Facility Thermal Mapping
Sensitech's Facility Thermal Mapping is a cost-effective service that helps to document the safe storage of temperature-sensitive products within warehouses and other storage facilities. 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.
A drug’s published label storage requirements are based on stability data collected and submitted during the drug-approval process. To protect the identity, strength, quality, and purity of a drug, the FDA and other regulatory agencies require that drugs be stored according to their label claim filings (21 CFR 211.142). Facility Thermal Mapping by Sensitech can help organizations comply with these regulatory requirements.
Facility Thermal Mapping by Sensitech is an efficient way to determine the precise temperature profile of a warehouse or other storage facility. While many warehouses are designed to adequately control environmental conditions, many variables can impact temperature and humidity within a facility, including airflow, facility layout, product storage locations, traffic patterns, HVAC performance, and seasonal extremes.
TempTale®4 monitors are self contained (non hardwired) and can be easily installed anywhere in a facility for maximum flexibility and effectiveness. Once downloaded, Sensitech’s validated monitors provide detailed, accurate reports on the thermal variances within a facility.
Benefits of Service
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Provides documented temperature and/or humidity profiles over time (summer and winter) that comprehensively identify conditions and variations across the unit being mapped
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Documents recommendations for use of each area and identifies locations unsuitable for storage of specific drug products
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Provides documentation to help comply with regulatory and standards-based guidelines
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Incorporates Mean Kinetic Temperature (MKT) calculations for separate areas
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Incorporates development of a monitor placement protocol for environmental control systems