This document provides guidance on good practices for the mapping of controlled temperature chambers, warehouses, and refrigerated storage areas used to store raw material, work in progress, or finished product. It is intended to be used when specifying commissioning and qualification activities. The principles described in this document may be considered for controlled temperature chambers such as cold rooms, freezers, and warehouses. The approach is consistent with that described in the ISPE Good Practice Guide: Cold Chain Management , with examples provided that are more pertinent to a warehouse.
A well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations .
Equipment Qualification (EQ)
Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation .
With the advent of ASTM-E2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”  may use a risk-based approach, with the equipment being verified; for further information see:
There should be a clear definition of the acceptance criteria; typically this is provided in a User Requirement Specification (URS) or equivalent document.
Temperature mapping is used to confirm that the system is operating to meet specifications, i.e. the temperature range within the unit is acceptable.
It is a standard practice in the pharmaceutical industry to provide monitoring with an independent system; advantages of this practice include:
Mapping results may be used to define the number and location of monitoring sensors for a warehouse, cold room, or chamber.
Temperature mapping a warehouse should start as early as possible during commissioning and qualification. This allows the early detection and resolution of any performance issues. It also allows potential operational constraints to be identified and discussed with users, to determine if the constraints are acceptable or require resolution.
Systems that support the warehouse Heating, Ventilation, and Air Conditioning (HVAC) should be commissioned prior to temperature mapping of the warehouse, to help ensure complete and representative testing. Alternatively, the operating state of support systems should be understood to allow evaluation of sub-system operational issues that may affect test results. Sub-system operational issues should be monitored independently in case investigation is required, e.g.:
Before temperature mapping commences, responsibilities should be defined (e.g., in a Commissioning Plan) and the following aspects should be considered:
Read more by downloading Controlled Temperature Chamber Mapping (Published: April 2012).