Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

07
June
Guidelines
For Food Safety
Validation and Verification of
Heat Treatment Equipment
and Processes

1
FOREWORD

The development of this Guideline is an initiative

of the Australia New Zealand Dairy Authorities’
Committee (ANZDAC). Members of ANZDAC are:
Australian Quarantine and Inspection Service
Dairy Authority of South Australia
Dairy Food Safety Victoria
Department of Health Western Australia
New South Wales Food Authority
New Zealand Food Safety Authority
Safe Food Queensland
Tasmanian Dairy Industry Authority
This Guideline is not intended as a mandatory
standard. The purpose of this Guideline is to assist
industry and regulators with the implementation of
food safety standards and the application of good
food safety practice. Accordingly, this Guideline may
require amendment from time to time in order to
remain aligned with food safety standards.

CONTENTS

Foreward 2
Introduction 4
1 Scope 5
2 References 5
3 Definitions 5
4 Standards for Heat Treatment Equipment and installation 6
4.1 Heat Treatment Equipment 6
4.2 Validation of heat treatment 7
4.3 Verification of heat treatment 8
5 Heat Treatment Commissioning and Modification 10
6 Pasteuriser Operators 10
Appendix A – Food Standards Code 1.6.2 11
Appendix B – Heat Treatments Equivalent to Pasteurisation 12
Appendix C – Pasteuriser Retro-fit Standard 13
Appendix D - Explanatory Notes 14
Guidelines
For Food Safety
Validation and Verification of
Heat Treatment Equipment
and Processes
 Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

Introduction

With the emphasis on food safety within the dairy industry and the regulated
implementation of HACCP based food safety programs there exists a need
to ensure that heat treatment equipment such as pasteurisers are designed,
installed, operated and verified in a manner that results in no untreated or
partially treated milk or dairy products.
This document prepared by a working group under the direction of the
Australia and New Zealand Dairy Authorities Committee (ANZDAC) was
developed to provide guidance on equipment and processing parameters that
are to be reviewed and assessed as part of validation and verification of heat
treatment.
Systems for the validation and verification of heat treatment should be
incorporated as an integral part of each dairy factory’s food safety program,
where critical heat treatment processes are conducted. For each heat
treatment process and/or pasteuriser the dairy factory will be expected to have
a program of checking and testing including procedures and recording of the
results of such activities.
The requirements for the pasteurisation and heat treatment of milk and dairy
products are contained in the Food Standards Code, the Export Control (Milk
and Milk Products) Orders 2005 and the relevant State, Territory or Country
legislation.

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 Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

1
Scope

The conditions and procedures in this document apply to both continuous flow
and batch heat treatment systems.

2
References

• AS 3993 - 2003 Equipment for the pasteurisation of milk and other

liquid dairy products – continuous flow systems.
• D121.1, Dairy Heat Treatments – NZFSA, 2003.
• IDF Bulletin 200, 1986 Monograph on Pasteurised Milk
• Export Control (Milk and Milk Products) Orders 2005.
• Food Standards Code published by Food Standards Australia New
Zealand.
• Relevant State dairy legislation

3
Definitions

Batch pasteurisation: A volume of milk or liquid dairy product heated and

cooled uniformly to achieve pasteurisation
Continuous-flow system: A system in which the product passes in
continuous flow through heating and cooling equipment in order to receive
the required heat treatment. Such systems usually incorporate one or more
regeneration sections in which there is transfer of heat between the hot
pasteurised product and incoming raw product.
Headspace: The space between the surface of the milk or liquid dairy
product and the lid of the heating vessel.
HTST: Hight Temperature Short Time Pasteurisation is used for continuous
flow pasteurisation.
New pasteuriser for the purposes of this document is one purchased direct
from the manufacturer or agent and which has not been previously used.
Note:
Any pasteuriser not conforming to this definition will be considered to be an
existing pasteuriser.

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 Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

4
Standards and Validation for Heat Treatment
Equipment

Heat treatment processes are often designed to balance a sufficient heat treatment
to achieve a safe outcome and minimal heating effect on the quality and flavour of
product. This minimum treatment means that the process should be tightly controlled
to ensure that the equipment design and operation are working effectively.
In some cases the intensity of controls can be reduced by increasing the heat
treatment so that there is a wider safety margin. For example where milk or milk
products are heated to greater than 85°C it may not be necessary to monitor
holding time, dependent on fat content and particle size.
4.1 Heat Treatment Equipment
HTST pasteurisers
It is expected that all new HTST pasteurisers, not including vacreators,
used for the pasteurisation of milk and the manufacture of dairy products
should meet the AS 3993 - 2003 requirements.
Existing pasteurisers are expected to meet the retro-fit standard described
in Appendix C as a minimum.
Other Continuous Flow Heat Treatment Systems
Continuous flow heat treatment systems which are not HTST, such as
UHT and vacreators, should ensure the following:
• The equipment should include:
–– an indicating thermometer, so that the temperature can be
monitored during processing,
–– a continuous recording device for time and temperature.
• Equipment needs to ensure that raw or partially treated product
cannot contaminate the pasteurised product
• Equipment needs to ensure that services, such as cleaning systems,
cannot contaminate the product.
Batch pasteurisation
Design of batch pasteurisers should take into consideration the following:
• Vessels should be enclosed during operation to ensure both product
and headspace temperatures meet the temperature specified
in the approved food safety plan, and to protect product from
contamination with condensate or extraneous matter.
• Vat agitation should be sufficient to ensure that the temperature
throughout the vat is constant and uniform.
• Outlets and fittings should be designed to ensure that there are no
dead spots where product may not be effectively heat treated.
• The equipment should include:
–– an indicating thermometer, so that the temperature can be
monitored during processing,
–– a continuous recording device for time and temperature
(such as a data logger), and
–– a head space thermometer.

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Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

• Equipment needs to ensure that raw or partially treated product

can not contaminate the pasteurised product (this is included
to ensure that raw milk from the feed line can not drip into the
vessel during or after pasteurisation).
• Filters to control particle size may need to be installed where
ingredients which have not been pre-treated and with variable
particle size are added such as addition of fresh fruit.
• Equipment needs to ensure that services, such as cleaning
systems, cannot contaminate the product.
All heat treatment equipment shall comply with Food Standards
Code Chapter 3 Food Safety Standards 3.2.3, clause 12.
All dairy factories should provide documented evidence to verify that
the heat treatment equipment complies with these standards.
4.2 Validation of Heat Treatment
Information should be available to describe how the heat treatment
system has been designed to ensure that it is effective; this is the
validation. The following information should be available for all heat
treatment processes, including HTST, UHT and batch:
4.2.1 Provide information on design of equipment, generally through a
schematic diagram but simple processes maybe described. This
should include (where applicable):
• Description of heating process such as plate heat exchanger; steam
jacketed vessel; stove top.
• Position of temperature probes;
• Type of agitation;
• Product flow and line connections identifying that raw and
pasteurised product is separated; and
• Evidence of assessment of potential processing risks such as dead
spots where heat treatment may not be effective.
4.2.2 Provide heat treatment critical limit specifications showing
assessment of critical inputs relating to products and source of
validation information. This information should identify:
• Time and temperature of heat treatment such as minimum 72°C
for 15 seconds or 63°C for 30 minutes, for whole milk.
• Description of product(s) being heat treated, there may be
different critical limits for each product eg milk and cream should
have different heat treatments.
• including fat content and particle size for each product type.
Refer to Appendix B.
The process must show compliance to the Food Standards Code
Standard 1.6.2, an extract is provided in Appendix A.
Information on heat treatments equivalent to pasteurisation for
common types of dairy produce is provided in Appendix B.
4.2.3 Document corrective action and controls to be implemented when
the system is found to be non-compliant. This information will
generally be contained within the food safety program.

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 Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

4.3 Verification of Heat Treatment

To verify the effectiveness of heat treatments operational monitoring
and testing procedures should be followed. This provides evidence
that the specifications set through validation continue to be met
during processing. Evidence of competency of personnel conducting
verification should be available in accordance with food safety
program requirements. Alternative verification systems may be
applied, and are expected to achieve an equivalent outcome.
These proposals may be assessed and approved by your Regulatory
Authority.
4.3.1 Provide evidence of Certification of compliance of HTST
pasteurisation equipment to AS3993-2003 conducted by competent
technical personnel, such as a qualified engineer.
4.3.2 Monitoring of pasteurisation and verification of equipment should be
conducted as follows:
• HTST as documented in appendix A of AS 3993-2003. The
following is a summary of these checks which are described in
detail in the AS 3993-2003:
–– Comparing indicating and recording thermometer readings;
–– Operation of diversion and alarms;
–– Operation of recording systems;
–– Thermometer and pressure gauge calibration;
–– Verification of integrity of heat transfer surfaces;
–– Heat exchanger gaskets;
–– Verification of holding time by direct measurement;
–– Diversion response time;
–– Leak paths (if appropriate);
–– Operation of pressure differential diversion (if appropriate);
–– Pressure differential control systems (if appropriate);
–– Secure medium integrity (if appropriate).
• Other Continuous flow systems
Daily - These checks are to be completed and recorded each
time the heat treatment equipment is used:
–– Product temperature monitoring recorded continuously
during heat treatment.
–– Compare indicating thermometer (product temperature)
reading to recording thermometer reading. If the difference
is more than 0.5°C corrective action should be taken (as per
food safety program).
Six Monthly
–– Calibration of thermometers and recording devices including
accuracy of time recording (as per food safety program).
Thermometer accuracy should be within 0.5°C.

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 Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

• Batch pasteurisation
Daily - These checks are to be completed and recorded each time the
pasteuriser is used:
–– Product temperature monitoring recorded continuously during
heat treatment.
–– Headspace temperature monitoring and recording to occur at the
beginning and end of the critical temperature cycle.
–– Compare indicating thermometer (product temperature) reading to
recording thermometer reading. If the difference is more than 0.5°C
corrective action should be taken (as per food safety program).
Six Monthly
–– Calibration of thermometers and recording devices including
accuracy of time recording (as per food safety program).
Thermometer accuracy should be within 0.5°C.
4.3.3 This verification should be conducted by suitably qualified/trained staff.
4.3.4 Records of verification activities should be retained and available for
audit purposes as part of the businesses food safety program.

5
Heat Treatment Commissioning and Modification

The program of checking and testing at commissioning (verification of equipment

prior to use) and following subsequent modifications ensures that heat treatment
equipment is always operated for the specified product in a manner that complies
with the appropriate standards. The results of the checks should be evaluated by
competent technical personnel, such as an appropriately qualified engineer.
When deficiencies occur, the frequency of checking should be increased until the
problem has been proven to be remedied. Any non-conforming product resulting
from these deficiencies should be handled in accordance with the businesses food
safety plan.
Any change that could affect any performance characteristic of the heat treatment
equipment for the specified product, and the reasons for it, should be documented.
New and modified heat treatment equipment should be commissioned before
they are put into normal use and then frequently checked until a record of proven
calibration and reliability has been established. For continuous flow pasteurisers
this should be in accordance with the AS3993-2003. For batch pasteurisers these
should be the 6 monthly checks described in Section 4.3. Other maintenance
operations and checks may also be conducted as is necessary to confirm the
reliability of the equipment to meet the standards.
All checks should also be carried out and documented where any modifications that
may affect operating conditions are made to existing heat treatment equipment.

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 Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

6
Pasteuriser Operators

Pasteuriser/heat treatment equipment operation is a critical process in

the production of safe dairy products. It is essential that operators of this
equipment are suitably trained to monitor, interpret records and take corrective
and preventative actions when necessary.
Clause 3 of Standard 3.2.2 in the Food Standards Code (Food handling - skills
and knowledge) requires that a food business should ensure that persons
undertaking or supervising food handling operations have:
(a) skills in food safety and food hygiene matters; and
(b) knowledge of food safety and food hygiene matters, commensurate
with their work activities.
Dairy factories should be able to demonstrate that operators of HTST
pasteurisers have completed suitable training and been assessed as competent.
Training in heat treatment under the VET food processing certificate program is
an option for demonstrating compliance to this requirement.

APPENDIX A

FOOD STANDARDS CODE – STANDARD 1.6.2 PROCESSING REQUIREMENTS

Clauses
1 Processing of milk and liquid milk products
(1) Milk must be pasteurised by –
(a) heating to a temperature of no less than 72°C and retaining
at such temperature for no less than 15 seconds and
immediately shock cooling to a temperature of 4.5°C; or
(b) heating using any other time and temperature combination of
equal or greater lethal effect on bacteria;
unless an applicable law of a State or Territory otherwise expressly
provides.
(2) Liquid milk products must be heated using a combination of
time and temperature of equal or greater lethal effect on the
bacteria in liquid milk that would be achieved by pasteurisation
or otherwise produced and processed in accordance with any
applicable law of a State or Territory.

Editorial note:
For the purposes of clause 1 of this Standard, milk and liquid milk products
includes milk and liquid milk products used in the production of any cream and
cream products, fermented milks, yoghurt, dried, condensed and evaporated
milks, butter and ice cream.

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Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

APPENDIX B

HEAT TREATMENT EQUIVALENT TO PASTEURISATION FOR COMMON

TYPES OF DAIRY PRODUCE
All dairy produce (excluding ice cream) with Ice Cream
Milks with <10% fat and no Dairy produce with ≥ 10% fat mixes
added sweeteners and particles and/or added sweeteners and with
concentrated dairy produce with particles
> 15% total solids and particles <1000
μm
Particle <200 μm 200 to 500 to <200 μm 200 to 500 to
Diameter Ø <500 μm <1000 Ø <500 μm <1000
Ø μm Ø Ø μm Ø
Minimum
holding Minimum Temperature (°C)
time
(seconds)
1.0 81.6 - - 84.4 - - -
2.0 79.0 81.6 - 81.8 84.4 - -
3.0 77.6 79.0 - 80.4 81.8 - -
4.0 76.5 77.6 81.6 79.3 80.4 84.4 -
5.0 75.7 76.5 79.0 78.5 79.3 81.8 -
6.0 75.1 75.7 77.6 77.9 78.5 80.4 -
7.0 74.6 75.1 76.5 77.4 77.9 79.3 -
8.0 74.1 74.6 75.7 76.9 77.4 78.5 -
9.0 73.7 74.1 75.1 76.5 76.9 77.9 -
10.0 73.3 73.7 74.6 76.1 76.5 77.4 85.5
11.0 73.0 73.3 74.1 75.8 76.1 76.9 -
12.0 72.7 73.0 73.7 75.5 75.8 76.5 -
13.0 72.4 72.7 73.3 75.2 75.5 76.1 -
14.0 72.1 72.4 73.0 74.9 75.2 75.8 -
15.0 72.0 72.1 72.7 74.8 74.9 75.5 79.5
30.0 70.7 70.8 70.9 73.5 73.6 73.7 -
60.0 69.4 69.4 69.5 72.2 72.2 72.3 -
Minimum
holding Minimum Temperature (°C)
time
(minutes)
1 69.4 69.4 69.5 72.2 72.2 72.3 -
2 68.1 68.1 68.1 70.9 70.9 70.9 -
5 66.4 66.4 66.4 69.2 69.2 69.2 -
10 65.1 65.1 65.1 67.9 67.9 67.9 74.0
15 64.3 64.3 64.3 67.1 67.1 67.1 -
20 63.8 64.8 64.8 66.6 66.6 66.6 69.0
25 63.3 63.3 63.3 66.1 66.1 66.1 -
30 63.0 63.0 63.0 65.8 65.8 65.8 -

Notes:
1. Ø signifies particle diameter
2. Minimum holding time
The minimum holding time is set at 1 second to give an adequate safety
margin. Shorter holding times will require validation to demonstrate the
effectiveness of the time temperature combination in controlling the hazard(s).
3. Lowest allowable temperature
The pasteurising temperature given for a 30 minute holding time is the lowest
allowable temperature for pasteurising the specified product types.
The information contained within this table is taken from the NZFSA, D121.1. Dairy
Treatments Standard 2003. This document references original data sources.

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 Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

APPENDIX C

PASTEURISER RETRO-FIT STANDARD

The minimum requirements for an existing HTST pasteuriser installation under
this program are:
(i) the holding tube shall meet the requirements of clause 12 of AS
3993.2003;
(ii) where a holding section is utilised in lieu of a holding tube then the
minimum temperature/time conditions (72°C/15 seconds or equivalent)
are to be certified by an appropriately qualified engineer of the
company supplying the unit;
(iii) the data to be recorded must include the following:
a) the time and duration of any diversion of the dairy product; and
b) the temperature of the dairy product as it leaves both the holding
section and the cooling section of the pasteuriser; and
c) the length of time of each process and the hour of the day when
these processes are carried out; and
d) the date and type of product being manufactured or processed;
and
e) the time during which the flow diversion device is in the forward
flow position; and
f) the reasons for any diversion or abnormal function of the
equipment.
(iv) double diversion valves to be fitted;
(v) fittings to be provided for salt conductivity tests;
(vi) a flow rate controller is to be installed where a timing pump or
homogeniser of fixed speed is NOT used;
(vii) valving is to be arranged to drop pressure in the raw side of the
regeneration section to zero if the plant goes into the divert phase;
(viii) the installation of pressure gauges and throttling valves to control the
discharge pressure of pasteurised product by maintaining a positive
pressure against the raw side pressure to eliminate the risk of cross
contamination through the regeneration section.
(ix) differential pressures are not required and do not need to be monitored
in systems that have been engineered to guarantee that at all times
(including equipment failure and fatigue), pasteurised milk cannot
become contaminated with raw milk or non-potable water supplies.
This result can be achieved, for example, by using double skinned plates,
which have leak escape passages separating pasteurised milk from raw
milk and non-potable water in the heat exchanger. Where this option is
employed, leak escape channels shall open to the atmosphere and shall
be able to be readily and routinely checked for signs of leakage. Where
leakage is detected, the affected plates shall be replaced. The sterile
loop system is another system which maybe applied.
Where a pasteuriser using double skinned plates or the sterile loop system is
installed items (vii) and (viii) would not apply.

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Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes

APPENDIX D

EXPLANATORY NOTES
These notes are designed to provide assistance and background information
for the assessment of compliance to this ANZDAC document.
Section 4.1 – Heat Treatment Equipment
Batch pasteurisation – “the equipment should include a headspace
thermometer.”
The USFDA PMO item 16p (A) Batch Pasteurisation provides a public health
reason that addresses this issue.
“Tests have shown that when foam is present on milk or milk product in
vats or pockets during pasteurization, the temperature of the foam may
be well below the pasteurization temperature. In such cases, pathogenic
organisms that may be in the foam will not be killed. Experience
indicates that some foam is present at some time in all vats, particularly
at certain seasons. Furthermore, in filling vats, milk or milk product
frequently is splashed on the surfaces and fixtures above the milk or
milk product level, as well as on the underside of the vat cover. Droplets
of this splash may drop back into the body of the milk or milk product,
and since they may not have been at pasteurization temperature for the
required time, they may contain pathogenic organisms.”
The auditor should also take into consideration the nature of the product/
ingredients being heat treated. In circumstances where all milk products
added to the batch have already received a lethal treatment eg pasteurised
milk or cream or powdered milk and no other ingredients that are assessed
as high risk, such as raw eggs, are added then the auditor may consider that
this is not a lethal heat treatment and therefore monitoring of headspace
temperatures may not be a critical control measure.
The factory may provide evidence of validation of alternative monitoring
of heat treatment to verify that the process is effective without headspace
monitoring. This may include adopting an increased level of heat treatment
eg higher temperature and/or longer time with a study of headspace
temperatures over a period of time with continuous recording during
processing. This information should be available to the auditor as a validation
of the process.
Competency of Personnel – Sections 4.3, 5 and 6
Where heat treatment is a critical process designed to ensure that the product
is safe for human consumption it is essential that personnel conducting
verification and validation of the equipment and processes are competent.
The factory’s food safety program should address personnel competency.
When contractors provide certification of equipment such as compliance to the
AS3993 – 2003 the factory should be provided with some evidence, from the
contractor, that they have the required knowledge to perform the assessment
through qualifications and/or experience.

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 Prepared by an ANZDAC working group
consisting of representatives from the
Australian Quarantine and Inspection Services;
Dairy Food Safety Victoria; New South Wales Food Authority
and SafeFood Queensland.

©ANZDAC (June 2007)