Niro A/S

Standard 6.01

Niro A/S Gladsaxevej 305 PO Box 45 DK-2860 Soeborg Denmark Tel +45 3954 5454 Fax +45 3954 5800 Reg No 12682

Sanitary Code For Component Design

Contents

Page

Preface................................................................................2 Part A - General requirements.......................................3-8 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. Design in general.................................................3 Product contact surfaces......................................3 Non-product contact surfaces .............................3 Cleaning in general .............................................4 Wet cleaning........................................................4 Pipes, fittings and valves .....................................4 Openings and covers ...........................................4 Permanent joints..................................................5 Non-permanent joints .........................................5 Retaining pins ......................................................5 Internal angles .....................................................6 Gaskets and gasket grooves ................................6 Coil springs...........................................................6 Rotating shafts.....................................................6 Flexible connections ............................................6 Conveyor belts .....................................................7 Supports and reinforcements..............................7 Components for processing air ...........................7 Air filtration equipment ......................................8

Part B - Accepted construction materials.........................9 Part C - Definitions..........................................................10

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Niro A/S

Standard 6.01

Preface
Scope
Niro sanitary code stated in this standard is applicable only in case of contractual requirements. Niro vendors / sub-vendors shall also comply to this standard when specified by Niro. This standard relates to the design and construction of the components only. In case 3-A certification already exists for a particular component, it must be used. In general, this standard is based on the sanitary guidelines and principles defined in applicable 3-A sanitary standards and practices, IDF Bulletins and CEN standards. However, some of the requirements stated in this standard may differ from these publications.

IDF
IDF (International Dairy Federation) is an independent, world-wide association. Among the activities of IDF is the publication of the Bulletin of IDF. Some of these Bulletins contain recommendations for the hygienic design of dairy equipment (e.g. Bulletin No. 218, 267 and 310). The Bulletins may be ordered through: International Dairy Federation 41 Square Vergote 1030 Brussels, Belgium Telephone: +322 733 9888 Telefax: +322 733 0413 E-mail: info@fil-idf.org Homepage: www.fil-idf.org

3-A
The objectives of the 3-A Standard, which originates from the US since 1950s, is to formulate the sanitary standards and accepted practices for equipment and systems. These standards are being developed jointly by the local, state and federal sanitarians, equipment manufacturers, and equipment users. 3-A Sanitary Standards and Practices may e.g. be ordered through: International Association of Food Industry Suppliers (IAFIS) 1451 Dolley Madison Boulevard McLean, Virginia USA 22101-3850 Telephone: +1 703 761 2600 Telefax: +1 703 761 4334 E-mail: 3A@iafis.org Homepage: www.iafis.org

CEN
CEN (European Committee for Standardisation) is responsible for European Standards in all fields except electrotechnical and telecommunications. All the national standards organizations of the EU and EFTA countries are members of CEN. Common hygiene requirements for machinery used for food processing is specified in the standard EN 1672-2. European Standards, transposed to national standards, may be purchased from the CEN National Members. For more information contact: CEN Central Secretariat 36, rue de Strassart B-1050 Brussels, Belgium Telephone: +322 550 0811 Telefax: +322 550 0819 E-mail: infodesk@cenclcbel.be Homepage: www.cenorm.be

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Niro A/S

Standard 6.01

Part A - General requirements

1. Design in general
Components and equipment should be designed, constructed and installed in order to: 1.1 Avoid cross-contamination between the heat-treated and non-heat-treated product. 1.2 Avoid hygienic hazards, such as dead-end pipes, and to minimize dust build-up. 1.3 Permit free drainage, when at all possible. 1.4 Permit easy, thorough cleaning, disinfection and visual inspection of product contact surfaces where practically possible. 1.5 Permit easy dismantling when necessary for manual cleaning, disinfection and/or visual inspection of product contact surfaces. 1.6 Permit that the necessary adjustments during operation can be made without the operator to approach the product zone. 1.7 Avoid hygienic hazards for utensils used for operating the equipment and permit easy, thorough cleaning, disinfection and visual inspection of such equipment. 1.8 Avoid damage of the stainless steel sheets in product contact surfaces 1.9 Avoid the use of other materials than stainless steel for supporting structure in connection with the product contact surfaces unless it is stated that there will be no problem with thermal expansion. 1.10 Avoid hollow construction details, if practically possible.

2. Product contact surfaces

Accepted materials for product contact surfaces are specified in Part B. The surfaces shall comply to the following requirements: 2.1 Stainless steel sheets Stainless steel sheets shall in general be cold-rolled of finish 2B or 2D according to EN 10088-2. If finish 2B or 2D is not available, warm-rolled sheets of finish 1D may be used for t > 4 mm, provided the total surface is ground. Roughness after grinding: Ra 1.0 m, Rz. 10.0 m. Surface finish shall comply to Niro Standard 2.0-, treatment T2. Damage to the surfaces shall be avoided during handling, manufacturing, transport and installation. The requirements in Niro Standard 1.6- shall be observed. 2.2 Machined surfaces Machined surfaces shall have a finish with roughness of Ra 1.6 m. 2.3 Cast surfaces Cast surfaces shall have a finish with roughness of Ra 1.0 m, Rz. 10.0 m. 2.4 Pipes See item 6.

3. Non-product contact surfaces

Non-product contact surfaces in exposed areas shall: 3.1 Have a smooth finish, free from pockets and crevices. 3.2 Be of a corrosion-resistant material or a material that is rendered corrosion-resistant. 3.3 Be non-absorbent, durable and cleanable under conditions of use.

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Niro A/S 4. Cleaning in general

In general the product contact surfaces shall be easily accessible for thorough cleaning, either when in an assembled position or when removed (see also item 9). Parts to be removed for cleaning shall be easily removable and dismantled, except: 4.1 High-pressure liquid product lines and such parts as fan wheels, conveying mechanism and similar parts need only be readily accessible for cleaning. 4.2 Rotary atomizers and air disperser cones need only be removable for cleaning.

Standard 6.01 7. Openings and covers

Any opening into the interior of equipment shall be protected against the entrance of contaminants by way of draining or dripping into the equipment. The following requirements shall be observed: 7.1 Open vessels or containers shall be provided with covers to preclude any drippage into the interior. Cover openings shall have an upward flange of at least 10 mm. Covers shall have a downward lip of at least 10 mm. 7.2 Equipment for dry product handling and storage shall be equipped with dusttight covers. 7.3 Manway openings shall not be less than 400 500 mm (oval) or 460 mm in diameter (round). They shall be located at the end, side or top of the vessel. Covers for manways located in the top shall be of the outside swing type. Covers located in the end or side wall shall be either of the inside or outside swing type. If the cover swings inside, it shall also swing outside, away from the opening. Threads or ball joints used to attach the cover shall not be located within the lining. 7.4 Hinges shall be demountable and easily cleanable. They shall not be of the piano type. 7.5 Openings for inspection shall be located to permit inspection of the total contact surface. The use of a mirror is acceptable. 7.6 Sight or light openings shall be designed so that the inner surfaces drain inwards, be relatively flush with the inner surface, be at least 90 mm in diameter and the outer flare of the opening shall be pitched to avoid liquid accumulation. 7.7 Sample cocks or valves shall have a relatively flush interior sealing surface and be easy to dismantle for cleaning. 7.8 All air vents for product vessels shall be designed to protect against entrance of foreign matters and shall be located within the processing room.

5. Wet cleaning
Product contact surfaces intended for regular wet cleaning shall be self-draining or self-purging except for normal adhesive liquid film. Where self-draining is not feasible, other drying methods, including air drying, may be used.

6. Pipes, fittings and valves

The following applies to pipes, fittings and valves for product and CIP: 6.1 Pipes, bends, tees, etc. shall be seamless or welded stainless steel pipe of high quality in accordance with ISO 2037. 6.2 Pipe connections shall if possible be of type clamp coupling according to ISO 2852. Other types of connections may be used if they comply with "3-A Sanitary Standard for sanitary fittings for milk and milk products No. 63". 6.3 Valves shall be supplied according to the requirements in this code. Note: The specified requirements for internal surfaces of pipes do not conform with the requirements of 3-A. If this is required, it shall be specified separately, and the pipes will then be supplied with a ground internal surface.

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Niro A/S 8. Permanent joints

Permanent joints for product contact surfaces (not intended for daily removal) shall be designed so that they are fully cleanable when assembled. The following methods are acceptable: 8.1 Welded joints Welded joints shall be continuously welded, shall be smooth and fabricated in a way so that the product contact surface is self-draining or self-purging (figure 1)
Figure 1

Standard 6.01
All welds shall comply with Niro Standard 1.4- and be surface treated according to Niro Standard 2.0-, treatment"T2". 8.2 Flanged joints Flanged joints shall be properly and accurately matched in order to obtain a sharp angle, which will create a tight pinch seal with the gasket at the interior sealing edges of the flanges. Interior surface shall be essentially flushed with no crevices or flaps of unsupported gasket. 8.3 Soldered or brazed joints In case it is technically possible, the silver soldered or brazed connections with lead-free materials are acceptable. Joints shall be carefully cleaned and polished. 8.4 Rolled or press fit joints May be considered for safety or functional reasons.

Product contact surface R Horizontal Acceptable R Horizontal Not acceptable

Radii R, for fillets of welds in product contact surfaces (figure 2): t t 5 mm: 5 mm: R R t R R 3.2 mm 6.3 mm

9. Non-permanent joints
9.1 Non-permanent joints for product contact surfaces which are intended for daily dismantling and manual cleaning shall be constructed for easy dismantling without the use of special tools. Exceptions may be made when conventional bolting is necessary to handle high pressures. (see also item 6.2). 9.2 Wing or "T" nut or Niro hand-wheel M12 style fasteners are preferred compared to hex or dome nut construction for fastening applications. This will facilitate the dismantling for cleaning and/or inspection purposes. 9.3 There shall be no exposed threads on product contact surfaces except where needed for safety or functional reasons. In those cases the threads shall conform with round thread according to DS 686 / DIN 405.

Figure 2

Note: a-dimension must not be smaller than specified.

Corner welds should be avoided where practically possible, i.e. design A is to be preferred to design B (figure 3).
Figure 3

Design A R 6 .3

Design B R

Product contact surface In order to avoid damage of the stainless steel, it shall not be welded directly to carbon steel, if the sheet thickness of the stainless steel is less than or equal to 4 mm. 1998-10-01

10. Retaining pins

Diameters of holes for retaining pins for product contact surfaces shall not be less than 4 mm. Page 5/10

Niro Sanitary Code For Components Design - Part A

Niro A/S 11. Internal angles

Internal angles of 135 or less on product contact surfaces shall have a minimum radii of 6.3 mm except: 11.1 Fillets of welds (see item 8.1). 11.2 Where necessary for functional reasons, such as intricately machined parts. When the radii is less than 0.8 mm, the product contact surfaces shall be easily accessible for inspection and cleaning. 11.3 For grooves in gaskets and for retaining grooves for gaskets the radii shall not be less than 3 mm. Retaining grooves for O-rings shall have minimum radii according to table 1. O-ring cross section diameter 6.3 mm 4.8 mm 3.2 mm
Table 1

Standard 6.01 13. Coil springs

Coil springs having product contact surfaces shall have openings between the coils of at least 2.4 mm, including the ends when the spring is in relaxed condition.

14. Rotating shafts

Rotating shafts shall fulfil the following requirements: 14.1 Seals for rotating shafts for liquid applications shall be of the mechanical shaft seal type, sanitary design, durable for the application, and easily demountable. 14.2 Seals for rotating shafts for dry products applications shall be of sanitary design, durable for the application, and easily demountable. 14.3 Rotating shafts shall not have lubricated bearings in the product contact area. Such lubricated bearings shall be mounted to provide a minimum of 25 mm exterior open space on the shaft between the mechanical seals for the bearing and the nearest part of the sanitary seal at the opening to the product contact area. The 25 mm minimum open space shall be open to atmosphere and be easily accessible for inspection.

Minimum radii of internal angles 2.4 mm 1.6 mm 0.8 mm

Note: There is no sanitary reason for a minimum radius on external angles in product contact. Nevertheless, it is customary to relief sharp edges slightly for safety reasons.

12. Gaskets and gasket grooves

12.1 Gaskets for product contact surfaces shall be removable or permanently bonded. 12.2 In general, gasket grooves or gasket retaining grooves shall not be more than 6.3 mm deep or be less than 6.3 mm wide. Exceptions may be made, however, as appropriate for gasket sealing applications on large equipment (see item 11.3).

15. Flexible connections

Flexible connections having product contact surfaces shall have straight sides without corrugations. It shall be installed in such a way that product cannot accumulate between the duct and the connection, and shall be easily demountable for cleaning.

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Niro A/S 16. Conveyor belts

16.1 Conveyor belts shall be endless. Metal stitching and lacing are not acceptable methods of joining belt ends. 16.2 Belts having absorbent core material shall have edges sealed with the same material as used for product contact surfaces.

Standard 6.01 18. Components for processing air

The following requirements apply to components and ducts for processing air: 18.1 Heated processing air Surfaces in contact with heated processing air (see definitions), except those of flexible connections, fans, burners and dampers, shall be of a corrosion-resistant material or a material that is rendered corrosion-resistant by a coating material other than paint. If part of the system is subject to washing, it shall be made of stainless steel (see also items 18.4 and 18.5). Otherwise the surface shall be treated as a non-product contact surface. The construction shall prevent the entrance of unfiltered air. 18.2 Not heated processing air All surfaces in contact with processing air, which is not heated (se definitions), shall be treated as product contact surfaces. The construction shall prevent the entrance of unfiltered air. 18.3 Exhaust air Surfaces in contact with exhaust air shall be treated as a product contact surfaces, if there is a risk for liquids may drip or be drawn into the product. Otherwise the surface shall be treated as a non-product contact surface. 18.4 Air disperser and perforated sheets for fluid beds Independent of air temperature, the design and construction shall comply with the sanitary requirements to the extent it is practically possible. Particular attention shall be paid to items 1, 8 and 11. The air disperser unit shall not have any closed rooms, which cannot be inspected and cleaned. The construction shall prevent the entrance of unfiltered air. 18.5 Plenum chambers for fluid beds The entire plenum chamber shall be treated as a product contact surface.

17. Supports and reinforcements

17.1 Supporting and reinforcement structures shall be free from pockets and crevices and be readily cleanable. 17.2 Supports for vessels and similar shall be designed to provide a distance of at least 100 mm from the vessel to the floor to facilitate cleaning. 17.3 Supporting framework and legs should, where practicable, be constructed from tubular stock rather than steel section. Tubular framing shall be totally closed or effectively sealed. 17.4 Walkways, platforms, stairs etc. shall be made from non-skid continuous steel plate rather than steel gratings. 17.5 Where bolts are used to connect steel members, the length of the bolt should ideally finish flush with the end of the nut.

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Niro A/S 19. Air filtration equipment

Equipment handling processing air and other air coming into contact with the process shall comply with the following: 19.1 General All fans, filters and heaters shall be placed in a closed room separated from the rest of the plant. The air intake to the room shall have a filter and a fan ensuring a slight positive pressure in the room. The principal set-up is shown in figure 4. 19.2 Efficiency of filter The efficiency of the filters shall be classified in accordance with EUROVENT. The filters shall fulfil the requirements in figure 4. 19.3 Material of filter The filter material shall not contain mineral fibres unless the operational temperature exceeds 100C.
Figure 4

Standard 6.01
19.4 Filter box Exchange of the filter box shall be carried out from the dirty side. The design shall ensure effective tightening of the filter box. 19.5 Filtration of compressed air Compressed air shall be free from oil. If the compressed air has a possibility of coming into contact with product, it has to be filtered by an EU 5 filter placed just prior to the consumption place. 19.6 Miscellaneous All ducts, tubes, pipes and casing of the filter shall fulfil the requirements of this code. During the operation of the plant, it is not allowed to open any door or cover.

Filter EU7 Filter Heater Heater Heater Heater

EU 4**

* Baby food plant: EU 9 ** Baby food plant: EU 6

M-air FB-air VF-air AUX-air CON-air M-air FB-air VF-air AUX-air CON-air

Heater EU 7* Filter EU 7* Filter EU 7* Filter EU 7* Filter

t t t t t

120 C 130 C 100 C 60 C 25 C

= Main process air = Process air for fluid bed in IFD- or SD/CD-chamber = Process air for Vibro-Fluidizer = Auxiliary air with product contact = Product conveying air

Note: If, for practical reasons, the fan and the damper are placed after the filter in the main air system, it shall be ensured that no unfiltered air enters the system, neither at the fan nor at the damper (purge air system shall be used). 1998-10-01 Niro Sanitary Code For Components Design - Part A Page 8/10

Niro A/S

Standard 6.01

Part B - Accepted construction materials

The following applies to materials for product contact surfaces: 1. Stainless steel Stainless steel shall be of the AISI 300 series or corresponding types. Where it can be demonstrated that the specific functional requirements exist, other types of stainless steel may be acceptable provided they offer comparable cleanability and resistance to corrosion. 2. Aluminium Aluminium is satisfactory for certain dry product applications and may be used for liquid product surfaces of processing equipment only when a specific functional requirement exists and that the parts are not subjected to strong caustic, cleaning solutions, or to the corrosive action of dissimilar metals. A suitable aluminium type should be chosen for the application. 3. Brass and bronze Brass and bronze are not acceptable for product contact surfaces or for bearing surfaces which are subject to cleaning solutions. 4. Plastic, rubber and adhesives Such materials shall comply with the requirements specified by: FDA - Food and Drug Administration, USA or EU-directives, Europe. 5. Carbon and ceramics Carbon and/or ceramics shall be inert, non-porous, non toxic, non-absorbent, insoluble and resistant to scratching, scoring and distortion when exposed to the conditions encountered in the environment of intended use and in cleaning and bacterial treatment. 6. Silver solder or brazing material Such materials shall be non-toxic, corrosion-resistant and contain no copper or lead. 7. Engineering plating Engineering plating shall utilize chromium or nickel electroplating with a thickness on product contact surfaces of not less than 5 m on stainless steel and 50 m on non-stainless steel surfaces. 8. Glass Glass shall be restricted to specific applications and shall be of a clear heat-resistant, shatter-resistant type. 9. Cotton, linen, silk and synthetic fibres Such materials shall be used only for dry product flexible connectors and for certain sifting and screening applications. 10. Paper Paper shall be limited to single service use e.g. for sanitary gaskets and filters. 11. Paint Paint shall be limited to the coating of non-product contact surfaces. Parts which have both a product contact surface and a non-product contact surface and are subject to washing shall not be painted. 12. Other materials Other materials having certain inherent functional properties and are required for specific applications shall be reviewed and evaluated for each application, based on the general requirements given by FDA Food and Drug Administration, USA or EUdirectives, Europe.

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Standard 6.01

Part C - Definitions
1. Product Any product or fraction thereof which is to be processed, handled or packaged by the equipment in sanitary conditions. 2. Product contact surface All surfaces that are exposed to the product, or from which liquids may drip, drain or be drawn into the product. 3. Non-product contact surface All other exposed surfaces than dealt with under product contact surfaces. 4. Processing air Air prepared by filtration which is intended to be used in contact with the product for such purposes as heating, cooling, drying or conveying or will be used for sealing a bearing or similar purposes. This includes compressed air, which will come into contact with product. 5. Heated processing air Processing air to be heated to at least 120C. 6. Not heated processing air Processing air which either will not be heated or will be heated to a temperature less than 120C. 7. Surfaces in contact with processing air All surfaces prior to coming into contact with the product, commencing at the discharge of final air inlet filter and ending at the first downstream product contact surface. 8. Exhaust air Processing air to be exhausted following its final contact with the sanitary product. 9. Surfaces in contact with exhaust air The surfaces of the air ducts, plenum chamber(s), if provided, and appurtenances from the final product contact surface through the exhaust system. 10. Manual cleaning The cleaning of all product contact surfaces by complete disassembly and manual brushing and/or application of cleaning solutions. 11. CIP (cleaning-in-place) The cleaning of all product contact surfaces by circulation and/or following cleaning solutions and water rinses into and over the surfaces.

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