Our managing director Chris Maughan has just written and article for EPM magazine. In the article he investigates the use of wireless dataloggers for autoclave validation detailing their benefits and limitations. Along with some useful advice on what specifications to look for when procuring a new system.
At Thermal Compliance we have been using Ellab dataloggers for some time and have noticed substantial benefits. If you would like to know more please contact us.
If you would like to read the article please visit https://www.epmmagazine.com/opinion/down-to-the-wire/
In 2011 we started using Veriteq multi channel dataloggers to speed up temperature mapping over standard wired systems. The effect was to significantly reduce temperature mapping times, increase productivity of our engineers and in report quality. In the last two years we have applied that same methodology to autoclaves using Ellab Tracksense Pro dataloggers and the results are staggering.
· Time savings of 30-60% for autoclave downtime.
· Data processing and analysis reduced from 3-4 hours to 20 minutes.
· Review time reduced significantly
· Removal of subjectivity in data processing
This has been done with a step change in accuracy from ±0.5°C using a thermocouple based system to ±0.05°C whilst complying with EN285. In particular section 6.4.1 on response time, which requires dataloggers to have a T90 of <5s.
For Site Directors and Production Managers this delivers substantial autoclave downtime savings. Using the tracksense pro system removes the need to perform leak rate tests, calibrations and preparing validation loads whilst on the autoclave.
Using Ellab sensors not only reduces the autoclave downtime, but it brings flexibility. Our clients benefit from loads being prepared offline whilst the autoclave is in use, validation runs can then be slotted in around the production requirements. For requalification only, autoclave downtime is the cycle time, for performance qualification loads need to be performed in triplicate but downtime saving is still significant.
For QA reviewers, data and results are clearly displayed with pass/fail criteria. The reports are clear and unambiguous. Data is repeatable and the subjectivity of the test engineers method of calculation removed. The software is validated and 21 CFR Part 11 Compliant.
For Validation Engineers, the system offers bespoke sensor design. We have a large array of sensors to suite challenging load requirements. Sensor insertion into load items is also fully supported by the manufacturer and if we don’t have the right sensor insertion for your requirements Ellab can assist in the design and fabrication of bespoke fittings in their facility.
If you would like more information our engineers are happy to help please call us on 00 44 (0)1833908002 or email Chris Maughan firstname.lastname@example.org . We would be happy to visit site and show you how the system can help with Autoclave Validation, Steam In Place, Freeze Drying, Temperature Mapping and Dry Heat Sterilisation.
Our managing Director Chris Maughan will be attending a ISPE decontamination and Validation workshop with ISPE on the 15th February. The 1/2 day work shop will focus on decontamination processes and rapid validation using Enzymatic Biological Indicators. For more information on this event ot to book please visit https://ispe.org/conferences/decontamination-and-validation
Porous load autoclaves usually control by either temperature or pressure. Assuming that all air has been removed from the autoclave chamber prior to the sterilisation phase the temperature and pressure should correlate. The theoretical temperature can be correlated by the pressure recorded by using steam table for example http://www.spiraxsarco.com/Resources/Pages/Steam-Tables/saturated-steam.aspx
Control of temperatures and pressures within the autoclave should fall within the control set points and correlate to steam tables. If excursions are identified then there are several potential route causes:
It is important to remember that high temperatures in an indication of dry heat, steam sterilisation is an effective method of sterilisation because of the moisture. Utilising dry heat as a sterilisation method requires much higher temperatures and extended hold times for example depyrogentation tunnels.
If you need any assistance with autoclave validation or steam quality testing please contact us.
Data loggers come in all shapes and sizes utilising different sensing technology from thermocouples to PT1000 sensors. The price and quality of these data loggers varies dramatically and the selection of sensor should be considered prior to perform a temperature mapping study.
We selected various calibrated data loggers with internal and external probes and placed them adjacent to each other in a -20°C Freezer. The graph below shows a snapshot of the results, comparing an external sensor logger to an internal sensor logger.
From the graph you can clearly see the temperature fluctuations of the freezer in the external sensor. The internal logger however does not record the same extreme temperatures. The air within the sensor acts as a buffer, effectively buffering the temperature fluctuations.
If you’re writing a risk assessment into the temperature mapping of your controlled temperature environments, consideration should be given to the sensors used to perform the mapping. Will the buffering effect of internal sensor impact the accuracy of your mapping exercise?
If you would like to read our full report on sensor selection and probe buffering please contact us.
Seasonal variations in weather can impact temperature and/or humidity control of warehouses. In order to ensure the stability of your warehouse it is recommended you perform summer and winter temperature maps.
In the UK and Ireland meteorological winter is between 01 December and 28 February. Meteorological summer is between 01 June and 31 August. So you should ensure your winter and summer maps fall between these periods.
We typically perform winter and summer maps over 7 days, this is to ensure the mapping includes changes in shift patterns, workflow etc. We can work to your own onsite protocols or generate bespoke protocols including the identification of sensor locations, risk assessments and validation requirements.
If you'd like to more please visit our temperature mapping services page or contact us for more information.