Procedures guidelines guideline for the hygienic production of liquid food part 1 site recommendations

Procedures & Guidelines
Guideline for the Hygienic Production of
Liquid Food
Part 1- Site Recommendations

FSQ-588013-0101


Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Table of contents
Introduction.............................................................................3
Grounds and Buildings ............................................................................3
Production phases ...................................................................................4

Production area requirements............................................5
Design for sanitation................................................................................5
Facilities....................................................................................................6
Water supply ........................................................................................ 6
Chemical storage .................................................................................. 6
Sewage and liquid waste........................................................................ 6
Waste.................................................................................................. 6
Sanitary waste...................................................................................... 6
Hand washing facilities .......................................................................... 7
Toilets.................................................................................................. 7

Equipment and Product transfer.............................................................8
Pre-processing area requirements ........................................................9
Storage facilities ................................................................................... 9

Processing area requirements ...............................................................9

Optimise equipment placement .............................................................. 9
Productive work environments................................................................. 9

Filling room requirements..................................................................... 10
High infection risk areas....................................................................... 10
Room ventilation.................................................................................. 11
Floors ................................................................................................ 13
Drains and gutters ............................................................................... 13
Walls ................................................................................................. 13
Ceiling................................................................................................ 13
Doorways ........................................................................................... 14
Lighting .............................................................................................. 14
Associated equipment ......................................................................... 14

Product Handling & Storage ................................................................ 14
Utilities.................................................................................................... 15
City Water.......................................................................................... 15
Chilled water....................................................................................... 15
Steam................................................................................................ 16
Compressed air................................................................................... 16
Electricity........................................................................................... 16

Acknowledgement...............................................................17

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Guideline for the Hygienic Production of Liquid Food

Part 1- Site Recommendations

Introduction
This document contains an overview of a hygienic production facility.
It is the responsibility of the Production department to ensure that production
procedures are observed meticulously and that maintenance routines and Good
Manufacturing Practices are followed and carried out according to predetermined
schedules.

Grounds and Buildings
The grounds 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 don’t 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.

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 productcontact 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

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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Production phases
In a production facility, the production area may include the following functions:
•

Pre-processing

•

Processing

•

Filling & Packaging

•

Product Handling and Storage

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Guideline for the Hygienic Production of Liquid Food
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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.

Design for sanitation
•

Use cleanable materials with smooth surfaces.

•

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 door sills, 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 subfloor 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
– maintain positive air pressures to protect against contamination from outside

air
– control air flows between processing areas to protect against cross
contamination

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.

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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
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.

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.

Sewage and liquid waste
Plumbing must be designed to properly drain sewage, liquid waste and filling machine
discharge 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.

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 harboring of pests

Sanitary waste
Sanitary waste should be kept separate from industrial or process waste.

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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
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

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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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Equipment and Product transfer
These include general requirements for equipment. Requirements related to specific
production phases are listed in the sections following.
•

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-productcontact 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

•

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-todiameter 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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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Pre-processing area requirements
General building requirements concerning sanitation and maintenance, as outlined
above, apply to this area of the production facility as well.

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 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.

Processing area requirements

As with the pre-processing area, general building requirements concerning sanitation
and maintenance apply to processing areas also.
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.

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

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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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
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 machine’s hygienic
design and function.
By ensuring that the highest environmental standards are maintained, you can
minimise the risk of product recontamination.

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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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Room ventilation
Over-pressure
The packaging machine should be installed in a room with an “overpressure” of
filtered air.
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. This is accomplished through over-pressure.
Over-pressure is achieved by bringing more filtered air into the filling room than the
exhaust system can expel. This excess pressure will cause air to flow out of the filling
room through the cracks around doors and other openings, preventing infiltration by
airborne bacteria.
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

•

locate the air inlet to the filling room at the rear of the filling machine; inlet height
to the filling room should be between 0.3 m and 0.5 m above floor level

•

air inlet to the filling room should be horizontally distributed along the wall.

•

locate exhaust outlets high up on the wall in front of the filling machine opposite
the inlet

•

all air handling components must be cleanable and corrosion resistant under the
same conditions encountered in the environment of intended use

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.

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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
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

2-4 mm water column
(5/64” - 10/64”)

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*

ASHRAE 52-76
20% DustSpot
Arrested contaminants: 10 microns
Note: ASHRAE 52-76 describes a testing method for
air cleaning devices only. This method is known to all
qualified air conditioning and ventilation suppliers.

Air exchanges

10 - 15 /hr
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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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Floors
The following guidelines should be followed with respect to the filling room floor:
•

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.

•

The floor should have a descending grade of 1.5% from the magazine end to the
discharge end of the machine

•

The floor tiles should be of sufficient strength to carry the point loads of the
machine. Broken or cracked tiles can provide an excellent breeding area for
bacteria.

Drains and gutters
Drains are a potential source of infection in the filling room. 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.
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.

The drains should not be constructed of materials that can corrode. Use tiled or
stainless steel gullies, plastic, stone, or ceramic drain pipes.

Walls
The filling room walls should be tiled to a height of 1–2 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.

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.
If any ceiling ductwork or exhaust hoods are installed, they should be designed for
easy cleaning.

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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Doorways
The number of doorways should be kept to a minimum. Hygienic access control for
staff should be implemented.

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

•

All lights should be easily accessible for maintenance and cleaning and must be
safely screened against any glass fragmentation of bulbs

Associated equipment
Associated equipment such as chillers, processing equipment, and electrical cabinets
should not be installed in the filling room.

Product Handling & Storage
•

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)

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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Utilities
Utilities needs to be of highest quality, and installed in such way, that the hygienic
level not be downgraded by soiling or re-contamination.

City Water
The city water used in filling machines 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, city water used in the packaging machine should:

•

have a low content of organic substances.

•

have a lime content no greater than CaCO3 3-5 DH, 50ppm.

•

have low chlorine content. Excessive chlorine can lead to corrosion even on
stainless steel. Cl2 less than or equal to 0.2 mg/L. Cl less than 30mg/L

•

have 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.

Chilled water
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.

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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations
Steam
Steam supplied to the packaging machine 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 and relatively free of water in
liquid form. If the steam main which delivers steam to the packaging machine 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.
•

A steam trap must be installed before each steam inlet to the machine, preventing
the build-up of condensate in the line

•

Steam supplied to the packaging machine must be filtered and free of condensate

•

Consumption 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 packaging machine

Compressed air
The air must be dry, clean and oil free. The customer should provide an external 50
micron 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 7 C less than the ambient temperature.

•

The air pressure must be at least 6 bar during production. This pressure can be
read on the pressure gauge on the machine.

Electricity
The electricity to the packaging machine must be stable and a very low voltage
variation to be accepted +/- 10% for the incoming voltage to the packaging machine.

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Guideline for the Hygienic Production of Liquid Food
Part 1- Site Recommendations

Acknowledgement
The following documents have been used as source of information:
•

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

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