Ensuring Thermal Stability Compliance of Critical Storage
From warehouses to stability chambers, temperature fluctuations inside controlled storage environments directly impact product safety and efficacy. Mapping thoroughly identifies risks requiring mitigation.
Our temperature mapping specialists have sensor-qualified thousands of controlled storage assets globally including:
- – Stability Chambers
- – Refrigerators and Freezers
- – chromatography Units
- – Cryogenic Tanks
- – Lyophilizers
- – Steam Sterilizers
- – Incubators
- – Research Laboratories
- – Mobile Coolers
Leveraging 21CFR Part 11 compliant data loggers with certification, our protocols reveal:
- – Temperature uniformity
- – Hot and cold spots
- – Effects of entry/exit
- – Mapping during worst-case scenarios
- – Impact of equipment cycles
“With 90 freezers requiring mapping, Valitech provided the certified loggers and manpower to complete in just 2 weeks – an impossible task internally.”
Sr. Facilities Manager, Atlantis Research
Our mapping deliverables include:
- – SOP
- – Sensor Placement Maps
- – Qualified Sensor Calibration Certificates
- – Raw Data Files
- – Gap Analysis Reports
- – CAPA and Preventions
- – Periodic Review Plan
With clear visibility into stabilizing storage environments, ensure product efficacy and safety while strengthening inspection readiness.