Precision, Performance, Confidence. ™
Questions? Please send an email to
fcalemea@flukecal.com
Precision, Performance, Confidence. ™
Questions? Please send an email to
fcalemea@flukecal.com
Solutions for Pharmaceutical, Biotech and Medical Device manufacturing and development requires precise, reliable tools that keep critical processes up and running and comply with stringent regulations. Calibration, verification and other tests are required for compliance with regulations like the Food and Drug Administration (FDA), European Medicines Agency (EMA) and Current Good Manufacturing Processes (cGMP). Failure to comply with these regulations can result in warning letters, consent decree or worse.
Fluke Calibration offers solutions for temperature, humidity pressure and flow calibration and verification. Click on the navigation to explore solutions that can increase the throughput, accuracy and reliability of your calibrations and measurements.
Sensors such as RTD’s, PRT’s, thermocouples, tri-clamp sanitary clamps, dial gauges, thermistors and others sensors that monitor and control temperature’s must be calibrated and verified. How often, depends on how critical the sensor is to the process - most sensors are calibrated every 3 to 6 months but we have seen them calibrated as often as once a week or each production batch in the pharmaceutical industry. One customer, at a large pharmaceutical company calibrates their RTD’s every week since they are critical to product quality and assurance!
Increase the throughput of your lab and field calibrations by using the Automated Test feature of the 1586A Super-DAQ. Fully automate the calibration process with a single temperature source that covers the calibration range. Users can start a test and walk away to perform other tasks while the 1586A automatically records data once the source has stabilized—no need to check and re-check temperature source stability, for up to 40 Units Under Test or UUTs in a single calibration batch.
The 1586A can be used in the lab where temperature sensors from manufacturing such as sterilization, chemical processing, fermentation, testing and packaging can be removed. Place the 1586A on a cart to calibrate sensors on incubators, bioreactors, or stability chambers in the field.
Mike Lawyer Regional Product Manager Temperature Mike Lawyer has been with Fluke Calibration for 20 years, starting with Hart Scientific before the merge with Fluke. He has had several roles within the Fluke Temperature Calibration team, including USA domestic sales, technical and sales support for the Fluke worldwide sales teams and now active as Europe Temperature Product Manager. Bouraoui Khachlouf Fluke Calibration Temperature Expert Bouraoui Khachlouf has spent 27 years in Calibration filed through different roles, include Calibration service in Airforce & private Lab, Selling & supporting Fluke Calibration products for more than 12 years with 7 of those directly working for Fluke, He currently works as a Temperature Expert with our MEAT Sales Team, helping customers figure out the best solution to fit their application. Bouraoui speaks Arabic, French and English and he is happy to help with all your questions.
Read how to Automate Temperature Sensor Calibration with the 1586A Super-DAQ
Watch the on-demand webinar: Automating Temperature Sensor CalibrationBest solutions for common temperature sensors:
Thermocouples, Resistance Temperature Detectors (RTD’s), Thermometers in the lab
Thermowells on bioreactors, tri-clamp sanitary clamps on mixing vessels, steam-in-place SPI, clean-in-place CIP, dial gauges in the field
When demonstrating to regulatory agencies that appropriate levels of temperature accuracy and uniformity are being maintained in freezers, refrigerators, incubators, autoclaves and ovens, chamber mapping needs to be completed, sometimes as often as seasonally. Power failure, open door studies and empty/full configurations are also tested. To complete chamber mapping, thermocouples or data loggers are first calibrated, as all testing equipment should be before a critical measurement. Once calibrated, they are positioned at specific locations within the chamber, then the process is run through in its entirety. The data is collected and analyzed to ensure temperature uniformity, and that there are no hot or cold spots within the chamber that could impact product quality.
The Fluke Calibration 1586A Super-DAQ Precision Temperature Scanner can be used for chamber mapping with TQ Software to comply with FDA 21 CFR Part 11. This also allows for easily measuring temperature uniformity of the chamber directly without having to apply thermocouple offsets manually.
If you are calibrating at temperature over 700°C, use the Fluke Calibration 9118A with an isothermal block and a 5650 Type-S reference grade thermocouple.
Mike Lawyer
Regional Product Manager Temperature
Mike Lawyer has been with Fluke Calibration for 20 years, starting with Hart Scientific before the merge with Fluke. He has had several roles within the Fluke Temperature Calibration team, including USA domestic sales, technical and sales support for the Fluke worldwide sales teams and now active as Europe Temperature Product Manager.
Bouraoui Khachlouf
Fluke Calibration Temperature Expert
Bouraoui Khachlouf has spent 27 years in Calibration filed through different roles, include Calibration service in Airforce & private Lab, Selling & supporting Fluke Calibration products for more than 12 years with 7 of those directly working for Fluke, He currently works as a Temperature Expert with our MEAT Sales Team, helping customers figure out the best solution to fit their application. Bouraoui speaks Arabic, French and English and he is happy to help with all your questions.
Data loggers are compact and easy-to-use recorders for monitoring humidity levels of equipment and facilities, including incubators, stability chambers, refrigerators, and freezers. These data loggers require periodic calibration. The 5128A RHapid-Cal Humidity Generator is ideal for calibrating humidity data loggers used to monitor pharmaceutical and biotech processes
To calibrate data loggers, place them directly into the Fluke Calibration 5128A test chamber. If the data logger display allows, it can be visually read through the clear door and compared with the 5128A reference value. Otherwise, put the data logger into “logging” mode. Then set and record the actual 5128A temperature and humidity at known points in time. The logged data is then compared against the actual 5128A temperature and humidity settings. Data loggers that are too large to fit on the shelf accessory can be placed in the bottom of the chamber. To accommodate even larger loggers, the chamber mixing insert can be removed, providing ultimate versatility.
Read the Top 7 Fearures of the 5128A RHapid Cal Humidity Generator
Watch a quick introduction video
Mike Lawyer
Regional Product Manager Temperature
Mike Lawyer has been with Fluke Calibration for 20 years, starting with Hart Scientific before the merge with Fluke. He has had several roles within the Fluke Temperature Calibration team, including USA domestic sales, technical and sales support for the Fluke worldwide sales teams and now active as Europe Temperature Product Manager.
Bouraoui Khachlouf
Fluke Calibration Temperature Expert
Bouraoui Khachlouf has spent 27 years in Calibration filed through different roles, include Calibration service in Airforce & private Lab, Selling & supporting Fluke Calibration products for more than 12 years with 7 of those directly working for Fluke, He currently works as a Temperature Expert with our MEAT Sales Team, helping customers figure out the best solution to fit their application. Bouraoui speaks Arabic, French and English and he is happy to help with all your questions.
Gas Flow meters such as Mass Flow Controllers (MFC) need to be precise, especially in pharmaceutical manufacturing where batch processes use gas and liquid to produce safe, quality product. Flow meters on bio-reactors, fermenters, storage tanks (for tank blanketing), pill coating, ovens, and dryers are critical. These meters measure gas or liquid released into reactors for the manufacturing of cells or medium, they measure gas release into storage tanks to blanket toxic gases to keep workers safe and the measure flow in pill coating to ensure a precise, even layer of thickness is coated to very specific specifications.
Fluke Calibrations lowest uncertainty available for gas flow meter and controller calibrations utilises the Molbox1+ Flow Terminal. Ideal for gas flow meter calibration, Mass Flow Controllers (MFCs) and other flow measurement devices.
Read the 4 Steps to more Effective Gas Flow Calibration
Watch the on-demand webinar: 5 Things to Consider when Calibrating Compressed Gas Flow Meters
Mark Finch
Regional Product Manager Pressure & Gas Flow products
Mark Finch has spent most of his career with Fluke. He has a metrology background working in and running an accredited calibration laboratory. This experience led to other roles including Quality and Service management. From 2000 he providing product training courses for hardware and software and developed courses for laboratory management, accreditation and ISO 9000. For the last 13-years he has been the Regional Product Manager for our Pressure and Gas Flow products working with the EMEA Sales Team. He says “My key function is to advise the best solution for our customers calibration and measurement needs”.
Probes, transmitters and other temperature sensors that are permanently mounted in freeze driers (lypohilizer), freezers, fridges, incubators, stability chambers, environmental chambers, ovens, dry heat sterilizers (depyrogentator) and warehouses can provide challenges when calibrating and verifying. Some sensors can be permanently fixed or difficult to remove, making calibrating with a single-point of verification the easiest choice. To ensure quality assurance, single-point verification is most effective when combined with other trends and information related to the process and equipment. To complete a single-point verification, use the Fluke Calibration 1523 or 1524 Reference Thermometer as the readout with a reference RTD or PRT (PRT are recommended) which will allow data logging to capture trends. Usually, the RTD or PRT is placed in thermal equilibrium next to the sensor, without removing it from the process. If applicable, wire the RTD and PRT through the door or gasket. Once it stabilizes, gather the readings to complete a single-point verification. Choosing the correct probe is important in this application, check out the selection guide below or reach out to one of our Fluke Experts for advice on your specific application.
Choose the right industrial temperature readout and probe
| Model | Probe Range | Junction Range | Size | Basic Accuracy4 | Depth |
|---|---|---|---|---|---|
| Secondary Reference PRT1 | |||||
| 5615-6 | -200 °C to 300 °C | -50 °C to 200 °C | 152mm x4.76mm (6.0 in x 0.188in) | ±0.013 °C at 0.010 °C | 100 mm (4.0 in) |
| 5615-9 | -200 °C to 420 °C | -50 °C to 200 °C | 229 mm x 4.76 mm (9.0 in x 0.188 in) | ±0.013 °C at 0.010 °C | 100 mm (4.0 in) |
| 5615-12 | -200 °C to 420 °C | -50 °C to 200 °C | 305 mm x 6.35 mm (12.0 in x 0.250 in) | ± 0.013 °C at 0.010 °C | 127 mm (5.0 in) |
| Precision Industrial PRT1 | |||||
| 5627A-6 | -200 °C to 300 °C | -0 °C to 150 °C | 152mm x 4.7mm (6.0 in x 0.187 in) | ± 0.05 °C at 0 °C | 100 mm (4.0 in) |
| 5627A-9 | -200 °C to 300 °C | -0 °C to 150 °C | 229 mm x 4.7 mm (9.0 in x 0.187 in) | ± 0.05 °C at 0 °C | 100 mm (4.0 in) |
| 5627A-12 | -200 °C to 420 °C | -0 °C to 150 °C | 305 mm x 6.35 mm (12.0 in x 0.250 in) | ± 0.05 °C at 0 °C | 127 mm (5.0 in) |
| Secondary Standard PRT1 | |||||
| 5628 | -200 °C to 661 °C | -0 °C to 80 °C | 305 or 381 mm x 6.35 mm (12.0 or 15.0 in x 0.250in) | ± 0.06 °C at 0 °C | 128 mm (5.0 in) |
| Full Immersion PRT2 | |||||
| 5606 | -200 °C to 160 °C | -200 °C to 160 °C | 50 mm x 3.1 mm (2.0 in x 0.125 in) | ± 0.05 °C | 76 mm (3.0 in) |
| Full Immersion PRT2 | |||||
| 5610 | -0 °C to 100 °C | -0 °C to 100 °C | 152 mm or 229 mm x 3.2 mm (6.0 or 9.0 in x 0.125 in) | ± 0.01 °C | 76 mm (3.0 in) |
117025 accredited calibration included. 2No calibration included. Check with your distributor for calibration options. 3NIST traceable calibration included. NVLAP accredited calibration optional 4"Basic Accuracy" includes calibration uncertainty and short-term repeatability. It does not include long-term drift. | |||||
Mike Lawyer
Regional Product Manager Temperature
Mike Lawyer has been with Fluke Calibration for 20 years, starting with Hart Scientific before the merge with Fluke. He has had several roles within the Fluke Temperature Calibration team, including USA domestic sales, technical and sales support for the Fluke worldwide sales teams and now active as Europe Temperature Product Manager.
Bouraoui Khachlouf
Fluke Calibration Temperature Expert
Bouraoui Khachlouf has spent 27 years in Calibration filed through different roles, include Calibration service in Airforce & private Lab, Selling & supporting Fluke Calibration products for more than 12 years with 7 of those directly working for Fluke, He currently works as a Temperature Expert with our MEAT Sales Team, helping customers figure out the best solution to fit their application. Bouraoui speaks Arabic, French and English and he is happy to help with all your questions.
Calibrate humidity sensors for clean rooms, production/manufacturing facilities, product warehouses and other places where humidity is critical to product quality. Humidity sensors used for monitoring/recording data loggers and hand-held devices require periodic calibration. In critical monitoring/recording installations, a single-point check with a hand-held unit only provides a single point at ambient condition, but its value is limited. In most cases, these sensors are hard wired and cannot be taken back to the lab; however, the portability and speed of the 5128A allows users to perform a three-point check on-site next to the sensor with the right equipment.
Insert the transmitter sensor or Unit Under Test UUT into the chamber, select a set point, and the 5128A chamber will quickly reach a stable and uniform temperature and humidity environment. Use at least three to four calibration points distributed across the humidity range.
Read the Top 7 Fearures of the 5128A RHapid Cal Humidity Generator
Watch a quick introduction video
Mike Lawyer
Regional Product Manager Temperature
Mike Lawyer has been with Fluke Calibration for 20 years, starting with Hart Scientific before the merge with Fluke. He has had several roles within the Fluke Temperature Calibration team, including USA domestic sales, technical and sales support for the Fluke worldwide sales teams and now active as Europe Temperature Product Manager.
Bouraoui Khachlouf
Fluke Calibration Temperature Expert
Bouraoui Khachlouf has spent 27 years in Calibration filed through different roles, include Calibration service in Airforce & private Lab, Selling & supporting Fluke Calibration products for more than 12 years with 7 of those directly working for Fluke, He currently works as a Temperature Expert with our MEAT Sales Team, helping customers figure out the best solution to fit their application. Bouraoui speaks Arabic, French and English and he is happy to help with all your questions.
To ensure product quality and assurance, calibrate pressure gauges in pharmaceutical manufacturing periodically with a high degree of certainty to comply with regulatory agencies and avoid waring letters. There are pressure gauges on many different processes such as sterilization, cell growth in bioreactors, lyophilization and more that require calibration. Many of these gauges are critical, especially on filters, pumps and steam-in-place SIP, clean-in-place CIP and production areas like gloveboxes and clean rooms. To automate the calibration of these gauges, the Fluke Calibration 6270A is used with COMPASS® software for improved consistency and throughput, run complete pressure calibration sequences on a single or multiple devices under test (DUTs).
The 6270A offers maximum pressure range with its modular design that allows for up to five pressure modules to be installed at one given time with uncertainty as good as 0.01%. This is the ideal solution for a calibration lab that services field calibration, validation and calibrating standards. If you need low pressure, the Fluke Calibration 7250LP offers a solution for low pressure in H20 applications.
Read our Guide to Getting Started in Pressure Calibration, Breaking down the Barriers
Watch the on-demand webinar: Preventing Contamination in Pressure Calibrations
Mark Finch
Regional Product Manager Pressure & Gas Flow products
Mark Finch has spent most of his career with Fluke. He has a metrology background working in and running an accredited calibration laboratory. This experience led to other roles including Quality and Service management. From 2000 he providing product training courses for hardware and software and developed courses for laboratory management, accreditation and ISO 9000. For the last 13-years he has been the Regional Product Manager for our Pressure and Gas Flow products working with the EMEA Sales Team. He says “My key function is to advise the best solution for our customers calibration and measurement needs”.
Heat treating or quenching is required to ensure that an implant or device is flexible but stays in form, providing durability. Medical devices treated in this way might be used for hip, ankle, knee, shoulder and other joints as well as heart valves and dental instruments. Fluke Calibration’s 6050H Extremely High Temperature Calibration Salt Bath is ideal for quenching because of its temperature control that maintains excellent temperature stability (±0.002 °C) and uniformity (±0.005 °C).
Mike Lawyer
Regional Product Manager Temperature
Mike Lawyer has been with Fluke Calibration for 20 years, starting with Hart Scientific before the merge with Fluke. He has had several roles within the Fluke Temperature Calibration team, including USA domestic sales, technical and sales support for the Fluke worldwide sales teams and now active as Europe Temperature Product Manager.
Bouraoui Khachlouf
Fluke Calibration Temperature Expert
Bouraoui Khachlouf has spent 27 years in Calibration filed through different roles, include Calibration service in Airforce & private Lab, Selling & supporting Fluke Calibration products for more than 12 years with 7 of those directly working for Fluke, He currently works as a Temperature Expert with our MEAT Sales Team, helping customers figure out the best solution to fit their application. Bouraoui speaks Arabic, French and English and he is happy to help with all your questions.
