Tips And Best Practices For Troubleshooting Biopharma Temperature Validation/Mapping

By Paul Daniel and Jon Aldous, Vaisala

The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics. To meet these requirements for temperature or humidity, we perform a mapping validation, usually as part of an installation qualification and operational qualification of the environment, be it: incubator, fridge/freezer, stability chamber, cold room, or warehouse.