THE QUANTITY CALIBRATION RIG

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THE QUANTITY CALIBRATION RIG Mobile Calibration of Tank Load Cells People - Ideas - Solutions www.insatechpharma.com

We enter the quantity of the calibration and how much water needs to go into the tank, and then it takes care of the calibration. It is easy. Calibration Technician, Danish Pharmaceutical Company. 2

THE QUANTITY CALIBRATION RIG Introduction Insatech Quantity Calibration Rig can be used for calibration of loading cells for level measurement equipment in e.g. production and fermentation tanks. The mobile Quantity Calibration Rig reduces down time by allowing calibration directly in production. This also minimizes both the risk of contamination by Active Process Ingredients (API) and weights scratching the tank surface. Insatech has delivered several rigs to various pharma sites in Denmark, Brazil and France. How it works The Rig can be connected directly to the pipework using e.g. Tri-clamps. After connecting a power cable the rig is ready to calibrate. The rig calibrates the loading cells by dispensing a pre-determined quantity of liquid into the tank instead of using master weights. The calibration is highly accurate and stable and a skewed distribution of calibration points can help target certain flow ranges. Operation The Quantity Calibration Rig has been developed with special focus on the pharmaceutical industry. The user friendly and mobile rig is easily maneuvered into the production area where it can calibrate instruments in-line. The rig can be delivered with a traceable DANAK accreditation with an accuracy of < 0.3% of the measured value and covers a flow range from 5 to 17.000 kg/h at a temperature of up to 40. It is also dependent on the water pressure. The rig is made with AISI 304 or AISI 316L materials and the piping is made from EN 1.4404/AISI 316L. This means that cleaning can be performed according to industry practice and all wetted parts are CIP-able. Other design parameters may be specified, including operation in hazardous areas (ATEX Zone 1). Service and Support Maintenance is limited to a yearly inspection of critical parts, and the flow meter needs to be calibrated once a year. We can also offer training in the use of the Quantity Calibration Rig as part of the delivery. If you choose to sign a service agreement with us, we will perform maintenance on the rig and ensure it functions correctly. Furthermore we will take responsibility for timely calibration of it. 3

TT 001 TE 001 FIT 001 4.000 40.000 kg/h MV009 2½ 2½ MV010 2½ 2½ FE 001 FIT 002 500 4.500 kg/h MV007 1 MV008 1 FE 002 FIT 003 FV001 50 500 kg/h MV011 1 FE 003 MV013 ½ FE 004 MV012 1 FIT 004 5 50 kg/h MV002 1 MV014 ½ PIT 001 5-40.000 kg/h MV001 2½ 2½ 4

INTRODUCTION A Cumbersome and Time Consuming Process Traditionally when you need to calibrate a load cell you would use master weights, but this is often a cumbersome and time consuming process that has a number of disadvantages. First of all you bring an external factor, the master weights, into your tank which introduces a risk of contamination. Also if you do not balance the weights properly the calibration becomes incorrect. Furthermore when you place or remove the weights, you might scratch or otherwise damage the interior surface of the tank. Maximizing Production Uptime and Cutting Costs With the Quantity Calibration Rig from Insatech Pharma you can eliminate the above mentioned disadvantages. The mobile rig is easily maneuvered to the loading cell that needs to be calibrated. After being connected to a power supply as well as the pipework, the rig is ready to perform the calibration. The rig uses water to calibrate, so the load will always be evenly distributed in the tank, and you do not risk scratching or damaging the interior surface. The whole process is automated and will save you hours on the calibration process maximizing your production uptime, minimizing contamination risks and cutting costs to a bare minimum! The rig has already proven its worth in the field as several rigs have already been delivered to various pharmaceutical sites in Denmark, Brazil and France. 5

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HOW IT WORKS Plug and Play Connection The Quantity Calibration Rig works by connecting the rig to preinstalled flanged pipework on the tank. This can be done using either flanges or Tri-clamps. Connecting the rig to the tank and Unit Under Test (UUT) is like plug and play. Highly Accurate and Stable Calibration After being connected to the UUT and a power supply the calibration can begin. You begin by entering the desired batch size into the batch computer. The batch computer controls a flow meter and a regulating valve. Once you start the calibration, the rig will pump water into the tank through a highly accurate and stable Coriolis mass flow meter. When the set point is reached the regulating valve will close, ensuring the exact quantity has been added. The Quantity Calibration Rig compares the results from the UUT with the Master Meter on the rig. After the calibration is done the data will be shown on the rig s display. Skewed Distribution Helps Target Certain Flow Ranges Before calibration you can select any number of calibrations points you need. The distribution of the calibration points can be skewed, which means that instead of a linear distribution you can target a flow range with more points. This is useful if you want to test e.g. the flow range you use the most. 7

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OPERATION The Quantity Calibration Rig has been developed with special focus on operating costs, user friendliness, accuracy and documentation. Furthermore, the rig is a turn-key solution and is delivered tested and calibrated, ready for use. User Friendliness Connections, instruments, and handles are to the extent possible placed ergonomically correct and allowing operation from one side. Furthermore the software is designed with usability in mind making your operator s user experience easy and effective every time. During the calibration all results are presented on the Human Machine Interface (HMI) after each point of the calibration. Mobility The Calibration Rig is designed to be mobile and the wheels allow the rig to be moved to wherever it is needed. The compact design of the rig means it fits through standard industrial doors and elevators. Easy Cleaning The Flow Calibration Rig is built with materials that are AISI 304 or optionally AISI 316L. Flow meters are made from EN 1.4404/AISI 316L or C22, depending on flow. All piping is made from EN 1.4404/AISI 316L with a surface roughness better than Ra 0.8. This means that cleaning can be performed according to industry practice and all wetted parts are CIP (Cleaning-in-place) and SIP-able (Steam-in-place). Specifications and Accuracy As a benchmark the Quantity Calibration Rig covers a flow range from 5 to 17,000 kg/h at a temperature of up to 40 C. Ambient temperature must be between +10 C and 40 C. The rig needs a power supply of 400 VAC, 16 A. Other design parameters may be specified, including operation in hazardous areas (ATEX Zone 1). The Quantity Calibration Rig can be delivered with a traceable DANAK accreditation with an accuracy of < 0.3 % of the measured value. Is the Standard Solution Insufficient? If the standard solution is insufficient for your specific use we can, as a pre-order, work out a User Requirements Specification (URS) in accordance with your requirements. Documentation from Basic to Full Validation Insatech Pharma documents the various components, the interaction between the components and the total delivery as agreed to with the customer. We work according to well recognized standards, e. g. Good Automation Manufacturing Practice (GAMP) and the rig is designed according to both the machinery directive and the low voltage directive. The extent of our documentation is as per agreement with the customer, and goes from the basic operations manual to full validation in accordance with common practice of the pharmaceutical industry. 9

TE 001 FIT 001 MV006 10 mm TT 001 000 40.000 kg/h SG001 MV009 2½ 2½ FE 001 MV010 2½ 2½ MV003 MV001 2½ 2½ Distance to floor: Min. 100 mm 10

SERVICE AND SUPPORT Minimal Maintenance The Quantity Calibration Rig is developed for pharmaceutical use and therefore easy maintenance and cleaning are of the essence and can be done according to industry standards. Maintenance is limited to a yearly inspection of critical parts, and the flow meter needs to be calibrated once a year. Maintenance and recommended spare parts may differ depending on the specifications, but will always be described in the delivered documentation. Service and Support is Readily Available We know that the after sales experience is important to you and your total product experience; this is why we have a well staffed service department ready to help you if challenges should arise. We perform repairs on location or at our workshop depending on what is most beneficial in the given situation. We also perform accredited calibration. The rig is built with standard components which makes spare parts easily obtainable. If you choose to sign a service agreement with us, we will perform maintenance on the rig and ensure it functions correctly. Furthermore we will take responsibility for timely calibration of it. Training The ever increasing complexity of measuring equipment makes proper training very useful. Insatech Pharma can offer equipment and application training either at your or our facilities. Furthermore the training will be targeted towards your various working situations ensuring that you get the highest benefit possible. 11

A TRUSTWORTHY AND COMPETENT PARTNER Over the years Insatech has become a trustworthy and competent partner, supplying technical solutions and giving advice to the process industry. We have great experience with the particular applications and high requirements for documentation in our primary market pharma, biotech, and food industry. Eng ine er in g n sig De Su nin g ducts Pro Train ing www.insatechpharma.com is or sio pp m t Co Docu 12 m e n t a ti o n m

OUR CUSTOMERS Our customers consist of a broad range of pharmaceutical production companies with both small and large capacity. Our main customers are Danish based, but our solutions have also reached diffent parts of Europe and South America. 13

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WHAT WE DO At Insatech Pharma we develop, produce and sell products within the fields of measuring and calibration. Our products are highly customizable and we are certain that we can meet your User Requirements Specification (URS). We have, for example, delivered products with DANAK Accreditation, for use in hazardous areas (ATEX) as well as meeting Functional Safety requirements IEC 61508 and IEC 61511. If you want to know more please contact us and let us know what we can do for you. In addition to the Quantity Calibration Rig you might be interested in the products below. Flow Calibration Rig The Flow Calibration Rig provides a risk free and swift way of calibrating flow meters in-line. Carrying out the calibration in-line eliminates costs from lost production, saves hours on the calibration process, and minimizes the risk of contamination by Active Process Ingredients (API). An added bonus is the check of the total test loop, which eliminates uncertainties that could occur in the laboratory. The rig is a plug and play solution: Easily maneuvered into the production area, connected to the Unit Under Test (UUT) and a power supply. Highly accurate and stable Coriolis mass flow meters ensure exact measurements of the flow. The flow rig can be delivered with a traceable DANAK accreditation, accuracy of < 0.3% of the measured value, and covers a flow range from 5 to 40.000 kg/h. Cleaning can be performed according to industry practice and all wetted parts are CIP-able. The Calibration Flow Rig is in use at a range of Danish pharmaceutical production sites. Insacal and Insacacal mk. II The Insacal Conductivity Master is primarily used in the pharmaceutical industry to validate and accurately document conductivity sensors in-line. Insacal can be used for in-situ calibration in closed loop, weighing only 4 kg, it is easily transported and saves you hours on total calibration time. Insacal is cleanable for cleanroom use according to industry standards, all wetted parts are CIP (Cleaning-In-Place) and SIP-able (Steam-In-Place). It is calibrated under our accreditation CAL Reg. No. 484 issued by DANAK (Danish Accreditation and Metrology Fund). The Insacal is used by our customers and calibration technicians alike. Further product development and 20 years of experience has been pored into the Insacal mk. II providing you with the same handy instrument, but focuses on validating low conductivity, with intelligent software that aids decision making. Further the mk. II makes it possible to reach an uncertainty that is 4 times better than the 2% specified in United States Pharmacopeia (USP). Pressure Calibration Rig The Pressure Calibration Rig is the cost effective alternative to traditional calibration of transmitters in the laboratory. Use of the Pressure Calibration Rig eliminates costly transportation time between production and laboratory. It reduces calibration time to about half an hour while the accuracy of the in-situ calibration is increased to laboratory level. The rig is a plug and play solution: After being connected to the pressure gas, Unit Under Test (UUT) and a power supply, the rig is ready to calibrate. The highly accurate and stable pressure controller prevents over - and undershooting. The Pressure Calibration Rig, -1...20 Barg / 0...21 Barg has an accuracy of 0.2835 mbarg and 0.2838 mbara (K2) and assures one year stability of the calibration. The rig is build with materials that are AISI 304 or optionally AISI 316L which allows cleaning according to industry practice. 15

Contact Insatech Pharma Group Algade 133 DK-4760 Vordingborg Denmark +45 5537 2095 mail@insatech.com www.insatechpharma.com People - Ideas - Solutions www.insatechpharma.com