Guideline For Hygienic Production of Liquid Site

Procedures & Guidelines
Guideline for the Hygienic Production of Liquid Food

Site & Building Recommendations
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1. INTRODUCTION ................................................................................. 4
2. PLANT PREREQUISITES AND ASPECTS ......................................... 4
2.1.
GENERAL PLANT PREREQUISITES .........................................................................4
2.1.1.
2.1.2.
2.1.3.
2.2.
ZONING ...............................................................................................................5
2.2.1.
2.2.2.
2.3.
Choice of location ............................................................................................................................... 4

Plant layout considerations................................................................................................................ 4
Sanitary conditions of the surroundings .......................................................................................... 5
Zone definition..................................................................................................................................... 6
Zoning Model....................................................................................................................................... 7
AIR HANDLING.....................................................................................................9
2.3.1.
2.3.2.
2.3.3.
Air Handling Zones ............................................................................................................................. 9

Air Filtering & Filter Grade for Food Industry Application............................................................ 10
Room ventilation ............................................................................................................................... 11
3. BUILDING REQUIREMENTS............................................................ 12
3.1.
DESIGN FOR SANITATION....................................................................................12
3.2.
BUILDING ELEMENTS .........................................................................................13
3.2.1.
3.2.2.
3.2.3.
3.2.4.
3.2.5.
3.2.6.
3.2.7.
3.2.8.
3.3.
Floors.................................................................................................................................................. 13
Drains and gutters ............................................................................................................................ 13
Walls................................................................................................................................................... 14
Ceiling................................................................................................................................................. 14
Pipe support system......................................................................................................................... 14
Doorways ........................................................................................................................................... 14
Lighting............................................................................................................................................... 15
Associated equipment...................................................................................................................... 15
FACILITIES ........................................................................................................15
3.3.1.
3.3.2.
3.3.3.
3.3.4.
3.3.5.
3.3.6.
3.3.7.
Water supply ..................................................................................................................................... 15

Chemical storage.............................................................................................................................. 15
Sewage and liquid waste ................................................................................................................. 16
Waste ................................................................................................................................................. 16
Sanitary waste................................................................................................................................... 16
Hand washing facilities .................................................................................................................... 16
Toilets ................................................................................................................................................. 16
4. SPECIFIC PRODUCTION AREA REQUIREMENTS ......................... 17

4.1.
PRODUCTION PHASES ........................................................................................17
4.2.
EQUIPMENT AND PRODUCT TRANSFER.................................................................18
4.3.
RECEPTION AREA REQUIREMENTS .......................................................................19
4.3.1.
4.4.
PRE-PROCESSING AREA REQUIREMENTS .............................................................19
4.4.1.
4.5.
Storage facilities................................................................................................................................ 19
Equipment requirements ................................................................................................................. 19
PROCESSING AREA REQUIREMENTS ....................................................................19
4.5.1.
4.5.2.
4.5.3.
Optimise equipment placement ...................................................................................................... 20

Productive work environments........................................................................................................ 20
Processing Room Temperature, humidity and air quality ........................................................... 21
FILLING ROOM REQUIREMENTS ......................................................................................22

4.5.4.
4.5.5.
4.6.
High infection risk areas .................................................................................................................. 22

Filling Room Temperature, humidity and air quality .................................................................... 23
PRODUCT HANDLING & STORAGE .......................................................................24

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4.7.
Table of Content
INCUBATION ......................................................................................................24
4.7.1 INCUBATION ........................................................................................................24

4.7.2 ...........................................................................................................................24
4.7.3 ...........................................................................................................................24
4.7.4 ...........................................................................................................................25
4.8.
LABORATORY LAYOUT .......................................................................................27
UTILITIES ................................................................................................ 37
4.9.
WATER .............................................................................................................37
4.9.1.
4.9.2.
4.9.3.
4.9.4.
Main or City Water............................................................................................................................ 37

Ice Water ........................................................................................................................................... 37
Cooling Water ................................................................................................................................... 38
Waste Water ..................................................................................................................................... 38
4.10.
STEAM AND CONDENSATE ..............................................................................39
4.11.
COMPRESSED AIR ..........................................................................................40
4.12.
ELECTRICITY..................................................................................................40
5. REFERENCE & FURTHER READING .............................................. 41
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1. Introduction
This document contains an overview of a hygienic production facility and is aimed for
Tetra Pak Processing and Filling operations. This document is intended to support
engineering projects in the implementation of hygienic design standards for food
production plants, buildings and facilities in the plant layouts. This guideline can be
applied as well when existing plants needs upgrading to fulfil the respective hygienic
requirements. This guideline does not claim completeness.
It is the responsibility of the Production department to ensure that production procedures
are observed meticulously and that maintenance routines and Good Manufacturing
Practices (GMP) are followed and carried out according to predetermined schedules.
2. Plant Prerequisites and Aspects

2.1.
General Plant prerequisites
Hygiene requirements are best facilitated by the correct and most appropriate building,
plant location and layout. In particular, good product routing and equipment location
schemes can prevent contamination risks, involving raw material, intermediate and end
product handling, waste management, equipment operation and personnel activities. A
plant layout with such features can also give additional protection to those process
operations most vulnerable with respect to hygienic deficiencies. [4]
2.1.1.
Choice of location
Following important hygienic aspects should be taken into consideration when choosing a
new plant site location:
Risk of flooding
Risk from neighbouring facilities and activities creating possible contamination sources
(e.g. waste water treatment plant, farms, heavy chemical industries, etc.)
Availability of high quality and constant water supply (for process, potable and cleaning
purposes)
A waste water plan has to be considered and the availability of municipal sewer or other
ways to dispose industrial effluent.
Presence of open waterways that attract birds, insects, vermin, etc.
The history of the site regarding possible earlier ground contamination. [4]
2.1.2.
Plant layout considerations
Safety aspects require that there is a tight control over movements of incoming and
outgoing materials as well as the personnel movements. For that reason the overall plant
layout should take into consideration things like:
The locating production areas, service areas, surrounding areas and main air intake/outlet
locations.
Access for personnel and traffic (incoming and outgoing material).
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The surrounding areas considering nearby rivers, canales and/or other geological conditions.
Neighbouring non-industrial sites as e.g. commercial buildings, rail road, housing, etc.
Waste collection areas.
Movement inside the plant area of personnel, vehicles and goods including raw materials,
packaging materials, intermediate products and waste.
Location of utilities including the wastewater treatment plant. [4]
Short and long-term development plans are important to consider in the plant layout, as e.g.
possible use of other products, production extension, etc. Those points are easier to realise if
the plant has taken into account a possible extension already.
2.1.3.
Sanitary conditions of the surroundings
The area around a production building should be kept in a sanitary condition. This
includes:
Storing equipment properly, removing litter, cutting weeds and grass that may attract
pests.
Maintaining roads, yards and parking lots so they dont become sources of contamination.
Draining wet areas that may cause contamination or harbour pests.
Protecting outdoor storage or processing vessels from contamination using special
coverings, proper ground maintenance, pest elimination, regular inspection and/or other
special operating procedures.
Waste treatment and disposal systems should be designed so that they do not
contaminate product or product contact areas. [3]
2.2.
Zoning
Zoning is understood as the physical segregation of different unit operations or activities

including the use of physical barriers in regards to the hygiene level. Zoning is as well
used to provide control over personnel, equipment and material movements as well as
circulation of ambient air.
Contamination prevention involves the protection of the product, however not only in the
close surrounding of e.g. a filling line, but also within the entire process area, that is a
zone. Therefore zones have to be defined according to the level of cleanliness and
hygienic classification to protect the different types of product, from for example, various
vectors carrying microorganism (cross contamination), pest and odours originating in the
factory environment and its surroundings. [4, 5]
Note: Zoning should be used as a preventive measure, as part in the total hygiene concept.
Zoning alone does not prevent contamination problems if surfaces in contact or surfaces very
near to product are not cleaned or maintained properly. [4, 5]
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2.2.1.
Zone definition
Typically the zones are defined in three hygiene levels as Basic Hygiene Zone, Medium
Hygiene Zone and High Hygiene Zone.
Basic Hygiene Zone (Green)
This applies to areas where a basic level of hygiene and Good Manufacturing Practise
(GMP) is required. Typical Basic Hygiene Zone applications are found in the warehouse
or incoming material reception areas. The milk reception area is as well a Basic Hygiene
Zone. [4, 5]
Personnel in this zone do not require special clothing, however the clothing have to be
clean at all times. Personnel movements do not require the same level of control or
verification as in Medium or High Hygiene Zones. [4, 5]
There should be no open product handling in a Green Zone area. Products should
always be covered and in packed form. Pest prevention is therefore very important as not
all packages can prevent penetration by certain insects or attack from rodents. [4, 5]
If appropriate sub-categories for the Green Zone can be used to distinguish between areas
outside the production building and zones without any product handling, like e.g. workshops,
canteens, offices, etc.
Medium Hygiene Zone (Amber)
This applies to areas where a medium level of hygiene and GMP is required. This can be
a process area for products where the consumer group is not especially sensitive or
where no further microbiological growth is possible in the finished product.
Contact with the product or with the interior of processing equipment may occur
occasionally for short periods of time (e.g. maintenance, cleaning, sampling of products
or handling of products with gloved hands, etc.)
Amber Zones are often defined as well for rooms where closed equipment with much
higher hygienic requirements inside the equipment is operated, e.g. most of Tetra Pak
Processing and Filling equipment.
Personnel clothing must be clean, with white coats and protective headwear (hairnets)
worn. Change of shoes for operators or covered shoes for visitors might be
recommended but is rarely essential.
Filtered and conditioned air with maintenance of overpressure is recommended for certain
applications.
Note: Typical cleaning procedures for such areas are dry cleanings or controlled wet
cleanings. When a controlled wet cleaning is applied limited amount of water is used.
Drying of all surfaces after controlled wet cleaning is essential. With controlled wet
cleaning, ceilings and walls often stay dry. This may influence the building design and
plant layout to ensure these surfaces stay dry. [4, 5]
High Hygiene Zone (Red)
This applies to an area where the highest level of hygienic design requirements is
essential. High Hygiene Zones are where processed products are exposed and
vulnerable to process environmental influences for recontamination. This zone
classification is typical for open processes or operations, where the highest level of
hygiene precaution needs to be adopted.
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Red Zones should be limited in size and the layout should be kept as simple as possible.
Supplementary equipment like fans, pumps, power supply, etc. should be placed outside
the area.
Special rules have to be applied for such zones like restricted movement of personnel and
materials. Protective clothing, change of shoes, etc. is essential before entering a red
zone is essential.
Filtered and conditioned air with maintenance of overpressure is essential to minimize
possible sources of contamination.
Dry cleaning practices or controlled wet cleaning procedures are normally required for
such designated areas. High Hygiene Zones are never subject to wet cleaning. [4, 5]
The High Hygiene Zone is often called Clean Room or even incorrectly generalized as
Sterile Rooms. However there are different types of Clean Rooms and different levels
and grading of air cleanliness within such rooms. The levels of air cleanliness are defined
in different Clean Room Classifications. More information about this issue can be found in
the chapter 2.4 Air Handling. [6]
2.2.2.
Zoning Model
As zoning classifications define different level of hygienic requirements, the applicable

zone has to be identified. Each factory must have an up-to-date zoning plan with all
internal circulations marked. Furthermore the different zones should be marked clearly
visible, particular the areas with personnel or material movements. The different zones
can be further classified, if applicable, into dry and wet processing areas. Adequate
barriers, both physical and virtual, must be installed to every potential vector to prevent
cross-contamination of potential and significant pollution.
In some cases a zone category can even be special classified for special applications and
extraordinary high hygienic requirements like e.g. in baby food processing lines or special
machine equipment demands. [4, 5]
Figure 1 on the next page shows a simple diagram on how a dairy building with Tetra Pak
process and filling equipment could be designed and how the zoning philosophy is
applied.
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Loading Dock
Social
Area
Warehouse
(dry)
Social
Area
Work
shop
Work
shop
Distribution Area
(dry)
Utilities
CIP
Utilities
Socia
l
Social
CIP
Filling Room
(controlled wet)
Utilities
Area
Lab
Intermediate Storage (dry)
Utilities
CIP
Chemical
and
other
Storage
Processing
(controlled wet)
Raw Material
Storage
(dry)
Reception
Pre-Processing
(controlled
(controlled
wet) wet)
CIP
Reception
(controlled wet)
= Green Zone Passage of Personnel or Material outside the production building

= Green Zone Passage of Personnel or Material inside the production building (dry)
= Green Zone Product handling or CIP (dry or controlled wet)
= Amber Zone Product process towards end product (controlled wet)
= Red Zone Special application or special filling machine equipment, not needed for Tetra
Pak Aseptic filling machines (dry or controlled wet)
= Air Locks (air overpressure) for passage of personnel and/or material
Fig. 1: Example for a Zoning Model with Tetra Pak operations
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2.3.
Air Handling
Air contains microscopic particles of dust and microorganism, which are often attached to
dust particles. Air is therefore a potential contamination source in food processing and
environmental air quality control should reduce this possibility of contamination.
Hygienic design engineering involves consideration of the aspect that all air taken into the
plant should be filtered and controlled as hygienically safe. A properly designed and
constructed air handling system will control airborne particulates and odours and will
minimise the risks to product from airborne contaminations.
The choice of the optimum system for each area and food application demands not only
the prior definition and specification of system requirements, but also knowledge of the
engineering of air handling systems. Therefore it is essential that reliable contractors or
consultants, with specialist knowledge and experience of air handling, filtration and
refrigeration technology in a food-manufacturing environment, be used during the design,
building and commissioning stages. [8]
2.3.1.
Air Handling Zones
Similar to the zoning definition the air system requirements may be categorised in three
areas according to the hygiene level and the product risk category in the production area.
As a general requirement air should always flow from a higher to a lower hygienic zone
classification and from lower to higher dust loaded areas. Usually an air pressure
differential (overpressure) between the zones meets this requirement. The overpressure
should be in the range from 5 to 15 Pa, if not differently specified, in order to prevent
ingress of unfiltered air.
Basic Hygiene Zone (Green)
The air system in a green zone should contribute to Good Manufacturing Practises
(GMP). However the air quality is not the limiting factor for hygiene, shelf life or
microbiological safety. The product in these areas is typically not receptive to
contamination as it is protected in the final package or be areas where raw materials are
handled prior to a thermal processing step.
Medium Hygiene Zone (Amber)
The air system in an amber zone should minimise product contamination. In those zones
for some type of products and/or processes the air quality is an important contributor to
the microbiological safety and quality. The overall hygiene level in such a zone is
maintained to minimise any type of product contamination.
High Hygiene Zone (Red)
The air system in a red zone should be designed to prevent any product contamination. In
this type of production area the air is likely to play an essential role in controlling the
microbiological risks.
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2.3.2.
Air Filtering & Filter Grade for Food Industry Application
Air filter selection for environmental and process use is a critical part of ensuring final air
quality in a food-processing environment. Filters and associated equipment must be
designed, installed and maintained correctly to ensure long service life with minimal risk of
system failure and product contamination.
The following table should give a general overview of filter grades and should help
to identify an initial requirement.
Approaching 100%
General air filter
Filter test
retention of particles of size
description
grading *
> 5 micron
Primary filters
G4 - F5
> 2 micron
Secondary filters
F6 - F7
> 1 micron
Secondary filters
F8 - F9
> 0.5 micron
Semi HEPA
H11**
> 0.3 micron
HEPA filters
H13 upwards**
(**Semi HEPA & HEPA filters are tested to EN 1822)

HEPA = High Efficiency Particulate Air filter.
The next table should serve as a selection guide for the appropriate filter according to the
defined zone and hygienic requirement in the food industry.
Application
Final Filtration Level*
Filter System Make Up
Basic Hygiene Zone

(Green)
Medium Hygiene Zone
(Amber)
High Hygiene Zone
(Red)
G4 minimum; F5 ideal
Panel filter or medium grade pocket

filter combination may be required.
G4/F5 panel or pocket filter followed by
rigid cell filter.
G4 panel or F5 pocket filter and rigid
cell filter to semi-HEPA
F7-F9 dependant on risk

F9-H12 dependant on risk
* The above used Filter grading are adapted and currently used by the European Union. The grading is based on the US
ASHRAE 52 standard, which was adapted by Britain as BS 6540 and in other European countries as Eurovent 4/5. In 1993
the EU adopted the standard as EN779 and in Britain this became BS EN779. The BS EN779 test does not grade filters by
particle size, and the results give a range of efficiency levels (F5 F9) from a new to a loaded filter condition. Higher
efficiency filters, better known as HEPA (High Efficiency Particulate Air) and ULPA (Ultra Low Penetration Air) filters, have
always been tested for efficiency using a challenge of known particle size. These filters are installed where critical high
quality air filtration is required. Test results should be expressed as a percentage penetration, but we usually discuss
efficiency when designing a system. The test used in UK until some years ago was BS3928 (Eurovent 4/4), now replaced
with BS EN1822.
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2.3.3.
Room ventilation
Over-pressure
As previously mentioned a general requirement is that air should always flow from a
higher to a lower hygienic zone classification and from lower to higher dust loaded areas.
Normally, the concentration of airborne bacteria is higher than average where food
products are stored and processed. To protect the product from infection by these
bacteria, the in-flux of non-filtered air through doorways and other openings must be
prevented. Usually an air pressure differential (overpressure) between the zones meets
this requirement. The overpressure should be in the range from 5 to 15 Pa, if not
specified differently, in order to prevent ingress of unfiltered air.
If the zone is defined as Medium Hygiene Zone for process equipment and packaging
machines a room with an overpressure of filtered and conditioned air is recommended.
In a High Hygiene Zone air overpressure of filtered and conditioned air is necessary.
Overpressure is achieved by bringing more filtered air into the room than the exhaust
system can expel. This excess pressure will cause air to flow out of the room through the
cracks around doors and other openings, preventing infiltration by airborne
microorganism.
Air intake and exhaust
Carefully select the location of the air source. Avoid dusty areas or areas where there is a
high concentration of exhaust gas, sewage vapour or other contaminants.
When designing the over-pressure condition, consider
The type of air filtration will affect intake and exhaust dimensions
The size of the exhaust must be smaller than the intake
Air conditioning will affect inlet and exhaust
All air handling components must be cleanable and corrosion resistant under the same
conditions encountered in the environment of intended use
Locate the air inlet on one side to the room; inlet height should preferably be between 0.3
m and 0.5 m above floor level. In case of a filling room place the air inlet at the rear of the
filling machines.
Air inlet should be horizontally distributed along the wall.
Locate exhaust outlets high up on the wall opposite the inlet (in case of a filling room, in
front of the filling machine)
Air exchanges
When determining the capacity of the air intake and exhaust systems, you must consider
how many air exchanges will be required to ensure a fresh supply of air in the filling
room.
To calculate the average volume of the room, calculate the area of the floor next multiply
this area by three meters (9.8 ft). Three meters is known as the sojourn height and is
used to provide a consistent way of comparing filling rooms (the actual height of the room
is not used). The air exchange rate is the number of times the ventilation system can
move the calculated volume of air in an hour. Further information about the specific
number of required air exchanges can be found in Chapter 4. Specific Production Area
Requirements.
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3. Building Requirements
3.1.
Design for Sanitation
Hygienic building design and engineering should ensure that few opportunities arise
within the building for infestation by pests (insects, birds, animals) and for accumulation of
dust or water as these factors create risk for microbiological growth. Special attention is
required in case of an extension to an already existing plant, as gaps and hollow bodies
have to be avoided.
All production areas should be constructed so that they can be easily cleaned and
repaired. This includes:
Providing enough space to properly place and operate equipment and store materials in a
sanitary manner.
Reducing the potential for contamination of product or product-contact surfaces; use
location, partitions, special use times or enclosures to separate product-contact areas
from contaminated areas.
Designing cleanable and maintainable floors, walls and ceilings with adequate aisle space
to allow operators to perform duties without contaminating the product; condensate from
pipes must not contaminate food or food-contact surfaces.
Providing adequate lighting in hand-washing areas, locker rooms, toilets, storage,
production and packaging areas.
Providing adequate ventilation in production areas to minimise odours and vapours and to
prevent airborne contamination of food-contact areas.
Preventing entry of pests, using screens or other means.
Route traffic from areas of higher hygiene to areas of lower hygiene.
Avoid hard-to-clean architectural features such as corner notches or structural members
that collect dust or other contaminants.
Optimise floor cleaning by avoiding unnecessary doorsills, stairs, elevations, or cavities in
floors.
Slope floors to efficiently route water away from processing areas.
Install floor surfaces suitable to the environment including:
Water, chemical and temperature resistance
Concrete floors should be coated to prevent deterioration from acid or other

corrosive materials
Use glazed dairy floor tile with reinforced, acid resistant joints on floors exposed to
thermal shocks; seamless flooring can develop cracks; install membranes under
tile to protect sub floor from leaks or chemical damage
Locate floor drains so they can be easily accessed and cleaned.

Provide ventilation for a sanitary environment:
Provide clean sources of air, temperature and humidity controlled to prevent
condensation,
Provide enough air changes per hour to maintain a stable clean air quality,
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Maintain, if applicable, positive air pressures to protect against contamination from

outside air.
Control air flows between processing areas to protect against cross contamination.
[3]
Note! Layout, installation, and construction details will influence the overall quality level of
the finished product. Where at all possible, consideration should be given to this at the
planning stage. It is easier, less expensive, and more effective to build the correct
production facility from the beginning than to change an existing one. For this purpose,
reference is made to the IDF document No: 324 1997, Hygienic Design and
Maintenance of Dairy Buildings and Services.
Building Elements
3.2.
3.2.1.
Floors
The following guidelines should be followed with respect to the Medium Hygiene Zone
(Amber) and if appropriate in Basic Hygiene Zones (Green) with Controlled Wet
cleaning requirements:
The floor should be finished in non-slip and acid/alkali resistant tiles or equivalent finish
e.g. epoxy coating. All floor/wall corners should be rounded for easy cleaning.
-Use glazed dairy floor tile with reinforced, acid resistant joints on floors exposed to
thermal shocks; seamless flooring can develop cracks; install membranes under tile
to protect sub floor from leaks or chemical damage.
Sufficient sloping of floor surfaces should be provided for drainages in wet and controlled
wet zones, thus preventing stagnant water formation. This can be achieved e.g. by a
descending grade of 1.5% from the highest point towards the drains.
The floor tiles should be of sufficient strength to carry the point loads of the machines and
equipment. Broken or cracked tiles can provide an excellent breeding area for
microorganism.
See as well chapter 3.2 Design for Sanitation.
3.2.2.
Drains and gutters
Drains are a potential source of infection particular in a Medium Hygiene Zone. All waste
and contamination washed from machines during cleaning must flow through gutters to
the drains. To minimise the contamination risk, flow gutters and drains must be accessible
and easy to clean. For this reason, the machine must not be located over a drain or a flow
gutter.
Generally the floor drainage is best accommodated by an open gully along the front of the
room, passing out of the room, and then directly into a hygienic drain. Hygienic drains
should be used exclusively in the production hall.
Special drains for specific equipment like separator should be taken into account.
The drains should not be constructed of materials that can corrode. Use tiled or stainless
steel gullies, plastic, stone, or ceramic drain pipes.
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3.2.3.
Walls
The walls in a Controlled Wet Medium Hygiene Zone e.g. the filling room or Basic
Hygiene Zones (Green) with Controlled Wet, should be tiled to a height of 12 m (3.3 6.5 ft). The tiles should be acid/alkali resistant.
Above the tile-line, the wall should be finished with an easy-to-clean surface (for example,
glass panelling in aluminium frames).
All window sills should be sloped for easy cleaning and to prevent their use as storage
shelves.
The quality of smoothness, porosity etc. of wall surfaces depends upon the zone
classification of the wall location. Higher quality finishes are required in zones of higher
hygiene classification.
3.2.4.
Ceiling
Since ceilings are not easily accessible, a very smooth, impervious finish should be used
to facilitate cleaning with a long-handled brush or mop.
Ceiling should not support any items or structures, which contain inaccessible horizontal
surfaces since dust will invariably accumulate on such surfaces, as for example noise
reduction pads.
If any ceiling ductwork or exhaust hoods are installed, they should be designed for easy
cleaning.
3.2.5.
Pipe support system
The pipe supports are preferably made as a common support system for all connecting
media to the process and filling equipment including, mechanical and electrical supply
and process piping.
If possible the support shall be attached to the roof structure and/ or walls to eliminate
support legs to the floor. This will make a more flexible plant without restrictions of
placement of process and filling equipment, passages etc.
The pipe support system has to be designed according to allowed stresses of steel and
deflection of the system. The deflection of the supports may not be underestimated as
pipes with two phase flow, steam, condensate and compressed air will not be sufficiently
drained if supports are not correctly designed. At design of floor supports special attention
must be taken to accidental loads from forklifts etc.
The supports shall be made of carbon steel and / or stainless steel. Due to the high
humidity in process areas the steel must be well rust protected. The support shall be
made of profiles with closed ends to avoid cavities that can collect dirt.
Pipe holders must be chosen with care, they must be able to handle expansion and/or water
hammer in process and mechanical pipes.
3.2.6.
Doorways
The number of doorways should be kept to a minimum. Hygienic access control for staff
should be implemented. Where appropriate, like for example in air locks to the medium
and high hygiene zone, automatic doors should be considered.
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3.2.7.
Lighting
Production staff must have a clear view for operating the machine and controlling the
packages.
Use as much light as possible from surrounding rooms and through ceilings
Avoid lighting that emits a pronounced frequency flicker
Reduce dark zones and avoid dazzling and reflective systems, enable proper ergonomic
environment for operators and maintenance personal.
All lights should be easily accessible for maintenance and cleaning and must be safely
screened against any glass fragmentation of bulbs. Light sources above open processes
should be, if possible, avoided. The protective covers to prevent class shattering on
breakage should be changed regularly as protective covers become brittle in time.
Light sources are preferably integrated into ceilings and walls in a way that avoids any
projections where dust can accumulate.
Light sources have watertight enclosures
3.2.8.
Associated equipment
Associated equipment such as chillers, processing equipment, and electrical cabinets

should not be installed in the filling room.
3.3.
3.3.1.
Facilities
Water supply
The water supply must have adequate capacity, temperature, and pressure to handle
normal production functions; water contacting the product or product-contact surfaces
must be safe and sanitary.
Piping systems carrying water for product or production processes must not have any
back-flow or cross-connection to waste or sewage plumbing.
The plumbing must be designed to carry water in sufficient quantities to all parts of the
production facility, as required by each process.
3.3.2.
Chemical storage
The chemical storage areas must be properly labelled so that toxic cleaning compounds
and sanitising agents are identified and stored to protect against contamination of
product, product contact surfaces, or packaging materials.
The access to the chemical storage should be controlled and limited to a certain number
of people. Proper safety precautions have to be considered as the availability of personal
safety protection (gloves, aprons, protective goggles, etc.) and protection of spilling.
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3.3.3.
Sewage and liquid waste
Plumbing must be designed to properly drain sewage, liquid waste away from the product
processing and packaging areas.
Plumbing should not become a source of contamination to the water supply, productcontact areas or the product itself.
The sewage disposal system must be designed to meet the needs of the process.
3.3.4.
Waste
Waste receptacles should be constructed and maintained to prevent product

contamination and emptied promptly to minimise possible contamination of product,
product contact areas, or harbouring of pests
3.3.5.
Sanitary waste
Sanitary waste should be kept separate from process waste.
3.3.6.
Hand washing facilities
Hand washing facilities must be convenient and available to all employees and have
running water at a suitable temperature, with the following available:
Established procedures for hand washing and sanitising
Sanitising and cleaning preparations
Disposable towel services.
Hand cleaning equipment or plumbing fixtures designed to minimise the recontamination
of hands
Understandable and accessible signage instructing employees to wash or sanitise their
hands
3.3.7.
Toilets
Toilets must be sanitary and accessible facilities designed according to local regulations
and must be available to all employees.
They must also be:
Kept in sanitary condition
Kept in good repair
Have self-closing doors
Designed to prevent exposure to product or product-contact areas
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4. Specific Production area requirements

This section discusses the requirements for a successful production area.
It describes general requirements for the entire production area and more specific
requirements for each phase of production. Be sure to follow all local regulations or
nationally mandated practices.
4.1.
Production phases
In a production facility, the production area may include the following functions:
Reception & Raw Material

Pre-processing
Processing
Filling & Packaging
Product Handling and Storage
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4.2.
Equipment and Product transfer
These include general requirements for equipment. Requirements related to specific

production phases are listed in the following sections.
All product-contact equipment and tools must be cleanable and be properly cleaned and
stored. All product and non-product contact surfaces should be cleaned and sanitised as
often as is necessary to protect against contamination. Follow all cleaning instructions
provided by equipment suppliers. Non-product-contact equipment must also be cleanable.
Seams on all product-contact surfaces should be preferably avoided or must be smooth
to minimise the accumulation of food particles, soil or the growth of micro-organisms
Holding, conveying and manufacturing systems must be kept sanitary
Cold storage compartments must have temperature measuring and control devices to
ensure that product is always stored at the proper temperature
All control or measuring devices must be kept accurate and maintained
Compressed air or other gases used in or near product must be treated to prevent the
product from being contaminated
Steam in contact with product must be of suitable quality.
Pipes should run in separate accessible gangways (pipe trains). The pipes can enter the
process area through the ceiling or open trays fixed to walls or columns should be used.
These trays should be designed hygienically to minimise presence of horizontal ledges,
openings or gaps where inaccessible dirt can accumulate.
Pipes that pass through the ceilings or walls should pass through a protection pipe
section at the point of traverse to allow for expansion or contraction. Holes in walls for
pipe traverse need to be sealed if a wall separates rooms of different hygienic zones,
when both sides of the wall are in rooms of the same hygienic level sealing is not
required.
Connections and piping between pieces of equipment should be permanent. Rubber or
plastic hoses should be avoided. Unnecessary changes in elevation should be avoided so
that traps are not created.
All product transfer pipes should be installed in such a way that fluid is allowed to drain.
Avoid dead ends. If they do occur in the installation, the ratio of length-to-diameter
should not be more than 1,5:1.
All dead ends should be cleanable and steam sterilisable. Piping should be as
straightforward as possible.
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4.3.
Reception area requirements
General building requirements concerning sanitation and maintenance, as outline in

chapter 2 and 3, apply to this area of the production facility. The Reception area can be
defined as a Basic Hygiene Zone with Controlled Wet cleaning requirements.
4.3.1.
Storage facilities
Storage tanks should be designed and located in such a way as to prevent damage to
raw product as it is transferred to the pre-processing or processing area.
Storage tanks must be equipped with the proper controls, CIP and refrigeration devices to
maintain and stabilise raw product quality.
Storage equipment should be designed to allow for efficient monitoring or testing of
microbial activity.
4.4.
Pre-Processing area requirements
Pre-processing is defined as the area where the product undergoes all necessary
treatments in preparation for the final heat treatment before packaging. Pre-processing
involves usually the pasteurization and standardisation of raw material and if applicable
further pre-processing steps, as for example mixing, blending and storing of intermediate
product for the final heat treatment, etc.
The pre-processing area is commonly defined as Basic Hygiene Zone with Controlled
Wet cleaning requirements.
4.4.1.
Equipment requirements
The equipment as storage facilities should fulfil the same requirements as described
under Point 4.3.1. Storage Facilities.
Special attention should be paid to the proper hygienic design and cleanability of the
different equipment parts to avoid any microbiological growth before the product is
finally treated in the process area.
4.5.
Processing area requirements
As with the pre-processing area, general building requirements concerning sanitation and
maintenance apply to processing areas. The Processing area should be defined as
Medium Hygiene Level as usually the last treatment to the product is employed before
the product is filled or packaged.
The specific design of a processing system will often dictate its own facility requirements.
However, following are some points that can apply to processing areas in general.
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4.5.1.
Optimise equipment placement
Locate equipment or process functions to optimise the flow of product - linear flows can
help to reduce product agitation or damage
Isolate processing functions from sources of contamination
Arrange equipment to reduce spread of contaminants
Possible to maintain
4.5.2.
Productive work environments
When possible, provide natural light and overviews of the processing facility
When possible, locate processing areas on one level to minimize isolation of employees
and promote communication by allowing for spontaneous contacts and views into other
work areas
Isolate noise or protect against noise, according to local regulations
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4.5.3.
Processing Room Temperature, humidity and air quality
It is recommended to filter the incoming air, and its temperature and humidity controlled.
The following table lists recommended ventilation data for a processing room.
Air temperature
15 to 30 C (60 to 85 F)
Humidity
30% to 70%
Air speed
0.2 - 0.3 m/sec

(8 - 12 in/sec)
Over-pressure
5 - 15 Pa
Sojourn height
3 m (10 ft)
Note: For all practical purposes, the sojourn height
is sufficient to calculate volume of air movement
and is normally the working space for personnel.
Filtration*
Filter test grading G4 better F5

Arrested contaminants: >5microns
Note: G4 and F5 describe a level of filtering
efficiency. Please consult chapter 2.3 Air
Handling for more information.
Air exchanges
3 / hour
(* The above specifications should be regarded as a minimum requirement. A stricter requirement for
the incoming air quality should be based upon customer product quality demands and equipment
installed.)
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Filling room requirements
When packaging food products, it is of utmost importance that the packaging machine be
placed in a working environment compatible with the machines hygienic design and
function.
By ensuring that the highest environmental standards are maintained, you can minimise
the risk of product recontamination. The filling room should be physically separated from
the Processing and Distribution area (see as well Chapter 2.2. Zoning).
4.5.4.
High infection risk areas
The degree to which the environment of the filling room is controlled strongly impacts the
quality and the shelf life of the product. Areas that are considered as high infection areas
include:
Rooms where processing equipment for sour milk products or milk powder processing
equipment is installed
Rooms where bottle washing equipment is installed
Rooms with strong air currents
Rooms with traffic to and from other areas of the production facility
Rooms with high humidity, such as the room where the processor is installed, or any area
where steam or hot water is discharged during pre-sterilisation and/or production
Areas where unnecessary activities, especially those that produce dust, are performed
Inadequate filtration for HVAC systems and/or poor air quality control.
The filling room should be located so as to avoid contamination from the above
sources.
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4.5.5.
Filling Room Temperature, humidity and air quality
Incoming air must be filtered, and its temperature and humidity controlled. The following
table lists recommended ventilation data for a filling room.
Air temperature
15 to 30 C (60 to 85 F)
Humidity
30% to 70%
Air speed
0.2 - 0.3 m/sec

(8 - 12 in/sec)
Over-pressure
10 - 20 Pa
Sojourn height
3 m (10 ft)
Note: For all practical purposes, the sojourn height
is sufficient to calculate volume of air movement
and is normally the working space for personnel.
Filtration*
Filter test grading F7

Arrested contaminants: >2microns
Note: F7 describes a level of filtering efficiency.
Please consult chapter 2.3 Air Handling for more
information.
Air exchanges
5 - 10 / hour
15 - 20/hr under exceptional climatic or polluted
conditions
(* The above specifications should be regarded as a minimum requirement. A stricter requirement for
the incoming air quality should be based upon customer product quality demands and the
technology installed.)
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Product Handling & Storage
4.6.
Maintenance of chilled chain after filling

(Pasteurised and ESL applications)
Cold store and distribution
(Pasteurised and ESL applications)
First in first out system for product storage
Product access and tracking system recommended for QC/QA purposes
(To be expanded)
4.7.
4.7.1
Incubation
Incubation Why?
Aseptic products require minimum 5-7 days of strict laboratory control before they can be
released for consumption.
4.7.2 Incubation Facility

A room should be planned to handle the incubation of packages during quality control
checks. It is an advantage to have direct access from the Q.C laboratory .A suggested
general specification follows.
4.7.3 Incubation room-guidelines

-
Insulated to conserve heat and to maintain constant temperature.
Door should be tight fitting to contain heat and any other odours.
Shelves should have trays to collect any spillage. SS should be preferred that
wood.
The room must be designed to permit easy cleaning to a high hygienic standard
and may require drainage.
Locate heating exhaust and ventilating units outside the room.
In the following layout, SS should be preferred compared to wood for making

shelves.
Do not forget the exhaust ventilation system; airflow is very important. In some
areas, heating is not necessary at certain times of the year, and may be some form
of cooling system will be needed to maintain correct incubation temperature.
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4.7.4 Incubation room dimensions
Size is dependent upon the maximum planned production, but remembers that expansion often
occurs, and an increase in QC samples automatically follows. Do not base the rooms sample
capacity upon the likely quantities envisaged when the plant first becomes operational; a
reduction by at least 50% for normal sampling usually occurs within the first months after
commissioning.
Absolute minimum: 6 m (3x2)
Normal size:
9 to 12 m (3x3 to 4x3)
Height Ceiling:
approx.2.4 m
Heat Inlet:
Ground level
Exhaust:
opposite wall, high up
Please Note: it is preferable to incubate over a period of seven days and normal good hygiene
practice must be adapted in the incubation room.
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4.8.
Laboratory layout
The size of the laboratory is determined by the tasks, which are assigned to the laboratory, and
by the number of different products to be tested as well as by the production capacity of the
plant.
Usually two laboratories are recommended, one for the control of raw material and another one
for control of processing and the final product. Furthermore a separate room should be
provided for the chief of the laboratory.
Also it is advisable to have separate rooms for bacteriological testing. An incubation room for
incubation of samples of the final product with possibilities to vary the temperature in the range
of 20-45C. 5 C as a fluctuation can be tolerated.
Reasonable working area (benches) for standing and sitting (especially as bacteriological work
is space consuming) should be available; surface of benches should be acid + alkaline stable.
In the bacteriological section the bench surface should be heat resistant. Bunsen burners
should be provided. A special section should be provided for writing. Two large basins with cold
and hot water for cleaning and rinsing. Equipment for automatic rinsing of pipettes can be
recommended. Water tabs placed high enough for water suction pumps (cold water).
Electrical connections should be adequate in order to perform the necessary tests. We only
outline some basic equipment, which obviously needs to be supplements and adjusted when
new or other assignment are placed on the laboratory.
Minimum two incubators, one operating at 30-35 C and the other at 45-55 C ( 2
C) . Provision for two further temperatures of incubation 20-25 C and 2-5 C is
recommended.
At least three water baths: one at 100 C and one at 80 C .the third one should
provide a temperature of 45-50 C.
Two or three balances permitting weighting up to 1000 g, if possible with digital

weight indication.
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-
A portable, preferably hand-operated (gun shaped) pH-meter for evaluation of the

incubated samples. it will also be used in the preparation work of the nutrient media
in the bacteriological laboratory. An accuracy of approximately 0.1 pH units is
sufficient.
Three of four burettes for acid and alkaline titrations.
Sterilizing equipment for preparation of nutrient media as well as glassware, etc.
Distilled water may either be obtained from outside or, a distillation apparatus
should be put up in the laboratory.
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Utilities
Utilities needs to be of highest quality, and installed in such way, that soiling or recontamination not downgrade the hygienic level.
The following explanations shall be regarded as general orientation of what should be
taken into account. Please consult the specific equipment requirements for further
details!
4.9.
4.9.1.
Water
Main or City Water
The water quality shall be according to Tetra Pak specifications. Deviations from these
specifications can cause damage to equipment or product.
It is important that the pipes for water are correctly designed due to the fact that some
process machines can require rather large flows.
Dead ends must be avoided; the water can cause infections if it is left for period in the
pipes.
The water used must be free of impurities, rust and minerals that can damage or leave
deposits on components. In addition, it must be of potable quality.
To minimise corrosion, avoid lime deposits, and to minimise the chance of bacterial
contamination, main or city water used should in alignment with the IDF (International
Dairy Federation) comply with the following recommended qualities:
Have a low content of organic substances.
Hardness 3 - 4 dH
Have low chlorine content. Excessive chlorine can lead to corrosion even on stainless
steel. Chlorine less than 0.2 ppm. Chloride less than 50 ppm.
Sulphate less than 100 ppm
Iron less than 0.3 ppm
Manganese less than 0.1 ppm
pH of 7.5 8.5
Be free of disease generating components, both particulate and chemical as well as
filtered to a maximum particle size.
Note! The above specifications are to be regarded as general. More stringent
specifications and/or local legislation should be adopted in preference. Please refer to
the equipment specific specifications!
4.9.2.
Ice Water
Ice water pipes can be made of black steel, but they have then to be rust-protected by
sandblasting and protective paint. Pipes and pipe holders shall be insulated to avoid
condensation. High return temperatures shall be avoided, to not cause disturbance in the
cooling plant.
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4.9.3.
Cooling Water
Cooling water can be either a secondary cooling system from ice water or a cooling tower
system.
If an evaporative cooling tower is used the risk of Legionella and Legionnaires disease
has to be taken into account.
For the secondary (or closed) water system in the packaging machine, use clean distilled
(type III) or de-ionised water.
Treatment with a microbicide is recommended to avoid microbial growth and associated
blockage of narrow pipelines and corrosion.
Best cooling effect is attained if the packaging machine cooling water system is
connected to the plant-chilled water system.
The chilled water must be free of impurities, rust and minerals that can deposits in the
cooling water system.
4.9.4.
Waste Water
General
Wastewater from dairies can be divided into the following categories:
- Industrial waste water
- Sanitary waste water
- Non-contaminated waste water
Industrial wastewater
Organic substances, which are found in milk and milk products are major contaminants of
the wastewater and such waste water shall be treated before discharging into a waterway.
Pollution of waste water is expressed by term Biochemical Oxygen Demand (BOD), which
means the amount of oxygen required to decompose polluted waste water by means of
biochemical oxidation.
Acids and alkali are used for cleaning/flushing of process equipment and process pipes.
This means that waste water with very varying degree of pH-value is discharged. Extreme
pH-values disturb the biological processes in a purification plant. Therefore, it is
necessary to neutralise the wastewater before it comes to the purification plant.
Sanitary wastewater
Waste water from WC, showers, sinks, lavatories etc. is not of great importance where
water and amount of pollution from a dairy are concerned.
Non-contaminated wastewater
Comprises different types of cooling water and does not contain any milk substances or
other pollutions.
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4.10.
Steam and Condensate
In practice, there are four recognised grades of steam quality:

Industrial steam - steam delivered from a normal industrial boiler.
Filtered (culinary or food grade) steam - normal industrial steam conditioned and filtered
to 5 microns or less.
Clean steam - steam raised in a clean steam generator, and usually from de-ionised or
distilled water.
Pure steam - steam raised in a clean steam generator and always from de-ionised or
distilled water with a purity such that it will contain virtually no pyrogens or endotoxins.
The most usual requirement of the food and drinks industries for steam in contact with
product is the filtered (culinary/food) grade steam or clean steam.
Steam supplied to Tetra Pak equipment must be of culinary quality. This means that the
steam is considered safe for use in food preparation. The water source must be potable
and acceptable to local regulatory agencies.
The steam should be free of entrained contaminants, dry and saturated. If the main steam
which delivers steam to the Tetra Pak equipment and all surfaces with which processed
product comes into contact is not culinary grade, then additional equipment needs to be
installed upstream of the machine.
To achieve culinary grade steam, a cyclone and active carbon filter or equivalent must be
installed upstream of the applicable equipment. This will remove impurities and odours.
The steam system shall be able to supply steam at the right pressure to all consumer.
Allowance has to be made for start-up loads.
The steam pipes shall slope in the direction of the flow. The pipes shall be insulated to
minimise condensation and heat-losses. At start the amount of condensate can be up to 2
3 times than during normal operation. All condensate pipes should be sloped in the
direction of the flow.
Steam traps shall be installed at all level changes upwards and every 30 40 m pipe
length. A steam trap must be installed before each steam inlet to the filling machine,
preventing the build-up of condensate in the line. Steam traps shall also be placed close
to process equipment to ensure that the steam is dry.
Air traps shall be placed at end points of steam pipes to vent out air and other gases at
start up.
The steam consumption on the Tetra Pak Aseptic filling machines is low, but a constant
pressure must be maintained
Pressure variation must be kept to a minimum, avoid sudden exhaust elsewhere in the
steam system that might starve the supply to the processing and filling equipment.
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4.11.
Compressed air
The air must be dry, clean and oil free. The customer should provide an external 50micron filter on the supply line upstream from the compressor.
A coalescing filter should be located in the air pipeline downstream from the compressor.
The water separator must be drained according to a maintenance schedule.
To prevent condensation inside of valves and cylinders, the temperature of the air
supplied to the machine should be 7C less than the ambient temperature.
The air pressure must be at least 0.6 MPa (6 bar) during production. This pressure can be
read on the pressure gauge on the machine.
It is important that the pipe system for compressed air is well sized due to the fact that a
pressure drop can affect the process control system.
To secure a safe supply of air, the pipe system can be designed as a ring line.
4.12.
Electricity
The electricity must be stable and a very low voltage variation to be accepted +/- 10% for
the incoming voltage for the equipment.
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5. Reference & Further Reading

Guidelines for Good Manufacturing Practices Low-Acid, Ultra Pasteurised Extended
Shelf-life products (Doc no: GMP 586085-102)
Installation Manual Tetra Rex TR/16 (Doc no: IM 586146-0101)
IDF document no: 324 1997, Hygienic Design and Maintenance of Dairy Buildings and
Services
EHEDG Guideline Doc. 26: Hygienic Engineering of Plants for the Processing of Dry
Particulate Materials
Zoning Just one Element of Prevention; Maggie Duke CT-QM Nestl S.A.; Presentation
Material Anuga FoodTec 2003
Introduction to Contamination Control and Cleanroom Technology; Dr. Mats Ramstorp;
WILEY-VCH Verlag GmbH, Weinheim (Germany), 2000
FEL Filtration Engineering Ltd.; Air Filter Testing from Filtration Engineering, Internet:
www.filtration-engineering.co.uk/air_filter_testing.htm
EHEDG Guideline Doc.: Guideline on air handling in the food industry
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Procedures & Guidelines

Guideline for the Hygienic Production of Liquid Food

GENERAL PLANT PREREQUISITES .........................................................................4

Choice of location ............................................................................................................................... 4

Air Handling Zones ............................................................................................................................. 9

DESIGN FOR SANITATION....................................................................................12

BUILDING ELEMENTS .........................................................................................13

Water supply ..................................................................................................................................... 15

4. SPECIFIC PRODUCTION AREA REQUIREMENTS ......................... 17

PRODUCTION PHASES ........................................................................................17

EQUIPMENT AND PRODUCT TRANSFER.................................................................18

RECEPTION AREA REQUIREMENTS .......................................................................19

PRE-PROCESSING AREA REQUIREMENTS .............................................................19

PROCESSING AREA REQUIREMENTS ....................................................................19

Optimise equipment placement ...................................................................................................... 20

FILLING ROOM REQUIREMENTS ......................................................................................22

High infection risk areas .................................................................................................................. 22

PRODUCT HANDLING & STORAGE .......................................................................24

4.7.1 INCUBATION ........................................................................................................24

LABORATORY LAYOUT .......................................................................................27

Main or City Water............................................................................................................................ 37

STEAM AND CONDENSATE ..............................................................................39

COMPRESSED AIR ..........................................................................................40

5. REFERENCE & FURTHER READING .............................................. 41

Guideline for the Hygienic Production of Liquid Food

2. Plant Prerequisites and Aspects

General Plant prerequisites

Plant layout considerations

Guideline for the Hygienic Production of Liquid Food

Sanitary conditions of the surroundings

Zoning is understood as the physical segregation of different unit operations or activities

Guideline for the Hygienic Production of Liquid Food

Guideline for the Hygienic Production of Liquid Food

As zoning classifications define different level of hygienic requirements, the applicable

Guideline for the Hygienic Production of Liquid Food

= Green Zone Passage of Personnel or Material outside the production building

Fig. 1: Example for a Zoning Model with Tetra Pak operations

Guideline for the Hygienic Production of Liquid Food

Air Handling Zones

Guideline for the Hygienic Production of Liquid Food

Air Filtering & Filter Grade for Food Industry Application

General air filter

retention of particles of size

> 0.5 micron

> 0.3 micron

(**Semi HEPA & HEPA filters are tested to EN 1822)

Final Filtration Level*

Filter System Make Up

Basic Hygiene Zone

Panel filter or medium grade pocket

F7-F9 dependant on risk

Guideline for the Hygienic Production of Liquid Food

Guideline for the Hygienic Production of Liquid Food

Design for Sanitation

Concrete floors should be coated to prevent deterioration from acid or other

Locate floor drains so they can be easily accessed and cleaned.

Guideline for the Hygienic Production of Liquid Food

Maintain, if applicable, positive air pressures to protect against contamination from

Drains and gutters

Guideline for the Hygienic Production of Liquid Food

Pipe support system

Guideline for the Hygienic Production of Liquid Food

Associated equipment such as chillers, processing equipment, and electrical cabinets