Observation of the temperature variations in a warehouse should be made over a period of time to establish a meaningful temperature profile, including the temperature variations and conditions in the different parts of the warehouse. Such observations provide data and information as to where various products should and should not be stored.

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Only climate control equipment for which a contractor has provided documentation to assure its suitability for temperature and humidity requirements should be considered for use in cold storage. Qualification procedures on a regular basis should be independently conducted on equipment in cold stores to guarantee suitability and proper functioning. The procedure should demonstrate the temperature profile for both air and product temperatures when empty as well as when loaded. The procedure should also demonstrate the time taken for temperatures to exceed the maximum temperature in the event of a power failure.

Qualification should consider thermal fluctuations that occur during stock replenishment and order removal. The results of the qualification should demonstrate the ability of the equipment to maintain the required temperature range in all areas, defining any zones which should not be used for storage such as those areas in close proximity to cooling coils, cold air streams from equipment ventilation, or doors. The variability of the system can be characterized by using the relative standard deviation. Thermal monitoring should establish that the system is rugged in that its temperature profile is consistent and reliable.

Shippers and distributors are to follow the proper storage and shipping requirements as indicated by the manufacturer. For particular cases, such as shipment of vaccines or other special care products, manufacturers may require special shipping and storage conditions generally referred to as “cold-chain management”.

The PIMM™ Continuous Temp Monitoring (PIMM™ CTM) program is the first monitoring program of its kind that allows distributors to share specific temperature performance data with their customer’s and/or brand owners without sharing every detail of their operations.

Our system provides instant feedback and alerts to allow distributors to properly manage their air temperatures across their refrigerated fleet. When an excessive temperature violation occurs, the system can project the damage on the underlying products with the use of the PIMM™ PPT simulated product temperature.

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Source: US Pharmacopoeia. Good Storage And Shipping Practices.

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