In the pharmaceutical industry, temperature mapping essential to determine whether storage areas, objects and means of transportation are suitable for storing and transporting drugs and vaccines. Mapping helps to identify temperature trends and potential hot and cold spots and critical control points. Dyzle provides a structured approach that meets traceable guidelines, giving you insight into the adequacy of your facilities.
How does Dyzle take care of the temperature mapping?
A step-by-step approach to qualifying storage and transportation facilities according to GxP, ISPE and WHO guidelines
Introduction text
In the pharmaceutical industry, temperature mapping essential to determine whether storage areas, objects and means of transportation are suitable for storing and transporting drugs and vaccines. Mapping helps to identify temperature trends and potential hot and cold spots and critical control points. Dyzle offers a structured approach that complies with GDP and GMP guidelines, giving you insight into the adequacy of your facilities.
Research
Our specialists gather detailed information about the specific space or object to be mapped. This includes understanding the physical characteristics, usage and environmental factors that may affect temperature stability.
Quote
Based on the survey, we prepare a customized quote that meets your specific needs and requirements. The quotation includes a detailed description of the mapping procedure and the resources required.
Protocol
Upon acceptance of the offer, we develop a protocol that outlines the steps and criteria for the mapping clearly define. This document serves as a guide for conducting the mapping and ensures consistency and compliance with applicable guidelines.
Installation and disassembly
Our experienced mapping engineers install the necessary equipment according to the established protocol. After the measurement period, the equipment is carefully removed, and the collected data is secured for analysis.
Mapping results
The collected data becomeand analyzed and processed into a clear report. This report provides insight into temperature profiles, identification of any hot and cold spots, and other critical control points within the relevant room or object.
Conclusions (Summary Report).
Based on the mapping results, we formulate conclusions and recommendations. The Summary Report contains a summary of the findings and indicates whether the room or object meets the set requirements for storage and transport of pharmaceutical products.
Through this structured approach, Dyzle ensures that your storage and transportation facilities meet the highest standards, ensuring the integrity of your products. Contact us today and find out how Dyzle can take your processes to the next level.
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