Mesa Labs’ Compliance and Validation Services experts have more than 14 years’ combined experience in:
IQ/OQ/PQ qualifications and temperature mapping of incubators, freezers, refrigerators, autoclaves, depyrogenation ovens, and lyophilizers.- Cleanroom qualifications, including viable and non-viable particulate monitoring for routine monitoring and ability to determine the placement of the non-viable particulate measuring equipment to meet ISO, FDA and EU requirements.
- IQ/OQ/PQ qualifications of manufacturing equipment, e.g. reactors, mixing vessels, homogenizers, fluid beds, filter dryers, etc.
When customers call Mesa for their Compliance and Validation Services, Zach Sparks – Manager of Validation Services – is the primary contact for scheduling the work, performing the work, and preparing the final report package. This primary point-of-contact system allows for direct communication and all-encompassing knowledge of your project.
All of Mesa’s final packages are completed to meet cGMP/GDP/GLP requirements and are well organized so that data and results are correctly referenced in the protocol and easily accessible.
Mesa performs all temperature mappings using DataTrace data loggers, which have NIST-traceable calibrations that were performed in our ISO 17025 accredited laboratory. The data loggers are serviced before every project to help ensure that there are no issues encountered due to defective data loggers or lost data.
In addition to temperature mapping of equipment and terminal sterilization equipment, Mesa also provides qualification/validation services for clean rooms and qualification of manufacturing equipment.