Continuous UHT Sterilization of Liquid Food

DOC 6
CONTINUOUS UHT STERILIZATION OF LIQUID FOOD

Second Edition, May 2017
European Hygienic Engineering and Design Group
EHEDG Secretariat
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60528 Frankfurt, Germany
Tel.: +49 69 66 03-12 17 or -14 30

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THE ENGLISH VERSION OF THIS EHEDG DOCUMENT IS THE OFFICIAL VERSION. THE RESPONSIBILITY
FOR THE PREPARATION, DEVELOPMENT AND ISSUANCE OF SUCH GUIDELINES LIES WITH EHEDG.
DUE TO THE TECHNICAL AND GENERAL NATURE OF THE GUIDELINES, EHEDG MAY NOT ASSUME ANY
LIABILITY RESULTING FROM THE INTERPRETATION, APPLICATION OR USE OF SUCH GUIDELINES.
EHEDG GUIDELINES ARE DEVELOPED IN CO-OPERATION WITH 3-A SANITARY STANDARDS.
DOC No. 6 ©EHEDG 2 of 31

Contents Page
Summary ............................................................................................................................................................. 5
Introduction ......................................................................................................................................................... 5
1 Objectives and scope............................................................................................................................ 5
2 Normative References........................................................................................................................... 6
3 Definition of Terms ................................................................................................................................ 6
4 General Considerations ........................................................................................................................ 6
4.1 Hygienic design of the sterilizer .......................................................................................................... 6
5 Special Considerations ......................................................................................................................... 6
5.1 Sterilizer process design ...................................................................................................................... 6
5.1.1 Holding section ...................................................................................................................................... 6
5.1.2 Direct heating ......................................................................................................................................... 7
5.1.3 Indirect heating .................................................................................................................................... 12
5.1.4 Plate heat exchangers (PHE) .............................................................................................................. 17
5.1.5 Scraped or swept surface heat exchangers (SSHE) ........................................................................ 17
5.1.6 Aseptic buffer tanks ............................................................................................................................ 19
5.1.7 Miscellaneous equipment ................................................................................................................... 21
5.2 Process operation ............................................................................................................................... 21
5.2.1 Pre-sterilization of equipment ............................................................................................................ 22
5.2.2 Production ............................................................................................................................................ 22
5.2.3 Water and product recirculation ........................................................................................................ 22
5.2.4 Flow diversion due to failure in operation conditions..................................................................... 23
5.2.5 Aseptic intermediate cleaning (AIC) .................................................................................................. 23
5.2.6 Cleaning ............................................................................................................................................... 23
5.3 Process monitoring and control ........................................................................................................ 23
5.3.1 Temperature ......................................................................................................................................... 24
5.3.2 Pressure ............................................................................................................................................... 25
5.3.3 Positive pressure on the sterile side ................................................................................................. 25
5.3.4 Pressure to avoid boiling ................................................................................................................... 25
5.3.5 Flow rate / level .................................................................................................................................... 25
5.4 Inspection and maintenance .............................................................................................................. 26
5.5 Conclusions ......................................................................................................................................... 26
6 References ........................................................................................................................................... 27
.............................................................................................................................................................. 28
.............................................................................................................................................................. 29
.............................................................................................................................................................. 30
.............................................................................................................................................................. 31

Continuous UHT Sterilization of Liquid Food*
May 2017
©EHEDG
Bengt Eliasson** Tetra Pak, Sweden
Stefan Åkesson Tetra Pak, Sweden
Franz-Josef Helms GEA TDS, Germany
Steven Hoefkens Stork Food & Dairy Systems, Netherlands
Anneginus Hummel FrieslandCampina, Netherlands
Huub Lelieveld Netherlands
Ole Poulsen SPX Flow Technology, Denmark
Paul Skudder SPX Flow Technology, United Kingdom
Ana Soares Mondelēz International, United Kingdom
Joern Stistrup SPX Flow Technology, Denmark
Jeroen Veldkamp Heinz, Netherlands
* Report prepared by the Working Group “Heat Treatment” of the European Hygienic Engineering &
Design Group (EHEDG)
** Chairman
The first edition (April 1993) was co-authored by
A.P.M. Hasting** (Unilever Research Laboratory, UK), P.C. Jepson (APV Baker, UK),
P.C.M. Lalande (Institut National de la Recherche Agronomique, F),
H.L.M. Lelieveld (Unilever Research Laboratory, NL), M.A. Mostert (Unilever Research Laboratory, NL),
J. Nassauer (Kraft General Foods Europe, D), R. Ringström (Alfa Laval, SE), S.A. Davies (APV Baker, UK)

Summary
Sterilization is a heat treatment aimed at destroying all vegetative microorganisms and spores to create a
product which can be stored at ambient temperature yet minimizing public health hazard. There are however
many reasons why, in practice sterilized products may present a microbiological health hazard. Due to the
sterilizer process design, the operation and control or inspection and maintenance of the sterilizer there are a
risk of untreated or recontaminated product may reach the consumer. This document provides guidelines to
avoid these issues.
Introduction
Thermal UHT sterilization is a process applied to a product with the aim of minimizing a public health hazard
and product spoilage caused by both vegetative microorganisms and spores. For sterilization by ultra high
temperature (UHT) treatment of milk a temperature at not less than 135°C in combination with a suitable
holding time is a legal requirement in the EU and complies with Codex Alimentarius recommendations. Other
products may require other conditions.
Other techniques such as ohmic heating are not covered but may form the basis of a future publication.
The principle of thermal sterilization is similar to that of pasteurization. The product to be sterilized is heated to
a specified temperature and maintained at or above that temperature for a fixed time. One of the main
difference between sterilization and pasteurization is that the temperatures required for sterilization are
significantly higher than pasteurization (>120°C compared to 70-90°C).
Sterilization is typically applied to low acid products requiring an extended shelf life at ambient temperature.
This requires an aseptic package and a continuous UHT sterilization plant is therefore operated in conjunction
with aseptic fillers. The sterilized product can be further processed but then under aseptic conditions.
For sterilization to result in a safe product, it is necessary that
1. The correct sterilization conditions are maintained during the entire period of operation
2. The recontamination of sterilized product is prevented.
Maintenance of the correct sterilization conditions requires that the product is held at the desired sterilizing
temperature for a fixed time and the plant design, operation and control must be such as to enable this to be
achieved.
Prevention of recontamination requires that equipment and packaging in contact with sterile product can itself
be sterilized and is impervious to bacteria.
1 Objectives and scope

The sterilization of food aims to minimize the risk of food poisoning and extend product storage life under
ambient conditions. Sterilization is, in theory, simple: the product to be sterilized is to be heated to a certain
temperature and kept at or above that temperature for a certain time. There are, however, several reasons
why, in practice, sterilized products might present a microbiological health hazard, as due to deviations in
residence time or temperature, not all product may reach the correct temperature for the time required for
sterilization. Further there may be a risk of recontamination of the sterilized product due to contamination with
not yet sterilized product or the cooling media. Other sources of contamination are from residues in not fully
cleaned equipment or from wrong operation of the equipment.
To minimize the risk that sterilized product is not safe, this Working Group of the European Hygienic
Engineering & Design Group (EHEDG) has prepared this guideline for continuous UHT sterilization of liquid
food.
In the case that liquid foods with particles need to be sterilized, the conditions applied must be adapted to take
into account the heat transfer to the centre of the particles.

2 Normative references
Designers and users must comply with hygiene laws that apply where the equipment is sold and used.
3 Definition of terms
Readers are referred to the EHEDG Glossary, which can be downloaded from www.ehedg.org.
Flow diversion
If the heat treatment temperature is too low, the flow of insufficiently treated product is diverted from going
forward and by this the production is temporarily paused. See also Doc. 1 Continuous pasteurization of liquid
food, sections 5.1.2 and 5.2.4 for further information.
4 General considerations
4.1 Hygienic design of the sterilizer
The sterilizer must be of hygienic design according to Guideline Doc. 8 on Hygienic equipment design criteria
and Doc. 10 on Hygienic design of closed equipment for the processing of liquid food. Doc. 8 also provides
data regarding the surface finish to be used.
Regarding materials of construction Guideline Doc. 32 on Materials of construction for equipment in contact
with food should be followed. Doc. 35 on Welding of stainless steel tubing in the food industry and Doc. 9 on
Welding stainless steel to meet hygienic requirements provides guidelines for the correct execution of sanitary
welding.
The following EHEDG papers will provide guidelines for the design and selection of components for the
sterilizer plant:
Doc. 1 Continuous pasteurization of liquid food
Doc. 14 Hygienic design of valves for food processing
Doc. 16 Hygienic pipe couplings. Note that the number of pipe couplings should be reduced to a minimum.
Doc. 17 Hygienic design of pumps, homogenisers and dampening devices
Doc. 37 Hygienic design and application of sensors
Doc. 43 Principles of Cleaning Validation
5 Special considerations
5.1 Sterilizer process design
The configuration of the sterilizer is very important. A continuous sterilizer consists of a heating section, a
holding section and a cooling section. In most cases a regeneration section is used to save energy. The
equipment must be of hygienic design and downstream from the holding section of aseptic design.
There are many types of continuous sterilization systems available but they all come into one of two
categories, direct or indirect. In a direct system the product is heated by condensation of steam brought into
direct contact with the product. An indirect system is one where the heating medium (steam/hot water) is
separated from the product by a physical barrier and heat is transferred across the barrier to heat the product.
The choice of system is dependent on many factors related to product quality, product characteristics
(viscosity, susceptibility to fouling), production requirements (capacity, run length) and economics (capital and
running costs).
5.1.1 Holding section
The function of the holding section is to ensure that each particle of fluid entering it receives a minimum
desired heat treatment. The residence time in the holding section is affected by the geometry and the flow rate.
Higher volumetric flow rates will decrease the residence time.

The residence time must not decrease below a certain minimum value; this may depend on legal
requirements and should be based on the concept of the minimum acceptable sterilizing effect or lethality. The
sterilization effect can be calculated by different methods for example F0 or B*, see Annex D for further
information. The flow pattern must be taken into account very carefully (the ratio of average velocity to
maximum velocity in a holding tube varies between 0.5 in a laminar flow which means a Reynolds number
below Re 2.300 to 0.82 in fully turbulent flow). FDA use Re 4.000 as a limit. Turbulent flow is the preferred
option but cannot always be achieved for viscous products. For laminar flow the holding tube may need to be
up to twice the length calculated on the basis of the average holding time in order to achieve the minimum
residence time. Specification of the correct residence time is the responsibility of the food manufacturer.
To ensure that the minimum residence time is maintained, it is essential that, during sterilization of a certain
product:
— The flow rate must not increase above the design flow rate.
— Holding tubes should be of a design where air pockets are not present thus reducing the effective holding
time. The product flow should be from the bottom to the top.
— The pressure in the system should be high enough to avoid boiling.
— The presence of uncondensed bubbles of steam or non-condensable gas, such as air, should be avoided
as much as possible, otherwise a variable holding time will occur.
— Fouling over the specified production time should be taken into account and the holding tube designed
accordingly.
— With direct heating plants, allowance must be made for the quantity of steam condensed in the product
when determining the required holding time.
— Any sensors located in the tube should be of aseptic design and installed in a way suitable for aseptic
operation.
— The number of fittings should be minimized and those used should be suitable for aseptic operation.
— If insulation material is used, care should be taken to ensure that it is not corrosive towards the material of
the holding section.
A similar approach for measurement of residence time as in pasteurization plant could in theory be used for
sterilization plant, although the elevated temperatures and pressures may create some additional practical
problems.
5.1.2 Direct heating
There are two types of direct heating, steam injection and steam infusion. In a steam injection process, steam
is injected directly into the product whereas in an infusion process the product is introduced into a steam
atmosphere.
A key requirement for direct heating is the availability of dry, saturated, food quality steam, produced by
evaporation of water according to local legal requirements for culinary steam. The quality described in the
FDA culinary steam requirements (3A 609-03 Method of producing culinary steam) is widely used where local
regulation is not present. This also means steam has to be filtered before used for direct heating. As the
steam condenses into the product, it must be considered a part of the product formulation and care must be
taken over the steam supply and the use of boiler water treatment chemicals. There are legislative restrictions
on the use of such chemicals.
Both injection and infusion are very rapid heating systems followed by rapid flash cooling, which means the
sterilization effect only happens in the holding section. This emphasizes the importance of a correctly sized
holding section for direct heating sterilizers.

5.1.2.1 Steam injection
A typical steam injection system is shown in Figure 3, with product preheated in a heat exchanger prior to
being heated to sterilizing temperature in the steam injector. The product at sterilizing temperature passes into
the holding section, which is maintained under pressure to prevent boiling of the product. After the holding
section the product is passed into a vessel operated below boiling pressure resulting in evaporation of the
water added during injection and flash cooling takes place. By controlling the temperature difference between
the preheating and vacuum cooling temperatures the condensed steam removal can be controlled. The
cooled sterile product can then be extracted from the vessel and further cooled indirectly and aseptically prior
to filling, buffer storage or further processing.
A key requirement is that the steam condenses immediately on contact with the product thus giving up its
latent heat. Failure to achieve this will result in uncondensed steam entering the holding section resulting in
variable holding times. In addition the response of the temperature probe may not be able to differentiate
between alternate slugs of steam and cold product. An adequate holding time for microbiological safety must
be provided in the holding section. The holding time accounted for starts after the first temperature probe in
the beginning of the holding section after the injector.
Control of the product flow rate to the steam injector is a key requirement for product safety since even small
variations in flow will result in substantial changes in holding time at an elevated temperature.
In practice, the design of the injector, the pressure of the steam and hence the amount of steam, the number
of nozzles and the product characteristics such as viscosity, all influence the way in which the steam
condenses and heats the product. The suitability of a chosen configuration should be checked experimentally
with the product to be sterilized. Common types of steam injectors are shown in figures 2 and 3.
The steam supply line must be of stainless steel downstream of the filter unit. The injection unit should be of
hygienic design. As product may enter the steam supply line through the injection unit, it must be possible to
clean both the inside and outside of the nozzle. The injection unit should be of hygienic design and must be
capable of being cleaned and the cleaning process must ensure that no residues or cleaning chemicals are
left in the steam supply line or injection unit.
Fig. 1 – Direct system – steam injection

Fig. 2 – Steam injectors “nozzle type”
Fig. 3 – Steam injectors “perforated pipe type”
5.1.2.2 Steam infusion
Steam infusion is a similar process to that of steam injection, the major difference being the replacement of
the steam injector by a steam infuser vessel into which the product is introduced, shown in figure 4. The
product is heated as it falls through the steam atmosphere to the bottom of the vessel, transferred to a holding
section and subsequent evaporative cooling vessel if required. In the example shown in figure 5, preheated
product is pumped into the infuser vessel. A product distributor within the vessel provides fine strings, film or
droplets of product thus generating a large product surface area for steam contact. The infuser vessel is
maintained at a controlled pressure to give the desired sterilization temperature. To prevent non-condensable
gases from accumulation in the infusion vessel, the vessel is fitted with a top venting line for continually
removal of unwanted gases. As for all venting systems in the production line it is the responsibility of the food
processor to judge the risk of microbial contamination.
Control of the product flow rate out of the steam infusion chamber is a key requirement for product safety
since even small variations in flow will result in substantial changes in holding time at an elevated temperature.
An adequate holding time for microbiological safety must be provided in the sterilizing holding section.
The control of the flow rate out of the infusion chamber can be done by controlling the product level at the
infusion chamber outlet either by level transmitter or controlled by a pump directly after the infusion chamber.

Control of the product flow rate is key requirement, as variations will impact holding time, similar to the steam
injection system. The recommendation here is to have the holding section flow rate as the master flow rate
and let the other flow rate control on the infusion system follow as the slave flow rate.
Steam infusion vessels should meet the following requirements:
— They must be of hygienic design
— All internals and connections should meet the same standards as the vessel itself i.e. cleanable and of
hygienic design. The product flow distributor may require special attention to ensure that it can be cleaned.
The steam supply inside the infusion vessel should not be in contact with product and does not require daily
CIP, however daily CIP is recommended as part of the general vessel cleaning sequence.
The lower part of the infusion vessel can be equipped with a cooling jacket at the product contact surface. The
purpose is to cool the inner surface and create a thin layer of condensate in order to minimise fouling.
Fig. 4 – Direct system – steam infusion

Fig. 5 – Steam infusion vessel
5.1.2.3 Flash cooling vessels
Flash cooling vessels should meet the following requirements:
— They must be of hygienic design
— All internals and connections should meet the same standards as the vessel itself i.e. aseptic design
Coupling, flanges and seals should be avoided as much as possible. All connections are critical as the
vacuum conditions in the vessel provide an increased risk of bacterial ingress. It is recommended to use
double seals for increased assurance, with the gap between the seals flushed with steam, condensate,
antimicrobial fluid (food grade) or operated under a lower pressure than the product side.
Fig. 6 – Flash cooling vessel

5.1.3 Indirect heating
Indirect heating is probably the most widely used technique for the sterilization of liquid foods and is, in
principle, simpler than the direct heating techniques. There are fewer control loops than for direct systems,
the key ones being flow and temperature control.
The simplest sterilizer configuration is shown in Figure 7. It consists of a heating section, a holding section
and a product cooling section. A back pressure device is also installed to prevent the product from boiling, as
the temperatures used are in excess of 100°C. Depending on the product the heating medium used can be
steam or hot water. The system shown in Figure 7 has no form of heat recovery and as such would be
economically unattractive.
Figure 8 shows a system with product to product heat recovery. Figure 9 shows a system in which the
product is preheated by heat recovery from the hot product using a secondary water circuit. After final
heating to sterilizing temperature and holding, the sterile product is cooled to the filling temperature in two
stages via a pre-cooler and final cooler. The heat recovery system is more complex in terms of plant design
but has a much reduced energy requirement. It is also possible to preheat the product with the sterilized
product after the holding section in a regenerative heat exchanger as shown in Figure 8 making a less
complex plant design and the same reduced energy requirement.
These are the most common means to prevent mixing of sterile with non-sterile product:
1. Positive pressure on the heat treated side

2. Indirect heat transfer by a hot water circuit
Note that the water in the closed water circuit as designed in Figure 9 is continuously sterilized by the high
temperature minimizing the risk of microbiological contamination. See EHEDG Guideline Doc 1 Section 2 for
more details on different measures to prevent untreated product entering the treated product side.
Fig. 7 – Indirect system – no heat recovery

Fig. 8 – Indirect system – with heat recovery
Fig. 9 – Indirect system – with heat recovery (water circuit)

5.1.3.1 General requirements for heat exchangers
The primary function of a heat exchanger in a sterilization plant is to deliver the desired heat transfer whether
heating or cooling, for the range of products being processed. The heat exchanger should be capable of
functioning reliably on a routine basis. A heat exchanger in a sterilization plant will not necessarily be
designed for maximum heat transfer efficiency. This is because other factors such as the fouling of heat
transfer surfaces and the balance between heat load on the product, capital and running costs are also taken
into account. There are a wide variety of heat exchangers used for heating and cooling duties in both direct
and indirect systems and the following requirements are common to all types:
— The heat exchangers must be fully cleanable and preferably drainable.
— Service fluids in contact with the heat exchanger should not be corrosive.
— Pockets (dead legs) should be avoided at the product side as they are difficult to clean and present areas
where product will reside for a much longer time than the mean residence time.
— All connections in the sterile area of the plant must be of aseptic design (i.e. cleanable, sterilizable and
bacteria-tight).
— Where gaskets are used to separate the product from the heating or cooling medium, there must always
be two gaskets between the two flows, while it must be impossible to build up pressure between these two
gaskets. Hence, the space between the two gaskets must have vent and drain grooves, large enough to
ensure that they cannot be blocked by leaking product, heating medium or coolant.
— Replacement gaskets must fulfil the requirements specified by the manufacturer of the heat exchanger.
— In the case of viscous or high fouling products the flow passage should not be too narrow otherwise
blockage may occur. For some products however, an increased velocity can assist in controlling fouling
and this must be considered in conjunction with the likelihood of product blockage. The design and the
production parameters should safeguard prevention of blocked tubes.
— To prevent stress corrosion, the design should be such that differences in thermal expansion and
contraction do not lead to unacceptable stress at any time.
5.1.3.2 Tubular heat exchangers (THE)
All THE's must satisfy the following important requirements in addition to those already stated in the general
requirements:
 Spacers, if necessary to ensure correct positioning of tubes in the product side, must be designed
such that they are easy to clean. Designs with spacers are not suitable for products with fibres or
particles.
 In the case of highly viscous products, the design should take into account the prevention of
channelling.
 If the product contains fibres and/or particles the cross section should be large enough everywhere to
prevent blockage of the flow of product.
 If sufficient turbulence cannot be achieved, mixing elements may be used to ensure a homogeneous
temperature at the end of the heating section. Mixing elements and their mounting should be hygienic.
In addition to the above requirements, it is recommended to ensure that, as far as possible, the flow of product
is upwards through the entire installation to eliminate the possibility of air being trapped in the system.
In certain countries provision of cleanliness is legally required and access for inspection therefore needed.

5.1.3.3 Types of tubular heat exchangers
There is a wide variety of THE's ranging from the simple jacketed pipe to the more complex forms such as the
concentric multitube heat exchanger.
Fig. 10 – Jacketed pipe or mono-tube heat exchangers
Jacketed pipes are amongst the most hygienic heat exchangers, if well designed and constructed.
Fig. 11 – Concentric multitube heat exchangers with single product channel
To ensure that a concentric multitube heat exchanger meets the hygienic design criteria, care should be taken
to ensure that the inlets as well as outlets (including connections between elements) are cleanable and are
without dead areas. Depending on the length of the tubes, spacers may be needed for support.
If there is more than one annular product channel, it is extremely difficult to meet hygienic requirements and

special attention should be paid to the connection sections. It will also be difficult to ensure that pressure
build-up between gaskets is prevented.
Fig. 12 – Coiled tube heat exchangers
Their characteristics are similar to those of the jacketed pipe heat exchanger and concentric multitube heat
exchangers with one product channel. Coiled heat exchangers, however, are difficult to inspect for cleanliness
or corrosion, other than with radiographic (X-ray) methods. Consequently, coiled heat exchangers are not
suited where regular inspection of the heat transfer surfaces is required.
Fig. 13 – Shell-and-multitube heat exchangers

To ensure that a shell-and-multitube heat exchanger meets the hygienic design criteria, care should be taken
that the inlets and outlets are cleanable, are without dead areas and welds are of good quality. Product pipes
may be connected in series or in parallel. If connected in series by welds, inspection will be difficult. If used in
parallel, shadow areas with low flow velocity and turbulence are difficult to avoid at the tube plates. Product
flow should preferably be through the tube side only unless the shell side is cleanable, of hygienic design and
possible to inspect.
5.1.3.4 Cleaning in-place of tubular heat exchangers
In some tubular heat exchangers, a shadow effect is unavoidable. This must be taken into consideration in
devising the cleaning procedure. Often, increasing the velocity of the cleaning fluid will be sufficient. In other
cases reversal of the direction of the flow of cleaning fluid may improve cleaning although this may not be
practical in the majority of cases.
5.1.4 Plate heat exchangers (PHE)
In addition to the general requirements stated above, the following points should be taken into account:
— It is the responsibility of the plate manufacturer to inspect the steel sheet used for absence of flaws.
— Plates may be susceptible to stress corrosion caused by mechanical damage resulting from pulsations
and vibrations. Such pulsations/vibrations should therefore be minimised by the use of appropriate
dampeners.
— Plates in contact with sterile product should be checked for mechanical damage and cracks at regular
intervals. Where practical experience is available on plate life, replacement of the plates should be carried
out as part of a standard maintenance routine.
Fig 14 – Plate heat exchangers
5.1.5 Scraped or swept surface heat exchangers (SSHE)
SSHE's are particularly suited to the heat treatment of viscous products. They may be of horizontal or vertical
design with a rotating dasher assembly, holding blades that scrape or sweep product from the surface to
maintain effective heat transfer.

Any cooling medium can be used but direct regenerative heating or cooling with product is impractical. Steam
is the normal heating medium, but hot water may also be used. Since the heat transfer area available is
generally much less than other types of heat exchangers, the temperature differences required to achieve
required heat fluxes are high. In the case of product heating this can result in increased fouling.
Aseptic seals are available for use in sterilization systems and must be used downstream of holding to prevent
recontamination where, for example, aseptic filling follows.
SSHE's should satisfy the following in addition to the general requirements:
— Any internal bearings must be hygienic in design and cleanable.
— Single seals are satisfactory for static applications; dynamic seals should be double with continuous
steam or other antimicrobial fluid flushing.
— There should be clear indication of the correct position and orientation of blades and rotational direction.
— The design should ensure that air pockets cannot remain trapped in the barrel. Hence, the product outlet
should be at the highest point.
— The inlet should be below the outlet and the barrel should be drainable. Consequently, the inlet should be
at the lowest point.
Other factors to be taken into account when selecting and using a scraped surface heat exchanger are:
— If the product is an immiscible mixture of liquids with different densities, it is necessary to consider the
relative densities and viscosities of the liquids when selecting a horizontal or vertical machine, in order to
avoid settling or separation.
— The consequences of blade configuration may be considerable. For example, a fully bladed machine may
give plug flow/mass rotation which gives consistent residence time but may also lead to temperature
distribution problems.
During CIP, the velocity through the annular space may well be lower than in the rest of the line. The standard
cleaning regime may not be sufficient therefore the design of an adequate CIP process for the heat exchanger
is essential.

Fig. 15 – Scraped or swept surface heat exchangers (SSHE)
5.1.6 Aseptic buffer tanks
Aseptic tanks can be used in conjunction with continuous sterilization plant to improve plant utilization and
flexibility. They will be installed between the sterilization plant and the filler. They are pressure vessels
(sterilization with steam under pressure and sterile air pressure during production) and need to be designed to
high standards in order to be acceptable for use in such applications. The basic elements of design are those
for any hygienic tank namely the avoidance of dead spaces, sharp corners and narrow recesses, the use of
materials compatible with product and cleaning chemicals under conditions of use and accessibility to the tank
after installation. There are a number of stringent requirements:
— The tank must be cleanable in place and fully drainable.
— The tank must be sterilizable, preferably independently of the associated process plant and filling machine.
— Other than for small capacity tanks, a water jacket is likely to be required for cooling after steam
sterilization. This jacket should be fully drained before sterilization.
— All tank internals and connections should meet the same high standards as the tank itself.
— For some products an agitator may be required. The proper design for CIP is required as shadow areas
could make CIP less efficient.
5.1.6.1 Agitators
The design of the agitator depends on the type of product inside the tank. Where smaller agitator blades are
required a magnetic coupled agitator may be used. The benefit of such a type is that it does not require a
shaft seal. Special attention to the maintenance of magnetic agitators is needed as for example metal particles
might attach and will be difficult to clean with normal CIP procedures.

For other types of agitators a steam or condensate barrier for the shaft seal is required. During the sterilization
step of the tank, the steam chamber of the agitator will also be sterilized with steam. A temperature sensor is
necessary to prove that the minimum sterilization temperature has been reached for the required time. To
avoid damage to the seals in most cases the agitator shaft has to stand still during sterilization. Later during
production the condensate valve will be closed and condensate will be collected inside the chamber. The
condensate will cool and lubricate the mechanical seals. From time to time the condensate valve may open for
a short period to release the cold condensate and allow fresh condensate to be collected again.
In some cases an antimicrobial liquid (food grade) may be used in place of steam within the barrier. It is
advised to monitor the level in the reservoir.
5.1.6.2 Sterile air supply
Most aseptic tanks are operated with overpressure (above atmospheric). The internal pressure prevents
contamination from outside and helps to push the product to the filler. The pressure difference between the
system and the surrounding atmosphere should be monitored and a pressure drop below a min. threshold
(typically 10 to 50 kPa gauge or 0,1 to 0,5 bar gauge) shall trigger an alarm to indicate that the tank contents
are potentially under risk of non-sterility. Usually compressed air will be used to charge the head space of the
aseptic tanks. There will be a requirement for a series of filters in front of the sterile air filters depending on the
air quality and pre-treatment. Usually the sterile air filter will be steam sterilized in situ together with the
aseptic tank. Care must be taken to avoid mechanical damage to the aseptic filter, which may be caused by
excessive steam or air velocities or particles in the media.
As filters may fail to retain bacteria to the required degree, it will increase safety to use two filters in series.
Furthermore, it is desirable that the installation and operation are such as to avoid contact of the condensate
with the filters at any stage. If this is unavoidable the filters should maintain their microbiological integrity in the
presence of condensate.
An integrity test shall be carried out at regular intervals as well as the requirement to replace the filter
cartridges following the filter manufacturers’ recommendations.
See also EHEDG Doc 30 Guidelines on air handling in the food industry for recommendations on process air
and air systems designed to provide process air for aseptic operations.
5.1.6.3 Aseptic barriers
It should be possible for sterile product in the tank to be maintained in a sterile condition even if the process
plant and/or filler become unsterile, for example during the cleaning of the UHT plant. This can be achieved by
an arrangement commonly termed an aseptic barrier.
5.1.6.4 Individual aseptic valves
A typical principle of an aseptic barrier is shown in figure 16. When the plant and tank are sterile and product
is to be transferred to the tank, valves 3 and 4 are closed and 1 and 2 opened. If the process plant becomes
unsterile and hence it is necessary to protect the product in the tank, valves 1 and 2 are closed and steam
purges the short section of pipe between them. A bypass line must also be fitted such that the back of valve 4
can be steamed so as to prevent any potential contamination via valve 4. This also prevents condensate
accumulation in the steam supply line. A temperature sensor in the outlet line between valve 4 and the
orifice/steam trap enables the status of the barrier to be monitored and ensure that the barrier temperature is
always sufficient. To avoid burn on in some cases lower steam pressure may be used in production mode. A
similar effect can be achieved if the condensate outlet valve is closed for most of the time to allow collection of
colder condensate. From time to time the condensate valve has to be opened to replace the cold condensate
with steam. A temperature probe inside the barrier may be used to trigger the valve action.
In some cases an antimicrobial liquid may be used in place of steam within the barrier.

Fig. 16 – Aseptic barrier with individual valves
5.1.6.5 Aseptic double seat valves
A more hygienic design avoiding dead ends uses aseptic double seat valves as shown in Figure 17. Further
details of aseptic double seat valves are given in the EHEDG Guideline Doc. 14 on Hygienic design of valves
for food processing.
Fig. 17 – Aseptic barrier using double seat valve
5.1.7 Miscellaneous equipment
To avoid the risk of re-contamination it is recommended to minimize any type of equipment on the aseptic side
e.g. after the holding section. Some equipment is unavoidable but when possible it is recommended to place
processing equipment before the final heat treatment.
5.2 Process operation
This section covers the operation of the sterilizer from pre-sterilization through start-up to cleaning in place.

The operator of the sterilizer needs to be properly trained and should follow the operating instructions
provided by the equipment supplier.
Before any new product is processed commercially, its minimum residence time within the holding section
should be calculated. The food manufacturer must ensure that the final product meets all microbiological
requirements. There are several sterility test methods that can be used where European Commission states
that products should remain microbiologically stable after incubating for 15 days at 30°C or seven days at
55 °C in closed containers (Ref: Commission Regulation (EC) No 1662 /2006 (amending Regulation (EC) No
853 /2004)). The sterility test requires relatively large samples to be tested to ensure the microbiological
quality. The microbiological quality of a UHT product cannot be tested by random sampling.
5.2.1 Pre-sterilization of equipment
Pre-sterilization of the equipment is necessary to ensure that prior to production all product contact surfaces in
the sterile area of the plant are fully sterilized. The sterile section of the plant includes everything downstream
of the holding section and thus can incorporate a wide variety of equipment. Pre-sterilization is carried out
thermally using either steam or pressurised hot water. A cooler in the pre-sterilization circuit is used to reduce
the return temperature unless a closed pressurised circuit is used. Tanks are sterilized with steam whilst other
equipment is generally sterilized with pressurized hot water. The main requirements are:
— All product contact surfaces must reach and maintain a minimum sterilization temperature for a defined
time.
— Design of equipment must therefore allow this to take place
— Sufficient back pressure to be controlled
— For tanks, adequate venting of air and drainage of condensate is essential.
— For all process plant dead spaces must be avoided. Thermal conduction of heat into dead spaces will not
provide an assured sterilization.
— It is also necessary to ensure that the temperature monitored is representative of that of the lowest
surface temperature within the equipment.
It is the duty of the manufacturer of the sterilizer to specify adequate pre-sterilization conditions. It is the
responsibility of the food producer to validate the effectiveness of the pre-sterilization prior to commercial
production.
5.2.2 Production
After pre-sterilization has been completed, the plant is brought to production conditions whilst circulating
sterile water through the system. This generally incorporates cooling the areas of the plant downstream of the
holding section by allowing cooling water into the coolers. When suitable conditions have been achieved,
product is allowed into the plant displacing the water. The main requirements for this phase of the process
are:
— During the cooling phase after pre-sterilization, the plant control system must maintain the sterilizing
temperature in the holding section at or above the minimum level.
— During changeover from water to product, both the sterilizing temperature and the flow rate must be
maintained to ensure that each particle of fluid entering it receives a minimum desired heat treatment.
This can be a potential problem if the product has a significantly higher viscosity than water.
It is the responsibility of the equipment supplier to ensure that the heat exchanger is capable of achieving the
desired temperature conditions at all times. A level control system should prevent air entering the system.
5.2.3 Water and product recirculation
When it is not desired to feed product forward to the aseptic tank or filling machine the product can be re-
circulated in the UHT unit while sterile conditions are maintained. Product re-circulation may deteriorate the

quality of the food product and a common method to avoid this is to displace the product with water whilst still
maintaining sterile conditions. Once production is ready to be re-started the sterile water is displaced with
product and normal production can continue. Product and water re-circulations should be minimised as these
increase risk of fouling and re-contamination.
5.2.4 Flow diversion due to failure in operation conditions
Flow diversion is not generally used in sterilization processes in the same way as with lower temperature heat
treatment plant due to temperatures above the boiling point of the product. Apart from the risk to process
integrity, recirculation of food products often seriously affects both physical and flavour characteristics.
It is, instead, a system which immediately seals off the route to aseptic tanks and fillers and is frequently
followed by plant shut down, CIP and re-sterilization. Valves used to seal off the route to aseptic tanks and
fillers must themselves be of aseptic design and will often also be used for recirculation of pressurized hot
water during plant pre-sterilization. To avoid contamination of the aseptic tank and/or filling machine an
aseptic barrier must be installed downstream of this valve.
In the few cases of diversion from the holding section a diversion cooler and back pressure control will be
required to maintain stability and suppress boiling in the holding section.
Details of valve and control requirements for diversion are given in the EHEDG Guideline Doc. 1 on
Continuous pasteurization of liquid food.
5.2.5 Aseptic intermediate cleaning (AIC)
In some cases, a brief cleaning sequence takes place during the production phase where the sterility is
maintained and production continues after finalized cleaning. This technique is used to extend production
times and the plant might not be totally clean after this operation. Since the temperatures and relevant
conditions are maintained at production levels to maintain sterility, the implications of elevated temperatures of
cleaning solution, ~135°C, on sections of the plant must be taken into consideration. After intermediate
cleaning, the chemicals must be removed from the plant by means of adequate water rinses.
5.2.6 Cleaning
Cleaning should take place at the end of production or after a process deviation and the cleaning procedure
should ensure that the main requirements met are:
— All product contact surfaces must be clean at the end of the cleaning sequence. Failure to achieve this
may compromise the pre-sterilization step.
— Chemicals must be compatible with the materials of construction at the in-use temperatures and
concentrations.
— After cleaning, the chemicals must be removed from the plant by means of adequate water rinses.
5.3 Process monitoring and control
In sterilization plant there are a number of critical points to monitor and control including:
— Temperature at the end of the holding section during production
— Re-circulation return temperature during sterilization prior to production
— Product flow rate during production
— Back pressure in holding section during production
— Aseptic tank temperature during sterilization prior to production
— Aseptic tank pressure after sterilization and during production

— Aseptic barrier temperatures or concentration of the antimicrobial in the liquid
— Cleaning parameters
It is essential that the control logic of the line will provide the appropriate action in response to process
deviations. Unacceptable deviations in critical process variables during production must result in automatic
shutdown of the line where unsterilized product is rejected. For example, the line would have to be shut down
if the sterilizing temperature fell below the minimum level. At an automatic shutdown, the product in the plant
is replaced with circulating water. Cleaning and pre-sterilization is necessary before production can continue.
It is essential to record critical process parameters from the line at an adequate frequency. Legal requirements
may also necessitate the continuous recording of certain data. In addition, data logging facilities enable a
considerable number of variables to be monitored and it is recommended that they are used to provide a
record of when the variables are outside the normal operating ranges.
Recording the process parameters enables the performance of the total line to be closely monitored during
operation to ensure that the desired performance standards are being achieved on a routine basis and that
the plant is operating to specification. It is particularly important to monitor the process/equipment interactions
which can result in adverse effects, such as fouling.
The major process variables to be controlled are:
— Temperature
— Pressure
— Flow
— Level
For each control variable it is necessary to assess:
— The quality of control required
— The speed of response required
— The action to be taken if the variable is outside the set range
— The likelihood of control problems arising from interaction with other control loops
— The position of the sensor
For critical variables such as sterilizing temperature, the quality of control needs to be high with a rapid
response to changes. If the temperature falls below a pre-set minimum, line shutdown must be automatically
initiated. By contrast, the level control in a vacuum vessel may be important in terms of ensuring fluid is
always present but the quality of control need not be as high, or the response time as rapid, as for sterilizing
temperature.
5.3.1 Temperature
Temperature control is almost exclusively achieved by controlling the opening of a valve that allows the
heating or cooling medium either into the heat exchanger or directly into contact with product. The sensors for
such critical variables as sterilization, pre-sterilization, sterile barriers and seals must be accurate, reliable and
have a sufficiently rapid response time so as not to compromise the safety of the process. The control system
must be capable of compensating for sudden temperature deviations at the inlet of the heating section (e.g.
due to switching over from the intake of hot water to cold product after pre-sterilization).
The sterilization temperature and the lower temperature limits that define when to divert product or stop the
sterilization must be based on legal requirements or discussed with health authorities, customers etc.
Specification of the correct temperature is fully the responsibility of the food manufacturer. When choosing a

set-point, the accuracy of the temperature-measuring system must be taken into account. Furthermore, it must
be possible to verify the temperature probes versus accredited references.
It is recommended to use two different temperature probes for the temperature control and temperature
recording. The probe for the control loop is ideally positioned close to the heater outlet to reduce the dead
band of the control loop. The probe for the recorder has to be positioned at the end of the holding section.
Products with a high viscosity have often a non-turbulent flow. In this case, especially at heater outlets the
temperature distribution across the cross section may not be even. To enable a better temperature distribution
a static mixer may be installed before the probe. Independent of the solution, the most important criteria to
meet is the measurement of the lowest temperature in the product.
5.3.2 Pressure
The pressure must be high enough to maintain sterilization conditions and the plant should shut down
automatically in the event of loss of pressure. A pressure alarm system is essential in some cases and
desirable for early warning in all lines.
5.3.3 Positive pressure on the sterile side
In some countries, regulations require that the sterilized product is always at a higher pressure than the
product or cooling medium to improve safety. See section 2.7.2 in EHEDG Guideline Doc. 1 on Continuous
pasteurization of liquid food for detailed information.
5.3.4 Pressure to avoid boiling
It is important to closely control the pressure within the sterilization line in order to suppress boiling. If the
pressure is insufficient, vaporisation will occur reducing the holding time. Furthermore, it is generally accepted
that the presence of vapour enhances fouling especially on heat transfer surfaces. As products usually contain
dissolved air, of which the solubility rapidly decreases with increase in temperature, it is recommended that
the pressure is a minimum 70 kPa (0.7 bar) above the saturated vapour pressure of the liquid. Control of
pressure may be achieved in a number of ways:
1. By using a pressurized storage vessel. The pressure in the vessel in turn may be controlled by controlling
the pressure of the gas above the product (e.g. sterile food grade air or nitrogen).
2. By using a constant back pressure valve. This would normally be an air loaded diaphragm valve with the
capacity to pass full flow back to the plant feed system in the event of filler stoppage. Depending on the
configuration of the line it may be necessary to have a sterile barrier installed.
3. By the use of a positive displacement pump with speed variation to control back pressure.
4. By the use of an orifice plate, when the flow rate is constant.
Combinations of these options may be used as well, depending on the subsequent process or packing system
and start up and shut down requirements. The position of the back pressure system will depend on the design
of the process but in some cases may require control in more than one position.
5.3.5 Flow rate / level
A stable flow is very important for a continuous sterilizer, as a fluctuation in the volumetric flow has a direct
effect on residence time in the holding section and a negative influence on the temperature control loop. The
flow control can be done in various ways, frequency controlled centrifugal pumps, positive pumps or other flow
promoting devices.
If the sterilizer is operated with variable flow a flow meter shall be used upstream of the holding tube to
generate an alarm in case the volumetric flow exceeds the designed flow rate for the holding tube. In case of
alarm the production must be stopped.
Please note: The volumetric flow is influenced by density and temperature. If the flow meter operates at lower
temperatures than the sterilization temperature the set point for the alarm has to be reduced accordingly to the

volume increase caused by the temperature difference. The accuracy of the flow meter shall be of industrial
standard and the manufacturers installation recommendations have to be followed.
Level control is achieved by adjusting the flow rate to or from the unit. The control system must be designed to
ensure that the minimum residence time is not compromised by increasing the flow rate above the allowable
maximum.
5.4 Inspection and maintenance
Regular inspection and maintenance is an essential part of plant operation since, without it, faults will develop
and the safety of the process may be severely compromised. Critical sensing instruments should be checked
according to manufacturer’s recommendation against a known standard. Plant records should be continuously
monitored to provide the earliest possible warning of problems. For example, a higher than normal heating
medium temperature at start up may indicate poor cleaning after the previous production run.
Any modifications or changes to the plant should only be implemented if the implications of the modifications
to the process have been thoroughly evaluated. Any change must be reported to the safety manager who
should investigate eventual product safety risks. For example, if pipe work is to be altered, extreme care
should be taken to ensure that the modification will not increase the risk of re-contaminating the sterile product
or adversely affect the cleaning of the plant.
5.5 Conclusions
In order to ensure the microbiological safety of a sterilization process the following must be achieved:
1. The measuring and control equipment must ensure that temperature, flow and back pressure are
maintained.
2. Unacceptable deviations in key process variables must result in automatic shutdown of the line.
3. The process must be stopped when fouling may compromise the product safety.
4. The process equipment downstream of the holding section must be aseptic and hence cleanable,
sterilizable and bacteria tight.

6 References
1) EHEDG Guideline Doc. 1 Continuous pasteurization of liquid food
2) EHEDG Guideline Doc. 8 Hygienic equipment design criteria
3) EHEDG Guideline Doc. 9 Welding stainless steel to meet hygienic requirements
4) EHEDG Guideline Doc. 10 Hygienic design of closed equipment for the processing of liquid food
5) EHEDG Guideline Doc. 14 Hygienic design of valves for food processing
6) EHEDG Guideline Doc. 16 Hygienic pipe couplings
7) EHEDG Guideline Doc. 17 Hygienic design of pumps, homogenisers and dampening devices
8) EHEDG Guideline Doc. 32 Materials of construction for equipment in contact with food
9) EHEDG Guideline Doc. 35 Welding of stainless steel tubing in the food industry
10) EHEDG Guideline Doc. 37 Hygienic design and application of sensors
11) EHEDG Guideline Doc. 43 Principles of Cleaning Validation
Order information on EHEDG guidelines can be obtained under www.ehedg.org > Guidelines > Download and
Order Information (https://www.ehedg.org/guidelines/download-order-information/).

Valve symbols used

Heat exchanger symbol used
Symbol used to illustrate any type of heat exchanger or heat exchanger section.

Colour code for drawings
Product Dark Blue
Water Light Blue
Bacterial film or soil Orange
Detergent Green
Acid Red
Disinfecting agent, steam, or sterile liquid Purple
Food quality grease or oil Yellow
Compressed Air Grey or Shaded Dots

Definition of sterilization effect
F0 Value
The combined effect of time and temperature on the sterilization of Clostridium botulinum spores is expressed
in terms of the F0 value in units of time, most frequently minutes. It is calculated according to the following
mathematical formula:
where:
t = sterilization time most often expressed in minutes, e.g. the holding time in seconds divided by 60
T = sterilization temperature in °C
B*
The effective bacteriological effect of UHT treatment is also defined by B* (known as B star).
These value is based on experiments performed by Horak (1980) with natural milk incubated at 55 °C to
enumerate thermophilic microorganisms. The result was presented in the form of a straight line relating log of
time with temperature for a constant sterilizing effect. These data were extrapolated to give the line that would
correspondent to 9 decimal reductions of this natural thermophilic spore population - B*value 1.
B* is based on the assumption that commercial sterility is achieved at 135°C for 10.1 sec. with a
corresponding z - value of 10.5 °C. This reference process is given a B* value of 1.0.
where:
z = the temperature increase, in °C, which is required to obtain the same lethal effect at a 10th of the time (for
example 10.5 °C for Bacillus stearothermophilus spores)
Reference: Tetra Pak Dairy Processing Handbook 2016

Continuous UHT Sterilization of Liquid Food

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DOC 6

CONTINUOUS UHT STERILIZATION OF LIQUID FOOD

Tel.: +49 69 66 03-12 17 or -14 30

DOC No. 6 ©EHEDG 2 of 31

DOC No. 6 ©EHEDG 3 of 31

Bengt Eliasson** Tetra Pak, Sweden

Stefan Åkesson Tetra Pak, Sweden

Franz-Josef Helms GEA TDS, Germany

Steven Hoefkens Stork Food & Dairy Systems, Netherlands

Anneginus Hummel FrieslandCampina, Netherlands

Huub Lelieveld Netherlands

Ole Poulsen SPX Flow Technology, Denmark

Paul Skudder SPX Flow Technology, United Kingdom

Ana Soares Mondelēz International, United Kingdom

Joern Stistrup SPX Flow Technology, Denmark

Jeroen Veldkamp Heinz, Netherlands

The first edition (April 1993) was co-authored by

DOC No. 6 ©EHEDG 4 of 31

For sterilization to result in a safe product, it is necessary that

2. The recontamination of sterilized product is prevented.

1 Objectives and scope

DOC No. 6 ©EHEDG 5 of 31

4.1 Hygienic design of the sterilizer

5.1 Sterilizer process design

5.1.1 Holding section

DOC No. 6 ©EHEDG 6 of 31

— The pressure in the system should be high enough to avoid boiling.

5.1.2 Direct heating

DOC No. 6 ©EHEDG 7 of 31

Fig. 1 – Direct system – steam injection

DOC No. 6 ©EHEDG 8 of 31

Fig. 3 – Steam injectors “perforated pipe type”

5.1.2.2 Steam infusion

DOC No. 6 ©EHEDG 9 of 31

Steam infusion vessels should meet the following requirements:

— They must be of hygienic design

Fig. 4 – Direct system – steam infusion

DOC No. 6 ©EHEDG 10 of 31

5.1.2.3 Flash cooling vessels

Flash cooling vessels should meet the following requirements:

— They must be of hygienic design

Fig. 6 – Flash cooling vessel

DOC No. 6 ©EHEDG 11 of 31

1. Positive pressure on the heat treated side

Fig. 7 – Indirect system – no heat recovery

DOC No. 6 ©EHEDG 12 of 31

Fig. 9 – Indirect system – with heat recovery (water circuit)

DOC No. 6 ©EHEDG 13 of 31

— The heat exchangers must be fully cleanable and preferably drainable.

5.1.3.2 Tubular heat exchangers (THE)

DOC No. 6 ©EHEDG 14 of 31

Fig. 10 – Jacketed pipe or mono-tube heat exchangers

Fig. 11 – Concentric multitube heat exchangers with single product channel

DOC No. 6 ©EHEDG 15 of 31

Fig. 12 – Coiled tube heat exchangers

Fig. 13 – Shell-and-multitube heat exchangers

DOC No. 6 ©EHEDG 16 of 31

5.1.3.4 Cleaning in-place of tubular heat exchangers

5.1.4 Plate heat exchangers (PHE)

Fig 14 – Plate heat exchangers

5.1.5 Scraped or swept surface heat exchangers (SSHE)

DOC No. 6 ©EHEDG 17 of 31

SSHE's should satisfy the following in addition to the general requirements:

— Any internal bearings must be hygienic in design and cleanable.