15/11/2022 Commercial sterilization of low-acid food in hermetically sealed containers: retort systems - Canadian Food Inspection Agency

Canada.ca > Canadian Food Inspection Agency > Preventive controls

> Controls for food

Commercial sterilization of low-acid food

in hermetically sealed containers: retort
systems

On this page
1. Introduction
2. Process design
3. Thermal processing equipment
4. Incoming material control
5. Empty container control
6. Product preparation and blending control
7. Filling control
8. Container closure control
9. Pre-thermal process control
10. Process control
11. Post-process control
12. Incubation
13. Deviations and corrective actions
14. Veri cation of product safety
15. References

1. Introduction
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Retorting is the in-container sterilization of food to render it shelf

stable at room temperature (commercially sterile).

The following provides recommended preventive controls for the thermal

processing of commercially sterile low-acid food in hermetically sealed
packages (containers) stored at room temperature.

The safety of thermally processed low-acid food is dependent primarily

upon four conditions:
1. The scheduled process is adequate to control Clostridium botulinum for
the product and processing system;
2. The product adheres to the scheduled process parameters and heat is
applied to all points in the product for a time and at a temperature
su cient to produce commercial sterility;
3. Container lling adheres to the scheduled process parameters, and
container sealing prevents microorganisms from entering and
contaminating the sterilized product; and
4. Post-process handling procedures protect the nished closures from
contamination or damage – which can lead to leakage or re-
contamination – through to distribution to the consumer.

2. Process design
Temperature distribution
A temperature distribution test identi es the location of the slowest
heating point (the "cold spot") in the retort. This "cold spot" is taken into
consideration when conducting subsequent heat penetration studies to
establish the scheduled process.

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Conduct temperature distribution tests on retort systems under worst-

case conditions during normal operation to ensure uniform
temperature distribution throughout the retort and to establish
operating procedures such as the vent schedule (steam retorts)
a retort system could consist of a single retort or a group of
identically equipped retorts
refer to Temperature distribution test for steam-still retorts for
guidance on important elements to consider when carrying out a
temperature distribution test
Conduct these tests upon installation, after making any changes that
could negatively impact on heat transfer, and at a su cient frequency
(such as every 2-3 years) to ensure equipment wear has not a ected its
performance

Scheduled process
A scheduled process is determined using heat penetration studies or other
equivalent scienti c methods by persons having scienti c knowledge and
expertise (competency) in thermal processing, for example a process
authority 1. These tests are carried out using the most adverse conditions
that could occur during normal production.

For every low-acid food formula, container type and size, ensure there
is a written description of the scheduled process, including:
the name of the processing expert responsible for its development
the formulation of the food
specify all ingredients and additives (concentration, type) and
their amounts
all critical factors and the associated critical limits
the accepted scienti c methods used to establish the scheduled
process (such as microbial thermal death time data, process
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calculations based on product heat penetration data, inoculated

packs), including the details of the experimental methods
Never alter a scheduled process except at the direction of a processing
expert

Thermal process design records

Keep records of the determination of the scheduled process, including
any heat penetration studies and temperature distribution tests

3. Thermal processing equipment

Use thermal processing equipment that is designed, constructed,
installed and maintained to deliver the requirements of the scheduled
process. For example, equip each retort with an accurate:
independent temperature measuring device (indicating
thermometer)
time/temperature recording device (to provide a permanent record
of the thermal treatment in relation to time)
pressure gauge
temperature controller
Take measures to prevent unauthorized adjustments to critical
equipment settings, such as by restricting access

Refer to the following documents for more information on thermal

processing equipment speci cations:

Regulatory requirements: Preventive controls, section 6.0 contains

guidance on the general design, installation, maintenance and
calibration requirements for equipment, including thermal processing
equipment

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Code of hygienic practice for low-acid and acidi ed low-acid canned

foods, Codex Alimentarius Commission (CAC/RCP 23-1979, sections
7.5.3.6 and 7.6)
Guidance on resistance temperature detectors used as indicating
thermometers for retort vessels

4. Incoming material control

The ability of a thermal process to reduce the microbial load to an
acceptable level is in uenced by the number of bacteria present in the
product before heat treatment begins.

Inspect incoming raw materials, ingredients, and containers upon

receipt to ensure that they are suitable for processing
refer to Incoming ingredients, materials and non-food chemicals
for guidance on preventive control measures for incoming
materials, for example written speci cations and supplier approval
Minimize microbial contamination and growth in raw materials and
ingredients prior to thermal processing

Commonly used containers include rigid containers such as cans and glass
jars, and semi-rigid or exible containers such as pouches and cartons. A
container must be able to withstand the thermal process and maintain its
hermetic seal for the shelf life of the product.

Source containers that meet the criteria identi ed in the scheduled

process and that can withstand the strain of subsequent handling
steps
refer to Guidance for food establishments concerning construction
materials and packaging materials and non-food chemicals for
recommended options to ensure containers are suitable

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5. Empty container control

Empty container handling
Control empty container handling to minimize damage and to prevent
the use of damaged, defective or contaminated containers, for
example
handle and transfer containers in a manner that minimizes
damage and contamination, such as from forklifts, conveyors and
transfer points
prior to use, monitor containers for damage that could
compromise the nal integrity (such as cracks and fractures) and
contamination (such as glass, rust and foreign material)

Container cleaning
Ensure that only clean containers are lled, for example
immediately prior to lling, clean rigid containers in an inverted
position such as by an air, water jet or suction system
any water or steam used is potable
any detergents or sanitizers used are suitable for this purpose
refer to Guidance for food establishments concerning
construction materials and packaging materials and non-food
chemicals
Protect clean containers to prevent contamination prior to lling, for
example
don't leave unprotected containers on the line between the cleaner
and the ller at breaks, during clean-up or extended downtime
have a glass breakage control procedure for lines that use glass
containers and for other glass breakage occurrences such as glass
thermometer bulbs.
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Empty container records

Keep records of empty container usage by lot and of controls of
container handling damage and/or visual monitoring of empty
containers
Keep records to demonstrate control of broken glass

6. Product preparation and blending control

Critical factor control
Control critical factors speci ed in the scheduled process and
formulation during preparation and blending to minimize food safety
hazards
Examples of critical factor controls related to product preparation and
blending are:
size control, such as dicing, grinding, slicing
temperature treatment control, such as heating, blanching,
defrosting and cooling
moisture control, such as rehydration and concentration (viscosity,
Brix)
proportioning control, such as weighing, volumetric control
(metering)
pH/acidity control, such as pH measurement and titratable acidity
for pectinization
additives such as preservatives and rming agents
Control time and temperature during preparation, blending and
holding of in-process materials to prevent conditions that could result
in excessive microbial growth or in the production of enterotoxin by
Staphylococcus aureus

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Product preparation and blending records

Keep records to demonstrate control of product preparation and
blending, for example
records showing adherence to critical limits speci ed in the
formula
records for critical factors speci ed in the scheduled process

7. Filling control
Filling of containers
Control all lling factors speci ed in the scheduled process, for
example:
ll temperature
ingredient distribution
orientation of products in the containers and handling
volume and weight control, for example proportion weights, ll
weights, head space
type and size of container
packing medium
Protect product from contamination during lling
Keep seam or seal areas as clean and dry as possible to ensure a
proper closure, for example ensure that
ller drip does not contaminate seam or seal areas
product is not over lled onto the sealing area
When lling glass containers, control breakage in the lling area, for
example
evaluate areas that may contaminate the product with glass
check the alignment and timing
inspect lling area regularly and remove any broken glass
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monitor for a possible broken glass containers, such as by using a

gap detector (counts the number of containers entering and
exiting the equipment; any discrepancy indicates a container
failure)
tear down equipment to the extent necessary to remove the
potential for glass contamination, for example seal, rubbers, valve
blow outs, valve dismantling

Filling records
Keep records to demonstrate adequate control of critical factors in
lling speci ed in the scheduled process, for example
temperature control records, such as ller bowl temperature
recorder charts and/or manual records
ingredient distribution control records, such as visual checks for
product orientation
weight/volume control records, such as portion weights from
multi-phase llers, total weights, head space

Filled unsealed container handling

Ensure that unsealed containers are conveyed from the ller to the
closing equipment in a manner that prevents breakage, damage, or
contamination of the container, the product, or the sealing/seaming
area, for example
don't leave containers on the line between the ller and the
closing equipment during breaks, cleaning, or extended downtime
maintain the lling area and equipment in a sanitary condition
have a procedure for dealing with damaged or broken containers
(pouches, glass jars)

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Extraneous material contamination control

Monitor equipment (metal detectors, magnets, etc.) during processing
to ensure it detects and removes extraneous material
Test equipment regularly to ensure it is operating in accordance with
the equipment manufacturer's speci cations

8. Container closure control

Container closure
Operate, maintain, routinely check and adjust closing equipment to
ensure a tight and secure seal
follow the equipment manufacturer's instructions
t and adjust sealing and closing equipment for each type of
container and cover used

Metal can seaming

Routinely adjust and maintain seaming equipment to give correct

seam contours and to prevent seam problems
take into account any variations in container materials, plate
thickness and temper when setting up the seamer
inspect ends for signs of damage before loading them into the
seaming equipment

Glass capping

Prevent damage or breakage of glass containers during the capping

process and ensure a hermetic seal, for example
protect the cap/lid hopper from glass contamination
inspect capper area regularly for broken glass

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adjust closing equipment to avoid chipping either the nish or

glass edge
remove broken glass from capping equipment and surroundings

Pouch sealing

Control the critical parameters during pouch closure to ensure a

hermetic seal, for example
use properly formed and undamaged pouches
ensure pouches are properly placed (aligned) within the jaws of
the sealing machine
use compatible sealing material
ensure sealing surfaces are at, smooth and parallel
ensure the sealing tool holds the surfaces together at the proper
pressure and temperature, and for the proper time

Vacuum-packed foods
Control container vacuum to meet the requirements of the scheduled
process, to protect the hermetic seal, to prevent permanent distortion
of container ends during processing and to maintain concave ends
during distribution and storage, for example
control all factors a ecting vacuum, such as ll temperature, air
exhaustion by steam or mechanical vacuum, ll weight/volume
and head space to prevent permanent seam distortion
monitor container vacuum to ensure adherence to the
requirements of the scheduled process

Visual and destructive examinations

These examinations should be performed only by individuals that are
competent in identifying container defects.

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Visually monitor sealed containers at a su cient frequency to identify

and control defects that may compromise the hermetic seal, for
example
check for external defects on at least one sealed container from
each closing head every 30 minutes or as recommended by the
container or sealing equipment manufacturer
Conduct additional visual examinations and non-destructive
measurements following a major jam, after an adjustment, or at start-
up following a prolonged shut-down
Conduct destructive examinations on sealed containers at a su cient
frequency to identify and control defects that may compromise the
hermetic seal, for example
check for sealing defects on at least one container from each
closing head every 4 hours (double seams, caps), every 2 hours
(heat seals), or as recommended by the container or sealing
equipment manufacturer
Adjust closure heads as needed based on the results of the visual and
destructive examinations

Refer to the container and/or sealing equipment manufacturer's

instructions for closure speci cations and guidance on how to conduct
these evaluations. Other resources include the CFIA's Metal can defects
manual and the Flexible retort pouch defects manual, as well as section
7.4.8 of the Codex Code of hygienic practice for low-acid and acidi ed low-
acid canned foods (CAC/RCP 23-1979).

Container closure control records

Keep records to demonstrate adequate control of the container closure
operation, for example
Visual Examination Records
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code lot
date and time of evaluation
examination results
corrective actions taken
Destructive Examination Records
code lot
date and time of closure evaluation
container closure speci cations
container closure measurements
corrective actions taken

9. Pre-thermal process control

Sealed container handling
Control container handling systems to minimize damage that could
compromise container integrity
identify and eliminate points where container damage could occur,
such as container transfer points, areas where containers abruptly
change speed or direction, controls to stop conveyors when
containers are stationary and synchronization of container
handling systems
where necessary, clean lled containers to remove product
residues from the outside of the container (reduces the risk of
external corrosion)
handle pouches in a manner to prevent puncturing by sharp
objects or abrasion from equipment
minimize the handling of pouches
avoid excessive exing, folding, movement and vibration of
pouches
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ensure that the mechanical coding process does not cause

damage to the containers, and that the codes are legible and
permanent

Maximum time lapse

Control the elapsed time between sealing of containers and the start of
thermal processing to ensure adherence to factors critical to product
safety
Generally, elapsed time should not exceed 1 hour unless
a longer time has been determined to be safe by an expert in
thermal processing
sealed product is held at temperatures that will not permit the
growth of microorganisms that could impact on the safety of
the process (that is, less than 4°C or greater than 65°C)
the heat transfer characteristics of the product are not
a ected
If the maximum lapse time is exceeded, treat this as a process
deviation and hold the product for safety evaluation by an expert in
thermal processing

Retort loading
Control the loading of baskets to meet the requirements of the
scheduled process and to prevent damage to the containers
adhere to the loading requirements speci ed in the temperature
distribution test and process schedule, for example, use of dividers
(type, layering, hole con guration), product orientation, number of
layers per basket, pouch placement
ensure there is no nesting of cans or pouch overlap unless it has
been included in the temperature distribution test and scheduled
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process
minimize impact damage during loading, for example
do not use damaged baskets or handle baskets roughly
adequately cushion containers during scrambled/jumble
loading
keep pouch racks free of rust and scale to prevent pin holes in pouches

Traffic control and process indicators

Control the movement of processed and unprocessed product to
prevent unprocessed product from by-passing the retort, to prevent co-
mingling of unprocessed containers with processed containers, and to
ensure that each basket goes to the appropriate retort
maintain physical separation between closing and retorting
immediately destroy (puncture) any containers of unknown
process status
where there are multiple retorts and products requiring di erent
processes, have a system of identi cation to verify that each
basket has been directed to the correct retort, such as a tag
system
if batch thermal treatment is applied, use a temperature-sensitive
indictor to visually indicate that the containers have been
thermally treated

10. Process control

Retort systems should only be operated by, or under the continuous
supervision of, an individual competent in thermal processing.

Initial temperature

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Control the temperature of the contents of the coldest container at the

start of the process to ensure that it is no lower than the minimum
speci ed in the scheduled process
monitor the temperature of the contents of the coldest container
with su cient frequency to ensure that it does not drop below the
speci ed initial temperature
use the same procedure for determining the initial temperature as
that used in the heat penetration test

Operating procedures
Control thermal process operations by having written operating
procedures that incorporate the critical factors identi ed the scheduled
process
include venting, processing and cooling procedures
include procedures for monitoring critical factors
include clear instructions for handling deviations
train operators on these procedures

Vent control
Establish venting schedules based on the temperature distribution test
Control venting to ensure adherence to the conditions under which the
temperature distribution test was conducted
ensure the vent schedule meets both the minimum time and
temperature requirements
adhere to the speci cations from the temperature distribution
test, such as loading con guration, steam manifold pressure, and
number of retorts being vented at one time

Process time control

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Control process time to ensure that the minimum time requirements of

the scheduled process are met
monitor and control process time using an accurate timing device,
such as an analog or digital wall clock
when more than one timing device is used , synchronize them
where the timing device does not indicate seconds, add a one
minute safety factor to the venting time and to the process
time the process only after the retort has been properly vented
and the scheduled process temperature has been achieved
check that the time on the recorder chart agrees with the time of
day indicated on the accurate timing device

Process temperature control

Control the process temperature to meet the minimum temperature
requirements of the scheduled process
monitor the indicating thermometer temperature at the start of
the process and at least once during the process to verify that the
minimum temperature is achieved and maintained
compare the indicating thermometer temperature with the
recorder temperature at least once during the process after
temperature equilibrium has been achieved
ensure that the recording thermometer does not vary by more
than 0.5°C (1°F) from the indicating thermometer and at no time
reads higher than the indicating thermometer
ensure that the recording chart produces a continuous record of
the temperature. In the absence of the continuous record (ink
skips), adequately document that the temperature was maintained
use the correct chart for the recorder (the number on the chart
matches that speci ed by the instrument manufacturer)

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Thermal process control records

Keep records of time, temperature and other pertinent details for each
retort load (or code lot, for continuous retorts) to demonstrate the
safety of each application of the scheduled process. For example,
record
product name
production volume
equipment used for the thermal process, including any
maintenance or modi cations to the equipment
container size and type
minimum initial temperature
any parameters of the thermal process, such as start and end
times, temperature, and pressure
deviations from the scheduled process and corrective actions
other relevant processing data
Keep these records for three years from the time of processing

Refer to Record keeping for guidance on how to ensure the integrity of

recorded processing data, including data captured via electronic recording
systems.

11. Post-process control

Cooling controls
Control cooling to minimize post-process contamination, thermophilic
growth and container damage
control pressure in the retort to prevent excessive pressure
di erentials between the interior and exterior of the container that

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may result in paneling, buckling, seam distortion and bursting

(follow the container and closure manufacturers' instructions)
cool containers as rapidly as possible to below 40°C to avoid
thermophilic spoilage
control the cooling of cans and jars to retain enough residual heat
to rapidly evaporate water for corrosion prevention
control the cooling rate of glass jars to prevent thermal shock

Cooling water control

Control the cooling water conditions to minimize the potential of post-
process bacterial contamination, for example
treat recycled cooling water with a bactericide prior to use
ensure that an e ective residual level of bactericide is maintained
throughout the cooling system (for example, monitor free
available chlorine level to ensure it is 0.5 to 2.0 ppm)
conduct monitoring at the location(s) in the cooling system where
the bactericide level is the lowest
maintain cooling systems to prevent buildup of organic and
inorganic materials which may reduce the e ectiveness of the
bactericide

Cooling water records

Keep records to demonstrate control of recycled cooling water quality
and bactericide treatment, for example
Water treatment records
date and time of analysis
concentration of residual bactericide and pH
method of analysis
code
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product
analyst
retort system/sample site
Keep these records for three years from the time of processing

Container handling and drying

Control container handling and drying systems to minimize damage
and/or post-process bacterial contamination.
Cans and Glass
tilt containers to remove excess water
until the container vacuum is achieved and the compound has
established proper sealing integrity:
handle containers in a manner to prevent contact with
unsanitary surfaces, for example, employee contact, water
splash from oors, sprays, aerosols, condensation and
unsanitary equipment
handle containers in a manner to minimize impact damage
and damage caused by equipment, for example, cable burns
and cuts, abrasion, dents, seam damage
dry containers as soon as possible after processing
Pouches
minimize handling
avoid excess exing, folding, movement and vibration
handle pouches in a manner to prevent puncturing and other
damage
secondary protective packaging can help to minimize pouch
damage

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if secondary packaging occurs elsewhere, use extreme care

when transporting pouches to the packaging location

Post-process container integrity verification

Monitor the integrity of processed containers, for example
pass canned product through low vacuum detection equipment
test this equipment periodically to verify it is working properly
conduct visual and destructive examinations on a random
selection of containers from a lot (see Metal can defects –
identi cation and classi cation and Flexible retort pouch defects
manual – identi cation and classi cation)
incubation testing (see next section)

Post-process container integrity records

Keep records of all post-process container integrity evaluations to
demonstrate the integrity of processed containers

12. Incubation
Incubation testing
Incubation testing is the holding of samples of hermetically sealed,
processed foods at a speci ed temperature for a speci ed period of time,
before examination for signs of spoilage. It is useful when establishing a
scheduled process (validation), to help diagnose spoilage issues and for
veri cation purposes.

Incubate the containers at a temperature and for a time that permits

spoilage organisms (if present) to grow and cause detectable spoilage,
for example

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37°C for 10 to 14 days to detect mesophiles

55°C for 5 days to detect thermophiles
other appropriate temperature and time combinations
Conduct post incubation tests to detect signs of spoilage (for example,
loss of vacuum, pH change)

Incubation testing records

Keep records of incubation time, temperature and the results of any
post incubation tests for three years from the time of processing

13. Deviations and corrective actions

Deviation control
Have procedures in place to identify, isolate and evaluate products
when critical limits are not achieved, and when other defects occur
which could a ect product safety, for example
have a system for identifying deviations when they occur
isolate, clearly mark and control all a ected product back to the
point of last control
have an expert in thermal processing evaluate thermal process
deviations for potential food safety risks
ensure personnel are adequately trained to conduct manual
sorting of suspects lots for leakage

Corrective action
Take e ective corrective action following any deviation to ensure the
safety of the product and to prevent recurrence of the deviation
investigate to determine the cause of the deviation
take measures to prevent recurrence of the deviation
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verify the e ectiveness of the corrective action

Notify the CFIA immediately if the investigation determines that unsafe
product is in distribution and take immediate action to protect
consumers

Deviation and corrective action records

Keep records to demonstrate the control of deviations and the
e ectiveness of corrective actions taken, for example
Deviation/Hold
product/code
date produced/held/released
reason for the hold
amount of product held
amount of product sorted
results of evaluation/sort, for example amount analyzed, analysis
report of the number and nature of defects
signature of personnel responsible for hold and evaluation
disposition of held product
signed authorization for disposition
Corrective Action
cause of deviation identi ed
corrective action taken to correct de ciency
assessment of e ectiveness of corrective action
date
signature of person responsible
Keep these records for three years from the time of processing

14. Verification of product safety

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Use supplementary methods to verify the e ectiveness of controls

a ecting product safety, for example
sampling and testing of in-process and nished products for the
presence of controlled hazards
sampling and analysis to verify that speci c manufacturing
controls are e ective, for example microbiological checks of
treated cooling water, microbiological checks of surfaces coming
into contact with hot, wet cans
independent, external audits
internal audits
incubation testing of nished products
screening, dud detection, weight veri cation
analysis of consumer complaint trends
vendor audits

15. References
CFIA references
Evidence showing a control measure is e ective

Flexible retort pouch defects – Identi cation and classi cation

Guidance on resistance temperature detectors used as indicating

thermometers for retort vessels

Heat-penetration studies

Metal can defects – Identi cation and classi cation

Packing food in containers

Temperature distribution test for steam-still retorts

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Other references
Codex Alimentarius Commission, Code of hygienic practice for low-acid and
acidi ed low-acid canned foods (CAC/RCP-23-1979)

Institute for Thermal Processing Specialists, Guidelines for conducting

thermal processing studies (02-13/14) (English only)

Footnote
1 A process authority is a person or organization that has the
competency to develop and evaluate thermal processes,
including competency the following areas:
considerable knowledge concerning product characteristics,
critical factors relating to the thermal process and the e ect
the commercial equipment and procedures will have on the
heating and cooling characteristics of the product and the
delivery of the thermal process
experience in conducting studies relating to thermal
processing of food, such as heat-penetration and
temperature-distribution tests, and thermal-death time and
validation studies and the application of other scienti c
methods relating to thermal processing
the ability to evaluate data generated by scienti c studies
and tests in order to document: the e ectiveness of the
thermal process relating to the production of safe and
commercially sterile product; and, that testing has been
carried out to identify all possible factors which could a ect
the heating characteristics of the product and the safety of
the nal product

Date modi ed:

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2019-12-23

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