Calibration Solutions High performance calibration systems for professionals C A L I B R AT I O N I PAGE 3 Calibration Software Platforms For trouble free operation the ValSuite™ and ETS Suite software are available offering safe, intuitive and easy execution of the pre-defined operation procedures, all of which are FDA 21 CFR Part 11 compliant. In-House Calibration at Your Facility To ensure accurate measurements it is essential to perform calibrations of probes and sensors on a regular basis. When setting up your own calibration laboratory it is important to use appropriate instrumentation and optimal room facilities. A perfect solution for in-house and factory calibrations For temperature calibrations the ValSuite™ Pro calibration and validation software can be integrated with Ellab Dry Blocks, LiquiCal™ baths and the Ellab Temperature Standard (ETS) for a complete and automated calibration. Ellab calibration equipment has a temperature range of -100 °C to +350 °C (optionally to + 700 °C) with accuracy up to ±0.005 °C. The software will auto-ramp the bath/dry block along with verify that your defined stability criteria is met. If necessary, the software is also capable of adjusting your sensors and probes as well. For pressure transducers, the nVision pressure calibrator together with ValSuite™ software offers manual calibration of TrackSense® Pro sensors as well as E-Val Pro/E-Val Flex sensors with accuracy up to ±0.025% of readings. For conductivity sensors, verification concentrations of KOH and NAOH (tablets in distilled water) together with ValSuite™ software offer manual verification/ calibration of TrackSense® Pro sensors. DANAK Accredited Factory Calibration at Ellab All Ellab validation equipment is factory calibrated at our highly sophisticated laboratories offering optional DANAK accredited calibration services for temperature, pressure and humidity. The Ellab metrology lab facilities are among the finest in the industry since Ellab believes the starting point for any measurement is to use a reproducible, traceable and highly precise system of standards. This system is implemented in accordance to the EN17025 norm (general requirements for the competence of testing and calibration laboratories). Ellab can assure full confidence in the data generated by the calibration procedure. Ellab is further demonstrating that a prescribed level of technical competence to perform specific calibration activities is achieved through ongoing accreditation by a recognized accreditation (notified) body such as DANAK. ValSuite™ Pro - Ellab’s highly sophisticated and very advanced validation software package with integrated calibration functionality offers manual, semi-automatic and full-automatic calibration of the Ellab temperature probes and sensors. The ValSuite™ software documents and guides you through the complete calibration process. The database structure in the software enables complete documentation and procedural control for the operators. Templates allow detailed test criteria to be pre-set by the assigned administrator. This ensures accurate documentation and correct implementation of required procedures for consistently repeated tests. In the ValSuiteTM Software menu it is now even possible to download calibration certificates (factory calibration) directly to your desktop. Once programmed and saved as template(s), workload is reduced immensely resulting in huge time savings. Using the intuitive menu, all data necessary for software calibration is processed. Offset values are generated and stored in the software. For TrackSense® Pro wireless loggers, ETI and E-Val Pro / E-Val Flex intelligent cable sensors a factory calibration routine is recommended on a regular basis, and user alerts can be programmed into the memory for smart handling. ETS Suite - Ellab offers an easy to use software to run one or multiple ETS units for manual calibration of external temperature sensors. ETS Suite can be used to run reference standard comparisons if multiple ETS units are being used. It can also be used to calibrate built-in sensors (i.e. control sensors in an autoclave). ETS Suite is also an integrated part of ValSuiteTM. The overall result is assurance that our laboratory is capable of producing data that is accurate, traceable and reproducible. At the same time our ISO 9001 quality management system is aimed at improving our ability to consistently produce valid results. Certificates issued from the accredited calibration will include a complete uncertainty budget for evaluation. Software Ellab is determined to offer easy and available calibration services and has throughout recent years established calibration laboratories at a number of Ellab distributors and subsidiaries. platform for full integration of hardware Customized “turn-key” Thermal Validation Solutions C A L I B R AT I O N I PAGE 5 ValSuite™ Pro Ellab Reference and Verification Instruments Calibration ValSuite™ Pro and Plus software allow for manual, semiautomatic or full-automatic pre and post calibrations of probes ensuring consistency, efficiency and proper documentation. Using the intuitive menus all data necessary for calibration is processed, generating offset values that are stored in the probes or software database. Calibration Set-up The ValSuite™ Pro software, in combination with the ETS, LiquiCal™ baths or Dry Blocks provide an automatic set-up, which simplifies the calibration routine eliminating errors and saving time. Ellab calibration and validation software uses a point-to-point method and can handle multiple points using interpolation. When choosing semi-automatic calibration, an ETS is to be connected to the PC. During full-automatic calibrations, both the ETS and LiquiCal™ bath or Ellab Dry Block are controlled. Advanced software allows for automatic execution saving time actual values and deviations in the calibration report. Equipment Management Tools ValSuite™ Pro also offers two different calibration management tools: • Temperature Standard Manager (TSM). • Sensor Adjustment Manager (SAM). Based on a database, TSM keeps track of used equipment in your calibration routines i.e. instrument type, serial number, manufacturer, calibration date, calibration expiry and certificate number. SAM provides complementary information on previously calibrated E-Val Pro/ E-Val Flex and TrackSense® Pro sensors. A calibration report is automatically generated which shows overall calibration results. The found offset values are linked directly to the ID number of sensor and will be taken into account whenever the sensor is used in future measurements. All data is transferred and displayed in the calibration report. The following performance criteria can be set: • Maximum allowed fluctuation/time for LiquiCal™ baths and Ellab Dry Block. • Holding time. • Maximum allowed fluctuation for ETS. • Maximum sensor temperature deviation and pass time. Operator: Process: Session Start: Session Stop: Session Name: Session Text: Validation Manager Vessel: Product: Calibration Time Zone: 02-02-2017 08:29:49 02-02-2017 10:03:13 Post calibration of sensors.d7x Post calibration of sensors The ETS is a robust , completely self-contained measurement system with integrated but also separated electronics for calibration and temperature A/D conversions which allows for extremely accurate temperature calibrations. The traceable ETS allows for temperature measurements by converting resistance into temperature using its builtin algorithms. When connected to the ValSuiteTM software the bath/ dryblock and ETS provide a perfect automatic setup. This saves time and allows for a convenient calibration. Using different standard solutions with defined concentrations it is possible to perform manual verification of conductivity sensors. After an initial rinse in carbon dioxide-free distilled water the sensor is placed in the standard solution(s) defined by the pharmacopeia or from certified producer. Avoiding air in the cell during this method provides accurate measurements but a regular factory calibration is highly recommended. Pressure Reference Instrument nVision Pressure Calibrator is an intrinsically safe, handheld device for generating and recording pressure up to 8 Bar. The device is portable enough to complete pressure calibrations anywhere. Readings have an accuracy up to ±0.025% and are fully temperature compensated, requiring no additional accuracy offsets for operating temperatures between -20 °C to +50 °C. Working as a secondary standard, the ETS is available in 3 different versions and comes with an accredited calibration certificate. Furthermore, an optional ETS display unit for stand-alone use is available. The unit includes a calibration certificate with test data at 5 different temperatures and the system is delivered with a pump, connection fittings and adaptors for Ellab pressure sensors. An aluminum protection suitcase is also supplied. Ellab Temperature Standard with optional Display Pressure Reference Instrument LiquiCal HM Pharma UTC offset 01:00:00 Validation Solutions Calibration Name: Description: Total Calibration Result: Calibration Report Passed Temperature Standard Manufacturer: All set-up conditions and acceptance criteria can be stored as templates and are shown together with Temperature Reference Instrument It is recommended that a reference instrument that is traceable to an accredited body such as SP or NLP in Europe or NIST in the US is used. Ellab A/S ETS20 110001 18255 01-10-2016 01-10-2017 Serial Number: Certificate Number: Calibration Date: Calibration Expiry Date: Stability Criteria Fluctuation Band: Fluctuation Time: Holding Time: Calibration Setup Operation Type Full-Automatic Calibration E-Val Pro Calibration E-Val Flex Module Semi-Automatic Calibration Pass Criteria Verification Temperature Standard Fluctuation Band: Sensor Temperature Deviation +/-: Pass Time: Status for Temperature Standard: Temperature Standard Info TS Pro Logger Serial Number ETI Manual Calibration 0,15°C 00:03:00 00:03:00 Calibration Type Device Type 110001 Stability Criteria 0,10°C 0,25°C 00:01:00 40,00°C 60,00°C 90,00°C 120,00°C 140,00°C Calibration Points Fluctuation Band : 0.200 Fluctuation Time : 00 03 00 Holding Time : 00 03 00 °C °C Add 0.0 Temp Adj. Point Remove 60 Calibration Summary Before Adjustment Insert 90 120 Deviation: Difference between Temperature Standard and Sensor in calibration point (middle point of pass time) Max Deviation: Max difference between Temperature Standard and Sensor in pass time Clear 140 Pass Criteria 60 Temperature Standard Fluctuation Band: 0.100 °C Channel Temperature Deviation Before Adjustment (+/-): 0.30 °C Channel Temperature Deviation After Adjustment (+/-): 0.30 °C Pass Time : 00 01 00 Templates Load Save Set Point Tolerance (+/-) 1.00 °C Endpoint 50.00 °C OK Calibration Set-up Passed Passed Passed Passed Passed Sensor TC15393 - Ch 1 TC15393 - Ch 1 TC15393 - Ch 1 TC15393 - Ch 1 TC15393 - Ch 1 TC15395 - Ch 2 TC15395 - Ch 2 TC15395 - Ch 2 TC15395 - Ch 2 TC15395 - Ch 2 TC15337 - Ch 3 TC15337 - Ch 3 TC15337 - Ch 3 TC15337 - Ch 3 TC15337 - Ch 3 ID 14469 14469 14469 14469 14469 14469 14469 14469 14469 14469 14469 14469 14469 14469 14469 Set point 40,00°C 60,00°C 90,00°C 120,00°C 140,00°C 40,00°C 60,00°C 90,00°C 120,00°C 140,00°C 40,00°C 60,00°C 90,00°C 120,00°C 140,00°C Before Adjustment Passed Passed Passed Passed Passed Passed Passed Passed Passed Passed Passed Passed Passed Passed Passed Printed: 02-02-2017 11:18:54 Cancel Calibration Report Deviation 0,05°C 0,05°C 0,00°C -0,08°C -0,16°C 0,07°C 0,06°C 0,03°C -0,10°C -0,17°C 0,08°C 0,09°C 0,01°C -0,09°C -0,14°C Max. Deviation 0,07°C 0,09°C 0,03°C -0,11°C -0,18°C 0,09°C 0,08°C 0,04°C -0,10°C -0,18°C 0,09°C 0,10°C 0,04°C -0,10°C -0,17°C Page 1 of 4 Conductivity Verification Instrument ETS10 ETS20 ETS25 -80 °C to +250 °C -50 °C to +150 °C -196 °C to 420 °C Accuracy -50°C to +150°C: ±0.015 °C ±0.020 °C ±0.025 °C Accuracy other temperatures: ±0.025 °C - ±0.025 °C Temperature range °C: Type of sensor: Dimension of Sensor: PT100 ø6.35 x 300mm C A L I B R AT I O N I PAGE 7 LiquiCal™ LiquiCal™ Solutions LiquiCal™ is a range of high performance liquid baths used for high precision temperature calibrations. The baths can be controlled via the ValSuite™ software allowing for an automated calibration and ramp control. It can also be used as a stand-alone unit. LiquiCal™ provides high temperature stability along with a large immersion depth, fast temperature change and quiet run. LiquiCal™ Features The models cover temperatures from -80 °C to 300 °C. The LiquiCal™ LL, SL and HL all have the same exterior dimensions, bath openings and liquid filling volume. The LiquiCal™ SM/HM micro baths are smaller in size facilitating mobility. On the LiquiCal™ LL, SL and HL baths a convenient overflow reservoir captures any excess fluid that results from fluid expansion.The bath’s 15.9 L (4.2 gallon) tank can easily be emptied by drain when needed. Also convenient fixtures to hold either sensors or loggers are available. Liquids for LiquiCal™ Baths To obtain optimal temperature stability and homogeniety in the calibration zone, liquids with the lowest possible viscosity (<25 CST) are preferred. Ellab supplies a range of liquids in 3.8 L (1 gallon) containers covering the temperature range of -90 °C to +300 °C safely. Type Temperature Range Ellab Halocarbon Oil Low - 90 °C to +90 °C Ellab Low Temperature Liquid - 80 °C to +5 °C Ellab Standard Oil - 30 °C to +160 °C Ellab High Temperature Oil +80 °C to +300 °C LiquiCal™ Accessories Drip Tray and Exhaust System LiquiCal™ SL LiquiCal™ HL Type Plug and Insert Logger Fixture LiquiCal™ SM LiquiCal™ HM Liquid bath -80 °C to +110 °C -45 °C to +150 °C Environmental +35 °C to +300 °C Range -20 °C to +140 °C +35 °C to +200 °C +5 °C to +45 °C / 0-90% RH ±0.005 °C ±0.005 °C ±0.04 °C ±0.02 °C 0.01 °C ø48 mm ø48 mm Insert Capacity Tank capacity 15.9 L 15.9 L 15.9 L 1.0 L 0.75 L Insert Material Heating power 700 W 700 W 700 W/900 W* 130 W 225 W Max. 3.5 hours Max. 2 hours - 45 minutes - *Booster RTC159A -25 °C to +155 °C +33 °C to +425 °C -30 °C to +155 °C -100 °C to +155 °C Insert Dimension 119 x 172 mm Power RTC 156A Display Resolution 119 x 172 mm Communication PTC 425A Environmental 119 x 172 mm Cooling time (25 °C to min.) PTC 155A Stability ±0.007 °C Display Resolution Access Opening Logger Holder Dryblock overview to make choice easy LiquiCal™ LL Stability Dry Block Accessories Main features are: • Temperature range: -100 °C to +350 °C (optional to +700 °C) • Unique active dual-zone block ensures perfect temperature homogeneity in the insert • USB communication • High speed heating and cooling times • Easy-to-read color VGA display with perfect overview of the actual calibration status • Quiet operation Bath overview to make choice easy Range Dry Block Solutions When a calibration at low and high temperatures is required, or when mobility is needed, a transportable Ellab Dry Block system is available. The high stability throughout the entire calibration zone is achieved by using an advanced and intuitive menu-driven controller with an easy to read color display. The Dry Blocks also incorporate a dual-zone heating technology where each heating zone is individually controlled to compensate for possible head loss over the top. Additionally, a line of custom made inserts that consist of wells that fit Ellab sensors/probes perfectly are available. RS232 115 V / 60 Hz or 230 V / 50 Hz 0 to +40 °C / 0-90% RH ±0.01 °C ±0.02 °C ±0.005 °C 1°C / 0.1°C / 0.01 °C 25.8 x 150 mm ±0.03 °C 1°C / 0.1°C / 0.01°C / 0.001 °C 25.8 x 155 mm 29.7 x 150 mm 18-24 sensors + ETS Aluminum Brass Aluminum Aluminum Heating time (min to max) 16 min 10 min 19 min 26 min Cooling time (max to min) 25 min 41 min 37 min 175 min* Communication Power *65 minutes from ambient to -80 °C USB 2.0 115 - 230 V / 50 - 60 Hz Ellab Since the late 1940’s Ellab A/S has been a leading manufacturer of process validation and monitoring systems used in the food, medical device and pharmaceutical industries. Calibration Certifications and Service Ellab maintains a complete calibration facility for annual certifications and service. Ellab A/S temperature, resistance, pressure and humidity calibration laboratory is accredited according to ISO 17025 by DANAK under registration no. 520. Service and maintenance contracts are available. Rental & Demos Demo systems are available for trial and rental. Please contact your local Ellab representative for details. Ellab A/S Trollesmindeallé 25 DK-3400 Hilleroed Denmark P: +45 4452 0500 F: +45 4453 0505 email@example.com www.ellab.com Publ. no. 9402_E / 2017.12.21 Ellab Academy - International Training Courses Ellab Academy offers regular training courses for end-users. On-site individual training and equipment installations are also available through Ellab. Our Validation Consultants are available to assist you with IQ, OQ, and PQ procedures.