What Is the HotFill Process ?A beverage processing method that achieves microbiological stability by heat sterilizing a high acid product and filling while hot to sterilize the container, headspace, and closureGeneral Biological Microbiological Requirements for packaged products (long term shelf life outside of the “cold chain”): Free from live microorganism (CFU) to secure shelf live and avoid quality deterioration due to microbiological activities within the closed package Free from harmful ( toxic, pathogen ) metabolism and byproducts Free from active bio catalysts (enzymes) avoiding changes deterioration by autolysis Avoid visual {color, consistency}, chemical {composition }, physical { density, gas generation, viscosity } and organoleptic {smell, taste, sensory} deterioration by either live activities or decomposition effects of killed microorganism {autolysis}
Trang 1Basics on Hot Fill Process
Trang 2What Is the Hot-Fill Process ?
A beverage processing method that achieves microbiological stability by heat sterilizing a high acid product and
and filling while hot to sterilize the filling while hot to sterilize the
container, headspace, and closure.
Trang 3Free from live microorganism (CFU) to secure shelf live and avoid quality deterioration due to microbiological activities within the closed
package
General Biological & Microbiological Requirements
for packaged products (long term shelf life
outside of the “cold chain”)
Free from harmful ( toxic, pathogen ) metabolism and by-products
Avoid visual {color, consistency}, chemical {composition }, physical { density, gas
generation, viscosity } and organoleptic {smell, taste, sensory} deterioration by either live
activities or decomposition effects of killed microorganism {autolysis}
Free from active bio catalysts (enzymes) avoiding changes & deterioration by autolysis
Hot Fill Basics
Trang 4Product classification (according to pH)
High acid product Low acid product
Low acid teas
Milk Tea+milk Coffee+milk Flavoured milk
Ice Tea Sport drinks Apple juice Orange juice
Trang 5Range of pH values for various juices
pH 4.6 is critical: pathogens cannot grow < pH 4.6
Trang 6Growth Factor of Microorganism
9
Recommended Sterilizing Temperature approx 90 ºC
Recommended Sterilizing Temperature min 120 ºC
Hot Fill Basics
Trang 7Temperature Classification of Microorganism
Trang 8Hot Filling
Hot Fill Basics
Trang 9Heat treatment parameters
D Value : Thermal death time / decimal reduction time Value : Thermal death time / decimal reduction time
Time required to kill 90% of microbes
z Value : Thermal resistance constant Value : Thermal resistance constant
Increase in temperature required to drop D 10 fold
z is generally 5-10°C (9-18°F)
F o Value : Time at 121°C to destroy an organism Value : Time at 121°C to destroy an organism
C botulinum 12 log reduction (12-D)
Trang 10Thermal treatment
The destruction of a population of microorganisms is a function of time and temperature
Both, temperature and time, are critical parameters :
The effect of time on microbial destruction
Trang 11 The rate of destruction with
temperature is a constant for any particular food environment
We can calculate equivalent times
and temperatures
For example: With z = 5.5,
95°C for 22 seconds = 90°C for 3 minutes
How do we calculate the time and
temperature needed to destroy microbes ?
Trang 120 5 10 15 20 25 30
8 7 6 5 4 3 2 1
65°C D=2.1 min
70°C D=0.93 min
75°C D=0.39 min
Trang 1350 60 70 80 90 100
100 30 10 3 1 0.3 0.1 0.03 0.01
Temperature(°C)
Minutesfor 10-Fold Reduction
Effect of Temperature on Yeast Kill Rates
Z-Value = 13 °C
Trang 14Equivalent Time-at-Temperature
Combinations
Log Reductions (Z-value
Log Reductions (Z-value = = 13°C 13 °C )
Trang 1542.2 31.6 23.7 17.8 13.3 10.0 7.5 5.6 4.2 3.2 2.4 1.8 1.3 1.0 0.7 0.6 0.4 0.3 0.2 0.2 0.10
Sec
2530 2 1897 4 1422 8 1067 0 800.1 600.1 449.9 337.4 253.0 189.7 142.3 106.7 80.0 60.0 45.0 33.7 25.3 19.0 14.2 10.7 8.0
Pasteurization Conditions
°F
158.0 159.8 161.6 163.4 165.2 167.0 168.8 170.6 172.4 174.2 176.0 177.8 179.6 181.4 183.2 185.0 186.8 188.6 190.4 192.2 194.0
Min = Antilog °C – Equivalent to
(°C)
Z -Value
Trang 16Microbial destruction
At high temperatures, microbes are destroyed faster than quality factors such as color and nutrients are reduced :
For this reason, a high temperature and short time, heat treatment is better for product quality than a lower temperature and longer time
Trang 17Destruction of Pathogenic Microorganism Inactivation of Enzymes
Noticeable total cfu damage & reduction
Trang 18Hot-Fill Technology for High Acid Beverages
Trang 19Hot Fill Manufacturing Process
Major Control Points
Understand and control initial microbial load of food ingredients and other incoming materials
Meet processing conditions
Product sterilization
Filling temperature
Head space and closure sterilization
Final product temperature
Sanitize incoming containers
Protect the filling environment
Perform system sanitation regularly
Monitor the quality of cooling water
Maintain GMP
Trang 20Hot-Fill Line Main Components
Thermal Processing System
Secondary Packaging System
Finished Product Date Coder
Washer Containers
Culiniary Steam Treatment
Quarantine & Release
Trang 21Hot-Fill PET Line Main Components
Trang 22requirements for Hot Fill
Washer validation
Blend beverage- Magnetic Separator & Strainer.
Blend beverage-Max Hold Time < 4 hrs (< 25*C).
Blend Syrup- Max Hold; < 18 hrs (< 25*C)
< 24 hrs (< 15*C)
Pasteurization 96-98*C for 5-10 secs.
Auto Low Temperature Divert.
Max Bev recirculation/bypass flow during
normal operation to be < 15% of beverage flow.
Cool bypass beverage < 38*C.
Trang 23requirements for Hot Fill
Max time at Beverage full flow recirculation is one pass through the process (batch size X flow rate).
Temperature recorders
Return line from CIP circuit.
Holding Loop Exit.
Filler Bowl or entry to Filler Bowl.
Recirculation cooling loop exit.
Filling Temperature; Filler Bowl not less than 86*C.
Trang 24requirements for Hot Fill
Pasteurizer Heat Exchanger Design
To minimize the potential for product cross contamination in the pasteurizer heat exchanger due to pinhole leaks or cracked plates by:
a) Monitor and record pressure readings in all sections of the pasteurizerb) Maintain sterile product pressure at 1-5 psi higher than non-sterile (Heating
or cooling medium) pressure by:
Installation of an operational alarm activated by a pressure differential of less than 1-5 psi Automatic shut down for sanitation when pressure
drops to 0
MOC –SS 304/316, 3A sanitary design, withstands 95-100*C for 30 minutes.
Recirculation system
enable partial to full-flow re-circulation (filler by-pass) capability
provide a line to drain or flush the system
cool re-circulated product typically to 38 °C, in a cooling heat exchange, before return to the process
Trang 25requirements for Hot Fill
Pasteurizer Heat Exchanger Design
Water used as heating or cooling medium is drinking quality Hot process water medium is generated in a clean loop using steam.
An inline meter is installed to measure flow through the heat exchange system.
Before filling: pre-heat glass bottles
Heat Closure before application by directing culinary steam at the inside surface for ≥ 0.1 second.
Closure & Headspace Heat Treatment Invert
containers or otherwise ensure interior surface is ≥ 77°C for no less than
7 seconds or equivalent.
Delay cooling for 45-60 seconds after filling.
Trang 26requirements for Hot Fill
Cooling Tunnel : Control in-package beverage temperature exiting the cooling tunnel to ≤ 40°C.
Cooling water must be potable chlorinated (1-2 ppm)
1-3 ppm free chlorine, < 8.0 pH, Hardness <100 ppm, Coliform, 0/100 ml,Total Count, < 25 cfu/ml.
Homogenizer : should be able to homogenize at 200 bar ; not less than 95% of the beverage should be below 2u.
Trang 27requirements for Hot Fill
CIP Step Pre-pasteurization (mixing /
blending tanks, storage tank, clarifier, homogenizer)
Post-pasteurization (heat exchanger, pipelines, filler)
•Rinse with hot water (>60°C) till residue is nil and thereafter for 3 more min
•Sanitize with hot treated water
•Rinse with hot water (>60°C) till residue is nil and thereafter for 3 more min
•Sanitize with hot treated water 93-99°C for 5Min
• Hot Acid circulated for 20 minutes (with nitric acid of 0.6 - 0.8 % v/v)
Trang 28Simple Syrup Splitting using Magnetic Flow Meter
Requirement: Simple
syrup must be split using calibrated Magnetic flow meter
Purpose: To ensure
transfer of accurate quantity of syrup required for an unit and to avoid any variation in beverage
quality
Reference: India Division
Maaza Beverage Brix CAP
Trang 29Washer Validation for sensitive beverages
Proper Pre-inspection & Post Inspection stations.
Double ended, two soak washer.
Caustic 2.8 +/- 0.2%, 77+/-2*C @ > 8 mins.
Low Soak Temp & Rinse pressure security.
Auto caustic & additive dosage.
Final rinse water to be potable & 5u filtered.
Micro of washed containers.
Validation protocol; 8 hours run.
Re-qualify washer
Every new package initial qualification
Every 6 months following initial qualification
Each time washer is taken down (drained) for service or maintenance or recharge.
When washing conditions are changed (liquid concentration, detergent formula, soak time, additives, or temperature).
Trang 30Homogenizer & Particle Size Distribution Analysis
• Particle Distribution Analysis is very important to know the pattern
of distribution of particles in the homogenized beverage.
• It is based on the Laser Diffraction Technology.
• Helps to know the % of particles over a defined range of particle size.
• Helps to study the Homogenizer Performance and Efficiency.
Trang 31MAGNETIC TRAPS
Trang 32A Typical Hot-Fill Thermal Processing System
Heat Exchanger
Balance Tank
Heat Exchanger
Tank Mix
Filler
Divert Valve
Filte r
Holding Loop
Magnetic Trap
Trang 33FILLER BOWL
CROWNER
In-feed Star Wheel
Crowner In-feed Star wheel Crowner out-feed Star wheel
1 2 3 4
5 6
Temperature Scanner ( Camera )
Pneumatic Cylinder
Juice –Online Low Temp Rejection System
Trang 34Heat Exchanger / Hold Loop
Trim Cooler
Incoming Product
Filled Package
@
89°C
97º C
5-10% Re-circulation
Trang 35Balance
Tank
Heat Exchanger / Hold Loop
Trim Cooler
Incoming Product
Filled Package
@
89°C
95º C
Product Return Cooler Saver
Tank
Hot-Fill Process
Production Stops Due to Process Deviation
• In case of production stops filled uncrowned bottles to be removed after 1 minute.
• Package < 81*C at Cooling Tunnel entrance to be rejected.
Trang 36Hot-Fill Process
Water Interface Recirculation
Balance Tank
Product Return Cooler
Heat Exchanger / Hold Loop
Trim Cooler
Water Recirculation (Water automatically replaces incoming product)
95º C
1 Pass- Citrus products and 3 pass for non-citrus
Trang 37Heat Exchanger / Hold Loop
Trim Cooler
Incoming Product Replaces Water
Filled Package
Trang 38Design Considerations for Thermal
Optimize product yield by designing for
minimum water interface
Reduce thermal abuse by minimizing product recirculation during filling, processing, and line stoppage
Trang 39Filler- One Example model
Trang 40Filling Environment Must Be Protected to Avoid Post Pasteurization Contamination
Filling/Capping must be done in a positive air pressure environment
Air turn over rate is 20-30 air changes / hour
Monitor, inspect and replace air filter routinely
Avoid materials in the filling room that cause
contamination (specifically corrugated boxes)
Trang 41Heat Exchanger Design
Trang 42PLATE HEAT EXCHANGER TUBE TYPE HEAT EXCHANGER
PRODUCTS WITHOUT OR WITH PULP UP TO
D.1 MM LENGTH 4 MM AND 5% OF THE
VOLUME OF THE BOTTLE
PRODUCTS WITH PULP WITH BIGGER DIMENSIONS
Two Common Types of Heat Exchanger Design
Trang 43Closure Design & Application Are Critical in Avoiding Post Filling Contamination
An improper applied closure will allow air & water to contaminate the product during cooling
Thread design on the closure & finish must create a hermetic
seal
Closures are sterilized by applying culinary steam jet to the liner.
Minimize splashing product on threads during transfer from filler
to capper
Hot Treated water spray is used to clean bottle threads prior to capping
Optimize torque during application to provide a hermetically
sealed bottle that can be easily opened by the consumers (12 - 20
kg ・ cm)
Cap Vision system is used to eliminate bottles with cocked caps
Trang 44Water Spray on Bottle Finish
Meant for packages using Closures
Trang 45Headspace Sterilization Is Critical
to Achieve Commercial Sterility
Head space and inner surface of closure are
sterilized with hot product (Min 80 ° C, 30 sec)
Containers are typically inverted to fully
expose the head space & closure to
sterilization temperature
Head space should be minimized:
To maintain package integrity (short filled PET
bottles will ovalize upon cooling)
To reduce oxygen
Additional Head space is sterilized by
showering in the first section of Tunnel Cooler
54°
C
Trang 46Head Space Sterilization Bottle Inverter
Trang 47Adequate Product Cooling
The cooling tunnel must be designed to accommodate filling speed and required product exit temperature
Even product distribution in the tunnel
Cooling water must be potable chlorinated (1-3 ppm)
Tunnel must be inspected and cleaned routinely
Cooling Tunnel Water; pH< 8, TH < 100, TPC< 25/ml & Coliform NIL
Trang 48EXTERNAL HEAT EXCHANGER COOLING SYSTEM
Trang 49To the heat exchanger
Condensat
e Air Steam
Access for cleaning and maintenance
No bottles jamming or falling
MOC ensures potability of water used
1 heat retention area 2-8 cooling areas
Trang 50Cooling Tunnel- Product Vs Cooling Water Temperature profile
Trang 51Cooling Tunnel Exterior
Trang 52Measure Closure and Headspace Heat Treatment
Can be achieved in First Zone of Cooling Tunnel by showering Hot water for a duration so as to heat interior surface of liner at ≥
77°C for not less than 7 seconds
Name Max Temp Time Above
75.0°C Time Above 65.0°C
Trang 53 CIP Cycle Example:
Hot water (>60°C) circulated for 10 minutes
Hot caustic, 65-70°C circulated for 20 minutes (with an
active alkalinity of at least 1%)
Rinse 5 - 10 minutes with Hot water (>60°C) water
Hot Acid circulated for 20 minutes (with nitric acid of 0.6 - 0.8 % v/v)
Rinse 5 - 10 minutes with Hot water (>60°C) water
Rinse 5 minutes with treated water
Hot sanitation step must be performed prior to
production start-up
An chlorinated water or acid sanitizer solution must
be left in the system during downtime
Proper Clean In Place (CIP) & Sanitation
Ensure System Sterility
Trang 54Hot Fill Manufacturing
Critical Control Points
Understand and control initial microbial load of food ingredients and other incoming materials
Meet processing conditions
Product sterilization
Filling temperature
Head space and closure sterilization
Final product temperature
Sanitize incoming containers
Protect the filling environment
Perform system sanitation regularly
Monitor the quality of cooling water
Maintain GMP
Trang 55Cause of hygiene Problems
50% of the hygienic problems are related to poor CIP
Aseptic transfer CIP Packaging machine
Packaging material Operationa l
Flo w
Time
Concentra- tion
ture
Trang 56Tempera-Mechanical cleaning effects
Velocity = Turbulence Time dependent
Temperature independent
1,5 m/s is required to achieve an adequate mechanical cleaning effect
1,5 m/s
Trang 57Required velocity in pipe
Trang 59 Usually smaller than yeast or mold
Found everywhere, even in extreme environments :
Pyrulobus : grow at 113°C
Picrophilus : grow on pure sulfuric acid
Are living with us : on skin and digestive tractus
We carry 1-2 kg, 1014 bacteria, 500 species
Some pathogens :
E coli O157:H7 , Listeria , Salmonella , Staphylococcus , etc
No heat & acid resistant
Some heat resistant, some require high
temperature to grow
e.g., Alicyclobacillus