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

1998-10-01

Sanitary Code For Component Design

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Niro A/S

Standard 6.01

Preface
Scope

IDF

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.

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).

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.

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

1998-10-01

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

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

Niro Sanitary Code For Components Design - Preface

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Niro A/S

Standard 6.01

Part A - General requirements

1. Design in general

2. Product contact surfaces

Components and equipment should be

designed, constructed and installed in order
to:

Accepted materials for product contact

surfaces are specified in Part B. The surfaces
shall comply to the following requirements:

1.1 Avoid cross-contamination between the

heat-treated and non-heat-treated product.

2.1 Stainless steel sheets

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.

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.

1998-10-01

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Standard 6.01

4. Cleaning in general

7. Openings and covers

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:

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:

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.

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.

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
400500 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.

1998-10-01

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Niro A/S

Standard 6.01

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

Horizontal

Horizontal

Acceptable

Not acceptable

Radii R, for fillets of welds in product

contact surfaces (figure 2):
t 5 mm:
t > 5 mm:

R 3.2 mm
R 6.3 mm

Figure 2

t
R

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

Design B

R 6 .3

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

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

Product contact surface

R

All welds shall comply with Niro Standard

1.4- and be surface treated according to
Niro Standard 2.0-, treatment"T2".

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.

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.

10. Retaining pins

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

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Niro A/S

Standard 6.01

11. Internal angles

13. Coil springs

Internal angles of 135 or less on product

contact surfaces shall have a minimum radii
of 6.3 mm except:

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.

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

Minimum radii
of internal angles

6.3 mm
4.8 mm
3.2 mm

2.4 mm
1.6 mm
0.8 mm

Table 1

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).

1998-10-01

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.

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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Standard 6.01

16. Conveyor belts

18. Components for processing air

16.1 Conveyor belts shall be endless. Metal

stitching and lacing are not acceptable
methods of joining belt ends.

The following requirements apply to

components and ducts for processing air:

16.2 Belts having absorbent core material

shall have edges sealed with the same
material as used for product contact
surfaces.

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.

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.

1998-10-01

Niro Sanitary Code For Components Design - Part A

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Niro A/S

Standard 6.01

19. Air filtration equipment

19.4 Filter box

Equipment handling processing air and

other air coming into contact with the
process shall comply with the following:

Exchange of the filter box shall be carried

out from the dirty side. The design shall
ensure effective tightening of the filter box.

19.1 General

19.5 Filtration of compressed air

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.

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

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

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.

The filter material shall not contain mineral

fibres unless the operational temperature
exceeds 100C.
Figure 4

Filter

EU 4**

* Baby food plant: EU 9

** Baby food plant: EU 6

M-air

EU7
Filter

FB-air

Heater

EU 7*
Filter

t 130C

Heater

EU 7*
Filter

t 100C

AUX-air

Heater

EU 7*
Filter

t 60C

CON-air

Heater

EU 7*
Filter

t 25C

VF-air

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

Heater

t > 120C

= 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

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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.

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.

3. Brass and bronze

10. Paper

Brass and bronze are not acceptable for

product contact surfaces or for bearing
surfaces which are subject to cleaning
solutions.

Paper shall be limited to single service use

e.g. for sanitary gaskets and filters.

4. Plastic, rubber and adhesives

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.

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.

1998-10-01

11. Paint

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.

Niro Sanitary Code For Components Design - Part B

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Standard 6.01

Part C - Definitions
1. Product

7. Surfaces in contact with processing air

Any product or fraction thereof which is to

be processed, handled or packaged by the
equipment in sanitary conditions.

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.

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.

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.

5. Heated processing air

11. CIP (cleaning-in-place)

Processing air to be heated to at least 120C.

The cleaning of all product contact surfaces

by circulation and/or following cleaning
solutions and water rinses into and over the
surfaces.

6. Not heated processing air

Processing air which either will not be
heated or will be heated to a temperature
less than 120C.

1998-10-01

Niro Sanitary Code For Components Design - Part C

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