WHO guidelines temperature mapping of storage areas free pdf download

WHO guidelines temperature mapping of storage areas free pdf download

1. Introduction
This technical supplement has been written to amplify the recommendations
given in section 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9:
Model guidance for the storage and transport of time- and temperature-sensitive
pharmaceutical products.4 The purpose of a temperature mapping study is to
document and control the temperature distribution within a storage area.
This document describes how to carry out a systematic mapping
procedure in any cold room, freezer room or other temperature-controlled
store. It does not cover mapping of small-scale cold chain equipment such as
refrigerators or freezers. Generally speaking, these products are independently
tested and prequalified for the storage of TTSPPs, although it is still important
that the equipment is correctly installed and operated.

The following Technical Supplements are also relevant:
■ Checking the accuracy of temperature control and monitoring devices
■ Qualification of temperature-controlled road vehicles
■ Qualification of temperature-controlled storage areas
■ Temperature and humidity monitoring systems for transport operations.

1.1 Requirements
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.

 

Free Download of the Guideline:  DOWNLOAD

 

Continue at:  https://www.who.int/publications/m/item/Annex-9-g-trs-961

 

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Manostaxx – Industrial Management Consulting

 

 

 

 

 

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