DAIRY PROCESSING EXPECTATIONS

Document Version Issued on Applicable from

QDS-GLOB-SQM17 June 2020 1 January 2021

TABLE OF CONTENT

1. Objective
2. Scope
3. Definitions
4. Processing Requirements
4.1. Microbiology CCPs
4.2. Validation Microbiology CCPs
4.3. Pasteurizers
4.4. Heat exchangers post Microbiology CCP
4.5. Spray drying areas
4.6. Drum drying areas
4.7. Toxin formation hazard
4.8. Addition of microbiology sensitive ingredients post Microbiology CCPs
4.9. Allergens
4.10. Raw materials minimum controls:
4.10.1. Raw milk
4.10.2. Whey non-pretreated-concentrated transported from another plant
4.10.3. Dairy concentrates heat-pretreated-concentrated transported from another
plant
4.10.4. Cream transported from another plant
4.10.5. Butter
4.11. Sanitary design processing equipment and plants
4.12. Food Safety related software validation and verification
4.13. Time-temperatures equivalent calculations
4.14. Holding time calculation

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 1. Objective

This document describes Barry Callebaut’s minimum quality and processing expectations for dairy
processing. These requirements apply in addition to the Barry Callebaut Supplier Quality Expectations
(​QDS-GLOB-COM78)​ and specifically address facilities manufacturing dairy products.

​ hich ​is a known

The objective of this document is to address the contamination with ​Salmonella, w
potential microbiological safety hazard for dairy products. Implementation of a validated and well
controlled thermal heat treatment is an adequate way of control and is a prerequisite for being an
approved supplier for Barry Callebaut.

Certificates demonstrating the validation of the thermal heat treatment shall be made available to
Barry Callebaut in the Supplier approval and reapproval process. The thermal heat treatment
validation study and all verification activities shall be made available to Barry Callebaut during audits
or whenever requested.

2. Scope

This document applies to suppliers and external manufacturers that supply dairy products to Barry
Callebaut and its subsidiaries.
This document provides guidance for validation of a kill step. It covers minimum requirements, based
on current information to ensure food safety during processing and handling.

3. Definitions

3A Standards - ​Formed by the US food and dairy industry, ​3A​ Sanitary ​Standards​ Inc. designates
specifications and best practice for the project, production, fitting and use of hygienic equipment. In
addition, as with FDA, the ​3A standards​ are established globally.

4. Processing Requirements

The manufacturing site shall establish a food safety management system based on the HACCP
principles of the Codex Alimentarius General Principles of Food Hygiene. GMP and prerequisite
programs must be implemented in processing, product handling and storage areas. Full details of
these requirements can be found in Supplier Quality Expectations (QDS-GLOB-COM78).

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4.1 Microbiology CCPs

For a continuous process, the following Microbiology CCPs can be applied. The table below shows
the acceptable critical limits for different product categories, if different critical limits are applied
then there is a need for a specific sound or scientific based validation.

PRODUCT CRITICAL LIMITS

(*)

Raw milk 72ºC/15 sec.

Cream 10-20% fat 75ºC/15 sec.

Cream >20% fat 80ºC/15 sec.

Products produced from raw milk concentrate up to 42.75% total 79.4ºC/25 sec.
solids and 18% fat

Z-values, for calculating equivalent time-temperatures

and/or

To be considered microbiology CCP, heat treatment for pre-pasteurized concentrate after transport
from another location (whey or skim milk)

and/or

To be considered microbiology CCP, heat treatment for products produced from raw milk
concentrate > 42.75% total solids and > 18% fat

Need sound-scientific based validation

(*) REFERENCE: ​Juffs,. H and Deeth, H (2007) Scientific Evaluation of Pasteurization for Pathogen
Reduction in Milk and Milk Products. Food Safety Standards New Zealand and Australia

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4.2 Validation Microbiology CCPs

Locally continuous pasteurizers shall be validated. Taking into consideration the worst case scenario.
At minimum:

Worst case scenario Method

Temperature Product temperature at the Calibration-verification against controlled

worst case defined reference thermometer.
temperature. Taking into
account probe tolerance

Time-flow Laminar flow. Empirical holding time test e.g. salt or,
colorimetric test.
Fastest particles travelling
above average speed. Calculation, including Reynolds number
calculations. (See section 4.15 Holding time
calculation)

Diversion system Fastest particles above the
critical speed-limit should
be diverted-not reaching
forward flow
Diversion time (temperature probe reaction
time, plus diversion time’s delays), shall be
shorter than fastest particles travelling time
between critical temperature probe and
diversion system-valves

The validation report from the pasteurizer-equipment supplier must be valid, taking the worst
case scenario into consideration, including product rheology. The product validation report should
fully match with the product being pasteurized.

4.3 Pasteurizers

At minimum, the following applies to continuous processing. In case a batch system is applied, full
validation (limits and pasteurizer) shall apply.

HAZARD Control measures

By design. By other non-design validated

To be stated at pasteurizer
validation report.
control measures.
If this is the case, it shall be
assessed at the pasteurizer
validation report.

PASTEURIZATION TEMPERATURE

Product temperature below
critical limit.
Temperature probe location.
Temperature probe located at
the coldest point of holding pipe,
normally at the end.
If the temperature probe is not
located at the coldest point,
delta temperature between
coldest vs monitoring
temperatures to be considered.

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Product temperature below
critical limit.
Activation of flow diversion
system.
Product temperature below
critical limit.
Temperature probe
monitoring critical
temperature ​deviates​.
Product holding time below
critical limit-product.
Flow-speed above critical
limit.
Location of flow meter.
Product holding time below
critical limit-product. jia88
Flow-speed above critical
limit.
Flow meter uncertainty not
considered.
Product holding time below
critical limit-product.
Flow-speed above critical
limit.
Activation of flow diversion
system.
Flow diversion system may
be slow and/or react at
settings not respecting CCP.
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Diversion valve-system to be Product-pasteurizer stops. Under
triggered below critical processed product to be
temperature. diverted out of forward flow.
One or more temperature probes Calibration- verification
also monitors pasteurization program.
temperature. In case delta
Accepted temperature probes
temperature exceeds the defined
tolerance to be considered.
limit
(monitoring-reference-controllin
g probe/s), diversion is triggered.
PASTEURIZATION TIME-FLOW
The flow meter monitoring NA
pasteurization, shall be located at
a position fully representative of
pasteurization step.
Pasteurization-flowmeter not to
be interfered. E.g. by buffer tanks
in between, cream separation,
etc.
By design, the flow-pumping Maximum flow verification
system cannot technically run program and/or verification
faster. against reference flow meter. .
Flow meter uncertainty certified
by device supplier. If not the
case, apply technical
knowledge-validation.
Diversion valve-system to be In case, some likely flow fault
triggered above critical flow. signals, e.g. when cream
separators discharge, valves
downstream flip, etc., the
diversion system is not directly
triggered by flow. Sound
validation of likely faulty signals
must be in place.
FLOW DIVERSION SYSTEM-VALVES
Fast Flow diversion system. Cut in-cut out test (shut down
steam) at start of production
Recording of diversion event at
run.
the valve.
5
 Recorded at pasteurization
charts.

By piping design, raw Flow diversion system operates NA

products may reach the flow above-far raw product level and
diversion system. E.g. when atmospheric piping separation.
the pipe in between the
balance tank and diversion
valve is below raw product
level in the balance tank.

Flow diversion valve when When flow diversion valve NA

diversion mode leaks into operates spring against
forward flow. compressed air, in case
compressed air failure, the valve
by the spring safely drives
diversion flow

And/or

Double valve system with leak

detection system

Flow diversion system may NA In case manual start up E.g.

be manually disabled by the evaporators, then the diversion
operator. system may be disenabled
providing it is clear in the
validating report, operator
driving equipment is all time
present and fully trained to
manually divert in case CCP is
not met.

Contamination of line-plates The flow diversion system and If not the case by design, then
with unprocessed product the temperature probe full sanitation of the equipment
when flow is diverted due to monitoring CCP are physically after diversion event-before
CCP not being achieved. close. production re-start.

Therefore, no piping-plates in
between probe/valve. E.g. No
cooling and regeneration
sections in between probe/valve.

OTHER

Full respect of CCP and Continues pasteurization NA

corrective action any time. recording

Recontamination due to NA Intense maintenance. No

product leaks through product leaks after microbiology

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 gaskets and/or broken CCP, as those may bring
membranes-devices post contamination into the product.
microbiology CCP

Product recontamination at See Section 4.4 Heat exchangers post Microbiology CCP
cooling and heat recovery
section raw-pasteurized.

4.4 Heat Exchangers Post-Microbiology CCP

The following applies to heat exchangers located post microbiology CCP and includes regeneration
and cooling sections for continuous pasteurizers.

HAZARD Control measures

By design. By other non-design validated

control measures.

Product recontamination at Pressure at the pasteurized side

cooling and heat recovery is higher versus the cooling
At the cooling section after
section between agent or raw product. E.g. by
microbiology CCP, water circuits
raw-pasteurized flows. combination of booster pump
to be monitored as well for micro.
and back pressure valve.
Plates maintenance and tests e.g.
By design, if well-constructed,
Note: Similar consideration pressure, pin holes, etc.
tubular heat exchangers leak
for chemical contamination
risk is less than at plate heat
by glycol if the case in
exchangers.
cooling sections.
Leaks at plates-gaskets may be Plates-gaskets DUO system should
minimized by DUO be intact and regular maintenance
plates-gaskets. Double gasket taken into consideration.
with leak channel in between.

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4.5 Spray Drying Areas
Spray drying areas shall be as dry as possible. Zoning wet-dry must be implemented and verified by
extensive environmental monitoring.
HAZARD
Wet environment in dry
areas increases micro growth
Wet conditions at air
des-humidification units.
Wet conditions at
steam-heating units e.g. fluid
beds
Water leaks from the roof
may introduce serious micro
risks from bird’s activity.
Product recontamination after microbiology CCP
After microbiology CCP
product recontamination by
deficient sanitation at
atomization units
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Control measures
By design. By other non-design validated
control measures.
Zoning dry-wet
Systems to prevent floors being
wet and/or contaminated by
shoes. E.g. dedicated dry shoes,
Zoning shoe covers, etc.
Water piping only used in
periodic wet cleaning leak-proof
physical disconnection from
products streams and
environment.
Drains used only in periodic wet
cleaning, close or inactive when
not in use.
Cold piping being isolated in Controlled systems in place in
order to prevent condensation. order to collect any water.
NA Steam piping under pressure to
be maintained preventing steam
/ water leaks.
Robust roof Immediate repair / maintenance
of roof leaks.
Procedure in case of leaks e.g.
Environmental monitoring,
segregation of the area, etc.
By design spraying nozzles and Validated cleaning procedure
rotating atomizers difficult to that can include manual cleaning
clean and fast drying alcohol sanitizers
and wipes.
8
 Micro contamination by
drying and transport air
After microbiology CCP
product recontamination at
spray dryers (chamber walls
and isolation)
Product contamination by oil
from the atomizer unit.
Product chemical
contamination by burners
residues-drying air
Chemical-oil contamination
at transport air
Physical contamination from
lines e.g. nut, etc.
Product contamination, also
for micro, when
maintenance interventions
Powder expansion gaskets
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Air filtration system Filters management e.g. changes,
monitoring filters performance,
Refer to the latest edition of
etc.
BARRY CALLEBAUT SUPPLIER
QUALITY EXPECTATIONS.
Air heating above 200ºC for
drying air.
By design modern spray dryers Validated cleaning procedure.
isolation system and CIP system
Intense line drying after
allow general dry conditions
sanitation / before production
during and after sanitation.
startup.
In case operators enter the
chamber, special GMP procedure
to be implemented.
Environmental monitoring after
sanitation and during production.
Chamber crack test as per risk
assessment. Guideline frequency
is yearly for aged spray dryers.
Product chemical contamination
Nozzle system is not lubricated. Food grade lubrication at rotating
atomization units
Burners’ indirect heating. Risk assessment if direct heating.
Combustion gases not in direct
contact with product.
Aspiration system for transport Air blowers oil free by design.
air.
Food Grade lubricated if any risk.
Product physical contamination
Minimize nut-bolts fixing Preventive maintenance
systems
Management of sieves and
By design some elements in magnets and metal detectors
spray dryers may need intense
Maintenance activities following
activities. E.g. cyclone rotating
GMP by trained staff.
valves.
Hand over back to production
Suitable materials for Food
protocol.
processing
9
 Other

Reworking loops e.g. fines, HACCP plans risk assessment GMP practices
bag filters, etc. missing
Traceability system
traceability and HACCP risk
assessment

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4.6 Drum Drying Areas

Drum drying areas shall be as dry as possible. Additionally, as applicable requirements for spray
dryers, the following must be taken into consideration.

HAZARD Control measures

By design. By other non-design

validated control
measures.

Zoning dry-wet. Vapors exhaust system.

Condensation from generated Collection system for Intense environmental

vapors could wet product and condensation monitoring at the exhaust
environment, if not effectively system and in this area.
Sufficient vapors exhaust
exhausted.
capacity

Product physical contamination

Open product may be physically Protecting devices Intense foreign bodies

contaminated, as it is exposed at prevention in this area.
the drum scraping system.

4.7 Toxin Formation Hazard

HAZARD Control measures

By design. By other non-design

validated control
measures.

Prior microbiology CCP, Slurry by design does not Slurry holding

development of heat resistant allow growth (Aw and/or
toxins e.g. when powder reworking pH values) of toxin
and/or recombined products formation microorganisms
i.e. Staphylococcus Aureus,
Bacillus Cereus.
time/temperature assessed
at HACCP plans to prevent
multiplication above Food
Safety e.g. 10
multiplications for
Staphylococcus Aureus.

Close product and GMP

practices to prevent
product contamination by
humans (significant
vectors).

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4.8 Addition of Microbiologically- Sensitive Ingredients Post-Microbiology CCPs

HAZARD Control measures

By design. By other non-design

validated control
measures.

Addition of microbiology sensitive Remove microbiology Follow latest edition of

ingredients post microbiology CCP sensitive ingredients. BARRY CALLEBAUT
e.g. Crystallization seeding lactose, SUPPLIER QUALITY
Lecithin, etc. EXPECTATIONS

4.9 Allergens

HAZARD Control measures

By design. By other non-design

validated control
measures.

Allergens other than milk in raw Full comply with BC raw Follow latest edition of
materials e.g. egg-lysozyme in material BARRY CALLEBAUT
whey specification-allergen SUPPLIER QUALITY
profile EXPECTATIONS
Added allergens e.g. soya lecithin
in spray dryers.

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4.10 Raw Materials Minimum Controls:

Raw milk

Whey non-pretreated-concentrated transported from another plant

Dairy concentrates heat-pretreated-concentrated transported from another plant

Cream transported from another plant

Butter

Minimum controls in this section are considered as a guideline. The main focus is Quality and Food
Fraud related risks. In some cases, the identified hazards may also result in Food Safety risks which
need to be assessed in the HACCP plan.

At all times, raw materials for Barry Callebaut products should fully comply with Barry Callebaut
specifications and legal regulations.

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 QUALITY FOOD FRAUD

RISK CONTROL RISK CONTROL

Raw milk Antibiotic presence Sound sampling and Incoming milk, Special
validated testing loose traceability focus/controls
(Also Food Safety
methods e.g. Snap and/or usage of for trader on the
risk for allergic
and Beta-star (quick peroxide milk origin
reactions)
methods), and
Delvotest (culture
method)

Clear rejection of
affected milk. Never
ever dilute.

Abuse of Raw milk controls Adulteration for Monitoring

temperature and during milk increasing of program based
time after milking. collection and at commercial value on risk
Microbiology of receiving. E.g. assessment
e.g. melamine (​also
raw milk Temperature,
Food Safety risk)
pH/acidity, etc.
and permeates, etc.

Whey Risks similar to raw Same as raw milk Whey origin not as Monitoring
non-pretreated / milk (antibiotic and per BC program based
concentrated microbiology) specifications e.g. on risk
and transported goat, sheep, etc. assessment
from another Food Safety risk Validate and usage of
plant microbiology CCP as lysozyme (​also
Pasteurization of
per previous Food Safety risk -
milk for cheese
sections allergen)
processing is not
considered valid
microbiology CCP

Dairy Risks similar to raw Same as raw milk Risks similar to raw Monitoring
concentrates milk (antibiotic and milk (permeates, program based
preheated / microbiology) etc.) on risk
concentrated assessment
and transported Food Safety risk Validated heat
from another treatment for
Apply
plant concentrated
pasteurization CCP
products when
for
transported.
non-transported
non-concentrated
dairy products

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 Cream Risks similar to raw Same as raw milk Usage of whey Monitoring
transported milk (antibiotic and cream if not program based
from another microbiology) considered at BC on risk
plant specifications. assessment

Additional risk of
lysozyme (​also
Food Safety risk -
allergen)

Butter Risks similar to Same as raw Same as raw Monitoring

milk/cream milk/cream milk/cream program based
(antibiotic and on risk
microbiology) assessment

4.11 Sanitary Design Processing Equipment and Plants

The design of equipment shall follow guidelines of sanitary standards e.g. 3A-standard and EHEDG. In
addition to design standards, the following is considered best practice regarding sanitary designs.

HAZARD Control measures

Water / humidity in dry areas Dry areas to be always kept dry

Washing areas only in wet areas

Drying step/chambers, after wet drying and eventual

treatment with Food Approved alcohol

Uncontrolled water in wet areas Flushing water, etc. to be collected and directed to the drain
system.

Controlled drain / suction systems disconnection from

product/piping.

Wet areas, to become almost dry areas.

Lines post microbiology CCP not Ideally fully segregated lines follow hygienic zoning.
segregated from raw product lines.
If not the case, very sound validation of procedures following
E.g. common silos and piping for
worst case scenario e.g. dead ends in piping.
raw and pasteurized.

Lines re-contamination by CIP units Ideally CIP units follow hygiene and allergen zoning i.e.
separate units for raw and post microbiology CCP: and for
Microbiology and allergens
allergen management.

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 If not the case, very sound validation of procedures following
worst case scenario e.g. dead end in piping and water
recovery tanks at CIP stations.

Lines re-contamination by CIP units When at risk simultaneous lines processing and cleaning,
usage of leak-proof valves e.g. double seat valves and/or
Chemical contamination
physical disconnection by multi junctions swing piping.

4.12 Food Safety Related Software Validation and Verification

Processing plants are mostly controlled by software. Software is not always easily visible. At
minimum, Food Safety related controls should be validated and verified. Special precautions are to
be taken when equipment is managed in remote mode, by equipment and/or software service
providers.

VALIDATION SOFTWARE VERIFICATION SETTINGS AND ALARMS

Pasteurizers CCP VALIDATION REPORT Yearly verification of settings and alarm

system-values. Includes at minimum:
(Reference Validation of the
Microbiology CCP latest ● CCP parameters
edition of BARRY CALLEBAUT
SUPPLIER QUALITY ● Alarm-delta temperature in between
EXPECTATIONS) probes monitoring CCP. See section 4.3
Pasteurizers

Daily verification of Food Safety related

alarms

Sanitation after VALIDATION REPORT Yearly verification of settings and alarm

microbiology CCP system-values
Suppliers must revalidate CIP
CIP recovery and units if lines post Daily verification of CIP alarms
non-recovery microbiology CCP not
systems segregated from raw lines.
Minimum frequency of every
two years or when a major
change occurs.

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4.13 Time-Temperatures Equivalent Calculations

The following thermal process equation may be used to calculate equivalent time/temperatures
(critical limits) when actual temperatures applied are different than those stated in the microbiology
CCP section:

T = temperature

F = the time required at actual applied temperature T

F​ref​ = the time required at given T​ref​ (i.e. the time/temp. stated microbiology CCP)

z = the z-value is the increase/decrease in temperature required to increase/decrease time by a

factor of 10, to be searched in sound scientific literature.

4.15 Holding Time Calculation

In order for all particles of milk to be held for at least defined microbiology CCP, the flow of milk
through the pasteurizer must be adjusted so that all particles receive the minimum required heat
treatment.

In laminar flow, the velocity of the fastest particle is typically twice that of the average particle
potentially resulting in some particles getting about half the required holding time if the holding tube
has not been 'sized' correctly.

The type of flow depends on the geometry of the holding-tube, flow rate of the fluid, and the
viscosity and density of the fluid. Reynold’s number, N​Re​, is frequently used to distinguish the type of
flow. It is accepted that the flow pattern is laminar for N​Re​, < 2,100. Turbulent flow exists when N​Re​,
exceeds 4,000.

Reynolds Number can be calculated using:

N​Re​ = ​ρ x v x D
µ
Where:
ρ = density, kg/m3
v = velocity of flow, m/s
D = diameter, m
µ= viscosity of product at the heat treatment temperature, Pa s.

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References

● Bergdoll, M.S. (1989). Staphylococcus aureus in Foodborne Bacterial Pathogens, edited by

Michael Doyle. Published by Marcel Dekker, New York.

● Code of Practice on HTST pasteurisation (Dairy UK) (2006) (P4) 8.

● Codex Alimentarius: Milk and Milk Products, 2nd Edition 2011

● European Hygienic Engineering & Design Group (EHEDG). www.ehedg.org/guidelines/

● 3-A Sanitary Standards.

www.3-a.org/Knowledge-Center/Resource-Papers/A-Primer-for-3-A-Standards-Practices

● Innovation Center for U.S. CONTROLLING PATHOGENS IN DAIRY PROCESSING

ENVIRONMENTS. www.usdairy.com

● Juffs,. H and Deeth, H (2007) Scientific Evaluation of Pasteurisation for Pathogen Reduction in
Milk and Milk Products. Food Safety Standards New Zealand and Australia.

● Pasteurized Milk Ordinanace (PMO), 2011 Revision.

● Regulation (EC) 852/2004

● Regulation (EC) 853/2004

● Regulation (EC) 2074/2005

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