| Introducing Validation equipment into a cleanroom environment has always been a challenge. Bulky Kaye Validators, Calibration Baths and Thermocouples are difficult to clean with IPA and Biocide. Improperly cleaned items can be a potential route for contamination. By using Ellab Tracksense Pro wireless dataloggers equipment can be cleaned easily. Reducing downtime and risk of contamination. The dataloggers are IP67 rated so can be fully immersed in liquid and cleaned effectively. Sensors can also be calibrated an pre programmed prior to cleaning into the room, reducing the volume of test equipment to be cleaned. |  |
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If you would like to read Chris' article, it is available on the Cleanroom Technology website below:
https://www.cleanroomtechnology.com/news/article_page/Guide_to_wireless_dataloggers_for_thermal_validation/156496
Our Engineers use a variety of dataloggers to suite various applications and specifications. We have a vast array of test equipment covering a temperature range of -196 to 400°C, with accuracies from ±0.05°C.
For more information about how Thermal Compliance can help you please contact us on 01748 327 24 (UK), 01 853 7877 (Ireland) or contact Chris Maughan chrism@thermalcompliance.co.uk If your temperature critical equipment has failed its temperature mapping, we may be able to help you.  Our engineers have significant experience with Refrigerators, Freezers, Ultra Low Freezers, Cold Store, Freezer Rooms and Incubators. We regularly see temperature mapping failures and work quickly to provide a solution. The equipment may not have reached end of life and there are multiple assignable causes for failures.
If you would like to talk to one of our engineers, please contact us on 01748 327 24 (UK), 01 853 7877 (Ireland) or contact Chris Maughan chrism@thermalcompliance.co.uk At Thermal Compliance we get asked a lot for a copies of our IQOQ, PQ and RQ Temperature Mapping Protocol templates. If you need help with protocols we are happy to help, but we don’t use templated protocols.
We write individual bespoke protocols to ensure the testing, validation equipment and acceptance criteria are suitable for the unit under validation. It is important to ensure the protocol is designed for process and we do this by: · Risk Assessment of the process · Selecting the most appropriate testing for the equipment use · Ensure the testing conforms to client SOPs · Selecting the most suitable validation equipment A well written protocol will clearly show critical parameters, acceptance criteria and results. It will be specific for the unit under test and is suitable for the process. By selecting the best equipment, execution timelines can be reduced while increasing the clarity in raw data and results. If you would like to see copies of our protocols, we have executed versions available for review. We have performed IQOQ and PQ validation on our Controlled Temperature Units, in our Training and Development laboratory. One of our engineers would be happy to visit your site and go through out documentation. Please contact Chris Maughan via email for more information.
When working with highly accurate sensors, the calibration bath is critically important to ensuring a good calibration. Some of our sensors have accuracies of ± 0.05°C and we perform testing from -196 to 400°C, so choosing the correct temperature bath is critical for effective calibration of our sensors. In addition to temperature ranges and accuracy we must also consider the design of the thermal wells within the calibration block. Oversized wells allow air between the sensor and the well insulating the sensor and reducing the accuracy of the calibration. This is often seen when doing low temperature calibrations and frost builds up in the airspace in the well insulating the sensor. For Example, calibrating 2mm thermocouples in a 4mm thermal well will result in a poor-quality calibration. The sensors must therefore be placed in a suitable calibration well. For the calibration verification of our Ellab sensors we have a 24 port Jofra Insert drilled with an Insulation cover. This provides extremely accurate and repeatable results from -100 to 150°C, with typical temperature deviations of around ±0.01-0.02°C. For Thermocouple calibration we typically use a Kaye 140 or 400 Calibration Bath. The accuracy of a thermocouple is around ±0.5°C so these baths are ideal for this. The wells of the Kaye 140 and 400 bath are also suitable for the size of most Thermocouples. When using our Vaisala Veriteq system, the design of the sensor impacts the calibration of the probes. The sensor has a stepped seal, so the neck of the probe is larger than the shaft of the probe and the measuring tip. This means that a standard drilled calibration bath, would create an air pocket around the sensor during the calibration. The ideal solution would be to use one of our fluids calibration baths, this however is not always practical when performing onsite calibrations. So we had an insert fabricated to ensure accurate calibrations using our Jofra RTC-159 Calibration Bath. The insert is designed to allow the sensing tip to be placed correctly.  For calibration baths we use
As with any calibration, it is important to ensure that sensors are positioned correctly. Sensors must be fully inserted into the well as temperature varies throughout the axial gradient. The RTC-159 has a unique dual-zone heating control system, which keeps the sensors uniform throughout the block despite thermal load.
Our engineers take pride in every aspect of the qualification process to ensure the highest quality calibration and validation. Using the suitable baths an inserts is one of the many ways our engineers work to continuously improve quality. Sensor selection is critical in any validation, but when it comes to sterilisation processes response time is an incredibly important parameter. We use Ellab Tracksense Pro dataloggers with response times of T-90 of ≤5 Seconds. At Thermal Compliance we have many different sensors all with a response time T-90 between 0.8-4.3 seconds. In addition to the benefits of response time, using dataloggers allows us to:
If you would like to know more about our validation services or the benefits of using wireless dataloggers please contact Chris Maughan Section 23.3.3.1.1 EN285:2015 requires a sensor response time T-90 of ≤5 Seconds. We perform independent response time testing, if you would like to know more please visit.
The next event PDA Ireland event will be ‘Practical Implementation of QRM - Are We Getting Value?’. This event will be held at the Radisson Blu Hotel and Spa, Cork on June 20th 2019. The event will be exploring the integration of QRM into the PQS and demonstrating effectiveness to achieve operational advantage & regulatory relief. Presenters include Kevin O'Donnell from the HPRA, guest speakers from Deloitte Life Sciences and Industry. If you would like to register for this event, please visit:
https://www.pda.org/global-event-calendar/event-detail/pda-ireland-chapter-implementation-strategies-for-qrm-event
If you would like to know more about making pharmaceuticals, please visit their website click here.
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