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 Oorja provide the services of temperature/RH mapping of All pharmaceuticals storage area like RM Store, FG store, Quarantine Area, Large Warehouses with 21 CFR part 11 compliance instrument. We provide detailed report of mapping activity generated by software with all parameter like MKT, Thermal Stability, Thermal Uniformity, Time Vs Temperature Trends, Determination of Hottest /Coolest Points.
Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.
We perform validation of sterilizer with 21 CFR part 11 compliance instrument and generate detailed report with all parameter like F0 calculation, Spread temperature, Span temperature Etc.
GMP requires that Drug manufacture should establish the quality of the pure steam used in the production of Drug substance. Therefore, the quality of pure steam must be validated. Steam validation document is intended to provide documentary evidence that the steam being generated and used meets the quality parameters of the pure steam.