Aseptic Processing Practices and Process Validation of Aseptic ...
Food Safety & Quality in Aseptic Packaging for liquid food · Some real life results of Tetra...
Transcript of Food Safety & Quality in Aseptic Packaging for liquid food · Some real life results of Tetra...
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Food Safety & Quality in Aseptic Packaging for liquid food
ABCE, Dubai, October 29th, 2017 Antonio Rendina – Aseptic Performance Management Director
Tetra Pak, DSO
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I would argue that……
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Good data collection and
analytics are key to deliver
Food Safety and Food Quality
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We specialise in providing customers with complete
packaging solutions for processing, packaging and
distribution of food products
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Who are Tetra Pak – some quick facts & figures
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Carton packaging material, billions of packs
188 Packaging machines in operation
8,860
Processing units in operation
76,000
Downstream equipment in operation
20,000
Present in +175 countries around the globe
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Who are Tetra Pak – some quick facts & figures
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Tetra Pak vision
We have…
“We commit to making
food safe and available,
everywhere”
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
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GLM_Station5/2017-09-21
Tetra Pak Public
FOOD. PEOPLE. FUTURES.
Tetra Pak 2017 Sustainability Report
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Protecting Food
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Working with our customers and partners
to make food safe and available everywhere
through our innovative and market-leading
food processing and packaging solutions.
Food safety
Food quality
Food availability
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Food Safety
Assurance that food will
not cause harm to
consumers when it is
prepared and/or eaten
according to its
intended use
Food Quality
Maintaining the quality
characteristics of food that
are acceptable to
customers and consumers
for the desired shelf-life
Food Availability
Sustaining dairy value
chain development,
nutritional programmes,
food categories expansion,
and reduction
of food waste
• From FAO/WHO Codex Alimentarius
• It encompasses:
- Microbiological safety of food
- Chemical safety of our systems
- Physical safety of our systems
• It includes quality factors such as
appearance, texture,
flavour and nutritional elements
• It is a commercial enabler
• It is a performance attribute
Tetra Pak Public
Bringing safe food to consumers
Food Protection
Antonio Rendina / Oct 29, 2017
• Development of new product formulations
• School feeding programmes
• Food waste reduction
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Food Safety Assurance that food will
not cause harm to
consumers when it is
prepared and/or eaten
according to its
intended use
Food Quality Maintaining the quality
characteristics of food that
are acceptable to customers
and consumers for the
desired shelf-life
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Bringing safe food to consumers
Food Protection
No preservatives
Long shelf life
Ambient distribution
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Any specific reason for the food industry to worry?
► Social media attention
► Growing consumer awareness
► Retailers taking the lead
► Complex logistic and traceability
► Brand protection
► Business critical consequences of failure
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Why should we worry about Food Safety & Quality
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Food safety and quality issues can
damage your commercial strategy,
your financial results, and your
brand equity 77% Food Producers experienced
recalls that had a financial impact
up to $30 million
Main costs come from business interruption, product
disposal and customer reimbursement
Source: Capturing Recall Costs - Measuring and Recovering the Losses, USA GMA and Ernst & Young 2011
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We have…
So, what does this mean to Tetra Pak
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
• Food safety non-negotiable – no compromise
• Equipment has to be designed and automated
to deliver of Food Safety
• In the next 30 min another 11 mio packages –
crucially important that NONE of these have
any Food Safety issue
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Microbiological Food Safety and Quality
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
It is about Public Health and Compliance Cost, waste, market acceptance
Microbiological Food Safety Aseptic Performance
It applies to What is released What is produced
Failures Not Acceptable Acceptable as per customer AQL
Statistical sampling
for batch release Not acceptable Acceptable
Secured by Process Control
Must Should
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Tetra Pak Type Validation Approach
► The process is defined by the manufacturer
► The user cannot change the process
► All critical parameters are measured by
instruments
► Instruments provide feedback control
► Instruments stop the process if any critical
parameter drifts outside the acceptable range
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Securing Microbiological Food Safety
Validating the equipment delivers the process.
Validating the process delivers the desired effect.
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Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Establish a “master registration” with US FDA
Equipment Filing to Food Authority
Filling Machine
System
Functional
Specification
Microbiological
Performance
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Microbiological Food Safety and Quality
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
It is about Public Health and Compliance
Microbiological Food Safety Aseptic Performance
It applies to What is released
Failures Not Acceptable
Statistical sampling
for batch release Not acceptable
Secured by Process Control
Must
Cost, waste, market acceptance
What is produced
Acceptable as per customer AQL
Acceptable
Should
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PP
QC
CCP PP
QC
CCP PP
QC
CCP PP
QC
CCP PP
QC
CCP
CCP: Critical Control Points
PP: Process and Operation Parameters
QC: Quality Check
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Aseptic Performance is the result of the whole line
Aseptic Performance
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20 factors
Raw material and end-product quality
raw product, incubated results,
storage control,
consumer complains
54 factors
Processing parameters Pre-processing, intermediate storage,
UHT treatment, aseptic transfer, CIP
84 factors
Filling machine Tube tighntess,
transversal sealing,
pack-mat splices, etc
96 factors
Soft factors Training, maintenance, hygienic awareness, quality management system,
competence, workforce, motivation, quality mindset
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
254 different factors
Many Factors influence Aseptic Performance
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Processes and People
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Process People Involvement Example
Fully Automated Only for maintenance and
calibration Air Sterilisation by Incineration
Automated Pre-conditions assumed and
preparation needed
Machine Sterilisation
- Assumes clean surfaces -
Supervised Evaluate result and perform
adjustments Package sealing
Manual Is completely performed by people Manual cleaning
Inc
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um
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nt
Inc
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isk
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mis
tak
es
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All processes cannot be totally independent of manual operation and people skill
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
AND / OR
IMPROVE
QUALITY OUTPUT
Increase level of
automation
Improve operation
management and
control
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Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Traditional sampling
Incubation
Package
check
(shop)
Blown Packs
+ Resampling
(warehouse)
Package
check
(microbiological)
Manually collected
Claims
(retailer
/ consumer)
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Digital
Quality
Sampling
System
What you can measure you can improve
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Incubation
Filling Machine logger + Quality Module
PC
Defective packs entered into
system at these points.
System helps automatically
correlate events in production to
quality issues.
Tetra Pak® DQSS
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Blown Packs
+ Resampling
(warehouse)
PC Claims
(retailer
/ consumer)
PC PC Package
check
(shop)
Package
check
(microbiological)
Automatic
sampling
unit with
confirmation
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DQSS: Tool for better monitoring of Aseptic Performance
► Tetra Pak toolkit for Aseptic
Performance Monitoring
► Simpler data collection
► All data available for analysis
and troubleshooting
► Historical trends readily available
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
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Comparison between line events
Operators sampling accuracy
Comparison between lines
Tetra Pak® DQSS
• Defect rate lowered 50%
• Reduction of lost of sales due to quality issues down 90%
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
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Antonio Rendina / Oct 29, 2017
Tetra Pak Public
Some substantial potential improvements*
Some real life results of Tetra Pak’s DQSS toolkit
CONSUMER COMPLAINTS # OF UN/STERILITIES TIME FOR TROUBLE SHOOTING
Before After
* Please note that result may vary from customer to customer depending on their current level of Quality Control
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Access to data will assist in managing people
Per Ohlsson / June 2, 2017
Tetra Pak Public
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Data will allow you to
understand the gaps
► Training
► Documentation
► GMPs
► SOP & Work instructions
► World Class Manufacturing
► Supervision and control
► Empowerment &
Responsibility
► Listening & Feedback
► Salary & Rewards
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Concluding Remarks
► Microbiological Food Safety is non-negotiable and should
be managed through automated process control
► Food Quality however depends on many factors
► Reliable, repeatable, predictable quality is achieved if
key factors are understood and controlled which can be
achieved through intelligent data collection and analysis
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
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Good data collection and analytics are key
to deliver Food Safety and Food Quality
I would argue that……
Antonio Rendina / Oct 29, 2017
Tetra Pak Public
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Thank You