What is Temperature Mapping?
Temperature mapping is the process of understanding the storage & transport conditions. Like all pharmaceutical Qualification activities, it is documented to form evidence of the suitability of the storage area for specific temperature-sensitive products.
Temperature Mapping is a mitigation activity to address the risk which the storage & transport environment imparts onto the temperature-sensitive product.
Temperature Mapping involves “snap-shot recording” of the temperature of the storage area, across many sublocations, for a sufficient time duration & recording interval for the data to be representative of “actual” conditions experience. 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 is Temperature Mapping needed?
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, temperature is an important element in maintaining the “therapeutic characteristics” of the product.
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 Temperature Mapping 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 facilities 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
For those who prefer DIY, CoolPac has developed a cost-effective and easy to use DIY Temperature Mapping Kit. Suitable for small or remote facilities.
For a more in-depth analysis of what temperature mapping entails click here.