Cleanroom Validation

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:

Warehouses
Cold storages
Transportation vehicles with controlled area
Portable refrigerators
Transportation boxes
Climatic chambers
Fridges
Etc.

Lab prova | Cleanroom Validation

OUR SERVICES

Validation is an essential part of Good Manufacturing Practices (GMP). It is, therefore, an element of the quality assurance program associated with a particular product or process.

HVAC Commissioning and Qualification

A well designed Heating, Ventilation and Air-Conditioning (HVAC) system play an important role in ensuring the manufacture of quality pharmaceutical and microelectronic products.

Equipment Qualification

All equipment involved in critical activities, such as air handling and filtration equipment, sterilization equipment, process equipment, laboratory equipment, thermal equipment, etc. should be subject to qualification.

Compressed Air Qualification

Compressed air in most of the GMP production processes comes into direct contact with the product, and as such needs to be identified as critical utility the variability of which has an impact on the product quality and therefore should be monitored or controlled.

Thermal Mapping

Facilities, equipment, systems, vehicles and containers used to distribute, store or handle products that requires controlled temperature conditions within specified range, need to be appropriately verified in terms of their designed purpose.

Validation and Qualification Documentation

All qualification and validation activities should be planned and take the life cycle of facilities, equipment, utilities, systems, process and product into consideration.

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