Definition: Validation studies demonstrating that thermal packaging systems (insulated boxes, gel packs, phase change materials) maintain required temperatures for specified durations under defined ambient conditions.
Why It Matters: Qualified packaging is essential for pharmaceutical cold chain shipments. Provides documented evidence of temperature protection duration. Required for GDP compliance and high-value product protection.
Qualification Parameters:
– Temperature range maintained
– Duration of protection
– Ambient temptemperature profile
– Payload configuration
– Coolant preparation requirements
Test Conditions:
– Summer profile (high ambient)
– Winter profile (low ambient)
– Transition profiles
– Various payload sizes
– Worst-case scenarios
Documentation Required: Packaging specifications, coolant conditioning procedures, assembly instructions, validation test reports, re-qualification intervals
Related Terms: Thermal Packaging, Gel Packs, PCM, GDP, Validation