All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process, before the installation is commissioned and handed over by the installer. Until this has been done, it is not safe to store TTSPPs in such areas. The temperature mapping procedures should:
■ demonstrate the air temperature profile throughout the storage area, when empty and in a normal loaded condition;
■ define zones which should not be used for storage of TTSPPs (for example areas in close proximity to cooling coils, cold air streams or heat sources); and
■ if required, demonstrate the time taken for temperatures to exceed the designated limits in the event of a power failure.
Depending upon the routine monitoring strategy, subsequent mapping exercises may also be required periodically – for example, every three years – in order to demonstrate continuing compliance.
Continue at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/supplement_8.pdf
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