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Anzdac Validation Heat Treatment
Anzdac Validation Heat Treatment
07
June
Guidelines
For Food Safety
Validation and Verification of
Heat Treatment Equipment
and Processes
1
FOREWORD
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
3
Definitions
5
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
7
Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes
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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
9
Guidelines for Food Safety: Validation and Verification of Heat Treatment Equipment and Processes
6
Pasteuriser Operators
APPENDIX A
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
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
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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.
13
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.