Effective Management of Critical

Control Points (CCPs) in the Food Industry

Abstract

This paper deals with the principles and techniques that need to be
applied to the food industry for an effective management of each
critical control point (CCP) found in the process or in the equipment
under examination. The application (to an aseptic filler CCP) is
shown, of the principles presented in the author’s paper, titled Packaging
Raw Liquid
Material
‘How to Monitor Food Equipment Critical Parts to Design Reliable Food Product
(PM)
Maintenance Tasks’, published in Issue 14.4. The use is extended
of Hazard Analysis and Critical Control Points (HACCP) principles, Heat
integrating them with Reliability Centred Maintenance technique to Treatment
PM
produce a maintenance approach guided by reliability principles
Sterilization
and food safety criticalities. The effectiveness of maintenance
is heavily dependent on the ability to identify the different CCPs Cooling
existing in a production line, and to define the critical control
parameters, processes and parts that characterize each CCP.
The ability to identify the Biological, Chemical and Physical risks Aseptic Filling
associated with the different critical control elements, to weight
them and to design specific maintenance activities, represents a Figure 2:
Aseptic processing Container
real competitive weapon in the hands of food companies.
and packaging Sealing

Sauro Riccetti End Product

Business Development Director, Storage & Distribution
Tetra Pak Italy

Introduction Million of
Aseptic and

T
Bacterias/ml
he industries involved in processing extended shelf
and packaging liquid foods, such as life (esl) filling
milk, fruit juice etc., have always been 900 equipment
conscious of the need to establish and criticalities
20°C
maintain the highest standard of hygiene. 30°C
500
The competition in the food industry leaves Equipment and
25°C
very little room for error for a company 100
technologies used to
when estimating production costs and the 15°C pack aseptic liquid
influence of product safety and production 10 foods are rather
effectiveness. As a result of these trends complex. Since
the organization of maintenance has 3 packaging of fresh
an important role to play in developing foods has a lower
2
competitive advantage. complexity, this paper
When we consider the process of 1 will mainly show the
4°C
transferring, pasteurising and sterilizing a 0.3 technical criticalities
Hours
liquid food such as milk, we know and have of aseptic packaging
0 4 8 12 16 20 24 28
learned from experience, that bacterial Figure 1 Bacterial growth in food product systems.
contamination of milk is often caused by Aseptic
the equipment used. The ‘state of the packaging can be defined as the filling of
art’ of the systems used to sterilise the factor in determining container sterilisation a commercially sterile food product into a
container or packaging materials (PM), effectiveness. sterile container under aseptic conditions,
of the sensors used to monitor critical Figure 1 shows bacterial growth, followed by hermetical sealing so that re-
parameters such as temperature, flow following a contamination, in raw milk, infection is prevented.
rate and concentration of fluids, and of the graph indicating the rate of bacterial As shown in Figure 2, aseptic
automation, represents an important development at different temperatures. processing and packaging comprises the

40 | Sept/Oct 2015 | ME | maintenance & asset management vol 30 no 5

 Effective Management of Critical
Control Points (CCPs) in the Food Industry

following phases:
• Sterilisation (direct or indirect
heating) of products before filling;
• Sterilisation of packaging
materials or containers;
• Aseptic filling: In this equipment unit, we have several
– sterilising the aseptic filler critical components and parameters:
before operation, a) Packaging material guides
– maintaining sterility during Different drive rollers and guides
production; enable PM to be guided both
• Package filling, forming, sealing and outside and inside the H2O2 bath
cutting; to avoid friction with metallic
• Production of filled hermetic parts and contact with hot
containers. surfaces. Smooth and constant
PM running or sliding within
In aseptic packaging systems PM is these units is important for its
sterilised by different methods. Hydrogen sterilisation and to avoid damage
peroxide (H2O2), with concentrations of Figure 3 Packaging material sterilisation via H2O2 bath on internal and external surfaces
up to 35%, temperatures up to 80°C and (caused by scratches and
PM contact times of up to 15 sec., has • Immersion time of PM into the H2O2 pinches).
been found to be successful for in-line and bath b) H2O2 temperature and
continuous aseptic packaging. Due to legal In this system this is normally a fixed concentration
restrictions the end food product must not parameter dependent on: The pre-set temperature of
contain H2O2 in quantity greater than 0.5 – length of hydrogen peroxide bath, the H2O2 is indirectly achieved
ppm. (parts per million). This is the reason – equipment speed, and through heat generated and
why PM sterilisation systems must not only – volume of package. irradiated by an inner water bath
provide an effective sterilisation circuit, • H2O2 temperature and concentration; heated up by a group of heating
but also a drying circuit able to remove, – normally established by the elements. H2O2 concentration
mechanically and/or by heat, the H2O2 equipment supplier, but they are can be automatically monitored
residues on surfaces in contact with food usually in the range of 30-35% by instruments, able to measure
product. Different methods of PM sterilisation (concentration) and 60-80°C its density variation, or manually
are currently used, but sterilisation efficiency (temperature); by the equipment operator.
should be established in terms of numbers • Hot air (to dry H2O2 residues on PM) c) Hot air station to dry and
of logarithmic cycle reductions of the most temperature and flow. sterilize the PM
resistant micro-organisms. – established by the equipment Air flow rate and temperature are
PM is usually sterilised either: supplier. two critical parameters of PM
• inside the filling equipment. or
• externally, and then introduced
aseptically into the aseptic zone of the
aseptic filler.
Micro-organism inactivation has
traditionally been carried out by heating.
H2O2 is one of the most widely used
chemicals for sterilising PM. To sterilise
PM surfaces (in contact with food), the
first successful aseptic filling system used
a combination of H2O2 and heat. Many
aseptic packaging systems use H2O2 at
concentrations varying from 30 to 35%,
followed by hot air (at 60–125°C) to increase
the sterilising effect and to dry H2O2
residues from packaging materials and
other food contact surfaces. Sterilisation
performance increases with both peroxide
concentration and temperature.
Figure 3 shows the PM reel being
unwound and the PM dipped into an H2O2
bath where it is sterilized by immersion. At
the H2O2 bath out-feed a dry hot air station
produces air knives, at a temperature of
100-130°C, able to dry H2O2 residues and
improve PM sterilisation efficiency. In this
type of system, PM sterilisation efficiency
Figure 4 HACCP hazard type
depends on:

maintenance & asset management vol 30 no 5 ME | Sept/Oct 2015 | 41


Figure 5 Analysis of a Critical Control Point
sterilisation efficiency. The gas phase,
obtained by evaporation of a solution
of H2O2 heated with hot air, has wide
potential applications in sterilisation.
Other criticalities may be introduced
by burnt PM and polyethylene
residues that can produce scratches
on the side of the packaging material
that comes in contact with food
product.
Maintenance, calibration and cleaning of
drive rollers and guides, and of thermo-
regulators on mechanical components
represent the tool to avoid the biological
hazard produced by a poor PM sterilisation
and by scratches and pinches on PM.
As indicated in Figure 4, through
Hazard Analysis and Critical Control Points
(HACCP) methodology all critical machine
parts and components (CCPs) that have
negative effects on food product safety
have to be identified together with the risks
associated with different failure modes.
HACCP identifies and assesses specific
hazards, estimates risks and establishes
Figure 6 Packaging material sterilisation process for pre-formed containers
42 | Sept/Oct 2015 | ME | maintenance & asset management vol 30 no 5
control measures that ensure product
safety – through problem prevention and
control rather than reliance on end-product
testing and traditional inspection methods.
Machine parts or components, in which
faults may produce biological, chemical
or physical hazard, are examined to
devise critical control limits and preventive
maintenance countermeasures. Figure 5
shows an example of an important critical
control point that needs be taken into such
consideration, i.e. PM sterilisation.
To carry out this activity effectively, it
is important to identify:
(a) The critical control parameters
Normally the physical magnitudes,
such as concentration, temperature,
pressure and so on, that determine the
execution of the equipment function
that needs to be brought under under
control;
(b) The critical control processes
The processes used to control critical
parameters;
(c) The critical control devices
The critical components or parts used
to control the processes and that need
to be regularly checked or inspected.
The team carrying out this activity
has to identify and define all potential
parameters, processes and parts that are
involved in establishing an effective control
of the critical point under consideration.
PM sterilisation is a chemical
process which has five control parameters
regarding:
1. The concentration of the chemicals;
2. The stability of the chemicals (of
their concentration, pH, etc)
3. The contact between the chemicals
and the PM used;
4. Chemical-PM contact time;
5. The temperature of the chemicals
used.
The quality of the chemicals used
is normally controlled by the supplier, but
periodical, parallel quality control must
be carried out by the user to ensure the
conformity of the product to declared
standards and specifications. The
user should, in particular, monitor the
stability of H2O2 to avoid an unwanted
variation of concentration, which is
measured either by the equipment
operator or by laboratory staff. In the
latest plant this parameter is controlled
by an automatic system such as an
infra-red spectrometer, which provides
a continuous and in-line measurement
of H2O2. The H2O2 concentration can
be measured over the entire pH range,
over a wide concentration range, and
with high precision and accuracy (errors
less than 1%). The system consists of
a bypass in which some electrodes are
positioned and electronically controlled.
The H2O2 consumption is measured by
the equipment operators or by automatic
systems. If the PM is dipped in the
H2O2 bath, contact time depends on
equipment design (length of bath and
equipment speed). Since this process is

Figure 7 Analysis of a Critical Control Point for PM sterilisation
a constant one this parameter does not
need to be measured. An optical device,
such as an absolute encoder, measures
the movement of the PM relative to the
machine driving system.
If PM is sterilised by a spraying
system combined with a UV light, then a
sensor should ensure contact time and
radiation exposure. Contact temperature
higher than 65 degrees is another critical
parameter normally controlled by a
thermocouple. The systems used to control
process parameters must be examined to
identify criticalities for which maintenance
procedures need to be designed. Other
PM sterilisation processes, which start
from a pre-formed container instead of
Effective Management of Critical
Control
Control
Points (CCPs)
Points (CCPs)
a PM reel, make use of the technology
shown in Figure 6.
The pre-formed container enters
the filler, and after the container is
bottom-sealed a spray nozzle, injects
a 2% concentration of H2O2 into the
package. At the next station UV radiation
reduces microbial contamination inside
the package. The synergy established by
a combination of H2O2, UV radiation and
hot air (blown into the package at the next
stage of the process) completes sterilising
and drying of the package material for
product filling. After final top-sealing the
container is conveyed to the filler out-feed
and to downstream plant..
As indicated in Figure 7, with this
Table 1: Hazard Analysis Summary Table
maintenance & asset management vol 30 no 5 ME | Sept/Oct 2015 | 43
in the
in Food Industry
technology we still have some other
different criticalities that need to be brought
under control via a reliable maintenance
design programme:
a. Hydrogen peroxide spray
The H2O2 concentration, the air
pressure used to spray sterilisation
solution into the package and the
microfiltration of pressurized air, are
some of the criticalities that need to
be monitored via regular maintenance.
b. UV lamp radiation
The electrical parameters of the UV
lamp power supply, and the feedback
signal from the UV light radiated into
the package need to be monitored to
avoid low sterilization efficiency.
c. Hot air to dry and sterilise the
package
Sterile air pressure/flow and
temperature are some of the critical
parameters that need to be monitored
to avoid low sterilisation efficiency and
anomalous H2O2 residues.
d. Filling station
There are different systems available
to achieve a smooth and precise filling,
but in any case, to avoid package
integrity problems, it is mandatory
to avoid product residues on the top
sealing area of the package. Also in
this case, maintenance design will
play an important role in ensuring
quality and reliability.
e. Package sealing
The technology used to achieve
package bottom and top sealing makes
use of heating bars, or ultrasonic or
induction heating elements.

Other criticalities are dependent on:
package position and stability, pressure of
sealing jaws, heat generation and transfer
to the package sealing area. Nowadays,
many critical parameters have been
brought under constant control by the
installation of sensors and transducers
that, connected to automatic control
systems, facilitate a reliable monitoring
activity. Nevertheless, despite the use of
these modern technologies maintenance
continues to play a fundamental role in
keeping food criticalities under control.
Corrections for mechanical wear, and
adjustment and calibration of physical
parameters can be undertaken only
through a reliable maintenance design
programme.
Table 1 on page 43 shows the
hazard analysis summary table for two
critical control parameters:
– H2O2 concentration (automatic and
manual), and
– UV irradiation.
The table summarizes the main
activities aimed at bringing these two
criticalities under control.
For each critical control parameter,
different control processes must be
found (i.e. the processes used to control
the physical parameters). The question
to answer at this stage is ‘What process
enables control of this parameter?’ For
each critical control process, different
parts and component must be used to
control each critical process (these are
normally the parts, components, groups
of components or instruments used to
control the process). The question to
answer at this stage is: ‘How can this
process be controlled?’ Finally, as soon as
44 | Sept/Oct 2015 | ME | maintenance & asset management vol 30 no 5
EffectiveAchieving
Management Top-Quartile
Control Points (CCPs)Reliability
Table 2 FMEHA applied to PM sterilisation
we have identified the critical parameters,
processes, and parts, we are in a position
to design the maintenance activities to
control the critical parts and components.
For critical operational practices
(pre- or post-production, or during
production) that are directly linked to
Biological (B), Chemical (C), or Physical (P)
hazards, potential deviations need to be
identified, together with critical limits.H2O2
is normally the chemical used to sterilize
packaging material, product pipes and the
environment where package forming, filling,
sealing, and cutting take place. Since H2O2
concentration is the most critical parameter
to control, a lowest concentration
measure, to avoid biological hazard as a
consequence of low sterilization efficiency,
must be carefully defined. On the other
hand, a highest concentration threshold
must also be defined, to avoid the risk of
explosion resulting from chemical reactions
due to H2O2 contamination contact with
metal fragments or impurities.
Table 2 shows the application of
Failure Modes Effect and Hazard Analysis
(FMEHA) to the H2O2 concentration that
affects the CCP PM sterilisation. FMEHA
integrates Failure Modes and Effect
Analysis (FMEA) and HACCP principles,
and provides a tool able to measure the
criticalities associated with equipment
reliability and food product safety. While
the use of an automatic alarm enables
a drastic reduction of the Risk Priority
Number (RPN) from 81 to 9, the manual
control of H2O2 concentration, carried out
by the equipment operator, represents
a risk and produces an RPN four times
higher.
of Critical
in the FoodReturns
Industry
In conclusion
The identification of each equipment CCP
must be followed by the characterization
of the CCP through the proper definition of
its critical control parameters, processes,
and parts. The use of the Hazard Analysis
Summary Table, together with FMEHA,
enables identification and measurement
of the criticalities, in order to compare
the risk of each CCP, control parameter,
process, and part. As result of this process
we obtain a global view of all the critical
elements, that are linked together and that
determine a full control of the CCP under
examination.
About the
author
Dr.Sauro Riccetti
has carried out
research on
maintenance
and process
engineering in the food industry.
His experience in Tetra Pak Italy, as
Training Manager, Customer Service
Director and
Business Development Director,
and his involvement in improvement
projects for the food industry have
enabled him to gain a wide experience
in maintenance and process
engineering in that sector.
He is also Adjunct Lecturer,
teaching automatic machines for the
food industry, at the University of
Bologna. He can be contacted at:
sauro.riccetti@gmail.com