FOOD REVIEW Seminar, IPB BOGOR, Recent Technology to

FOOD REVIEW Seminar, IPB BOGOR,
Bogor, October 20, 2015
Recent Technology to Support
Thermal Process Validation
Mr. Klaus Kofod, Sales Manager
ELLAB A/S, Denmark
www.ellab.com
IFTPS Guidelines for Conducting
Thermal Processing Studies – April 2014
Cold Spot – Temperature Distribution
Temperature distribution studies are conducted in a sterilizer (retort) using distributed
temperature measuring devices (TMDs) to establish venting procedures, venting schedules,
come‐up requirements, temperature stability and uniformity, all of which are necessary to
establish reproducible and reliable heating and cooling performance throughout the retort.
Temperature distribution studies are typically performed using estimated production retort
operating conditions or parameters.
Location of Temperature Measuring Devices in the retort
§ 
One attached or in close proximity to the reference TID probe.
§ 
One attached or in close proximity to the temperature control
§ 
Two located in at least two containers filled with test medium for the purpose of determining initial
product temperatures. These containers should be located in the positions that are representative of
the potential worst case locations in the retort load.
§ 
A minimum of five (5) TMDs per basket/crate are typically used. These should be located in different
layers or otherwise separated in each basket/crate.
www.ellab.com
IFTPS Guidelines for Conducting
Thermal Processing Studies – April 2014
Cold Spot – Heat Transfer Distribution
The objectives of Heat Transfer Distribution Studies include identification of the slowest to heat
location in a retort to the extent that it impacts process delivery within the retort load when
using the same process, product, package, and load conditions. Identification of recommended
locations to place Heat Penetration containers for Process Establishment .
Temperature and Pressure must be independantly controlled and documented.
Location of Temperature Measuring Devices in the retort
§ 
TMDs to measure temperatures surrounding the test packages should be located in proximity to those
test packages. These TMDs are to be used to accurately calculate fh values of adjacent test packages.
§ 
TMDs to measure product temperatures to be used for data analyses should be securely fastened inside
the test package so that the measuring junction/tip is held in the test package cold spot.
§ 
At a minimum, five (5) probed product packages/HIUs should be located in separate suspected or known
slower to heat areas of each basket.
§ 
All baskets in the retort should contain test units..
www.ellab.com
IFTPS Guidelines for Conducting
Thermal Processing Studies – April 2014
 
Cold Spot - Heat Penetration
 
 
 
 
The purpose of a heat penetration study is to determine the heating and cooling behavior of a
product/package combination in a specific retort system for the establishment of safe thermal
processes to deliver commercially sterile products and to assist in evaluating process deviations.
Before commencing a heat penetration study, where applicable, an evaluation of retort
Temperature Distribution and Heat Transfer Distribution should have been completed.
A goal in conducting these studies is to identify the worst case temperature response expected to
occur in commercial production as influenced by the product, package and process.
Location of Temperature Measuring Devices in the retort
§ 
One attached or in close proximity to the temperature control
§ 
A minimum of two TMDs are recommended for retort temperature measurement: one situated close to the
sensing bulb of the retort reference TID, the other located near the test containers.
§ 
Worse case overpressure conditions should be used when collecting heat penetration data.
§ 
A heat penetration test should evaluate at least 10 working TMDs for each test run. If the retort cannot
accommodate this quantity, the number of replicate test runs should be increased.
www.ellab.com
Why are these tests important ?
SAFETY
 
All bacteria must be killed if the food is to be commercial safe to eat and nutricious
Energy savings
 
Lower temperature, shorter process time, increase production, cost efficiency
Improvement of Quality
 
Preserving vitamins, proteins, taste, presentation, consistency
Process Validation & Documentation
 
Regulations from FDA/USDA, EEC, HACCP, ISO9000 and other authorities
 
 
Export
Demands from Authorities and Customers
www.ellab.com
Test Equipment
 
IFTPS Guidelines - Institute for Thermal Process Specialists – www.iftps.org
 
 
 
Data Acquisition System – The data acquisition system should be calibrated prior to use. It
should also be equipped with sufficient channels to accurately monitor and record temperature/
pressure within the process delivery system. Manual recording of data may be used if a
sufficient sampling frequency can be maintained.
Temperature Measuring Device (TMD) – TMDs may be thermocouples, wireless data‐loggers, or
other similar devices. All TMDs must be of sufficient accuracy, size, and length, and in sufficient
quantity, to adequately and accurately monitor the process environment.
Pressure Indicating Devices – Operational gauges, electronic indicators, and/or wireless
dataloggers may be used to monitor pressures associated with the retort operation during a test.
These devices should be calibrated prior to the start of data collection. Typical pressure
measurements could include: retort vessel pressure, steam line pressure, and other line
pressures that may be critical to the process.
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Test Equipment
 
 
 
 
Reference Temperature Indicating Device (TID) – This may be a retort Mercury‐In‐Glass
(MIG) thermometer or other valid reference temperature measuring device including a
digital thermometer of sufficient accuracy and precision. The reference temperature
measurement device must conform to applicable regulations. For example, US‐FDA
regulation 21 CFR Part 113 establishes the requirement that temperature indicating
devices and reference devices must be tested against a reference device for which the
accuracy is traceable to NIST, or other metrology institutes.
Packing Gland (Stuffing Box) – This is needed for entry of lead wires into the retort when
wired data collection devices are used. Materials used should be soft enough to provide a
tight seal without over‐tightening and damaging the TMDs.
Slip Ring – This allows for transfer of thermocouple outputs from a rotating environment to
a stationary electrical contact outside of the retort.
Heat Input Unit (HIU) – Appropriate material such as a polymer, clay, or food product with
repeatable/definitive thermo‐physical properties, and capable of being used for heat
transfer distribution studies.. Packaged product may also be used as an HIU.
www.ellab.com
Test Equipment
 
 
 
 
Measurement System(s) – Measurement systems include as applicable: thermocouples/TMDs
(with extension wires as applicable), data acquisition system, pressure measurement devices,
and flow meters.
Prior to conducting thermal process studies, standardization or calibration of test equipment
should be performed. Thermocouples ideally would be calibrated in the test retort(s).
An acceptable method of calibration is to bundle all TMDs and locate them in close proximity to
the known accurate reference TID. The retort is brought up to the same sterilization set‐point
temperature and pressure as defined for the test and the retort is allowed to equilibrate.
Equilibration time may be dependent upon the specific retort and/or retort type. The
temperature differences between the reference TID and TMDs are then calculated and
documented. These differences may be applied as correction factors for each TMD. A typical
range of correction factors for thermocouples is usually not more than 1‐2F° (0.6 – 1.2C°).
Large correction factors may indicate an issue with the TMD that merits investigation and
corrective actions prior to use in thermal processing studies.
Come‐up time (CUT) is defined as the time requirement for the reference TID to read at or
above the minimum process temperature AND all TMDs to read within 1F° (0.5°C) of minimum
process temperature within 1 minute of starting the hold time.
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Test Equipment
Non‐thermocouple TMDs such as wireless data‐loggers should be within manufacturer’s
specifications at the time of their use provided those specifications are consistent with conditions
of intended use of the TMD.
Alternatively, TMDs may be calibrated off‐line in an established calibration program within the
temperature range to be used during data collection. The difference between the TMDs against
the known accurate reference device should be calculated and documented as part of the study
data. This difference may be applied as correction factors for each TMD.
Verification of the calibration of all TMDs after completing thermal processing studies is
recommended. Off‐sets which are substantially different than the pre‐study values should be
evaluated relative to the data that were collected.
For steam/air retort processes, the accuracy of pressure measurements should not result in
calculated intrinsic (unsafe) Steam Air Ratios ≥1% for the actual process value.
For non‐overpressure retort systems (primarily saturated steam), the accuracy of pressure
measurements should not result in an overestimate (unsafe) error of the equivalent saturated
steam temperature (corrected for sea level) of ≥0.2Fo (0.1Co), if process temperatures are
planned to be calculated from pressure values for any evaluation or consideration.
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Choosing the System
Real-Time Cable Based Systems
The advantage is real-time data, but installation is time consuming and risks for damaging
probes during loading and unloading
Real-Time Wireless Datalogger Systems
The advantage is real-time data, and installation is easier than using cable probes. Double
Sensors available so Heat Transfer and Penetration can be performed simultaneously.
Cannot be used in all kinds of systems
Wireless Datalogger Systems
Installation is easier than using cable probes. Double Sensors available so Heat Distribution
and Penetration can be performed simultaneously. Can be used in all kinds of systems. Data
is downloaded after processing and not Real-Time
www.ellab.com
Choosing the System
High Accuracy and Reliability of Equipment
It is important to bear in mind that a systemic error of 1ºC of the temperature
measurements corresponds to an inaccuracy of 26% in the Fo-Value at 120 ºC.
FDA-USDA Regulations
The US regulators are concerned about disparity in thermal emf between thermocouples,
connectors and extension wires, and reversed polarity at the thermocouple-extension wire
junction. They are also concerned that a datalogger and the sensor can be accurate, precise
and that results of the testing are reproducible.
ELLAB Validation Solutions
Both the E-Val PRO, E-Val Flex thermocouple based systems and the TrackSense Pro
wireless datalogger systems are well suited for performing Temperature Distribution, Heat
Transfer and PenetrationTests and compliant to all worldwide regulations.
www.ellab.com
Thermal Process Validation Solutions
www.ellab.com
E-Val PRO Real-Time Cable System
 
 
E-Val PRO is designed for validation applications that require
compliance with FDA guidelines and international GMP standards
Real-time monitoring of:
§  
Temperature
§  
Pressure
§  
Rotation
§  
Deflection
§  
Relative humidity (not real-time)
§  
Time
§  
Fo/Po Calculations
§  
Fittings for all applications
www.ellab.com
E-Val Pro Highlights
Expanded memory for storing up to 10
individual studies with a total of 11.5
million samples
Stand-alone operation using Authentication
system (access login)
- or PC
connected through LAN/USB
Programmable autostart (time/TMP) also in
stand-alone mode
Internal rechargeable battery pack for 2
hours operation – optionally 8 hours
Secure shutdown in case of power failure
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E-Val Pro – Temperature Performance
Measuring Range: -200°C to +1300°C
(ready for -270°C to +1820°C)
 
 
Resolution: 0.01°C
 
Operating Range: 5-50°C
 
 
 
 
Accuracy of the E-Val Pro Module (Sensor Array)
is +/-0.05°C (type T) in an operating environment
of +20°C to +30°C
Accuracy of a calibrated Ellab type T smart TC is
+/-0.05°C from -50°C to +150°C
Total system accuracy with calibrated Ellab type T
smart TC is +/-0.10°C
Whole 3 Modules / 120 channels in one ValSuite
Session/Study.
www.ellab.com
E-Val Pro Design – Sensor Array
 
Sensor Arrays work as Precision Voltmeter
 
4 channel multipurpose sensor array
 
§ 
TC type T & K (ready for type J, B, E, N, R
and S)
§ 
4-20 mA
§ 
0-10V
§ 
I/O relay
12 channel TC sensor array, type T & K
(ready for type J, B, E, N, R and S) as well
as other low power analog/digital inputs
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E-Val Pro Design – Thermocouples
Type T ultra premium grade, 7 strand thermocouple
 
 
 
 
 
 
Welded Copper/Constantan tip combined with FEP
insulation provides well-defined measuring point
Vacuum proof FEP insulation and PTFE protection
cap provides extended cycle lifetime
STC thermocouples have drains approx. 3 ft. from
the plug in order to drain any capillary water from the
autoclave
Ellab smart thermocouples are easy to clean/disinfect
due to round and smooth design with no screw
terminal connections / open-ends
The E-Val PRO thermocouple temperature probes
are direct interchangeable without calibration.
www.ellab.com
E-Val Pro Design – Smart Plug
Integrated PT1000 sensor for cold
junction compensation
ID # for traceability
Memory for calibration offsets
(factory and user)
Fully sealed/mounted TC or optional plug
with screw terminals
Unique & coded plugs available for:
Thermocouples, Ellab pressure and RH
sensors and 4-20 mA or 0-10 V sensors
www.ellab.com
TrackSense Pro Wireless Dataloggers
Temperature
 
§ 
Pressure
 
§ 
Accuracy: ±0.25% full scale
Relative Humidity
 
§ 
Accuracy: ±0.05°C
 
Accuracy: ±2%
Fittings for all applications
www.ellab.com
TrackSense Pro Sensors
Interchangeable TMP Sensors
§ 
Single rigid sensor
§ 
Double rigid sensor
§ 
Single semiflex steel sensor
§ 
Single smartflex PTFE sensor
§ 
Double semiflex steel sensor
§ 
Double smartflex PTFE sensor
§ 
Double combi rigid & flexible sensor
§ 
Quad flexible PTFE sensor
§ 
Multipoint rigid sensor
www.ellab.com
TrackSense Pro Sensors
Interchangeable Pressure/Temperature Sensors
§  
Measuring Range: 10 mBar to 10 Bar abs
§  
Measuring Accuracy: ±0.25% full scale
§ 
Operating Temperature: 0°C to +150°C
Interchangeable Humidity Sensors
§ 
Measuring Principal: Capacitance
§ 
Operating Temperature: -40 to +80°C
§  
Measuring Accuracy: ± 2%
www.ellab.com
Wireless TSP Mini & Micro
Mini Loggers – when size matters
§ 
Measuring Range: 0°C to +140 °C
§ 
Volume: 4.9 qcm
Micro Loggers – Temperature
§ 
Measuring Range: -20°C to +140 °C
§ 
Volume: 3,9 qcm
Micro Loggers – Pressure/Temperature
§ 
Measuring Range: -20°C to +140 °C
§ 
Pressure Range: 10mbar to 6 bar abs
Micro Loggers – Can Rotation Counter
§ 
Measuring Range: -20°C to +140 °C
§ 
1 sec Sampling Rate – 4 hours of operation
www.ellab.com
TSP SKY – Wireless Real Time
 
 
Introducing RF Data Transmission
Enjoy all benefits of having real time
process information available on your
PC and the reduced setup time with
selfcontained wireless dataloggers
www.ellab.com
TSP SKY Target Applications
 
Freeze Driers/Freezers
 
Hot Air Chambers
 
Warehouses
 
Smoke houses
 
Pasteurization
 
Autoclaves
§ 
Water Spray/Cascade
§ 
Steam-Air
§ 
NOT in Full Water Immersion Autoclaves
www.ellab.com
TSP Compact Wireless Loggers
 
NEW Cost Effective Integrated Logger & Sensor
Temperature loggers (-30 to+140°C)
 
§ 
35, 50, 75, or 100 mm Single Sensors
§ 
SmartFlex Single Sensors
§ 
Semi-Flexible Single Sensors
§ 
14.500 data points
Pressure logger (10 mBar - 6 Bar abs)
 
§ 
7.200 data points
Pressure/Temperature Combi logger
 
§ 
10.000 data points
 
User replaceable battery. 1000 working hours
 
ValSuite PRO, Plus, Basic Software 2.8 upwards
www.ellab.com
Ellab Temperature Indicator ETI
FDA compliant alternative to MIG
thermometers
 
§ 
Eliminates mercury spillage/contamination
§ 
Eliminates reading errors – increases accuracy
Displays & dolengths process retort
temperature
 
§ 
 
Required by FDA (US Food and Drug Administration)
Complies with 21CFR Part 113
§ 
§ 
21Code of Federal Regulation ~ FDA (Food & Drugs)
Part 113—Thermally processed low-acid foods packaged
in hermetically sealed containers
www.ellab.com
Accessories for Heat Penetration Tests
Positioning in the Container
§ 
Air- and Watertight
Slowest heating component
§ 
Avoid physical changes to the product
§ 
Container geometry should not be affected
§ 
Slowest heating zone
§ 
Fixed position of the probe
§ 
Reproducible results
§ 
Applications of Ellab Solutions
§  
E-Val PRO Real-Time Thermal Validation System
§  
Temperature – Pressure – Deflection – Rotation – RH%
§  
TrackSense® Pro Wireless Datalogger System
§  
Temperature – Pressure – Rotation – RH%
§  
TrackSense Pro SKY Wireless Real-Time Logger System
§  
Temperature – Pressure – RH%
www.ellab.com
Accessories for Heat Penetration Tests
Accessories assure correct position in the cold spot
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Accessories for Heat Penetration Tests
 
Internal Mounting in Cans, Jars, Bottles,
Pouches, Trays and other containers
www.ellab.com
ValSuite Pro Validation Software
 
 
 
The ValSuite Software ackages are
working on a database platform
and therefore securing highest
compliance to FDA 21 CFR part 11
Validation Report & Guide with IQ,
OQ available
Easy data collection for both E-Val
PRO and TSP SKY real-time
systems and TrackSense Pro
system in the same data sessions
www.ellab.com
ValSuite Documentation
www.ellab.com
Applications
 
Food Industry
§ 
Steam Still Autoclaves
§ 
Water Cascade Retorts
§ 
Cooking/Smoking Chambers
§ 
Rotary Cooker/Coolers
§ 
Hydrostatic Retorts
§ 
Crateless Retorts
§ 
Pasteurization Tunnels
§ 
Baking Ovens
§ 
Freezers and Chillers
§ 
Heat Penetration Tests
www.ellab.com
Discharge
Infeed
Validated Systems
 
 
Validated Systems – ISO 9001 Certified
The design of our systems complies with requirements
and guidelines in relevant elements of external references
such as ISO/IEC 12207 Software life cycle processes,
FDA 21 CFR 11 Electronic signatures and GAMP5 for
validation of automated Systems in Pharmaceutical
Manufacture. Our systems are CE-approved and the
measuring results are approved and accepted FDA/USDA,
EEC and other regulatory authorities. ATEX Certification
www.ellab.com
FOOD REVIEW Seminar, IPB BOGOR,
Bogor, October 20, 2015
THANK YOU FOR YOUR ATTENTION
Mr. Klaus Kofod
ELLAB A/S, Denmark
Ms. Laniwati Kuestanto
Prima Instrument Analitika, Jakarta
www.ellab.com