Refrigerators and freezers used to store drug products are required to maintain the product temperature between the limits as defined on the product label. Typically, a refrigeration unit specification would be set to 5° with an allowable range of ±3° to store products labeled 2°–8°. Freezer tem-peratures may vary and typically range from −25° to −10°. Some frozen drug products, however, require lower temper-atures, e.g., dry ice or liquid nitrogen temperatures.
Regular operating procedures and maintenance protocols should be in place along with written contractual agreements for all maintenance and evaluation procedures including the following:
- Items should be stored in the units in a manner that allows adequate air flow to maintain the specified conditions.
- Units should be positioned in the facility so that they are not subjected to environmental extremes that could affect their performance. If this cannot be prevented, the mapping protocol should include a provision for testing during the anticipated environmental extremes.
- Large commercial units such as walk-in cold rooms are qualified via a temperature mapping study or other type of qualification process to determine the unit’s suitability for storing drug products. A suitable number of temperature-recording devices should be utilized to record temperatures and to provide temperature area maps. Thereafter, the units should be monitored as determined by the results of the mapping study.
- Units should utilize recording systems to log and track temperatures. Alarm systems should be an inte gral part of the monitoring system for both refrigera tors and freezers. While automated systems monitor units continuously, manual checks should be performed as appropriate to the validation program. When automated systems are not available, manual systems may be used.
PIMM™ Cold Chain Management (CCM) provides “end to end visibility” for your pharmacy cold chain. Our system monitors, analyzes and manages the entire distribution process from supplier plants, 3rd party carriers, 3rd party cold storage/distribution centers, outbound delivery fleet and in-store cold storage.
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