The pharmaceutical industry is one of the most regulated industries in the world, so it’s no surprise that temperature mapping is imperative for temperature-controlled storage areas. Temperature mapping identifies hot and cold zones so necessary actions can be taken to equally distribute air, which in turn, will ensure the products’ integrity.
Under 21 CFR 205.50, the FDA states that all prescriptions drugs must be at the appropriate temperatures and under appropriate conditions in accordance with requirements. The regulation goes on to state that electronic temperature and humidity recording devices can be used to document proper storage of prescription drugs. But that is as far as the FDA goes when it comes to how to proper conduct a temperature mapping study.
The World Health Organization (WHO) provides greater detail into how temperature mapping studies are carried out for those who store and transport time and temperature sensitive pharmaceutical products.
“All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process, before the installation is commissioned and handed over by the installer.”
Electronic Data Logging Monitors
WHO recommends the use of data loggers along with its corresponding software to store and analyze the data collected during the study. When choosing a data logger for study, the logger must meet the following:
- Be technically suitable for the specific mapping task and for the intended operating environment.
- Provide a reliable and continuous reliable record of time-temperature data.
- Have an appropriate temperature range so that all anticipated temperature extremes can be recorded (e.g. from -30°C to +60°C).
- Have a user-programmable data sampling period, with time intervals ranging from one minute to 15 minutes or more and sufficient memory for the intended length of the study and the chosen recording interval.
- Have a NIST- traceable 3-point calibration certificate with a guaranteed error of no more than ± 0.5°C at each calibration point.
- Allow the recorded time-temperature data to be downloaded to a computer system for subsequent analysis.
- Have data storage and analytical software that complies with applicable regulatory requirements (21 CFR part 11).
Mapping studies should be conducting over 24 to 72 hours, if not longer. The results will determine hot and cold spots where temperature sensitive products should not be stored, and actions should be taken to either fix those spots or install data loggers in that area for continuous monitoring. Temperature mapping is not just a one-time thing, it’s an exercise that must be carried out every three years in order to demonstrate continuing compliance, or whenever significant modifications are made to the store.
MadgeTech data loggers exceed the requirements outlined by WHO. With an ISO 17025 accreditation, MadgeTech offers a variety of temperature data loggers, which are held to the highest standards in the world. The MadgeTech 4 Secure Software aids users in compliance of 21 CFR Part 11 requirements, containing criteria such as electronic signatures, access codes, secure data file and an audit trail.
To help find the right data logging system for your temperature mapping study email us at [email protected] or give us a call at (603) 456-2011.