An Air Detector is fitted to an autoclave chamber to detect residual air within the Autoclave. They are commonly used in the UK and Ireland and are an expectation of the MHRA and HPRA.
Air detectors are in process challenge devices which can be setup to detect residual air from the air removal process and Non-Condensable Gases delivered to the chamber via the steam distribution system. Their setup and use are detailed in EN 285:2015 and HTM2010 Part 3. Thermal Compliance can assist with the setup of temperature and pressure type air detectors along with the EN285:2015 testing requirements including:
The newly revised Annex 1 refers to a daily performed air removal cycle or the use of an air detector system. '8.61 There should be adequate assurance of air removal prior to and during sterilisation when the sterilisation process includes air purging (e.g. porous autoclave loads, lyophilizer chambers). For autoclaves, this should include an air removal test cycle (normally performed on a daily basis) or the use of an air detector system. Loads to be sterilised should be designed to support effective air removal and be free draining to prevent the build-up of condensate.' Section 8.61, EU GMP Annex 1, Manufacture of Sterile Medicinal Products |
EN285:2015 TestingOur Engineers regularly perform EN285:2015 Thermometric testing, including:
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Air Detector SetupWe have significant experience in the setup of Temperature and Pressure type air detectors.
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Autoclave TrainingOur Autoclave Validation Training Courses, provide a detailed understanding of Air Detectors and EN285 Testing.
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