· 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
· 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 chrism@thermalcompliance.co.uk . 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.
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 chrism@thermalcompliance.co.uk . 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.
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