ASEPTIC PACKAGING
Managing aseptic
food packaging
The processing and packaging of liquid foods, such as milk and fruit juice,
requires the highest standards of hygiene and security. Sauro Riccetti looks
at the management of critical control points in aseptic food packaging.
ompetition within the food
C industry means that there
is very little room for error
when balancing production
costs with those of ensuring product
safety. As a result, the ability to
identify and manage CCPs (Critical
Control Points) has an important
role in developing a company’s
competitive advantage.
Bacterial contamination of milk
is often caused by contamination
of the equipment used to sterilise
the packaging. The condition of
sterilisation systems for containers
or packaging materials (PM) and
sensors used to monitor critical
parameters, such as temperature,
low rate, concentration and
automation, is an important factor in
determining container sterilisation
effectiveness.
This article addresses the technical
criticalities of aseptic packaging
systems, i.e. the illing of a sterile
container with a commercially sterile
food product under aseptic conditions
and the hermetic sealing of the
container to prevent reinfection.
Aseptic and ESL (Extended
Shelf Life) illing equipment
criticalities
The phases of aseptic processing and
packaging are:
• Sterilisation (direct or indirect
heating) of products before illing;
• Sterilisation of packaging
materials or containers;
• Aseptic illing:
- sterilisation of the aseptic iller
before operation,
- maintaining sterility during
production;
• Package illing, forming, sealing
and cutting;
• Production of illed hermetic
containers.
20 Vol 29 Issue 3
Packaging material can be
sterilised by a range of different
methods. Many aseptic packaging
systems use hydrogen peroxide
(H2O2) at concentrations varying
from 30 to 35%, followed by hot air
(60–125°C) to increase the sterilising
effect and to dry hydrogen peroxide
residues from food contact surfaces.
Sterilisation performance increases
with both peroxide concentration and
temperature. Regulations require
that the end food product must not
contain >0.5 ppm H2O2. Consequently
PM sterilisation systems must
also provide a drying circuit able
to remove (mechanically and/or by
heat) the H2O2 residues on surfaces
in contact with the food product.
Sterilisation eficiency should be
established in terms of numbers
of log cycle reductions of the most
resistant microorganisms.
Packaging material is usually
sterilised either inside the illing
equipment or externally and then
introduced aseptically into the
aseptic zone of the iller.
The packaging material reel is
guided into a hydrogen peroxide bath
where it is sterilised by immersion
Figure 1: Packaging material sterilisation
through hydrogen peroxide bath
Packaging
material
Hot
Water
Packaging
material reel
H2O2
bath
(Figure 1). At the bath outfeed, a
Bacterial
contamina-
tion of milk
dry, hot air station produces air
knives, at temperatures of 100-
130°C, able to dry H2O2 residues
and improve PM sterilisation
eficiency. This depends on:
is often • Immersion time in the H2O2 bath
caused by (normally a ixed parameter
contamina- dependant on length of hydrogen
tion of the peroxide bath, equipment speed
equipment and volume of package);
used to • Hydrogen peroxide temperature
and concentration (normally in the
sterilise the
concentration range 30-35% and
packaging.’
60-80°C);
• Hot air (to dry H2O2 residues on
PM) temperature and low.
Critical Control Points
In the sterilisation process above,
there are several critical components
and parameters:
• Packaging material guides
Drive rollers and guides direct PM
through the H2O2 bath to avoid
friction with metallic parts and
contact with hot surfaces. Smooth
and constant low of packaging
material within these rollers is
important to ensure sterilisation
and to avoid damage on internal
and external surfaces from
Dry hot air
scratches and pinches.
station • Hydrogen peroxide temperature,
concentration, stability and
contact time
Pre-set temperature of hydrogen
peroxide is indirectly achieved
through heat generated and
irradiated by an inner water
bath. H2O2 concentration can
be monitored automatically or
H2O2 manually by measuring density
bath
variation.
• Hot air station to dry and sterilise
packaging material
Air low and temperature are two
critical parameters that control
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PM sterilisation eficiency. The
gas phase obtained by evaporation
of a solution of H2O2 heated with
hot air, has wide application in
sterilisation. Other criticalities
may be introduced by burnt PM
and polyethylene residues that can
produce scratches on PM that may
contact the food product.
Maintenance, calibration and
cleaning of drive rollers, guides,
thermoregulators and mechanical
components avoids biological
hazards caused by poor PM
sterilisation and scratches on PM.
HACCP
Hazard Analysis and Critical Control
Points (HACCP) methodology
requires all critical machine parts
and components affecting food
product safety, to be identiied
together with the associated
risks for different failure modes.
HACCP identiies and assesses
speciic hazards, estimates risks
and establishes control measures
that emphasise product safety
through problem prevention and
control, rather than reliance on
end-product testing and traditional
inspection methods. Machine parts
or components, which could cause
biological, chemical or physical
hazards, are examined to devise
critical control limits and preventive
Pack.Material
Sterilisation
H2O2 H2O2
Stability Concentration
35% 30 to 50%
Infrared Infrared
Spectrometer Spectrometer
Control Point Control Parameter
Figure 2: Analysis of a Critical Control Point
www.fstjournal.org
IN Pre-Formed Bottom
Container Sealing
Figure 3: Packaging material sterilisation process for pre-formed containers
maintenance countermeasures
(Figure 2).
To carry out this activity effectively,
the team involved has to identify and
deine all:
• critical control parameters
(normally concentration,
temperature, pressure)
• critical control processes (used to
control critical parameters);
• critical control devices (critical
components or parts used to
control the processes that need to
be regularly inspected).
Hydrogen peroxide
The quality of the chemical 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 the declared standards
and speciications. These can
be carried out by the equipment
operator or laboratory staff. The user
should monitor the stability of H2O2
to avoid variation of concentration
over time. The latest equipment
uses an automatic system, such as
an infrared spectrometer, to provide
continuous, in-line measurement
of H2O2 over a wide range of
concentrations and pH values
with high precision and accuracy
(error <1%). Automatic control
systems are able to track changes in
Contact Contact
Contact Time
Temperature
Dip-In >6 sec. >65°C
Conductivity
Probe
Encoder Thermocouple
Control Process Control Device
ASEPTIC PACKAGING
H2O2 UV Lamp Hot Air Food Top
OUT
Spray Radiation Filling Sealing
concentration over time to determine
the quality of product supplied. An
optical device, such as an absolute
The latest encoder, can measure the movement
equipment of packaging material through the
uses an H2O2 bath, which is affected by bath
automatic length and equipment speed.
system, If packaging material is sterilised
such as an by a spray system combined with
infrared UV light, contact time and radiation
spectro- exposure should be monitored.
meter, to Contact temperatures higher than
provide 65°C are normally controlled by a
thermocouple. The systems used to
continuous,
control process parameters must
in-line be examined to identify criticalities
measure- for maintenance or monitoring
ment of procedures.
hydrogen
peroxide...’ Pre-formed containers
Pre-formed containers require an
alternative sterilisation approach
(Figure 3). The bottom of the
container is irst sealed and then a
spray nozzle injects a 2% solution of
H2O2 into the package. UV radiation
is used next to reduce microbial
contamination inside the package
followed by blowing hot air inside
prior to product illing. After inal top
sealing, the container is conveyed
to the outfeed and to downstream
equipment.
Critical control points in this
process are:
• H2O2 spray (H2O2 concentration, air
pressure for spraying sterilisation
solution and microiltration of
pressurised air).
• UV lamp radiation (UV lamp power
supply, feedback signal from UV
light radiated into the package)
• Hot air to dry and sterilise the
package (Sterile air pressure/low
and temperature)
• Filling station (a smooth illing
is mandatory to avoid product
residues on the top seal).
• Package sealing (performance
of heating bars, ultrasonic or
induction heating elements used
for sealing).
Criticalities depend on: package
21
 ASEPTIC PACKAGING

Critical Identify speciic Control Critical limits Monitoring procedures Corrective Veriication Record(s)
Control potential measures for each CCP action(s)
Points hazards*
CCPs What Frequency Who
H2O2 (B) Vegetative Infrared See operator Calibration Once a year Tech. Depart. (1) Calibrate H2O2 density Production
conc pathogens spectrometer manual the probes variations & calibration
(2) Replace the records
device Instrument
replacement
H2O2 (B) Vegetative Manual >30% H2O2 Once per Machine (1) Add H2O2 H2O2 Production
conc pathogens veriication <50% conc production operator (2) Add de- variations of records
shift ionised water concentrations
(3) Replace
H2O2 in bath
UV light (B) Vegetative Fibre-optic See tech. UV light power Once every Tech. Depart. (1) Calibrate UV light power Production
irradiation pathogens spectrometer Manual and frequency three months the probes and frequency records
(2) Replace the variations
device
Table 1: Hazard analysis summary * Biological (B), Chemical (C) or Physical (P)

position and stability, pressure of
sealing jaws, heat generation and
transfer to the package sealing area.
Mechanical wear, adjustment and
calibration of physical parameters
can be achieved by a reliable
maintenance design programme.
Table 1 shows the hazard analysis
summary table of two critical control
parameters: H2O2 concentration
(automatic and manual) and UV light
irradiation. For each parameter,
control methods must be identiied
and appropriate maintenance
activities designed. For critical
production practices that are directly
linked to biological, chemical,
and physical hazards, potential
deviations need to be identiied
together with critical limits. A
minimum H2O2 concentration to
avoid biological hazard must be
deined; a maximum concentration
For each
threshold must also be determined
parameter, to avoid the risk of explosion due
control to contact with metal fragments or
methods impurities.
must be
identiied Failure Mode Efect Hazard
and Analysis
appropriate Table 2 shows the application of
maintenance Failure Mode Effect and Hazard
activities Analysis (FMEHA) technique to
designed.’ identifying the H2O2 concentration
affecting the CCP PM sterilisation.
FMEHA integrates Failure Mode
Effect Analysis (FMEA) and HACCP
principles and is a useful tool to
measure the criticalities associated
with equipment reliability and food
product safety. While the use of an
automatic device with an alarm
enables a drastic reduction in the
Risk Priority Number (RPN) from
81 to 9, the manual control of H2O2
concentration by the equipment
operator is a risk with an RPN four
times higher.
Conclusion
The use of the hazard analysis
summary table together with
the FMEHA technique enables
identiication of CCP, measurement
of criticalities and comparison of the
risk of each CCP, control parameter,
process and part. This provides
a comprehensive view of all the
interrelated critical elements for
effective management of CCP.

Part or process name: Design/manufacturing resp.:

Series No./Dev.Step: Engineering release date:
Part/Process Hazards: Critical Potential Potential Severity Potential Occurrence Current Existing Frequency
CCP biological, limits & failure effects of causes of controls monitoring
operational chemical or deviations mode failure(s) failure procedures
practice physical for each
CCP
Infrared Biol See No PM 9 Probes 3 Yearly PM 300 hours
spectrometer technical Wrong sterilisation fault calibration check list
manual position wrong
position
Manual Biol >30% Wrong No PM 9 Operator 3 Daily Daily Every
veriication <50% measure sterilisation mistake procedures check production
H2O2 conc lists shift

Other areas involved: Suppliers & plants afected:

Prepared by: FMEHA date:
Detection Risk Priority Recommended Area individual Actions Severity Occurrence Detection Risk Priority
Number action(s) responsibility & taken Number
completion date
3 81 Automatic Technical Install automatic 9 1 1 9
monitoring dept monitoring
with alarm system
3 81 Operator training Training centre Regular training 9 2 2 36

Table 2: FMEHA technique applied to PM sterilisation

Article available online at: www.fstjournal.org/features/29-3/aseptic-packaging

Dr Sauro Riccetti is adjunct professor at the University of Bologna, Italy. He gained wide experience at Tetra Pak Italy
in training, maintenance and process engineering in the food sector. Email: sauro.riccetti@gmail.com

22 Vol 29 Issue 3 ... More online