Temperature / RH Mapping

All temperature/RH controlled storage areas must be mapped as part of a fully documented verification process. The purpose of temperature /RH mapping is to ensure that all areas of the process equipment or storage area achieve the required temperature/RH. The outcome of the temperature/RH mapping is to understand the temperature/RH distribution in a storage area, and to define hot or cold spots of the process equipment or storage area.

We Ishanvi Technical services LLP provide the services of temperature/RH mapping of All storage area like RM Store, FG store, Quarantine Area, Large Warehouses with 21 CFR part 11 compliance. We provide detailed report of mapping activity with all parameter like MKT, Thermal Stability, Thermal Uniformity, Time Vs Temperature Trends, Along with Hottest /Coolest Points.

Cold Chain Validation suddenly became a hot topic when the results of a government investigation into Cold Chain distribution compliance were published. The facts release indicated that nearly a quarter (23) of all drugs distributed in the USA, are of unknown efficacy. The distribution of these temperature sensitive products in vehicle containers that lacked validated methods of maintaining the correct internal temperature or even the ability to produce a validated history of what the actual conditions were; has rendered these products 'adultered', i.e. of unknown efficacy or safety. Vehicle body internal temperatures; with seasonal variations, can range from a high of 50 to a low of -40 (degrees centigrade). In contrast the mandated internal temperature for distribution containers for standard drugs and medical products is 2 to 8 (degrees centigrade), with much lower temperatures specified for some drugs.

This shocking news has certainly guaranteed that Cold Chain Validation compliance will be top of everyone's audit list, specifically when drug interactions with the end user are considered as critical. The implications of products being damaged and out of specification may induce many companies to replace doubtful goods or even trigger the regulators into initiating product recalls. This problem is expected to create a veritable stampede as distributors scramble to ensure that all the vehicles and containers they used in this essential everyday service, are rendered Cold Chain compliant, as soon as is possible.