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CASE STUDY #5 - WAREHOUSE TEMPERATURE AND HUMIDITY PROFILES

Project objective: Evaluation of temperature and humidity controls in product storage facility.

Project description: Chicago Controls was requested to evaluate the temperature and humidity control of the
warehouse used to store pharmaceutical products. The products stored in this facility required storage within specified temperature and humidity limits in order to meet product expiration dating approved by regulatory agencies. This workalso required development of worst case sampling locations for the facility.

Chicago Controls project activities: Chicago Controls evaluated the storage facility. Studies were conducted using wireless temperature and humidity data loggers located at strategic locations to profile the entire facility. Several problem areas were identified. These areas exceeded required temperature limits. Root causes for temperature excursions were
determined. Corrections were made if possible. If corrections were not possible, engineering solutions and signage were developed to prevent product storage in high temperature areas. Further studies during a 72-hour test period confirmed that the facility would demonstrate acceptable temperature control.

Results: The customer was able to qualify the facility for product storage.

Customer benefit: There were three significant customer benefits in this project:

1. Identification of problem areas. Areas with inadequate temperature control were identified. Problem root causes were determined. Corrective action was completed. These activities accomplished the project objective.

2. Sampling locations. Worst-case sampling locations to be used in future protocols were determined.

3. Facility validation. The customer was able to successfully quality the facility for storage of product. There were no problem areas with temperature or humidity excursions in validation trials. Protocols utilized identified worst-case facility sampling locations

Summary: The contributions of Chicago Controls enabled successful qualification of the facility.