Cold Room Mapping and Validation

Cold rooms used for storing temperature sensitive goods should be mapped and validated. Cold storage is a relatively simple cold room that is commonly used to store material between 2˚C to 8 ˚C. Such cold rooms are now available commercially as walk-in chambers and are used for the storage of critical pharmaceutical products, samples, and raw materials where excursions in temperature conditions may affect the quality of stored material(s) in terms of their appearance (color), consistency, potency, and impurity levels. Hence it is essential to qualify cold storage chambers under the worst-case scenarios.

Some pharmaceutical manufacturers perform only Installation Qualification (IQ) of cold rooms, but the Operational Qualification (OQ) and Performance Qualification (PQ) is also essential because data-based conclusions should be arrived at by challenging the system for all the attributes that may have bearing on the performance of the chamber for maintaining the desired temperature conditions.

The final result of the study will be as follows
  • Mapping temperature variations within the cold room.
  • Measuring temperature variations at each location within the chose area, by day of the week, and time of day.
  • Documenting high and low temperature fluctuations caused by the environmental control systems operating at the time of the study.
  • Identifying potential airflow issues that may be the cause of temperature variations.