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Our current arrangement for monitoring refrigerated areas where IMPs are stored involves the use of air probes. We're looking into procuring buffered probes in the hope that this may potentially lead to fewer temperature deviations in the event that a fridge door is left ajar for a small period of time.
I'm informed by a colleague who has recently been through an MHRA inspection of their aseptic unit that the MHRA will look for both air and buffered probes if a buffered probe is to be used. If this is the case, does anyone know if it would be acceptable, from an MHRA perspective, to only act (i.e. follow standard temperature deviation protocol) when the buffered probe goes out of range and not when the air probe is out of range but the buffered probe is in range? Does anyone have any experience of adopting the above approach for commercial studies and have they experienced any problems with it?
Thank you in advance for an help you may be able to give with this.
David McRae ([email protected])
Clinical Trials Pharmacist
Prince Charles Hospital
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