1. Firstly to demonstrate that an area (e.g. lab/warehouse/cleanroom/production floor) can effectively maintain the correct temperature and/or humidity.
2. Secondly, to ensure routine monitoring sensors located in the area give an accurate reflection of the overall storage conditions.
Eirdata can give you this assurance of compliance with our Temperature Mapping Services, working with our proven, market leading, ISO9001 certified partner to provide the healthcare and pharmaceutical industry with thermal validation and temperature mapping services in order to ensure optimum conditions for the production, testing and storage of pharmaceutical products.
They are one of the longest established companies specialising in temperature mapping, hold an ISO9001 certification for “the validation of temperature controlled environments” and their depth of knowledge and experience working for many of the world’s leading pharmaceutical manufacturers and healthcare providers gives you unrivalled confidence.
For example, we will design, execute and document the study to meet the expectations of the most rigorous auditors. Our documents are regularly viewed by various regulatory authorities and we ensure that any product we produce meet their requirements.
Contact Ray O’ Neill, on 087 2457972 or roneill@essltd.ie or for further information click this link Temperature Mapping
Here’s what the Regulators say:
“Temperature mapping should be performed on all storage areas to ensure that all locations are likely to remain within the specified temperature limits over the seasons of the year” IMB Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances IA-G0011
“Temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage” Eudralex Chapter 3 ‘Observations of the temperature variations in a warehouse should be made over a period of time to establish a meaningful temperature profile’. USP General Chapter <1079>
