A generic animal health manufacturer in the Kansas City area needed to verify controlled room temperatures of a new warehouse designed to hold raw materials, in-process and finished goods, packaging supplies and two final-packaging lines, a sample retention room, and a cold room.
Working with the customer, Performance Validation gained an understanding of the intended use of the new warehouse. Based on our expertise, gained through prior mapping experience, we were able to communicate areas that, based on their intended use, were at a higher risk of temperature fluctuations. Potential risk to products from temperature fluctuations was reduced by placing the more critical storage areas in areas that, by design, should be more stable in temperature.
An engineering study was conducted to evaluate the warehouse temperature control at the builder’s recommended set-points. This study concluded that the area was within temperature tolerance and full temperature mapping commenced. Temperature mapping helped locate the areas of the warehouse that were at the extremes of temperature. The permanent temperature monitoring devices were then placed at these extremes. This provided the customer with a scientific/ process based rationale for the probe placement that could be used to justify the monitoring points to an external regulator.
An engineering study was conducted to evaluate the ability of the cold room to meet specifications. The unit used a single temperature controller and was found to maintain temperature criterion at that location, while other parts of the cold room were not within tolerance. By gathering field data, and using that data for extrapolation, we were able to provide the client with a temperature set-point that kept all areas of the cold room within temperature criterion.
Based on the pre-planning and the engineering studies the formal mapping of the warehouse, sample retention room, and cold room were completed within schedule and budget. The client was able to approach the upcoming audits of their new expansion with peace-of-mind
Adjustment of the cold room temperature setpoint provided confidence that the entire room met specifications, increasing the effectiveness/use of the room and reducing the potential product risk from temperature fluctuations.
The temperature mapping studies provides the customer with confidence that the process and scientific rationale that the controlled temperature space meets regulatory requirements.
For more information please contact:
Dalton Pierson, Senior Validation Specialist
Kansas City Area