Cleanroom Validation | GMP IQ OQ PQ Qualifications | Thermal Mapping

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Cleanroom Validation | GMP IQ OQ PQ Qualifications | Thermal Mapping

Thermal Mapping

Thermal Mapping

Lab prova | Thermal Mapping

Facilities, equipment, systems, vehicles and containers used to distribute, store or handle products that requires controlled temperature (humidity) conditions within specified range, need to be appropriately verified in terms of their designed purpose.
In addition, for pharmaceutical products, support of adequate VALIDATION AND QUALIFICATION DOCUMENTATION is required.
Following the guidance of Good Distribution Practice (GDP) and Good Storage Practice (GPS), thermal mapping is critical activity that need to be performed during qualification of the storage and distribution chain (e.g. cold chain as a temperature-controlled supply chain).
Worst-case approach should be implemented (e.g. for warehouses, yearly weather picks are summer and winter conditions).

Thermal mapping of the facility should be well designed to support assurance of uniformity of the temperature (humidity) across the storage facility, and able to define worst-case areas of the facility and locations that shows most fluctuations.
The transportation process should not compromise the integrity and quality of the products. Continues data acquisition of the temperature (humidity) should be present and it is recommended that monitors are located in hot and cold spots defined during thermal mapping execution.

The storage and distribution chain of pharmaceutical products and materials up to their point of use are normally associated with:

Lab prova | Cleanroom Validation

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Cleanroom Validation

LAB PROVA was founded with the aim to fullfill the need of the local market for laboratory that would be able to provide professional cleanroom validation service. Specific needs of the pharmaceutical industry, through the years, naturally shaped our professional approach, dedicated to customer satisfaction.

Knowledge about applications, experience, research and development helped us to establish strong co-operation with world leading manufacturers of measuring equipment, for a wide range of industrial applications.