AccuFlux® Heat Flux Monitor & Control

KEY FEATURES

• True PAT measurement for Lyophilization
• QbD Tool—Ability to develop Design Space in a single run
• Eliminates the need for thermocouples in the vial
• Continuous monitoring for both freezing and drying
• Non-Invasive and non-interruptive
• Batch size independent
• Works in both the lab and production
• Localized measurement instead of batch average
• Extreme sensitivity and stability
• Develop cycles in the lab for transfer to production
• Measure equipment performance changes
• Measure product container variations

Lyophilization Heat Flux
MEASUREMENT AND CONTROL DURING NUCLEATION, FREEZING AND PRIMARY DRYING

ACCUFLUX is the first in-situ real time process monitoring and control system for lyophilization and is the only tool that is a Process Analytical Technique (PAT) allowing monitoring and control of every step in the freezing and primary drying phases of your freeze drying run.

ACCUFLUX is designed to obtain a precise direct reading of thermal transfer to the vial. Knowing the energy transfer allows the process to be verified, optimized, repeated and controlled without the use of thermocouples or other invasive measurement techniques.

FREEZING

• The Kv is used to verify that there is no material change in heat transfer between batches.
• The shelf temperature can be adjusted to maintain a constant heat flow.
• During freezing the heat flux will reach zero when the vial has reached equilibrium.

PRIMARY DRYING

• Monitor Primary Drying dynamics.
• Control the rate of drying by adjusting the shelf temperature to control the heat flux.