What is Temperature Mapping?
Temperature mapping is the process of measuring temperature in a storage area, over a period of time, thereby gaining evidence on the reliability of the area to maintain a set temperature. It usually forms a part of the Installation Qualification (IQ) and/or Operational Qualification (OQ) of the storage area.
Temperature Mapping is a mitigation activity to address the risk that the storage environment imparts onto the temperature-sensitive product.
Temperature Mapping involves “snap-shot recording” of the temperature of the storage area, across many sub-locations, for a sufficient time duration & recording interval for the data to be representative of “actual” conditions experienced. Decisions can then be made to modify the storage area to get better temperature control or to simply decide where best to locate temperature sensors enabling ongoing monitoring of the environment.
Temperature Mapping is a pharmaceutical qualification process and should conform to the usual expectations of any qualification/validation activity inside a GxP environment.
Why do medicines need to be stored at stable temperatures?
Patient safety is the end objective for all manufacturers, wholesalers, and healthcare workers. When administering medicine to patients it’s expected that the medicine will deliver the desired therapeutic effect. The efficacy or potency of the medicine is affected by the quality of many things.
To maintain the quality of products in the storage & transport segments we must understand the common risks and mitigate their effect. In pharmaceutical or biological products, the temperature is an important element in maintaining the “therapeutic efficacy” of the product.
In many pharmaceutical and biological products, the temperature is an important element in maintaining the “therapeutic characteristics” of the product. Too hot or too cold the environment and irreparable damage to active ingredients may occur, making the medicine ineffective when given to a sick patient.
Storage and transportation activities are key stages in the life cycle of pharmaceutical products. In the globalized world that we now live in, the storage & transport segments of the supply chain have increased. All of these points in the storage and transportation process are potential points where the temperature could adversely affect the efficacy of the product.
What are the Regulatory Requirements for Temperature Mapping?
Government regulators are enforcing strict guidelines on controlled temperature storage facilities to ensure compliance with GMP requirements. By having CoolPac operate your temperature mapping schedule, you can rest assured that our routine temperature mapping service will produce comprehensive reports that will assist in optimising your controlled temperature-controlled storage facilities.
Why Use CoolPac’s Service?
CoolPac’s temperature mapping service will help you to understand the temperature dynamics of your facility and ensure you monitor your most vulnerable areas.
Our temperature mapping equipment is small and non-intrusive, ensuring facilities of all sizes can be mapped cost-effectively. Using the data collected, information is analysed and a detailed report is written.
CoolPac has conducted temperature mapping studies to help clients in a variety of industries to understand their facility’s capabilities. Understanding their temperature-controlled storage areas has allowed them to…
- Maintain compliance for storage of products
- Ensure product efficacy.
- Identify problem areas.
- Peace of mind