Trailer and Container Thermal Mapping
Sensitech's Trailer and Container Thermal Mapping is a cost-effective service that helps to document the safe storage of temperature-sensitive products within trailers and containers. Sensitech® has been providing analysis of cold chain storage and distribution systems for more than 15 years to all stages of the life sciences supply chain.
The FDA requires drug products to be stored under appropriate conditions, including temperature and humidity, so that their identity, strength, quality, and purity are not affected (21 CFR 211.142).
While regulatory requirements around product quality have always been important, the publishing of U.S. Pharmacopeia <1079> Good Storage and Shipping Practices in November 2005 had a significant impact on the industry. Since the publication of <1079>, a host of new regulatory and standards-based guidance documents have been published by organizations and countries including Health Canada, Irish Medicines Board, Mexico’s Ministry of Health, Argentina, Brazil, World Health Organization (WHO), the Parenteral Drug Association (PDA) and many others.
While each document is slightly different, a common theme is that all supply chain partners (manufacturers, distributors, wholesalers, re-packagers, and transport logistics providers) need to work together to ensure product quality and patient safety.
Benefits of Service
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Provides documented temperature or humidity (or both) profiles over time (summer and winter) that comprehensively identify conditions and variations across the unit being mapped
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Documents evidence to support the storage of specific products in specific locations and compliance with regulatory and standards-based guidance
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Identifies potential problem areas and recommendations for reduction of variability
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Provides documentation for development of a Monitor Placement Protocol
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Includes the development of a Qualification Protocol (QP) based on actual field tests that include load configurations, conditions, expected environmental extremes, and the projected transportation channel