Hygienic Design Manual

Installation
Heineken
Zoeterwoude,
HMESC registration: 99.04.04.100.EN
Issue: 11
Status: Final
99.04.04.100
Hygienic Design Manual
CONTENTS PAGE:
1. GENERAL 5
1.1 INTRODUCTION 5
1.2 REFERENCES 5
1.3 SCOPE 5
1.4 KEY WORDS 7
2. HYGIENIC CATEGORISATION 8
2.1 INTRODUCTION 8
2.2 HYGIENIC ZONING 8
2.3 HYGIENIC ZONING PATTERN 8
2.4 EQUIPMENT CLASSIFICATION 9
2.5 STERILE CLASSIFICATION 9
2.6 EHEDG TEST PROCEDURE 9
3. GENERAL REQUIREMENTS 10
3.1 INTRODUCTION 10
3.2 EUROPEAN DIRECTIVES 10
3.3 EHEDG CRITERIA 10
3.4 HYGIENIC OPERATION 10
3.5 FUNCTIONAL REQUIREMENTS OF HYGIENIC DESIGN 11
3.6 BASIC REQUIREMENTS FOR PRODUCT-CONTACT SURFACES 11
3.7 BASIC REQUIRMENTS FOR NON-PRODUCT CONTACT 13
3.8 HYGIENIC BASIC DESIGN OUTLINES 13
4. MATERIAL REQUIREMENTS 14
4.1 GENERAL 14
4.2 PLASTICS 14
4.3 ELASTOMERS 15
4.4 ADHESIVES 15
4.5 SURFACE TREATMENT & COATINGS 15
4.6 STAINLESS STEEL (SS) 15
4.7 INSULATION MATERIAL 16
4.8 SIGNAL TRANSMISSION LIQUIDS 16
4.9 COOLANTS 16
4.10 LUBRICANTS 16
5. PIPING SYSTEMS REQUIREMENTS 17
5.1 INTRODUCTION 17
5.2 PIPELINES 17
5.3 ELBOWS 18
5.4 TEES 18
5.5 FLANGES 19
Issue : 11 HYGIENIC DESIGN MANUAL HMESC : 99.04.04.100

Date : 16 july 2009 INSTALLATION Page : 2 / 47
99.04.04.100
5.6 GASKETS 20
5.7 COUPLINGS 21
5.8 HOSES 22
5.9 HYGIENIC METERING 23
5.10 PIPE SUPPORTS 23
5.11 MANUFACTURE & INSPECTION 23
6. VALVES 24
6.1 BUTTERFLY VALVES 24
6.2 BALL VALVES 25
6.3 DIAPHRAGM VALVES 25
6.4 NON-RETURN VALVES 26
6.5 MIX-PROOF VALVES 26
6.6 TWIN-DISC BUTTERFLY VALVES 30
7. OTHER ACCESSORIES 31
7.1 COMPENSATORS 31
7.2 SIGHT-GLASSES 31
7.3 SAFETY RELIEF VALVES (UNDER AND OVERPRESSURE) 32
7.4 PROCESS CONTROL AND INSTRUMENT CONNECTIONS 33
8. PUMPS 34
8.1 GENERAL 34
8.2 CENTRIFUGAL PUMPS 34
8.3 POSITIVE DISPLACEMENT PUMPS 35
9. HEAT EXCHANGERS 36
9.1 GENERAL 36
9.2 TUBULAR HEAT EXCHANGERS 36
9.3 PLATE HEAT EXCHANGERS 37
9.4 SCRAPED SURFACE HEAT EXCHANGERS 37
10. PROCESS EQUIPMENT 38
10.1 CONSTRUCTION 38
10.2 SPRAY BALLS 39
10.3 DRIVE SHAFTS AND BEARINGS 39
10.4 EQUIPMENT ARRANGEMENT 40
11. VERIFICATION AND MAINTAINING THE HYGIENE REQUIREMENTS 41
11.1 VERIFICATION AND MEASURES 41
11.2 INTRODUCTION TO HACCP 42
11.3 HEINEKEN AND HACCP 42
11.4 INTRODUCTION TO CE CERTIFICATION OF MACHINES 42
11.5 THE HEINEKEN MACHINE DIRECTIVE MANUAL 42
12. REFERENCES 43
12.1 DIRECTIVES 43
12.2 STANDARDISING ORGANISATIONS 43
12.3 INTERNATIONAL STANDARDS 44
12.4 EHEDG GUIDELINE DOCUMENTS 45
12.5 BDMS AND BEAMS ERROR! BOOKMARK NOT DEFINED.
12.6 TECHNICAL REFERENCE MANUAL 45

99.04.04.100
APPENDIX A 46
A1 - EHEDG CLEANABILITY TEST 46
A2 - EHEDG STERILISABILITY TEST 47
A3 - EHEDG BACTERIAL IMPERMEABILITY TEST 47
ISSUE HISTORY:
ISSUE REFERENCE DESCRIPTION

Paragraph 2.3 Synchronisation Hygienic Zoning with SS essay HMESC 99.04.04.001
Paragraph 2.5 Elaboration of Sterile Classification
06 Paragraph 5.2 Introduction reducer (top flat) in pump suction
Paragraph 5.11 Addition Automatic Welding Penetration and ppm O2 measurement
Paragraph 10.1 Addition to man hole >> sealing vulcanised to cover
Paragraph 11.2 Words "likely future" removed
07 Paragraph 11.3 New text
Paragraph 11.4 Removed
08 Chapter 12 Update of references
09 Removal of references to HMESC article specs. Reference to Machine Directive
10 Paragraph 4.6 Material references/codes

99.04.04.100
1. GENERAL
1.1 INTRODUCTION
The brewing of a high-quality beer, free from flavour defects and with a long shelf life, is possible only in
absence of infection throughout the entire production process. One of the most important factors involved
in the prevention of infection is the hygienic design of the process equipment and associated pipelines.
A concern required Hygienic Operation and developments such as “Hazard Analysis Critical Control Points”
(HACCP), recall and compel us to remain alert with respect to requirements for hygiene.
This manual is mandatory in the engineering for new or modified installations.
1.2 REFERENCES
See Chapter 12
FDA
FDA (Food & Drug Administration) is an American organisation, which works closely with industry to help it
to develop complete and well-prepared product applications. Although American focussed, the qualification
‘FDA listed’ could be met as specification for materials that are certified for application in the food industry.
Internet link www.fda.gov
3-A Sanitary Standard

Once a 3-A Sanitary Standard has been developed and becomes effective, manufacturers may receive
authorization from the 3-A Symbol Council to use the Symbol. Voluntary use of the 3-A Symbol on dairy
and food equipment serves three important purposes:
• Assures processors that equipment meets sanitary standards;
• Provides accepted criteria to equipment manufacturers for sanitary design; and
• Establishes guidelines for uniform evaluation and compliance by sanitarians.
Internet link www.3-a.org
European Hygienic Equipment Design Group (EHEDG)

EHEDG is a consortium of equipment manufacturers, food industries, research institutes and public health
authorities. EHEDG aims to promote hygiene during the processing and packing of food products and
assists industry in complying with European hygienic machinery directives.
Internet link www.ehedg.org
Standards
Within the Heineken concern the basics of hygienic design have been laid down in the Rules, Standards &
Procedures in the HeiQ.For projects hygienic basics are forwarded to the Suppliers as Technical
Reference Manual (TRM). Besides the engineering methodology, the TRM is built on three hygienic design
pillars i.e.:
• Site specific specifications ;Selected piping components, accessories
and pumps
• HMESC 99.04.04.130 – 200 Plant Design Guidelines ;Arrangement outlines for layouts, piping
and equipment
• HMESC 99.04.04.500 – Hygienic Civil Design Manual ;Input for Civil Consultant
1.3 SCOPE
The 3-A Sanitary Standard and EHEDG accreditations are used for components that are suitable for usage
in the production areas of a brewery. Individual materials could have status FDA approved. The point here
is that those qualifications certainly contribute to clarity in hygienic design, but the skills and experience of
the Engineer remains determined; new developments, hygienic zoning, sterile classification….

99.04.04.100
The instructions in this manual have been drawn up based on experiences within the concern and will be
kept up to date in view of the great importance of a hygienic operation in Heineken breweries. They are of
a general nature, together with the other HMESC guidelines referenced, the contents of this manual serve
as guidelines for Engineers, Installers and Plant Owners.

99.04.04.100
1.4 KEY WORDS

Cleanable / ability The property possessed by equipment or surfaces, which enables all soil to be
removed from them.
Cleaning The removal of soil from a surface.
Cleaning In Place (CIP) cleaning and disinfections of equipment without a need to disassemble that
equipment. CIP is integral part of the production regarding hygienic zoning.
Crevice or Crack A crevice or a crack is a defect in the surface that is detrimental to the ability to
clean that surface.
Dead-ends An area that can be accessed by product but from which product cannot be
removed under normal operations, or with the use of CIP.
Disinfection The treatment of objects and surfaces with chemical or physical agents such that
pathogenic micro-organisms are entirely absent and the numbers of other micro-
organisms on that object /surface are reduced to an acceptable minimum.
HACCP Hazard Analysis Critical Control Points - the analysis of risks associated with the
production process, and the control of critical points in the production.
Joint An interface between two or more components.
Non-product A surface, which is, protected such that in normal circumstances it will not come
contact Surface into contact with product. The requirements are:
• Protection class IP 65 (electrical equipment)
• Protection from direct splashing
• Absence of direct access by the product to the surface
• Surfaces from which a cross-contamination of the product is excluded (e.g. a
surface above open product, from which condensate can drop in the product)
• Capable of inspection
Product contact Area All surfaces of the machine that intentionally or unintentionally come in contact with
the product, or from which product or condensate may drain, drop or be drawn into
the product or container.
Seal A material that ensures for an effective closure of an opening so as to prevent the
undesirable penetration of any substances.
Self-draining The design /construction of surfaces so that liquid residues do not remain on them.
Shadow Area The area within the product zone in which the CIP liquid is not able to come into
immediate contact with the surface; where there is no sufficient exchange of the
CIP liquid to reach clean conditions.
Smooth The condition of a surface that is required for it to be suitable for use in hygienic
design. 'Smooth' implies that the surface is free from gaps, cracks or other defects
in which soil could accumulate.
Soil Every undesirable material, including product residues, whether or not micro-
organisms are present.
Splash surface A surface that is intended not to come in contact with product, however may do so.
G.e. parts that can allow product, condensation, etc. to fall into the product are
regarded as product-contact surfaces.
Requirements: All parts that are to be cleaned by hand must be visible and
capable of being cleaned. In case this is not feasible then they
must be capable of CIP (EHEDG) Drainability = the absence of
recesses or areas in which liquid residues can remain.

99.04.04.100
2. HYGIENIC CATEGORISATION
2.1 INTRODUCTION
Hygiene may be defined as ensuring compliance, both during the design and use of processing equipment,
with all conditions which need to fulfil, to achieve the greatest possible suitability of the process for the
purpose for which it is intended and to guarantee the greatest possible safety for the consumer of the
product. Areas are subject for hygienic zoning and Equipment can be classified into classes.
2.2 HYGIENIC ZONING
Hygienic zones can define the various areas within production facilities. EHEDG has recommended:
Zone B as a basic zone category where a basic level of hygienic design should be applied. Open areas are
allowed in a B-zone. It can contain:
B0 is an area outside of the buildings, but within the perimeter of the site, to control or reduce
hazards related to the environment.
Zone B1 is described as non-production areas like offices, workshops, power supply areas,
canteens and redundant buildings/rooms. The hazards created by pests and birds should to
be controlled or reduced and also the introduction of unwanted materials into hygienic areas.
Zone M, a zone of a medium level of hygienic design protect the interior of food processing equipment from
contamination e.g. by penetration and control or reduce hazards that can affect a higher hygiene zone. In a
M-zone, the building should be closed, watertight and be equipped by an appropriate ventilation system.
Zone H, a zone of a high level of hygienic design protect product contamination during open processing
e.g. bottling of beer. In a H-zone, additional measures like an appropriate ventilation system are necessary.
• The B-zone is used in breweries for areas with requirements for basic hygienic design like brew
houses, due to robust media and high temperature processing. The hygiene requirements for the
exterior of the equipment are as for M-zone to maintain a good hygienic operation in housekeeping.
• The M-zone is used in breweries for areas of closed processes like fermentation or filtering, where
double-seated valves with dynamic seals are state of the art. A cleanable design of the exterior of the
equipment and a hygienic environment minimise the penetration trough the seals.
• The H-zone should be used for culturing /propagation and filling stations where clean bottles and open
filling equipment are reasons for contamination from the environment and the exterior of equipment.
• Regarding hygiene, CIP is considered as integral part of production. The various zones should be
made clearly visible; the room arrangement of a building should correlate with the zoning concept.
• Hygienic Zoning shall be seen in correlation with Ventilation patterns; see HYGIENIC CIVIL DESIGN
MANUAL – HMESC 990404.500 § 3.4.
2.3 HYGIENIC ZONING PATTERN
To minimise interpretations within Hygienic Zoning herewith a patterning of the brewery production areas:
Filling Area
Filling Area
Bright Beer
Production
Production
Filtration &
Application Field >>

Handling
Services
Material
Pasteur
Pasteur
Utilities
House
Room
Cellar
Yeast
Brew
Tank
Raw
yes
no
Issue
v
v
Surrounding (civil) B /B0 M M M H M M H B1
Equipment B /B0 B M M M M M M B1
Pumps /Ventilators B /B0 B M M M M M M B1
Accessories B /B0 B M M M M M M B1
Piping B /B0 B M M M M M M B1

99.04.04.100
2.4 EQUIPMENT CLASSIFICATION

Aseptic Aseptic Equipment means cleanable and sterilisable equipment (avoiding
‘cold’ and /or not wettable spots), which in addition prevents the ingress of
microorganisms. Equipment used in aseptic areas (e.g. clean rooms) must be
cleanable and sterisable.
Sterilisability: Cleaned equipment, which can be disinfected to destroy all viable
micro-organisms, including. bacterial spores, where relevant, by means of a heat
treatment with saturated steam at a temperature of 120°C during a period of 30
minutes.
Microbial impermeability: The property possessed by equipment preventing the
penetration of bacteria, yeasts and moulds from outside (the surroundings) into
the equipment (the product area) or from inside of the equipment to outside of the
equipment.
Hygienic Class I Equipment that can be cleaned in place and disinfected in order to destroy all
micro organisms without needing to be dismantled.
Hygienic Class II Equipment that can be cleaned, subsequent to disassembly and after reassembly
disinfected to destroy all micro organisms.
2.5 STERILE CLASSIFICATION

DIN 11864 prescribes Sterile Classes applying to screw, flange and clamp couplings that could be
extrapolated for usage for roughness classifications to other material surfaces as well:
Internal Roughness 1)
Sterile Class Mapping with Hygienic Zoning
Surface Bead
H1 Ra < 1.6 μm Ra < 3.2 μm Correlates with Hygienic zone B
2 3
H2 Ra < 0.8 μm Ra < 1.6 μm ) ) Correlates with Hygienic Zone M 4)
H3 Ra < 0.8 μm Ra < 0.8 μm Correlates with Hygienic Zone H 5)
H4 Ra < 0.4 μm Ra < 0.4 μm
H5 Ra < 0.25 μm Ra < 0.25 μm
1
) For a more detailed mapping HMESC 99.04.04.001 – STAINLESS STEEL is recommended for review.
2
) Default inner bead finishing of DIN 11850 - pipe is Ra < 1.6 μm;
3
) Fittings – elbow, T-piece and reducer – by DIN 11852 are only available with inner finish < 1,6 μm.
4
) In practice used for all SS pipe throughout hygienic zones.
5
) Hygienic Zoning H3 applies only to DIN 11864 fittings and some civil requirements
Within the Heineken concern Sterile Class H2 (Ra < 0.8 /1,6 μm) applies with the addition that lower
roughness values are welcome and higher roughness values can be only acceptable, provided that:
• The material passes the cleanability test
• And that the cleaning flow remains within an acceptable range.
2.6 EHEDG TEST PROCEDURE

To facilitate the design, testing and maintenance of hygienic food-processing equipment,
it is important to be able to assess the relative cleanability of various components of the
equipment using standardised test procedures (see chapter 11).
Accessories and components having a test certificate according to EHEDG or equivalent methods (e.g. the
3-A Sanitary Standard) are preferred.

99.04.04.100
3. GENERAL REQUIREMENTS
3.1 INTRODUCTION
The stated General Requirements are binding by law (Machinery Directive, Food Hygiene Directive).
3.2 EUROPEAN DIRECTIVES

• Machinery Directive, 2006/42/EC of the European Parliament and of the Council of 06 June 2006 on
the approximation of the laws of Member;
• The criteria listed are: - Materials (food grade), smooth surfaces and joints.
- No protruding parts, sharp corners or edges.
- Surfaces shall be cleanable; if required capable of being disinfected.
- Liquids must be capable of simple drainage.
- The design and construction must be such that the infiltration or
accumulation of substances in non-cleanable zones is avoided.
- The design and construction must be such that ancillary materials
cannot come into contact with foodstuffs.
• Materials and objects that are permitted to contact with foodstuffs; 89/109/EC and 90/128/EC.
• Food hygiene (HACCP); 93/43/EC.
3.3 EHEDG CRITERIA

• Hygienic Design Criteria: - Surfaces and Geometry
- Design and Installation
• Materials: - Non-toxic / Non-corrosive / Non-absorbent
- Capable of withstanding contact with product and cleaning agents.
- Plastics (PP, PVC, PC, PE).
- Elastomers (EPDM, NR, NBR, Viton{FPM}, Silicon rubber{PMQ}).
- Adhesives / lubricants (FDA standards) (EHEDG Doc 23).
- Stainless steel (AISI 304[L], 316[L]).
• Surface roughness; Ra ≤ 0.8 μm , see also paragraph 3.9 – Sterile Classification.
• No exposed threads; angles > 90°.
• Cleaning in Place.
• Smooth external finish,
• No dead ends.
3.4 HYGIENIC OPERATION

The main subjects that should be taken into account establishing a Hygienic Operation:
1 Site Selection ;In case of a Greenfield
2 Brewery Arrangement ;Both for Greenfields and Brownfields
3 Constructional Details ;Finishing; Provisions
4 Infrastructure Provisions ;Civil, Mechanical, Electrical
5 Sanitary Provisions ;Human facilities
6 Good Housekeeping ;Operational issue >> Hygiene Plan
The creation process – new breweries but also brewery renovations and extensions – knows two manuals
for hygiene to be taken into account. Although this manual says something about materials, for a hygienic
execution of Civil Provisions HMESC 99.04.04.500 – THE CIVIL HYGIENIC DESIGN MANUAl applies.

99.04.04.100
3.5 FUNCTIONAL REQUIREMENTS OF HYGIENIC DESIGN

The design principles
Hygiene shall always be taken into account during the design of brewery machinery and equipment. It
should comply with a correct combination of processing, microbiological and mechanical requirements. The
objective of a design, which complies with the hygienic requirements, is the minimum of the time needed to
clean the equipment, and consequently a maximum in the net production time of the equipment and a
guarantee of the appropriate hygienic quality of the product.
Cleanability
The equipment shall be capable of being easily cleaned and disinfected, and shall protect the product from
becoming contaminated.
Penetration by micro-organisms
The equipment shall be constructed in a way such that the penetration by micro-organisms external to the
system is prevented. Main sources to penetrate closed process equipment are seals of valves and pumps.
Inhibition of the growth of micro-organisms

The construction shall avoid the presence of dead ends and gaps and cracks in which micro-organisms
could shelter and multiply. NB in favourable conditions micro-organisms are capable of extremely rapid
rates of multiplication.
The surroundings of process equipment

The growth and accumulation of micro-organisms on processing equipment must be avoided. This is
necessary to help ensure that micro-organisms do not penetrate the process equipment. Consequently the
surroundings of process equipment shall be kept clean and dry (hygienic house-keeping).
Hygienic requirements versus other requirements

The designer will need to find a compromise when the hygienic requirements are in conflict with other
functional requirements imposed on the equipment. In such situations this may result in an increased
frequency of cleaning, or more intensive cleaning. In this event the user's instructions shall need to draw
attention to the additional cleaning requirements.
Validation of the hygienic quality

In spite of the designer's knowledge and experience of hygienic practices it may be necessary for the
designer to take measures that provide for a capability of inspecting, testing and validating equipment with
respect to its compliance with hygienic requirements. In critical situations it may be necessary to include
the level of hygiene in the maintenance checklist.
Deviations
Deviations from the hygienic requirements indicated are permissible only when it has been demonstrated
that the equipment involved is capable of being cleaned and disinfected in an adequate manner, and when
this demonstrated ability has been laid down in writing.
3.6 BASIC REQUIREMENTS FOR PRODUCT-CONTACT SURFACES

The design and installation of all equipment and pipelines must satisfy the following basic requirements.
⌧
• Shall be easy to maintain, clean and disinfect so
• Metal on metal joints, unless welded;
as to prevent chemical or microbiological soiling;
• May not liberate toxic substances into the
• Non-alignment of equipment and pipelines;
product, for the protection of the consumer;
• Gaps and fissures; • Prevent a detrimental effect on product quality;
• O-rings, unless these provide a smooth seal; • Self draining /evacuating /no dead ends
• Thread ends; • Shall have smooth changeovers in construction.
• Sharp corners.
The rudiments ‘sharp corners’ and ‘dead ends have been further elaborated.

99.04.04.100
SHARP CORNERS
A corner is deemed to be a sharp corner when the radius is < 3 mm.
⌧ ⌧
radius ≥ 3 mm Weld: grid 150

= Ra ≤ 0.8 μm
DEAD ENDS
A pipeline contains a dead end when the length of the dead end from the direction of the flow is > 0.5 the
diameter of the pipeline. The ratio of the depth/breadth of the dead end is > 0.5.
⌧
D
D
L L
Acceptable in the event that: Acceptable in the event that:

it is unavoidable and the Unavoidable L ≤ D/2
dead area can be drained Unacceptable when L ≥ D/2
If the flow direction during cleaning is towards the dead end and the ratio L ≤ D/2 cannot be reached
because of design reasons, the minimum ratio should be L ≤ D.
The pressure relief/bypass valve for the positive displacement pump shown at left has a dead leg with a
large amount of product (shaded area) when the valve is closed, as shown (note also that the pump is not
in a position that allows draining). The same valve, in the arrangement shown at right, can be mounted in
such a way as to avoid dead legs in the bypass and to allow draining of the pump.

99.04.04.100
3.7 BASIC REQUIRMENTS FOR NON-PRODUCT CONTACT

• All non-product contact surfaces must be designed and constructed in a way that the accumulation of
moisture and soil is prevented
• The design must also permit inspection, maintenance, easy cleaning and disinfection.
• Water and condensation from non-product contact surfaces may not come into contact with product
contact surfaces
• No liquid may remain on non-hermetically sealed joints (such as seals and gaskets)
• If liquids like condensate can occur, horizontal surfaces must be drainable to avoid stagnant fluids.
3.8 HYGIENIC BASIC DESIGN OUTLINES

• Equipment /pipelines should be self-draining./self-evacuating. A surface is hygienically self-draining in
case that the angle of inclination is ≥ 3°. The product should not being compromised when draining.
• Sterile classes prescribe an internal roughness of R < 1.6 μm up to R < 0.25 μm It should be noted that
the rougher the equipment surface the more frequent cleaning and disinfection is needed. This is time-
consuming and cost raising; moreover cleaning /disinfection do not preclude all risks of infection.
• Equipment construction, arrangement of auxiliaries and piping systems with the avoidance of:
- Dead ends as shown or alike
- Shadow areas
- Spaces with stagnant or entrapped liquid
- Entrapment of air
• Take care of a proper cleaning function. The Reynolds numbers (Re) during cleaning and disinfection
should comply with:
- For round pipes Re > 50,000
- For falling films Re > 1,000

99.04.04.100
4. MATERIAL REQUIREMENTS
4.1 GENERAL
Framework Directive 76/893, new version: 89/109 containing General Requirements – Health related
requirements – Inertness to foods,
The materials used shall comply with certain specific requirements. Materials coming into contact with the
product should be inert regarding the product under all processing conditions; they should also be inert with
respect to all cleaning agents and all disinfectants, under all conditions in which they are used.
This means that the design shall comply with the following requirements:
• Corrosion-resistant.
• Mechanically stable.
• Non-absorbent.
• Non-toxic.
• Surface roughness Ra ≤ 0.8 μm .
• No exposed threads.
• Cleaning in place
• Smooth external finish, no dead ends.
• Materials used:
- Plastics (PP, PVC, PC, PE).
- Elastomers (EPDM, NR, NBR, Viton {FPM}, Silicon rubber {PMQ}) (FDA para.177.2600).
- Adhesives / lubricants (FDA standards).
- Stainless steel (AISI 304[L], 316[L])
• Capable of withstanding contact with;
- Product (sub-recipes)
- Cleaning agents and disinfectants.
- Decalcification agents.
The materials to be used and the dimensions of pipelines and fittings are laid down for each brewery /
project in the Technical Reference Manual (TRM).
The following stainless-steel piping is used within the Heineken Concern:

• Dimensions in accordance with DIN 11850 / HMESC 74.02.02
• Tolerances in accordance with ISO 1127 D3/T3
• Material no. 1.4432 (AISI 316L) or 1.4307 (AISI 304L)
• Welded longitudinal joint; with a rolled joint and annealed in accordance with DIN 17455-k2g
• Cold-rolled strip in accordance with DIN 17441-h is used to construct the pipes; the specified
roughness value is approx. 0.3 μm, and the material needs no further finishing treatment.
4.2 PLASTICS
Plastics Directives 2002/72 (summarises of 90/128 and its 7 amendments)
Synoptic Document; containing toxicological rating of monomers and additives for plastic components
The following plastics can be cleaned easily, and may be used in hygienic equipment:
• Polypropylene (PP).
• Polyvinyl chloride without plasticiser (PVC).
• Polyoxymethylene (POM).
• Polycarbonate (PC).
• High-density polyethylene (HDPE).
• Perspex® (PMMA)

99.04.04.100
4.3 ELASTOMERS
The food industry makes use of a wide range of elastomers for seals, gaskets and couplings. The following
types are recommended:
• Nitrile rubber.
• Nitrile butadiene rubber (NBR).
• Silicon rubber (PMQ).*)
• Fluoro elastomer (Viton, FPM).
• Ethylene Propylene Diene Monomer (EPDM).**)
*) Also suitable for use at elevated temperatures (up to 180°);
**) EPDM cannot withstand the effects of oils and greases. New special EPDM types allow applications
in contact with products containing oil and grease
The use of excessive compression must be avoided. The best way of controlling the level of compression is
obtained by means of a stop surface, or by a metal-to-metal support. The elastomer Rubber requires a
compression of minimum 5 percent, with a maximum of 25 percent.
A decision to use polytetrafluoroethylene (PTFE) requires a careful consideration: the material may be
porous and is difficult to clean. Moreover PTFE does not exhibit the resilience required to guarantee a good
seal. Materials to reinforce elastomers (such as fibreglass) may not come into contact with the product. A
new generation of modified PTFE-materials available with approved properties e.g. like easy cleanability.
4.4 ADHESIVES
Adhesives used to retain gaskets in place must be free of odour and flavour. The type should also be in
accordance with the recommendations issued by the Supplier of the equipment. The latter requirement is
necessary to ensure that the use of the adhesive will not result in localised corrosion of the stainless steel
in the vicinity of the adhesive. (Ref FDA: Code of Federal Regulations 21 CFR175).
4.5 SURFACE TREATMENT & COATINGS

All surface treatments and coatings shall be approved by the Food and Drugs Administration (FDA), or by
an equivalent agency. Coatings must also be capable of withstanding the effects of cleaning agents and
disinfectants used in the brewing industry.
4.6 STAINLESS STEEL (SS)

SS complies with the hygienic requirements from the food, dairy and beverage industry. Applied SS type
depends on the properties of the medium and the welding requirements. A well-known classification system
for SS is the American Iron and Steel Institute (AISI) system. Another system is the German system, which
designates the types according to a Material Number.
SS alloys could be compared by PREN (Pitting Resistant Equivalent Number) value. This is an empiric
value based its chemical composition the resistance against pitting corrosion can be determined.
PREN = %Cr + 3,3 %Mo + 30 %N
SS Alloy Chrome Molybdenum Nitrogen PREN value
AISI 430 (ferriet) 16 16
AISI 304[L] (1.4301 [1.4307]) 18 18
AISI 316[L] (1.4401 [1.4432]) 17 2 24,6
Duplex 2205 (1.4462) 22 3 0,15 36,5
Super Duplex 2507 25 4 0,3 46
AISI 304[L] (Matr. no. 1.4301 [1.4307]) is used in conditions in which the liquids contain little chloride.
Chloride ions can cause pitting corrosion in this type of SS. AISI 316[L] (Matr. no. 1.4404 [1.4432]) is used
in conditions in which liquids contain chloride, provided that they are not subject to high temperatures (< 60
°C). Stress corrosion may occur if the metal is exposed to higher temperatures (60-150 °C). AISI 316 is
recommended for the construction of parts of equipment such as valves, pump housings, rotors and axles;
however AISI 316L (low carbon) is recommended for pipes and tanks, as it is easier to weld.

99.04.04.100
4.7 INSULATION MATERIAL

The prevention of microbiological growth or (pitting) corrosion due to chloride ions could be avoided by:
• The application of chloride ion free insulation material;
• The pre-treatment of the outside of the pipe to be insulated;
• The protection of insulation to prevent the penetration of either water or product. This protection can be
achieved by the use of a fully welded external cover, or a moisture-proof cover.
• Aforementioned is satisfied by the closed-cell insulation

used in combination with a cover.
• Foamed Glass sections shall be sealed (to prevent
the crumbling of the material). A suitable sealant is Foster
Vapor-Safe (obligatory for outside pipelines).
⌧ PIR/PUR
• Moisture-proof layer is obligatory;
• PIR/PUR requires a pre-treatment of the pipe to prevent
pitting corrosion in the presence of chloride ions
• Due to its fire resistance characteristics, PIR/PUR is not
in favour, leading to high assurance fees
Rockwool
• Hot insulation
• The release of fibres from mineral-wool insulation, must
be prevented by a treatment with a silicon binding agent.
Pre-insulated pipe
• Has advantages for long length piping concerning vapour
tightness, moisture-proof execution and cosmetically.
• Pre-insulated pipe – medium pipe, outer jacket and
insulation in between – has a high insulation capacity,
high strength, is 100% sealed and is easy to clean.
4.8 SIGNAL TRANSMISSION LIQUIDS

Damaged or leaking membranes enclosing liquids used for the transmission of signals may allow the liquid
to come into contact with product. Consequently these liquids shall be food grade liquids. Silicon oil or
glycerine is frequently used for this purpose.
4.9 COOLANTS
Allowed coolants are Ethanol-water solution and Mono Propylene Glycol-water solution.
If required by law, ethanol-water solution shall be denaturised. The additive used shall be non-toxic to
prevent health hazards in case of leakage of the coolant. If corrosion inhibitor is added, select an inhibitor
based on molybdate due low toxicity.
4.10 LUBRICANTS
Grease and lubricating oils, possibly in contact with product, shall comply with the FDA (Foods and Drugs
Administration) regulations, in particular with the requirements stipulated in Chapter 178.3570.
EHEDG Doc 23 describes food grade lubricants

99.04.04.100
5. PIPING SYSTEMS REQUIREMENTS

Reference: PLANT DESIGN GUIDELINES HMESC 99.04.04.001 /171 /172 /173 The Piping Series
5.1 INTRODUCTION
Sanitary piping is used to transport liquid product and gases (CO2) that come into contact with the product.
The hygiene of processing installations may be exposed to risks due to:

• Microbiological problems caused by residues of product.
• Chemical contamination associated with the use of cleaning agents, disinfectants, and lubricants.
• The presence of foreign objects originating from raw materials, machines, etc.
5.2 PIPELINES
Pipelines shall be designed and installed in a logical and economical way.
Attention should be given to aspects such as:
• The restriction of the number of elbows to a minimum; fewer elbows => fewer welded joints.
• The restriction of the number of humpbags and cambers to a minimum.
• Pipelines shall be self-draining /self evacuating; i.e. humpbags should be avoided. In case a humpbag
is unavoidable, then measures shall be taken to ensure that the pipe is subject of adequate cleaning.
• Dead ends in pipelines should be avoided; when their presence is unavoidable the pipe shall be
arranged in a way such that it is subject of adequate cleaning.
• Pipes should be as short as possible
taking the necessary flexibility in mind.
• The inside surface of the pipe in the Deviation
max.20% of
vicinity of the weld shall be rendered as wallthickness
smooth and as leveled as possible.
• Vents and drainage points may not be Distance 0 – max. 0.25 mm
installed in sanitary pipelines. In case that
they are unavoidable then they shall be subject to adequate cleaning.
• Eccentric reducers (level base) shall be used in horizontal pipes (such as pipe bridges). Eccentric
reducers (top base) shall be used in suction of pump to avoid cavitations and gas forming in pump.
⌧ Support & drainage At pump suction
Note: These are not permitted prior or subsequent to instruments that are sensitive to variations of
the flow in the cross-section (such as magnetic flow meters)

99.04.04.100
5.3 ELBOWS
The design shall endeavour to avoid elbows wherever possible. This requirement is stipulated in order to
restrict the number of welds to a minimum (related with sanitary requirements and required flexibility).
The use of welded elbows in Heineken's breweries should preferably be restricted to a minimum. Bending
of (small) pipe has the advantage that fewer welds are required. Specialised equipment should be used.
The approval of samples of bent pipe should by the responsible client engineer is required.
5.4 TEES
It is preferable that tees of the largest possible radius are used: these are also suitable for orbital welding.
D
D
S
S
B
A
D
D
A A A A
Tee with large radius (orbital welding) Tee with short radius
Tees with a short radius are used for branches intended for the installation of a fitting or process-control
instrument immediately adjacent to the tee. Tees with a branch smaller than the main pipe may be drawn.
Examples:
D
L
L
L=<½ D
The distance between centreline of the pipe to the fitting in the branch must be kept to a minimum. This is
to ensure that the dead end also will be cleaned adequately.
The Varivent in-line connection is advertised as an appropriate sanitary connection for process-control
instruments.
C
DN
68

99.04.04.100
5.5 FLANGES
Heineken uses the following flanges for pipe joints and the installation of fittings:
d1
In principle welding neck flanges satisfy the s
hygienic requirements imposed on piping; d2

excessive contact pressures should be avoided.
h
b
They must be accurately centred.
k
D
⌧ Slip-on flanges are less suitable, since they need

to be welded on both sides; the end of the pipe
must be welded to the contact-surface face of the
flange, and then levelled flush with the surface.
d2
b
d5
k
D
⌧ Blind flanges should not be used in sanitary d2
pipelines.
b
k
D
d2
Lap-joint flanges in combination with collar rings
e
or welding neck collars satisfy the hygienic
b
requirements, provided that they are correctly d6
k
centred. D
d1
Stub ends can, by virtue of their rounded s1
construction, be used to bridge small differences
h
in internal diameter.
s2
d4
⌧ Welding neck collars may not be provided with s

d1
packing grooves.
h
h3
d4
⌧ Flat welding collars need to be welded on both

e
h3
sides; the weld on the packing side must be

levelled flush with the surface. Consequently flat d5
welding collars are less suitable. d4
d1
Flanges in accordance with DIN 11864-2 A and B
S
(aseptic) amply satisfy hygienic requirements.
Types suitable for orbital welding are preferred;
there may be variations between flanges from
different manufacturers. The centring rim of the
b
flange requires a certain amount of room for

l
assembly. The flanges are not suitable for

connections to DIN 2501 flanges or fittings.
Flanges with a nominal diameter of less than 80 d
mm may not be used on tanks subject to D
certification (M8 bolts not permitted). DIN 11864-2A
DIN 11864-2B

99.04.04.100
Care should be taken to ensure the appropriate alignment of the centreline of the flanges during the
assembly of flanged connections. Gaskets should be correctly centred so as to ensure that the gasket does
not protrude into the pipe. Care should be taken to ensure that fittings are aligned with the flange and the
gasket. In principle flanged connections should be avoided wherever possible.
Example of a cyclone tank valve using a

butterfly valve with threaded holes (. The
tank is fitted with a welding neck flange from
the ISO series; the pipe is fitted with a stub
end and a loose flange from the metric DIN
series.
Welding neck flange,

DIN2632 (PN10, DIN 100)
ISO series, internal
Flange of Stainless Steel DIN 11850 butterfly valve

welded directly to the outlet cone of the tank.
Stub end with loose flange, DIN 2642

DIN metric series, internal diameter 100
5.6 GASKETS
EPDM Shore A 70°,
• Flat gasket, 3 mm from DN100 onwards satisfy hygienic d1
requirements on the condition that the internal diameter is d2
identical to that of the pipe
Elastomer-OR
• The thicker form of EPDM O-rings with an integral steel
inlay in the vulcanised rubber;
• Hygienic application if the internal gasket and pipe
diameters are identical ;
• They are also available in sizes appropriate to manholes
(e.g. 510, 610 mm internal diameter).
Gylon
• A modified type of PTFE under Gylon brand can be used
at temperatures between -200 and +260°C; d1
• Their ability to retain their form renders, qualifies them for d2
hygienic applications;
• The material is non-toxic, and meets FDA standards.
DIN 11864 Flange coupling (gasket included) DIN 11864-2A
• Pipe flange coupling 2A meets hygienic requirements;

DIN 11864-2B
• Pipe flange coupling 2b meets aseptic requirements.

99.04.04.100
5.7 COUPLINGS
In the past Heineken implemented Heineken and DIN couplings, the latter in accordance with DIN 11851,
in combination with the standard seals.
These types are no longer considered to be a sanitary. Regarding DIN 11851 the replacement of the seal
ring by aseptic inner parts provides a sanitary solution.
The DIN 11864-1 A coupling is advertised as hygienic solution, while the B series of these type of coupling
could be used for aseptic requirements.
⌧ What is known as the Heineken coupling no longer

meets the hygienic requirements; the reason is
S
that the packing is derived from the DIN coupling.
Older models with a flat packing are more suitable.
Rd
A
L
The DIN 11851 coupling is suitable for conversion

to a hygienic coupling by the use of a special
gasket set.
Rd
B
A
Aseptic inner parts L
The DIN 11864-1 A coupling for hygienic purpose

The DIN 11864-1 B coupling satisfies even aseptic
A
requirements. B
Rd
A
B
L
The ISS, ISO 2853, coupling satisfies hygienic

requirements. The gasket must be provided with
S
metal reinforcement so as to prevent the unlimited

compression of the rubber. Use long model for
D
A
Tr
orbital welding
Short model shown
Tri-clamp couplings in accordance with ISO 2852

meet hygienic requirements. This type is primarily
used in American equipment. Although
compression is unlimited, deformation of the
gasket should not exceed 25 %
Tri-clamp according DIN 11864 – 3 available in

hygienic (A) and aseptic (B) execution
Short model shown

99.04.04.100
5.8 HOSES
Hoses must be capable to withstand medium-pressure. The lining shall be of FDA-certified thermoplastic
rubber, e.g. : Gates Brew Master®.
Note: Care should be paid to the ageing of rubber and to the critical point at the changeover from metal
to rubber. The casing on the outside of the hose should be of a length at least equal to the length
of the attachmrd pipe accommodating the hose.
The undulated construction of stainless steel hoses makes them unsuitable for hygienic applications (incl.
their compensating characteristics).

99.04.04.100
5.9 HYGIENIC METERING

Mix-proof valves shall be used for metering in sanitary pipes.
⌧
CIP RETURN DOSING POINT
DOSING POINT
CIP
PRODUCT LINE PRODUCT LINE
5.10 PIPE SUPPORTS

Supports for pipes should be constructed such that the accumulation of moisture or soil is prevented. This
requirement can be established by closed box profile supports. A correct support on the floor is achieved
when the edges of the baseplate are rounded off to an appropriate extent, the baseplate mates flush with
the top layer of the floor, and stainless steel capped nuts are used to anchor the support.
5.11 MANUFACTURE & INSPECTION

References: AWS D18.1 /18.2 Spec for Welding of Austenitic SS Pipe Systems in Sanitary Applications.
HMESC 74.00.02.000, Manufacturing Instructions Stainless Steel Piping, chapter 5.
HMESC 74.00.02.010, Degreasing Pickling & Passivation Instruction
Welding work must be done using the Gas Tungsten Arc Welding (GTAW) process, commonly referred to
as TIG (Tungsten Inert Gas). Permanent metal-to-metal product contact joints shall be continuously welded
and free of imperfections. During welding, there should be a protective gas at both welding surfaces. If
welding is carried out properly, no post-welding treatments (grinding or polishing) are needed.
For pipe-work, the preferred method is automatic orbital welding. A properly programmed orbital welding
machine is capable of producing consistently high-quality welds. Welds on the non-product contact side
needs to be also continuous and should be smooth enough to allow proper cleaning.
Inner pipe welds shall be inspected by endoscope. When the inspection satisfies a project defined level,
also from a hygienic design point of view it is advised only to degrease and not to pickle and passivate.
Orbital welding machine >>>
Preferably with Automatic Penetration Control and ppm

O2 measurement.

99.04.04.100
6. VALVES
6.1 BUTTERFLY VALVES
Butterfly valves EHEDG tested or equivalent satisfy the hygienic requirements. However it is important to
verify that the rubber used in the valve has received FDA certification. For Hygienic Zoning M and H the
roughness of the valve regarding the parts that come into contact with the product should comply with the
standard Ra ≤ 0.8 μm (sterile class 3).
Testing of butterfly valves shows that hygienically designed valves besides surface roughness Ra ≤ 0.8 μm
should have disk and shafts in one peace, consequently the valve body divided into two parts. This
construction enables a smooth bearing of the two shaft ends.
Butterfly valves, wafer type (applies also for lug type)

Hygienic Zone B
The EPDM compound has FDA certification
Disk and shafts may be separated parts.
Butterfly valves, wafer type (applies also for lug type)

Hygienic Zone M and H:
The metal parts of the valve in contact with the product
are polished to a roughness of Ra ≤ 0.8 μm and disk and
shafts are in one peace. EHEDG certification, or
equivalent, is recommended
DIN 11850 Wafer Type, with flanges

The metal parts of the stainless steel valve coming into
contact with the product shall satisfy the requirements for
roughness of the surface. A certification of the seat
material, which provides permission for its use with
foodstuff, is required; the seat should regularly be
inspected for wear and leaks (HACCP). For these types
'Lipseal' sealing is used.
DIN 11850, Welding stud DIN 11851, thrd end
In addition to the general requirements for butterfly
valves, valves with threaded connections must be fitted
with the special seal manufactured by SKS.
Heineken series, Welding stud, Rd thrd end

⌧ This is not suitable for hygienic applications, due to the
Heineken threaded connection with enclosed packing.
Flanged connection / Thrd end DIN 11851

This type of valve is suitable for use as a tank valve,
provided that it is equipped with the SKS seal

99.04.04.100
6.2 BALL VALVES

Ball valves could be obtained in various makes, models and materials. Stainless Steel models could be
used for draining and venting of water and cleaning pipeline systems, while certain types (two-part models)
comply with a certain level of hygienic rtequirements.
The two-part model has been tested at the Technical University of Munich. The design is excellent but the
problem seems to be that the right material for the sealing part has to be found. The material used needed
a too high compression to seal in the right way.
⌧ The standard three-part ball valve does not

have a hygienic construction.
A (two-part) model tested by EHEDG is an

alternative for the stainless steel butterfly valve.
Ball valve based V-Flow Control Valve as

stainless steel /flanged model has up to DN50
hygienic characteristics.
6.3 DIAPHRAGM VALVES

Diaphragm valves with an internal high finish (Ra = 0.6 μm) meet sterile class 3 requirements to a large
extent. Weld ends are suitable to orbital welding and the diaphragm material is FDA approved. Dependent
on the size, the valve should be mounted horizontally angled with an angle of 15º and 35º for self-draining.
Manually operated
Remote controlled

99.04.04.100
6.4 NON-RETURN VALVES

When possible the use of non-return valves in sanitary pipelines should be avoided. Usually in computer-
controlled systems operated valves can be used instead of non-return valves.
The following types of non-return valve may be used in situations in which the use of this type of valve is
unavoidable:
This type is suited solely for vertical installation
This valve manufactured by Gestra is suitable

for both horizontal and vertical installation.
Sealing: EPDM
6.5 MIX-PROOF VALVES

Mix-proof valves are used in automated distribution systems and could be regarded as nodes in a network.
Opening /closing these valves determines the liquid route to be followed in the piping system. These routes
are specified in computer programs; the valves are remotely controlled in accordance with the controlling
computer requirements.
Mix-proof valves are intended to provide a safe separation of product and cleaning agents. These valves
are provided with an upper and a lower valve seat, which are separated by a chamber open to the
atmosphere (this chamber is referred to as the open-drain chamber).
The following requirements are applicable to mix-proof valves:

• Shall be suitable for the simultaneous passage of multiple types of liquid, separated by an open drain;
• The top and bottom halves of the valve should be capable of independent passage operation;
• The open drain chamber shall be capable of an appropriate cleaning (product residues may not remain
in this chamber!);
• The valve must be constructed robustly from stainless steel;
• The sealing material needs to be suitable for contact with the product (such as beer, yeast) and shall
possess FDA certification or equivalent. Moreover it must be able to withstand the effects of cleaning
agents (both alkaline and acidic) at a temperature of 90°C and of disinfectants (at room temperature).
Note: Butterfly valves equipped with two butterfly discs and slots do not meet the requirements above-
mentioned; these will be discussed later (see paragraph 6.6).

99.04.04.100
Two-port mix-proof valve divided in main parts indicated and below presented in open and closed position:
Mix-proof valves should be of a

hygienic design, achieved by measures
including the following:
• The internal parts of valve housing,

the valve stem and the valve seats Control Unit
should be of a smoothness such
that they are capable of appropriate
cleaning, i.e. a Ra ≤ 0.8 μm.
• The valve should be constructed in

such a manner that the design does
not contain any
- Air pockets;
- Dead ends;
- Sharp corners; Actuator, spring closed /air to open
- Sags.
• The sealing of the two halves of the

valves should be constructed in a
way such that product cannot
access or remain in the groove Spindle /chamber
under the sealing, see Detail A. cleaning connection
Valve body
Detail A
Upper seat
Lower seat
Drain
CLOSED POSITION OPEN POSITION

The cleaning of the valve stem in the drain chamber will suffice when an open valve with static seals is
cleaned from top to bottom, or from bottom to top through the valve (See example - Open position).

99.04.04.100
Mix-proof valves serve computer controlled production processes:
• Single set-up
• Matrix set-up
SINGLE VALVE
APPLICATION
MATRIX APPLICATION
Multi-port valves represent an important and complicated item category within process installations. Models
and options are a continuous subject for consideration and adjustment. Justified valve choices require to be
acquainted with the state of the art and to have a well understanding.
The valves are characterised by two or three port chambers, disc-set arrangement, connection pattern and
operating element. The mix-proof models can be adapted to specific process requirements through the
options, balanced, leakproof and seatlifting (one or two seats). Shuttle valves (3 ports) can be mix-proof
between upper and middle chamber. 3-ports mix-proof models are not recommended for application.
Delivery programs of suppliers differ from each other, resulting in different disc-set arrangements and some
specific valve configurations per supplier. Anyhow Heineken prefers all mix-proof to be cleaned; however it
is supplier responsibility that each mix-proof valve operates thoroughly hygienic taking into account:
• Designs with conical seats (see pictures) can cause problems. Leakage can arise during actuating if the
leakage area is not sealed during closing of the lower seat. In consequence fluid drops from the leakage
outlet after closing the valve. During this time the function of the seats cannot be controlled.
• The principle of double seals does no longer apply with seat lifting. Even if the leakage chamber is open to
the outside (no overpressure) a cross contamination can occur if a part of the valve contains product.
• In extreme circumstances both cleaning options stem rinsing and seat lifting could be used combined. In
most cases one option suffices; in case of seat lifting a stem rinse option is not present.
• Customer shall verify clean and safe valves operations by HACCP procedure (check mechanism).

99.04.04.100
The options balanced – leakfree – seatlifting – visually stipulated.
⌧ Unbalanced Balanced
Balanced
lower seat
⌧ With switch losses Leakfree
Spindle cleaning ⌧ Seat lifting – Cluster Application

Seat lifting – Single or Independent Valve
Cleaning Application (also in matrices)
Under, above or both seats
Product
Cleaning

99.04.04.100
6.6 TWIN-DISC BUTTERFLY VALVES
Twin-disc butterfly valve with drain area and drain valves (spring-loaded).
Although this valve complies with the functional requirements for the separation of product and cleaning
agent, the drain chamber and the drain valves are not cleaned in an appropriate way. Consequently this
type of valve is not recommended for situations in which the valve will come into contact with the product.

99.04.04.100
7. OTHER ACCESSORIES
7.1 COMPENSATORS
In the first place endeavours should be made to accommodate thermal expansion by means of expansion
loops in the piping. Compensators must be used when expansion loops are not feasible. Care must be
taken to ensure that compensators in horizontal piping do not retain product or cleaning agents subsequent
to the drainage of the pipeline.
In withstanding with the aforementioned statement, the Varicomp Expansion Compensator is advised for
application within multi-port valve matrices to born tension stresses and vibrations.
Filled Arch, Varicomp Expansion

Straight through liner, Compensator for hygienic and
Vacuum Support Rings. aseptic applications
Note: Rubber coming into contact with product should possess FDA certification or equivalent.
7.2 SIGHT-GLASSES
The Varivent in-line housing should be used for sight-glasses. Sight-glasses shall be fitted such that no
product or cleaning agent is retained between the glasses subsequent to the drainage of the pipeline. The
surface should have the same internal diameter as the pipe. A minor protuberance is permissible.
If dead ends arise from studs for sight glasses the

depth of the dead end should be as short as
possible.
These sight-glasses should be installed such that
A double T sight glass has to be mounted in a residues cannot accumulate behind the glasses.
way to be drainable DN≤50 may be used solely in vertical pipes.

99.04.04.100
7.3 SAFETY RELIEF VALVES (UNDER AND OVERPRESSURE)

Safety relief valves used on tanks and in pipes shall be of a hygienic construction. The most hygienic types
of safety relief valves have sealing contact surfaces, which are cleaned during the cleaning of the system.
Under-pressure relief valve

The cleaning of the sealing contact surfaces of
under /overpressure safety relief valves is enabled
Seatlift by equipping the device with a seatlift cylinder.
cilinder
The seatlift cylinder is used to raise the relief valve
a few millimetres from the seat during the standard
cleaning cycle of the tank served,
Packing The system's spray nozzle then sprays cleaning
contact
surface
agent into the interior of the relief valve, thereby
cleaning the sealing contact surfaces.
Spray nozzle
Over-pressure relief valve
Seatlift
cilinder
Packing
contact
surface

99.04.04.100
7.4 PROCESS CONTROL AND INSTRUMENT CONNECTIONS

Instruments shall be suited to the Varivent® in-line unit or to an equivalence construction approved by
EHEDG. The Varivent® in-line unit is applicable up to pipe size DN125.
Varivent® in-line unit

C
DN
K
68
Calibration
For in-line calibration of flow meters, line size based standard Varivent® valve bodies are used.
Process control and instrument connections to equipment and pipelines ≥ DN150 are welded directly to the
tank or pipeline, provided that this method of installation does not result in dead ends.
Flange T
- For welding in tanks and vessels (conical
or dished bottom, tank wall max. 8
- For installation of e.g.VARIVENT®
pressure or level sensors or sight glasses
etc.
Note: Observe welding instructions for welding the flanges
and use welding device (device also available on loan)
Flange U
- For welding in tanks, vessels (conical and
dished bottom) and pipelines ≥ DN150
- For installation of VARIVENT® pressure
and level indicators or sight glasse etc.
Note: Observe welding instructions for welding the flanges
(no welding device required)
Examples of Instruments connected:
2 1
DN
PI in pipeline TE PT LS

99.04.04.100
8. PUMPS
8.1 GENERAL
For a more technical view on pumps, see HMESC 99.04.04.200 the Plant Design Guide entry on Pumps.
The machine directive requires that a pump must be self-drainable (arranged).
8.2 CENTRIFUGAL PUMPS

Centrifugal pumps are used for product (i.e. wort, beer, yeast, sediment), water and cleaning. Product
pumps should be suitable for appropriate cleaning and meeting the requirements of the hygienic zoning.
The requirements to be met by pumps suitable for use are:
• Materials of construction of pump and impeller: stainless steel ;B, M and H hygienic Zoning
• Seals: EPDM (FDA approved) ;B, M and H hygienic Zoning
• Internal surface roughness of pump and impeller Ra ≤ 0.8 μm ;M and H hygienic Zoning
Ra ≤ 3.2 μm is permissible for cast stainless steel in B Zone.
• Materials used for mechanical seals should be suitable for contact with product and cleaning agents.
The material for the seats shall be impervious, such as Sil, C, high-density C, or hard metal.
• The seal of the internal mechanical seal shall make use of an exposed spring or should otherwise be
constructed such that the spring is protected (i.e. is not accessed by the product / cleaning agent).
• Mechanical seals should be easily accessible for cleaning agents.
Examples below are a snapshot in time, so be aware of alternatives and new developments:
Example A (EHEDG approved) Example B (EHEDG approved)

Pump with mechanical Pump with external
seal immediately after mechanical seal
Impeller
the impeller
Often applied centrifugal pumps in the brewery:
Hygienic Zone B Hygienic Zone M & H

Non-clogging impeller Vitachrom meets the
pump for solids-laden strength hygiene standards
products. for plant components.
• Stainless Steel • Stainless Steel
• FDA approved materials • FDA approved materials
• No EHEDG required • EHEDG certified
• External seal flushing • Internal seal flushing
Hygienic CIP Hygienic Zone M & H

• This hygienic pump is • Centrifugal pump meting
characterised by its self the hygienic criteria of
priming capacities, sterile technology.
• The pump is ideally • EHEDG Test Certificate
suited to pump liquids
• Sanitary Standard 3-A
with entrained air/gasses.

99.04.04.100
8.3 POSITIVE DISPLACEMENT PUMPS

Within Heineken production sites Positive Displacements are mainly applied for the pumping of volatile
fluids (yeast, slurries) and for accurate proportioning purposes (dosing).
Based on type, a Positive Displacement Pump causes more or less pulsation. A right pump choice, a well
sized piping system and the use of pulse damper can minimise consequences of pulsation (vibration,
noise, instrumental damage). A gentle handling of the product by pump contributes to a hygienic operation.
Especially this category pumps knows a variety in types. Below a snapshot is shown of pumps used in
breweries with hygienic characteristics.
Sine Pump
• The gentle, virtually pulse-free action of the sinusoidal rotor avoids
product deterioration during pumping >> EHEDG certified.
• The pump body is constructed of 316 stainless steel and various
materials can be matched to suit the specific application.
• Sine pumps are suitable for CIP cleaning and they can also be
easily dismantled without removal from the process line.
Flexible Impeller Pump

• This hygienic pump is inexpensive to buy and operate. Its gentle
pumping action effectively handles thin, viscous, shear sensitive,
and particle-laden fluids.
• Being self-priming, this pump may be mounted either above or
below the source of liquid.
• Its simple construction makes them easy to use and service.
• The pump carries the 3-A symbol.
Diaphragm Pump
• This sanitary pump gently handles the widest range of viscosities
and particle sizes (Up to 6" (15 cm)).
• The pump design meets the requirements of sanitary processing
industries and it is FDA approved to meet general 3-A standards.
• Additionally, they are oil free, low maintenance and easy to
assemble /disassemble.
Lobe Pump
• This positive displacement rotary pump has been designed for
applications meeting hygienic processing standards.
• Being EHEDG certified (as fully CIP cleanable to their protocol),
the lobe pump is ideally suited to applications in food industries,
where full cleanability and corrosion resistance are paramount.
• The pump operates with a high efficiency, low shear pumping
action for assured gentle handling of delicate and sensitive media
Hose Pump
• Robust hygienic pump with EHEDG Certificate
• Suited to pump clear, abrasive and viscose fluids
• Simple hose (dis) mantling
⌧ Pulsation

99.04.04.100
9. HEAT EXCHANGERS
9.1 GENERAL
A wide variety of heat exchangers is used to serve heating /cooling purposes
in direct and indirect heating /cooling systems.
The main types are, ● Tubular Heat Exchangers,

• Plate Heat Exchangers;
• Scraped Surface Heat Exchangers
Each type is suitable for particular applications and has particular requirements. Herewith a listing is shown
of the common hygienic requirements to all types of Heat Exchangers.
• They should be fully cleanable, smoothly to be drained and accessible for inspection;
• The construction materials under in-use conditions shall withstand any CIP fluid used;
• Service fluids should not be corrosive;
• If the service side of the Heat Exchanger is drained, removal of all service liquid shall be assured.
• Pockets (dead legs) or crevices should not be present at the product side, as they are difficult to clean
and product will reside in them for much longer than the mean residence time.
• All connections in the sterile area of the plant shall be aseptic;
• There must always a product safe separation between the product flow and the heating or cooling
medium e.g. by mix-proof valve or block and bleed valve.
• Replacement gaskets fulfil the requirements specified by the manufacturer of the Heat Exchanger.
• In case of high-fouling products, the flow passage should not be too narrow, to prevent blockage. For
some products, increased velocity helps control fouling and product blockage.
• To prevent stress corrosion, the design should prevent differences in expansion and contraction
leading to unacceptable stress at times of maximum differences in temperature, such as start-up,
shutdown and cleaning.
• Product flows should be designed such to avoid air entrapment within the system.
9.2 TUBULAR HEAT EXCHANGERS

In addition to the common ones aforementioned
the tubular heat exchangers share the following
requirements:
• The manufacturer shall ensure that welds are

of a sufficient quality, taking into account the
applying Design Code and project-specified
process and cleaning conditions.
• Spacers require being easy to clean.
• The design should be prevented from 'channelling' of highly viscous products. In case of insufficient
turbulence, hygienic mixing elements may be necessary to ensure a homogeneous temperature
• The design shall be prevented from vibrations or resonance, which loosen screwed connections such
as of pipe couplings; yet if this occur, product safety shall be ensured (e.g. installing aseptic dampers).

99.04.04.100
9.3 PLATE HEAT EXCHANGERS

Plate Heat Exchangers are widely used. In addition to the common requirements listed in paragraph 9.1,
the following points should be taken into account:
• It is the manufacturer's responsibility to inspect the steel sheet plate for absence of flaws;
• Appearing stress corrosion of plates caused by mechanical damage due to pulsation and vibration
should therefore be minimised by use of dampers.
• The plates in contact with sterile product should be regularly checked on mechanical damage. If such
information on plate sheet is available, plates shall be replaced.
• Plates should have a surface roughness not exceeding an average Ra value of 1.0 μm, however
preferably Ra < 0,8 μm.
Commonly used type Entirely Stainless Steel

Single plate:
9.4 SCRAPED SURFACE HEAT EXCHANGERS

Scraped Surface Heat Exchangers (SSHE) consist of a jacketed cylinder with a rotating dasher holding
rows of scraper blades. The product is pumped through
the cylinder while the heating or cooling
medium is circulated between the cylinder
and the jacket. The medium can be steam,
water or a refrigerant.
<< Example Principle >>
• They should he fully cleanable and drainable;
• A minimum of fittings should be used and shall be suitable for aseptic operation;
• Fluid velocity and the slope of the tube should avoid air pocket formation;
• Product entering the tube must not contain uncondensed bubbles of air or steam, to
prevent variable holding times;
• Constant product flow rate is required;
• It should be possible to determine the minimum holding tube residence time for any product;
• The flow rate shall not exceed the design value or not reaching the required residence time;
• If fouling is likely, its influence on the minimum residence time should be taken into account;
• Any sensors should be designed and installed for aseptic operation;
• Any insulation should not be corrosive towards the material of the holding section.

99.04.04.100
10. PROCESS EQUIPMENT

10.1 CONSTRUCTION
Process Equipment – to serve production and cleaning purposes – in breweries have been classified as
Hygienic Class 1 Equipment. Although geographical a different hygienic zoning could apply, for process
tanks and equipment a consistent set of hygienic requirements throughout a brewery applies:
• Inner surface roughness Ra ≤ 0.8 μm ;see paragraph 2.5 - Sterile Classification
• Smooth bottom and top change-overs ;see paragraph 3.7 - Sharp Corners
• No dead ends or closed studs ;see paragraph 3.8 - Dead ends
• No annoying or hygiene decreasing thermal remaining deformation due to welding;
• Internal welds decolourised and ground to Ra = 0.8 μm;
• 100 % cleaning pattern by a right choice of type, capacity and number of spray-ball(s);
• Avoidance of shadow areas by a sophisticated (conical) arrangement of auxiliaries;
• Self-draining /evacuating: to self-draining an angle of inclination ≥ 3°applies.

In practice a slope of 2 % is acceptable for Horaps (risk: water residue);
• Supports should be constructed such that the accumulation of moisture

or soil is prevented e.g. to be established by closed profile supports.
HOLES MUST BE FILLED-UP
• Supports should be poured smoothly in their surrounding. Along side

an example enabling Hygienic Operation; no obstacles; easy to clean.
• Product connections according to DIN 11864 A. Only cooling CONCRETE

connections can be executed not sanitary;
• Instruments connections by Varivent flange type U;
• Alternatively Instruments could be flanged to the equipment. PT100 wells, could be welded directly in
tank wall, giving the best construction /hygienic solution.
Instrument connection ⌧ Instrument Connection Flanged Direct in tank wall

Varivent
• The large sized nozzles may not be sealed with flat gaskets:
Top Nozzle Manhole, provided that the Swivel Bottom

sealing is vulcanised to cover:

99.04.04.100
10.2 SPRAY BALLS

Commonly for the cleaning of vertical tanks /vessels one Spray Ball is used, centrally positioned in the top
of the tank. In horizontal tanks however one or more specific Cleaning Machines are used;
Spray Ball for vertical tanks Cleaning Machine for horizontal tanks
Hairpin
Hole
a) Heineken makes use of permanent installed Spray Balls for vertical tanks. The type of spraying head
to be used depends on the diameter and height of the tank.
• It is important that the diameter of the feed pipe is smaller than the diameter of the spraying head ;
the resultant transition will ensure that the connection with the spraying pipe and part of the feed
pipe will also be cleaned;
• The spraying head should be attached to the feed pipe by means of a hairpin;
• Spray Balls shall be capable of cleaning themselves (self-cleaning) and shall not retain residual
amounts of liquids (self-draining);
• Burs on the inside of fixed spray balls must be removed prior to assembly. Requirements pertaining
to surface roughness are applicable to both the internal and external surfaces of spray balls.
b) Heineken makes use of Cleaning Machines for horizontal tanks. A characteristic of Cleaning Machines
is that they make use of lower flow rates than spray balls, although the required liquid imprint is usually
larger than is those of spray balls. The attachment of the cleaning machine to the feed pipe should
also make use of a hygienic design.
10.3 DRIVE SHAFTS AND BEARINGS

Apparatus such as stirrers, homogenises and mixers should preferably be arranged in such a way that
sealing of shaft passages in the product area is avoided by mounting them above the product area. If a
shaft passage is indispensable, dynamic seals shall be used.
When shaft ends and couplings are in contact with the product, crevices
caused by metal-to-metal contact and dead spaces in grooves shall be
avoided. If adhesives are used for metal-to-metal joints, they and the
bonds created by their use should follow the recommendations given for
permanent joints.
Hubs, nuts and coupling shafts must be carefully sealed under
controlled compression to avoid metal-to-metal contact areas and
crevices and gaps that can harbour soil. Corners (e.g. hubs and nuts)
must be radiused and horizontal areas sloped. To avoid any screwed
joints, the blades of appendages (e.g. stirrers, homogenisers, mixers,
cutters) should be welded to the hub.
If the motor drive is arranged above the product, it should preferably be placed next to the equipment. The
possibility of contamination by lubricants and soil from the motor or gear entering the product area shall be
avoided by using drip trays in combination with throw rings on the shaft. A hygienically designed cowl
should cover the motor.

99.04.04.100
It is advised to avoid bearings in the product fluid. However when bearings are unavoidable the outlines
below apply:
• The bearing shall be mounted clear of the base to

allow free-flow cleaning of the feet;
• The shaft must have free space or grooves from top

to bottom for lubrication by the product and to facilitate
cleaning;
• When lubrication is required lubricants compatible

with food shall be used;
• The hygiene risks of sealed bearings shall be

covered by risk decreasing provisions.
10.4 EQUIPMENT ARRANGEMENT

The subject Equipment Arrangement is served by project engineering. Hygienic requirements to Equipment
Arrangement are integrally part of the applying engineering outlines, which have been laid down in the
Plant Design Guideline entries below:
HMESC 99.04.04.120 – Masterplan ; production phasing - installed and yet to-be installed
HMESC 99.04.04.130 – Drainage ;functional & hygiene requirements to open /closed systems
HMESC 99.04.04.140 – Pipe Bridge ;Pipe Bridge design outlines taking in account civil hygiene
HMESC 99.04.04.150 – Platforms, stairs & ladders according to NEN–EN–ISO 14122
HMESC 99.04.04.160 – Plot Plan ;to benefit operable, inspection and maintenance purposes

99.04.04.100
11. VERIFICATION AND MAINTAINING THE HYGIENE REQUIREMENTS

11.1 VERIFICATION AND MEASURES
Verification of and Measures for Hygiene

Requirements
Requirements
according to Requirement Verification
Chapters 3-5
General Material specification (food, process and cleaning
Durable
requirements specifications, etc.) and/or practical or functional test
Food area, splash Cleanable and/or capable of Visual inspection (drawing(s) ; on machinery) and/or
area, non-food area
being disinfected practical test, micro biological test or functional test
Food and non-food Material specification (food, process and cleaning
Corrosion resistent
area specifications, etc.) and/or practical or functional test
Material specification or practical test for materials and
Food area Non toxic
articles intended to come into contact with food
Food area Non absorbent
Not transfer undesirable
Food area odours, colours or taint to the
food
Not contribute either to the
Food and non-food contamination of food or Material specification or practical test for materials and
area have any adverse influence articles intended to come into contact with food
on the food
Food area Surface design Visual inspection (drawing(s) ; on machinery)
Food and non-food
Surface finish Measuring
area
Food area Permanent joints Visual inspection
Food area Dismountable joints Visual inspection
Food area Fasteners Visual inspection

Food and non-food Visual inspection (drawing(s) ; on machinery) and
Drainage
area practical tests
Food and non-food
lnternal angles and corners Measurements
area
Food area Dead spaces Visual inspection
Bearings and shaft entry
Food area Visual inspection
points
Food area Panels, covers, doors Visual inspection
Food area Cupboards & Sideboards Visual Inspection
Food area Control devices Visual inspection
Splash area See relevant subclauses above
Non-food area See relevant subclauses above
Services See relevant subclauses above

99.04.04.100
11.2 INTRODUCTION TO HACCP

Hazard Analysis by Critical Control Point (HACCP) is a management tool, developed in the late 1960s, to
ensure the safety of foods for space flights. lt was subsequently recognised as an effective alternative to
conventional endpoint-testing by the World Health Organisation (WHO) and the United Nations Food and
Agriculture Organisation (FAO), amongst others, and recommended for use in commercial food production.
HACCP Principles are now incorporated in national food safety legislation of many countries, as well as a
component of the standardisation of international food quality control and assurance practices.
11.3 HEINEKEN AND HACCP

The Heineken HACCP Guide is inline with the ISO 22000 standard for food safety management system.
This guide is meant to assist breweries to implement and improve their HACCP (Hazard Analysis Critical
Control Points) based Food Safety system. Starting point of this guide is the Product Integrity Policy and
the Codex Alimentarius. Practical and specific brewery HACCP information forms a part of the Guide and is
mainly based on the publication of the European Brewery Convention and Brewers of Europe: "Managing
Food Safety in the European Brewing Industry through the Application of HACCP Principles". This
publication is used as basis, but made fit for Heineken.
11.4 INTRODUCTION TO CE CERTIFICATION OF MACHINES

While implementing projects within the European Economic Area (EEA), Heineken is subject to European
directives, in particular the Machine Directive and the associated CE (Conformité Européene) certification.
The essential requirements of the Machinery Directive have to be met in respect of both safety and hygiene
risks. The Directive requirements and the safety and hygiene risks identified by the risk assessment
process required by ISO 12100 can each usually equally well be met by a range of safeguarding or hygiene
design options.
11.5 THE HEINEKEN MACHINE DIRECTIVE MANUAL

This manual has been developed with the aim of enabling Heineken Operating Companies to correctly deal
with the Machine Directive obligations. This manual discusses all the relevant aspects of the CE
certification of machines at Heineken.
The heart of the manual is contained in chapter 4. This chapter is specific to Heineken and specifies who
has to do which CE activities during a given stage of a project. This chapter refers to the eight modules that
are included in the manual for the practical content of the work involved.

99.04.04.100
12. REFERENCES
12.1 DIRECTIVES
EUROPEAN UNION
Directive 2006/42/EC
(Machine Directive) of the European Parliament and the Council of 06 June 2006 on the approximation
of the laws of the Member States relating to machinery.
Council Directive 89/109/EEC
of 21 December 1988 on the approximation of the laws of the Member States relating to materials and
articles intended to come into contact with foodstuff.
Commission Directive 90/128/EC
of 23 February 1990 relating to plastic materials and articles intended to come into contact with
foodstuff.
of 27 July 1976 on the approximation of the laws of the Member States relating to common provisions
for pressure vessels and methods for inspecting them.
of 25 June 1987 on the harmonisation of the laws of the Member States relating to simple pressure
vessels.
European Parliament and Council Directives 97/23/EC of 29 May 1997 on the approximation of the
laws of the Member States concerning pressure equipment.
of 21 December 1988 on the approximation of the laws, regulations and administrative provisions of the
Member States relating to construction products.
USA FOOD AND DRUG ADMINISTRATION (FDA), www.access.gpo.gov

CFR Title 21—Food and Drugs, Chapter I, Part 110—Current Good Manufacturing Practice in
Manufacturing, Packing of Holding Human Food.
Subpart B—Buildings and Facilities
CFR Title 21—Food and Drugs, Chapter 1, Part 177—Indirect food additives: Polymers
CFR Title 21—Food and Drugs, Chapter 1, Part 175—Indirect food additives: Adhesives and
components of coatings
12.2 STANDARDISING ORGANISATIONS

ISO, www.iso.org
ISO 14159: Safety of machinery—Hygienic requirements for the design of machinery.
CEN, www.cenorm.be/cenorm/index.htm
European Standards on Information for Use of Machinery
ISO 12100: Safety of machinery -- Basic concepts, general principles for design
NEN-EN 1672-2 rev: Food processing machinery – Basic concepts – Part 2: Hygienic requirements:
Under Approval
NSF Internationaal (USA), www.nsf.org:
Draft: NSF 116-01ds: 03-Dec-2001 Nonfood compounds used in food processing facilities – Food-grade
lubrications, Revision of Draft standard for Trial Use 116 – 2000
NSF/ANSI 14-2003: Plastics Piping System Components and Related Materials
DIN, www.beuth.de
(Norm-Entwurf) DIN 11864, Armaturen aus nichtrostenden Stahl für Aseptik, Chemie und Pharmazie.

99.04.04.100
12.3 INTERNATIONAL STANDARDS
ISO 12100 Safety of machinery – Basic concepts, general principles for design
NEN-EN 1672-2 Food processing machinery - Safety and hygiene requirements - Basic concepts -
Part 2: Hygiene requirements.
ISO 2037 Stainless steel tubes for the food industry

DIN 11850 Stainless steel tubes for the food industry
NEN-EN 10204 Products of metal – Types of certificates
NEN-EN 287 Examination of Welders - Fusion Welding
ISO 3834 Quality requirements for fusion welding of metallic materials
ISO 15607 Specification and qualification of welding procedures for metallic materials --
General rules
Welding procedure specification
Welding procedure test
Requirements and recognition of Welding Procedures for Metallic Materials - Recognition by the Use of
Recognised Filler Metals
NEN-EN 473 Qualification and Certification of Personnel for the Non-destructive Test - General
Bases
ISO 14731 Welding Supervision - Assignments and Responsibility.
ISO 3834 Fusion Welding of Metallic Materials - Standard Quality Requirements
AWS D18.1 /D18.2 Specification for Welding Stainless Steel Pipe systems in sanitary applications

99.04.04.100
12.4 EHEDG GUIDELINE DOCUMENTS
Internet link: http://www.ehedg.org/guidelines.htm
Recommendations for Aseptic Filling, see also the K.I.P.P. (key word “aseptic”)
12.5 STANDARDS
Heineken has laid down their production processes into Brewery Process Standards, Brewery Process
Descriptions and Brewery Process Equipment Standards available in the HeiQ.
12.6 TECHNICAL REFERENCE MANUAL

The Technical Reference Manual composes the method, the data and the instructions to draw engineering
drawings and to specify the articles to be used. Besides a reference to indoor purposes the TRM is also a
reference for outdoor engineering and manufacturing. The Hygienic Design Manual is a prominent part of a
project or customer TRM. Herewith the TRM contents in a glance:
Article Catalogue Custom /project selected
Drawing Management Instructions HMESC 99.02.01
Coding Instructions HMESC 99.04.02
P&ID cell library HMESC 99.04.03.0
Piping Specification Practice HMESC 99.04.03.1
Hygienic Design Manual HMESC 99.04.04.100
Plant Design Guidelines HMESC 99.04.04.120 - 200
Manufacturing Instructions Carbon Steel HMESC 74.00.01.000
Manufacturing Instructions Stainless Steel Piping HMECS 74.00.02.000
Pickling and Passivating of Stainless Steel Equipment and Piping HMESC 74.00.02.010
Insulation specifications
Pipeline Support specifications
Paint instructions

99.04.04.100
APPENDIX A
A1 - EHEDG CLEANABILITY TEST
The in-place cleanability test is used to assess the extent to which a design complies with the hygienic
requirements, i.e. whether the design results in regions in which product or micro-organisms are protected
from cleaning. The test can also be used to examine the effect of various cleaning agents on different
designs, and to compare the cleanability of different designs. The cleanability of the processing equipment
or machine is compared with the cleanability of reference pipes of various known surface roughnesses.
Reference
TI pipe
R Test item
Cleaning agent (equipment
Steam to be tested)
FI
Rinsing
water
Condensate PI
The test involves 3 steps:
1. Soiling
The test equipment and the reference pipe are soiled with diluted acidified milk, spiked with spores of
a thermophilic bacteria (Bacillus stearothermophilis var. calidolactis). The use of this thermophilic
species for the assessment of the cleanability allows the equipment to be tested in non-sterile
surroundings. As a result of the elevated temperatures required for the growth of this species of
bacteria there is a minimal risk of contamination of the surroundings. Furthermore, the spores of this
species are resistant to the cleaning agent used in the test. The test equipment and the reference pipe
are soiled by passing the acidified spiked milk through them under pressure. This is repeated several
times. The test equipment and the reference pipe are then blown dry with air, resulting in the adhesion
of the milk residues and the bacterial spores to their internal surfaces.
2. Cleaning
The test equipment and the reference pipe are then cleaned with a cleaning in place (CIP) system.
A mild cleaning agent is used; the temperature is about 63°C. The flow rate through the pipes should
always be adjusted to 1.5 m/s; a standard flow rate allows the comparison of the cleanability of
processing equipment of different dimensions. The reference pipe should contain traces of milk
subsequent to the cleaning operation if it is to serve as a suitable reference.
3. The detection of residual soil

Subsequent to the cleaning operation the internal surfaces of the test equipment and the reference
pipe are examined on the presence of visible traces of milk. The presence of traces in the equipment
tested and the absence of traces in the reference pipe is indicative of a poor hygienic design.
The location of these milk residues is often indicative of the presence of a dead end in the equipment.
nd
The 2 part of this step is carried out when no visible traces are observed in the equipment tested.
The internal surfaces are first covered with a nutrient medium. During incubation at 58°C any residual
spores in the equipment multiply to form colonies. These colonies result in the discolouration of the
medium. A comparison of the degree of discolouration of the medium in the test equipment and the
reference pipe is a measure of the cleanability of the processing equipment. The location of the
discolouration is also indicative of the position of any dead ends present in the processing equipment.

99.04.04.100
A favourable result from duplicate cleaning tests signifies that the processing equipment complies with
the requirements stipulated for classification in Hygienic Class I (capable of cleaning in place). An
unfavourable result from the cleaning tests may lead to recommendations to make certain
modifications to the design. In the absence of these modifications the processing equipment will be
eligible only for a Hygiene Class II test (manual cleaning subsequent to disassembly).
Processing equipment passing the cleanability test can then be tested for its sterilisability and
impermeability to bacteria so as to determine whether the equipment is eligible for classification as Aseptic
Class equipment.
A2 - EHEDG STERILISABILITY TEST

As processing equipment is frequently sterilised prior to use it is important to ascertain whether this method
of sterilisation is suitable for the design. Equipment of a poor hygienic design offers micro-organisms an
opportunity to survive the sterilisation treatment, due to the protection provided by product residues in dead
ends. This in-line steam sterilisation test has been designed to determine whether the internal surfaces of
processing equipment can be rendered free of viable micro-organisms.
Couplings of a poor hygienic design can exhibit dead ends which retain product residues are incapable of
being accessed by steam during the sterilisation process.
The process equipment is manually cleaned and sterilised prior to the test. The various components of the
equipment are then contaminated with an aqueous suspension of Bacillus subtilis (Bac 1-12) spores. The
contaminated equipment is allowed to dry, and is placed in a special test rig for sterilisation. The
sterilisation process makes use of steam at 121 °C during a period of 30 minutes. It is important that the
test rig has been thoroughly sterilised prior to the test, and that it is possible to pump a sterile medium
through the equipment. It will be clear that all components of the test rig must also be capable of effective
sterilisation by means of this steam treatment, and that the rig must not permit the ingress of micro-
organisms. Following the steam sterilisation of the equipment an initially sterile medium is pumped through
the test rig. This takes place during a period of two hours on five consecutive days. In the event that the
medium remains sterile after the completion of the test then the processing equipment is eligible for
classification as in-line sterilisable equipment.
Processing equipment found to be incapable of sterilisation under the conditions used in this test may
nonetheless be capable of sterilisation when subjected to higher steam temperatures and/or longer
sterilisation times.
A3 - EHEDG BACTERIAL IMPERMEABILITY TEST

This test has been developed to determine whether ambient micro-organisms can access the product via a
given piece of processing equipment. Small motile bacteria can penetrate microscopic openings much
more easily than micro-organisms such as yeasts and moulds. For this reason the bacterial impermeability
is tested using a species of motile bacteria, i.e. Serratia marcescens.
The processing equipment is first sterilised using the test rig for the sterilisability test. The external surfaces
of the equipment are then soiled with bacteria. This contamination is carried out twice a day on three
consecutive days. Where possible conditions in actual practice are simulated by bringing the equipment
into operation ten times subsequent to each contamination. In analogy with the sterilisability test the
medium is pumped through the equipment for a period of two hours on five consecutive days. In
the event that the medium remains clear after the completion of the test then the processing
equipment is eligible for classification as being impermeable for bacteria.
Processing equipment passing the steam sterilisability and bacterial impermeability tests may be regarded
as being aseptic (Aseptic Class)


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Installation

Issue : 11 HYGIENIC DESIGN MANUAL HMESC : 99.04.04.100

Issue : 11 HYGIENIC DESIGN MANUAL HMESC : 99.04.04.100

ISSUE REFERENCE DESCRIPTION

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3-A Sanitary Standard

European Hygienic Equipment Design Group (EHEDG)

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1.4 KEY WORDS

Cleaning The removal of soil from a surface.

Joint An interface between two or more components.

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Application Field >>

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2.4 EQUIPMENT CLASSIFICATION

2.5 STERILE CLASSIFICATION

2.6 EHEDG TEST PROCEDURE

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3.2 EUROPEAN DIRECTIVES

3.3 EHEDG CRITERIA

3.4 HYGIENIC OPERATION

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3.5 FUNCTIONAL REQUIREMENTS OF HYGIENIC DESIGN

Inhibition of the growth of micro-organisms

The surroundings of process equipment

Hygienic requirements versus other requirements

Validation of the hygienic quality

3.6 BASIC REQUIREMENTS FOR PRODUCT-CONTACT SURFACES

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radius ≥ 3 mm Weld: grid 150

Acceptable in the event that: Acceptable in the event that:

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3.7 BASIC REQUIRMENTS FOR NON-PRODUCT CONTACT

3.8 HYGIENIC BASIC DESIGN OUTLINES

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The following stainless-steel piping is used within the Heineken Concern:

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4.5 SURFACE TREATMENT & COATINGS

4.6 STAINLESS STEEL (SS)

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4.7 INSULATION MATERIAL

• Aforementioned is satisfied by the closed-cell insulation

4.8 SIGNAL TRANSMISSION LIQUIDS

EHEDG Doc 23 describes food grade lubricants

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5. PIPING SYSTEMS REQUIREMENTS

The hygiene of processing installations may be exposed to risks due to:

⌧ Support & drainage At pump suction

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hygienic requirements imposed on piping; d2

⌧ Slip-on flanges are less suitable, since they need

⌧ Blind flanges should not be used in sanitary d2

construction, be used to bridge small differences

⌧ Welding neck collars may not be provided with s

⌧ Flat welding collars need to be welded on both

sides; the weld on the packing side must be

flange requires a certain amount of room for

assembly. The flanges are not suitable for

certification (M8 bolts not permitted). DIN 11864-2A

Issue : 11 HYGIENIC DESIGN MANUAL HMESC : 99.04.04.100

Example of a cyclone tank valve using a

Welding neck flange,