AccuFlux® Heat Flux Monitor & Control
THE POWER OF ACCUFLUX®
- Know that your product has nucleated properly
- Know when your product is fully frozen
- Know when your product has stabilized at its annealing temperature
- Know if there are any material changes to your freeze drying process
- Monitor and Control the Freezing process
- Monitor and Control Primary Drying Dynamics
- Know the amount of water removed
- Optimize your freeze drying process
- Know that the product was processed as expected
- Transfer protocols to production the first time
- Have a real time tool for predicting process time
- 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.
- 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.
- Monitor Primary Drying dynamics.
- Control the rate of drying by adjusting the shelf temperature to control the heat flux.
FREEZING – NUCLEATION AND CRYSTALLIZATION
During freezing the product may not change temperature, such as during removing latent heat in the freezing step. Although the product temperature doesn’t change, there is a significant heat transfer event taking place. Post nucleation latent heat removal
(the speed of heat transfer), has a major impact on ice crystal size, orientation and distribution.
The ice crystal structure dramatically influences the drying performance and final product appearance. Measuring the heat flow provides feedback for shelf temperature control during the freezing process to control the crystal structure.
Imagine being able to reproduce the conditions in your production freeze dryer in your laboratory system. Using the AccuFlux measurement, the shelf temperature can be dynamically adjusted to control the energy transfer to simulate your production system, allowing you to produce a protocol that is fully transferrable to production the first time.
Need further information?
Don’t hesitate to contact us, our customer service representatives are happy to help! Just fill in the contact form and we will get back to you as soon as possible. Use the link below to get in touch with us.
Via A. Pacinotti, 19 05100 - Terni, Italy
+39 075 9729017 / firstname.lastname@example.org
Stefano Montagnoli - CEO
Mobile Phone: +39 335 8078512
Sanesi Paolo - Technical Director
Mobile Phone:+39 348 3345859