Mesa Labs’ Validation Services team not only offers IQ, OQ, and PQ protocols, but also performs thorough Temperature Mapping Studies for our customers.
The objective of a Temperature Mapping Study is to document temperatures within defined areas where temperature sensitive products are stored or shipped. This can range in size from a small refrigerator to transport trailers and large warehouses. Using our proven analytical process, the Mesa team works with your staff to not only conduct a temperature study, but also to empower your staff with the know-how to improve your processes and environments.
If it is discovered during an audit that temperature mapping has not been completed and it is determined that the raw materials, in-process materials, finished products, and components are not being stored in the correct environmental conditions, a company could be exposed to FDA Form 483 observations, and even potential product recalls.
Our temperature mapping process follows a comprehensive and proven methodology, including: