A small Midwestern drug distribution warehouse needed to demonstrate temperature control throughout storage areas of the warehouse in accordance with USP controlled temperature requirements. Being a small distributor, cost was a major consideration.
Performance Validation (PV) was selected for the project because of their temperature mapping expertise, internal equipment inventory and history of many successful validation projects for similar applications. PV used internally developed temperature mapping protocols, based on previous experience, USP requirements and industry best practices with only slight modification needed for the particular customer/application which detailed the mapping procedure and location of the mapping devices throughout the warehouse. Travel costs were eliminated by PV through the programming of the wireless data loggers off-site, shipping the loggers to the warehouse for placement by the customer, and then downloading/analyzing the data loggers upon return from the customer, again off-site.
The customer was very pleased with the provided mapping protocol and execution between PV and the customer went very smoothly. The warehouse mapping results were clearly communicated in the overall package summary with identification of any storage areas outside of the acceptance criteria and the overall minimum and maximum temperature locations.
The project accomplished the following for the drug distribution warehouse:
- Identified a storage area around an an external personnel door with temperatures too cold. The customer later identified and replace a faulty door seal at this location that was allowing cold air infiltration during the winter season.
- Identified a room where product may be kept short-term with temperatures too hot. The customer closed a few of the overhead heat vents in the area that had been opened for transport driver comfort in the winter season.
- Identified overall hot and cold locations within the warehouse where permanent monitoring devices should be re-located or installed to ensure controlled temperature requirements are maintained year-round.
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Vice President, Indiana Division Director
Performance Validation, Inc