International SeminarEmerging Issues and Technology Developments in Foods and IngredientsJakarta, September 29.-30.09-2010

Recent Technology to SupportThermal Process Validation

Mr. Klaus Kofod, Sales Manager

ELLAB A/S, Denmark

www.ellab.com

ELLAB Company Profile

Established in 1949 in Denmark

Leading Manufacturers of Thermal Process Validation SolutionsLeading Manufacturers of Thermal Process Validation Solutions

Ellab companies inDenmark

United States

United Kingdom

GermanyGermany

France

Philippines

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Represented in 120 countries worldwide

Heat Distribution Tests

Heat Distribution TestTh f thi t t i t fi d th ithi th h b th t h thThe purpose of this test is to find the area within the chamber that has the minimum (coldest) temperature during the normal cycle. Anything that is placed in this area will be the last to reach the sterilising temperature. This “cold spot” area will be where one thermocouple will be placed during all future testing of thearea will be where one thermocouple will be placed during all future testing of the steriliser.

The heat distribution test is carried out by placing a number of thermocouplesThe heat distribution test is carried out by placing a number of thermocouples (independent temperature measuring devices) into the empty chamber of the steriliser. The temperatures within the different areas of the chamber are measured during the cycle. The area of the lowest temperature reading is

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located and documented as the “cold spot” for future testing purposes.

Heat Penetration Tests

Heat Penetration TestTh f h t t ti t d i t d t i th h ti d liThe purpose of a heat penetration study is to determine the heating and cooling behaviour of a product/package combination in a specific retort /cooking system for the establishment of safe thermal processes and evaluating process deviations and to find the ”cold spot” in the product/container and to ensure thatdeviations, and to find the cold spot in the product/container, and to ensure that all products receive the heat scheduled.

A Heat Distribution Test should be completed before commencing the HeatA Heat Distribution Test should be completed before commencing the Heat Penetration Test. The 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.

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Why are these tests important ?

SAFETYAll bacteria must be killed if the food is to be safe to eat and nutricious

Energy savingsLower temperature, shorter process time, increase production, cost efficiency

Improvement of QualityImprovement of QualityPreserving vitamins, proteins, taste, presentation, consistency

Process Validation & DocumentationRegulations from FDA/USDA, HACCP, ISO900 and other authorities

ExportDemands from Authorities and Customers

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Test Equipment

IFTPS GuidelinesInstitute for Thermal Process Specialists – www.iftps.org

The calibrated system should be equipped with sufficient channels to accurately monitor and record temperature/pressure within the process delivery

tsystem.

Use thermocouples or other devices of sufficient accuracy in sufficient quantity to adequately monitor the process water temperatures within the retort.

The retort MIG/RTD m st conform to applicable reg lations and shall ha eThe retort MIG/RTD must conform to applicable regulations and shall have been checked for accuracy against a certified TMD within the past year, preferably more recently.

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Test Equipment

The datalogger should record the temperatures of each sensor at sufficient intervals not to exceed one minute throughout the testintervals, not to exceed one minute, throughout the test

Prior to the actual temperature distribution study, standardization or calibration should be performed in the test retort.

One method of calibration is to bundle all sensors and locate the in closeOne method of calibration is to bundle all sensors and locate the in close proximity to the known MIG/TMD.

Bring the retort up to the same temperature and pressure as designed for distribution test and allow temperature to equilibrate.p q

Check the accuracy of the sensors against the reference instrument (ETI). Any single sensor should be within 0.3°C of the reference.

The range for all sensors should not be more than 0.6°C.

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Choosing the System

Real-Time Cable Based SystemsThe advantage is real-time data, but installation is time consuming and risks for damaging probes during loading and unloading

Real-Time Wireless Datalogger SystemsThe advantage is real-time data, and installation is easier than using cable probes. Double Sensors available so Heat Distribution and Penetration can be performed simultaneously. Cannot be used in all kinds of systems

Wireless Datalogger SystemsInstallation is easier than using cable probes. Double Sensors available so Heat Distribution and Penetration can be performed simultaneously. Can be used in all

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kinds of systems. Data is downloaded after processing and not Real-Time

Choosing the System

High Accuracy and Reliability of EquipmentIt 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 RegulationsThe 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 V lid ti S l tiELLAB Validation SolutionsBoth the E-Val Flex thermocouple based system and the TrackSense Pro wireless datalogger systems are well suited for performing Heat Distribution and PenetrationTests and compliant to all worldwide regulations

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PenetrationTests and compliant to all worldwide regulations

Thermal Process Validation Solutions

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E-Val Flex Real-Time Cable System

E-Val Flex 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)Relative humidity (not real time)

Time

Fo/Po Calculations

Fittings for all applications

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Fittings for all applications

E-Val Flex, Technical Specifications

Operating temperature:Operating range: +5 to +50º C

Resolution: 0,01º C and +/-1 mbar

Measuring ranges:Measuring ranges:-200 to +400° C

0 to 4 bar (absolute)(on demand upto 10 bar

-8 to +8 mm

0 to 100 %

0-60 RpM

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p

E-Val Flex Modules, Accuracy

Accuracy:Module: ±0,05 ºC

Factory calibrated thermocouples: ±0,05 ºC

Total system: ±0,1 ºCy ,

Real-time clock: better than 3 seconds per 24 hours

Digital pressure sensor: 0,15 % full scale (±6 mbar)

D fl ti S 8Deflection Sensor: ±8mm

Revolutions per Minute: ±1 RpM

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E-Val Flex Modules, Accuracy

Individual cold junction compensation:Each channel is individually compensated by means of a Pt-1000 element securing highest accuracy with interchangeable thermocouples without calibrating

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Temperature Sensors

Watertight connectorsThe male connector is watertight and completely prevents water/humidity dripping through the thermocouple cableinto the E-Val Flex module.

Smart Temperature ProbesELLAB premium grade 7 strand thermocouple probeswith electronic ID embedded in male connector forwith electronic ID embedded in male connector foreasy identification of position of probes.

Factory CalibrationFactory calibrated thermocouples with an accuracy of +/- 0.05 C.

Interchangeable TC’sThe smart thermocouple temperature probes are direct

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p p pinterchangeable without calibration.

E-Val Flex Solutions

Key advantagesHighest Accuracy

Direct interchangeable probes

Stand-alone → Runs without PC, adds flexibility, y

8 MB memory → Stores up to 8 hours data when logging every second with 16 channels

4 8 or 16 channel modules → Expandable up to 804, 8 or 16 channel modules → Expandable up to 80 channels logging every second

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E-Val Flex Solutions

Key advantagesEthernet network → Fast and reliable data transmission

Network solution → E-Val Flex modules can be accessed remotely

LCD display → View real-time data without PCp y

Battery power → Backup in case of power failure, or if electricity is not available

Weight: 1 9 Kg → Easy handling and portabilityWeight: 1,9 Kg → Easy handling and portability

Size, 180 x 170 x 60 mm → Easy handling and portability

2-years warranty → Building Confidence

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TrackSense Pro Wireless Dataloggers

TemperatureAccuracy: ±0.05°C

PressureAccuracy: ±0 25% full scaleAccuracy: ±0.25% full scale

Relative HumidityAccuracy: ±2%

Fittings for all applications

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TrackSense Pro Sensors

Interchangeable temperature sensorsSt d d f 80°C t 150°CStandard range from -80°C to +150°CHigh temperatures with a thermal barrier from 0°C to +400°CHigh Accuracy from ±0.05 °CSingle rigid sensorsD bl i idDouble rigid sensorsSingle flexible sensorsDouble flexible sensors

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TrackSense Pro Sensors

Interchangeable Pressure/Temperature SensorsM i R 10 B t 10 B bMeasuring Range: 10 mBar to 10 Bar abs

Measuring Accuracy: ±0.25% full scale

Operating Temperature: 0°C to +150°C

Interchangeable Humidity SensorsMeasuring Principal: Capacitance

Operating Temperature: -40 to +80°C

Measuring Accuracy: ± 2%

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Wireless TSP Mini & Micro

Mini Loggers – when size mattersMeasuring Range: 0°C to +140 °C

Volume: 4.9 qcmq

Micro Loggers – TemperatureMeasuring Range: -20°C to +140 °C

Volume: 3 9 qcmVolume: 3,9 qcm

Micro Loggers – Pressure/TemperatureMeasuring Range: -20°C to +140 °C

P R 10 b t 6 b bPressure Range: 10mbar to 6 bar abs

Micro Loggers – Can Rotation CounterMeasuring Range: -20°C to +140 °C

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1 sec Sampling Rate – 4 hours of operation

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 pselfcontained wireless dataloggers

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TSP SKY – Wireless Real Time

Real time wireless data logger

Operational temperature -80 °C to +140 °C

2 4GHz (same frequency in US and Europe)2.4GHz (same frequency in US and Europe)

License free ISM-band (Industrial, Scientific, Medical)

Transmission range approximately 15 m

S i li it i ith V lS it ™ ftSuperior online monitoring with ValSuite™ software

View data, statistics and lethality calculations real time

If Sky transmission is temporarily lost the logger is still l i d ill d h Sk t i i i dlogging and will dump when Sky transmission is resumed or the logger is read in the reader station

Data will never be lost or corrupted if using wireless transmission

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transmission

TSP SKY Target Applications

Freeze Driers/FreezersHot Air ChambersWarehousesSmoke housesPasteurizationAutoclaves

Water Spray/Cascadep ySteam-AirNOT in Full Water Immersion Autoclaves

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Accessories for Heat Penetration Tests

Positioning in the ContainerAir- and WatertightSlowest heating componentSlowest heating componentAvoid physical changes to the productContainer geometry should not be affectedSlowest heating zoneFixed position of the probeFixed position of the probeReproducible results

Applications of Ellab SolutionsE-Val Flex 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

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Temperature – Pressure – RH%

Accessories for Heat Penetration Tests

Normal & Vacuum Sealed Cans and Jars

Aluminum/Plastic ContainersAluminum/Plastic Containers

Unfilled Small Containers

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Accessories for Heat Penetration Tests

Flat Plastic & Aluminium Pouches

Stand Up Pouches (Doy Packs)Stand-Up Pouches (Doy-Packs)

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Accessories for Heat Penetration Tests

Filled Metal Containers

Retortable CartonsRetortable Cartons

Sausages (Hot Dogs)

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Accessories for Heat Penetration Tests

Internal Mounting in Cans, Jars, Bottles,P h T d th t iPouches, Trays and other containers

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ValSuite™ Pro Software Packages

The ValSuite Software Packages are working on a database platform and therefore securingon a database platform and therefore securing highest compliance to FDA 21 CFR part 11Validation Report & Guide with IQ, OQ availableavailableEasy data collection for both real-time and wireless systems in the same data sessions

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ValSuite Documentation

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ValSuite Reports

CommentsSpecifications and photos of test equipmentSpecifications and photos of test equipment

Limit ReportLimit ReportTemperature, Pressure, Fo-Values

Time Event MarkersCUT, Equilibration, Holding, Cooling

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ValSuite Reports

Advanced Validation ReportTemperature, Pressure, Fo-Value evaluation of the

h l it i ith /f il i di tiwhole process criterias with pass/fail indication

Statistic ReportsMin Max Average Delta of all parametersMin, Max, Average, Delta of all parameters

Heat Penetration Ball Calculations

Unit – Positioning of Sensors

Word Documents

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Print in hard copies and PDF

Ellab Temperature Indicator ETI

FDA compliant alternative to MIG thermometersthermometers

Eliminates mercury spillage/contamination Eliminates reading errors – increases accuracy

Displays & dolengths process retortDisplays & dolengths process retort temperature

Required by FDA (US Food and Drug Administration)

Complies with 21CFR Part 113Complies with 21CFR Part 11321Code of Federal Regulation ~ FDA (Food & Drugs)Part 113—Thermally processed low-acid foods packaged in hermetically sealed containers

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Applications

Food IndustrySteam Still Autoclaves

Water Cascade RetortsWater Cascade Retorts

Cooking/Smoking Chambers

Rotary Cooker/Coolers Discharge

Hydrostatic Retorts

Crateless Retorts

Pasteurization Tunnels

Infeed

Pasteurization Tunnels

Baking Ovens

Freezers and Chillers

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Heat Penetration Tests

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 processessuch as ISO/IEC 12207 Software life cycle processes,

FDA 21 CFR 11 Electronic signatures and GAMP5 for

validation of automated Systems in Pharmaceutical

M f t O t CE d d thManufacture. Our systems are CE-approved and the

measuring results are approved and accepted FDA/USDA,

EEC and other regulatory authorities. ATEX Certification

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International SeminarEmerging Issues and Technology Developments in Foods and IngredientsJakarta, September 29.-30.09-2010

THANK YOU FOR YOUR ATTENTION

Mr. Klaus Kofod

ELLAB A/S, Denmark

Ms. Laniwati Kuestanto

Prima Instrument Analitika, Jakarta

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