e.g., carbon, sapphire, quartz, fluorspar, spinel, 2015 NSF NSF/ANSI/3-A SSI 14159-1 20146ceramic materials).4
13、.2.2.4 Product contact surfaces may be modified by surface treatment or coating(s).4.2.2.5 Gaskets, O-rings, etc., shall be non-toxic, non-porous, non-absorbent, and unaffected by food products. 4.2.2.6 Absorbent fabric may only be used for single use applications, e.g., single service filters.4.3 N
14、on-product contact surfacesIn addition to the general requirements (see 4.1), materials used for non-product contact surfaces under the conditions of intended use, shall: be of corrosion resistant material or material that is treated (e.g., coating, painting) so as to be corrosion resistant to both
15、product and cleaning/sanitizing materials. When coated, the coating shall adhere; be non-absorbent (except where allowed under 4.2.2.6); and not contaminate or otherwise have any adverse effect on the product.Parts removable for cleaning having both product contact and non-product contact surfaces s
16、hall be designed to ensure that hygiene risks are eliminated in accordance with the requirements for product contact surfaces.5 Design and construction5.1 Product contact surfaces5.1.1 Surface textureSurfaces shall be free of imperfections such as pits, folds, cracks, and crevices. Surface textures
17、shall have a maximum Ra of 32 in (0.81 m). When necessary, due to functional needs, the following may be used: Glass-beaded or shot-peened surfaces shall have a maximum Ra of 125 in (3.2 m). Coatings shall have a maximum Ra of 200 in (5.0 m). Machined plastics shall have a maximum Ra of 125 in (3.2
18、m). Black iron pipe used for the processing and transport of fully rendered fats is exempt from surface texture requirements.NOTE The 2B mill finish on stainless steel sheet is also considered as smooth or smoother than a No. 4 finish. No further finishing is required if the finish is free of defect
19、s, such as pits, scratches, chips, or flakes in the final fabricated form. 5.1.2 Cleaning and inspectionSurfaces shall be cleanable. For equipment intended to be disassembled, the design shall ensure that product contact surfaces be easily accessible for cleaning and inspection, and the demountable
20、parts shall be easily removable. Alternatively, equipment designed to be cleaned in place shall be designed so that product contact surfaces and all non-removed appurtenances thereto can be mechanically cleaned and are easily 2015 NSF NSF/ANSI/3-A SSI 14159-1 20147accessible and easily removable for
21、 inspection.5.1.3 Sanitization and sterilizationWhere appropriate, equipment shall be designed such that all product contact surfaces can attain the required sanitization or sterilization conditions.5.1.4 Microbial ingressWhere appropriate (e.g., aseptic process), equipment shall be designed to prev
22、ent microorganisms migrating from the external environment onto product contact surfaces, either directly or via soils.5.1.5 DrainingSurfaces of equipment intended to drain shall be self draining or be drainable (see figures B.1 and B.2).5.1.6 Dead spacesThere shall be no dead spaces (see figure B.3
23、).5.1.7 Joints5.1.7.1 Permanent metal-to-metal joints shall be continuously welded. Jointed surfaces shall be flush (see figure B.4).5.1.7.2 Dismountable joints shall be flush and sealed at the product contact surface (see figure B.5).5.1.7.3 Only in cases where welding or bonding is impractical, si
24、lver soldering, press fitting or shrink fitting may be employed where necessary for essential functional reasons.5.1.7.4 Silver-bearing solder may be used for flushing joints and producing fillets for minimum radii requirements. In cases where welding is impractical, silver-bearing solder may be use
25、d for essential functions, such as mounting of cutting blades and cutting blade mounting pins and bushings.5.1.7.5 Welding, press fitting, shrink fitting or soldering shall produce product contact surfaces with a smooth finish free of imperfections such as pits, folds, inclusions, cracks and crevice
26、s.5.1.8 CoatingsCoatings shall be free from surface delamination, pitting, flaking, spalling, blistering, and distortion. Surface coatings and platings must remain intact. Surface coatings shall not crack or peel. Coatings and platings shall not be used on product contact surfaces that are not inspe
27、ctable. Paint shall not be used on product contact surfaces or on parts having both product contact and non-product contact surfaces. 5.1.9 Internal angles, corners and groovesInternal corners and angles of less than 135 in product contact areas shall have smooth and continuous UDGLXVLQ LQPP RUJUHDW
28、HU/HVVHUUD GLLPDEHXVHGIRUQHFHVVDUIXQFWLRQDOUHDVRQVRU WRfacilitate drainage provided these areas can be readily cleaned. The radii shall not be less than 1/32 in (0.031 in, 0.79 mm) except that the radius intersection of press-fits, shrink-fits, and flat sealing surfaces may be zero.Internal three-pl
29、ane intersections shall have a radius of in (0.25 in, 6.4 mm) or greater.Where used, grooves shall be wider than their depth. 2015 NSF NSF/ANSI/3-A SSI 14159-1 201485.1.10 Seals, gaskets, O-rings, joint rings5.1.10.1 Seals, gaskets, O-rings and joint rings shall be designed to minimize product conta
30、ct and be cleanable.5.1.10.2 Excessive compression can cause damage to rubber components and can cause the elastomer to extrude into the product zone adversely affecting cleanability. Where an elastomer is used as a seal between solid surfaces, the compression of the elastomer shall be controlled (s
31、ee figure B.7).5.1.11 FastenersFasteners (e.g., screws, bolts, rivets) shall be avoided. Where technically unavoidable, fasteners shall be cleanable (see figure B.8). There shall be no exposed screw threads or recesses.Threads which may become product contact surfaces during dismantling operations s
32、hould be designed to be cleanable, such as ACME 60 Stub, or equal, with not more than 14 threads per inch and a with a major diameter of not less than 5/16 in (0.31 in, 7.9 mm).5.1.12 Process flow disruption caused by intrusionsIntrusions (e.g., springs, openings, perforations) shall be avoided exce
33、pt where functionally necessary.Where necessary, such process flow disruptions and intrusions shall be cleanable in place or easily accessible for cleaning, sanitizing, and inspection.5.1.13 Shafts and bearings5.1.13.1 Where shaft seals are required, they shall be hygienic in design (i.e., packless)
34、 and shall be easily accessible for cleaning sanitizing, and inspection.5.1.13.2 Where a shaft passes through a product contact surface, the portion of the opening surrounding the shaft shall be protected to prevent the entrance of contaminants (see figure B.9).5.1.13.3 Lubricated bearings, includin
35、g the permanent sealed type, shall be located outside the product contact surface with adequate clearance open for inspection between the bearing and any product contact surface (see figure B.9).5.1.13.4 Bearings or bushings having a product contact surface shall be avoided. When technically necessa
36、ry, these bearings or bushings shall be of a non-lubricated or product-lubricated type (see figure B.10) and be cleanable. When a bottom support bearing or bushing is used, it shall not interfere with drainage of the equipment.5.1.13.5 When provided, a shaft driving mechanism shall be securely mount
37、ed in a position that ensures a physical separation from product contact surfaces for cleaning and inspection.5.1.14 Sensor and sensor connectionsAll sensors and sensor connections having product contact surfaces shall be installed to avoid crevices and dead spaces and be drainable (see figure B.3).
38、5.1.15 Other connectionsAll pipelines and other appendages entering the equipment shall be hygienically sealed and designed to prevent the ingress of soil. 2015 NSF NSF/ANSI/3-A SSI 14159-1 201495.1.16 Openings and covers5.1.16.1 Panels, covers, and doors shall be so designed that they avoid any adv
39、erse influence (e.g., entry and/or accumulation of soil) and shall be cleanable (see figure B.11).5.1.16.2 If any exterior flange is incorporated in the opening, it shall slope and drain away from the opening.5.1.16.3 Covers shall be sloped to an outside edge(s).5.2 Non-product contact surfaces5.2.1
40、 GeneralAll equipment, supports, and framework shall be designed in such a manner as to prevent the retention of moisture and the ingress and harborage of pests and soils. All equipment, supports, and framework shall be designed in such a manner as to facilitate cleaning, inspection, servicing and m
41、aintenance. Equipment shall be designed such that non-product surfaces can attain the required sanitization or sterilization conditions. Permanent metal-to-metal joints shall be continuously welded wherever possible; when not possible, permanent metal-to-metal joints shall be completely sealed. Perm
42、anent metal-to-non-metal or non-metal-to-non-metal joints shall be continuously bonded.Equipment to be mounted without supports shall be designed to allow the installer of the equipment to mount flush and seal the equipment to the supporting surface (see figure B.13).There shall be no dead spaces.Th
43、e possibility of adverse galvanic reactions between dissimilar materials shall be taken into consideration (see figure B.12)5.2.2 Cleaning and inspection Surfaces shall be cleanable. For equipment intended to be disassembled, the design shall ensure that relevant areas are easily accessible for clea
44、ning, and inspection and the demountable parts shall be easily removable. Alternatively, equipment may be designed to be cleaned in place. Cleaned in place equipment shall be designed to allow access for inspection after cleaning.5.2.3 InsulationThe insulation material shall be properly mounted and
45、completely sealed to prevent the ingress of contaminants (e.g., moisture, pests).5.2.4 Supports5.2.4.1 Supports (e.g., legs) are to be smooth with rounded ends or with flat, load bearing feet suitable for sealing to the floor and have no exposed threads. Sufficient clearance around and under the equ
46、ipment for cleaning and inspection shall be provided (see figure B.13).5.2.4.2 Where casters are used, they shall be of sufficient size to provide sufficient clearance between the lowest part of the base and the floor for easy cleaning and inspection. Casters shall be easily cleanable, durable, and
47、of a size that permits easy movement of the equipment.5.2.4.3 Where the equipment is to be floor or wall mounted, supports shall be designed for sealing to the mounting space. 2015 NSF NSF/ANSI/3-A SSI 14159-1 2014105.2.5 Product contact with equipment fluidsEquipment shall be designed, fabricated,
48、and installed to prevent the ingress of unwanted fluids (e.g., lubricating and hydraulic fluids, signal transfer liquids) into the product. 5.3 Requirements for specific equipment5.3.1 Pneumatic equipmentExhaust air shall be piped below and away from product surface areas. Air directly contacting product or product contact surfaces shall meet the requirements of 3-A Accepted Practice, No. 604-05.5.3.2 Equipment that uses a single pass water flush Equipment that uses a single pass water flush shall have a drain that directs water to a non-product contact