Validation of Lyophilization Processes
How can I validate my lyophilization process?
The lyophilization process is essentially freeze-drying, where the environment is at a very cold temperature and the product is within a “vacuum”. During the process, there is a concern with making sure that the shelf is heating up the product to proper temperatures. Typically, this is a stainless steel shelf of a certain size that can be heated from underneath. This heat is applied to the product while under a vacuum and when already in a frozen state, which allows the water within the product to sublimate from a solid state directly to a gas, without compromising the integrity of the product. For this reason, we want to closely monitor not only the shelf temperature, but the product temperature as well. Validating the lyophilization process in this way guarantees it is effective.
Micro Flex Data Logger for Validation of Lyophilization Processes
Validation meets the convenience of real-time data
Typically, we would have used thermocouple probes to validate a lyophilization process; however, recognizing the need for a proper solution, we have developed the NEW Micro Flex Logger! The Micro Flex Logger is a small, 2mm diameter probe that can fit inside vials for vial monitoring. To accompany the Micro Flex, we also have the Surface Flex attachment. The Surface Flex goes onto the Micro Flex Probe to allow you to monitor the surface of a lyophilization process. Together, these new products make it easy to have the right probe set for monitoring your product, so you can collect the surface temperature right from the vial.
Similar to the thermocouple, the Micro Flex Logger has ideal response time needed in changes to temperature. The puck we use for the Micro Flex Logger is made of brass, and the brass has a very efficient temperature response time. Since the Micro Flex Logger is built from the foundations of our MPRF product line, it allows the convenience of having real-time data as your process is happening. Now, you can make changes or decisions on the fly based on the evidence in front of you – not based on hunches or intuition. You will know if you need to make X, Y or Z changes in the process as it is happening. Feel confident as you validate your process, and save time. If you are monitoring a process remotely, your real-time data will instantly let you know if there is a problem that needs to be addressed.
How does it work?
To perform a validation using the Micro Flex Logger, start by placing surface flex probes in the locations you think are the coldest. Then, put a probe into a vial and confirm that the vial is reaching the proper temperature within the period of time it should take to reach it. This is a typical validation process, but with the Micro Flex Logger and Surface Flex attachment, we now have the right probe set to get it done efficiently.
Remember to perform a temperature mapping on your shelf as well. To do this, use a systematic approach by putting loggers at regular intervals across the shelf, with probes in all corners and the middle. You will need to decide how many to space out across the plate for the best results.
If you have any questions about the new Micro Flex Logger or Surface Flex attachment, or need assistance with your next lyophilization process validation or temperature mapping, please contact us!