Recommended Solutions for Lyophilization
Ensure the Safety of Your Freeze Drying Processes
Qualifying your freeze dryer is crucial to the quality and reliability of your final product – there’s no two ways about it. The real question is when should your freeze dryer go through qualification? And additionally, how often and with what equipment?
The Right Equipment for Your Freeze Dryer
Ellab recommends performing a qualification of your process under one of the following conditions:
- Your internal SOP requires it
- You have installed a new system
- You have implemented major changes to your system
- You have had to relocate your setup
- Your process has not been qualified for 6-12 months
Performing the appropriate qualifications is one thing, but having the right equipment to do the job can be a science in of itself – however, it doesn’t have to be. With reliable products like:
- LyoPro data logger: Eliminate data gaps and stay FDA compliant with a data logger designed to perfectly fit any vial size and freeze dryer
- TrackSense Vacuum Sensor: Ensure the integrity of your chamber throughout the entire process
- TrackSense Thermocouple Sensor: Get a high-powered device equipped with ultra-thin sensors that ensure next to no impact on the sample.
Reasons why You Should Perform Batch Control
The loss of a batch within the freeze drying industry can carry a heavy price tag. Which is why monitoring the entirety of the process could essentially save you a fortune. There are in fact many additional benefits to performing batch control:
- Every process would be documented, and your product would be verifiably safe to use
- Learn how your product behaves during the process, which in turn allows you to optimize future runs
- Catch potential errors early to initiate emergency protocols
Avoid the Loss of Batch
To perform batch control of freeze dryers and ensure product integrity, Ellab recommends having at least 5 measuring points per shelf:
- 1 sensor in every corner of the shelf
- 1 sensor in the center of the shelf
We would also heavily recommend using either the LyoPro wireless data logger or TrackSense Thermocouple or SmartFlex Sensors to complete the job.
Either option can work with more than 100 data loggers and sample for the entirety of the process – thereby providing a complete overview of the study.
They can also be setup for live transmitting so you can view critical data in real-time – allowing you to catch potential errors early on in the process.
Guarantee the Accuracy of Your Sensors
Within the freeze drying world, there’s little room for error – which makes regular calibrations a must have.
Performing pre- and post-calibrations of every sensor is the only way to ensure that the measuring devices were accurate going in, and accurate coming out.
Calibrations Right when You Need them
To address the importance of calibrations within freeze drying, Ellab has ensured that it’s easier and more controlled than ever.
The ValSuite software, which is typically used for qualifying and validating processes, can also be used as a calibration software. The software not only allows your measuring and calibration equipment to function together, but also allows you to perform the calibrations yourself without the need for a third party.
Ellab’s temperature sensors can easily be user-calibrated within any of our calibration solutions.
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Field Service and Consulting
Get on-site validation, qualification and calibration services, as well as expert GMP consulting.
LyoPro used to Qualify a Freeze Dryer with 15 Shelves
“The data loggers (LyoPro) proved ideal for shelf temperature mapping, without the need for feeding thermocouples through the chamber wall. Ellab went from proof of concept to delivering a system with 75 independent measuring points in less than 4 weeks. It has been a real pleasure working with Ellab on this project.”
Rasmus Kirkegaard Stage
- Technical Compliance Engineer at Bavarian Nordic A/S
Choosing the Right Solution for Freeze Drying
Ellab has a lot of well-established solutions for the qualification, validation and monitoring of freeze dryers. Ultimately, the LyoPro data loggeris what we would recommend for most freeze drying setups as it:
- Maintains the integrity of your isolator by providing wireless transmission from within the process
- Eliminates data gaps and provides a complete study by storing data backups within the internal memory
- Can easily be inserted into your process by being steam sterilized and inserted either manually or through automatic loading
- Provides repeatable and instantaneous measurements with pin-point accuracy and fixed measuring points
- And much, much more…
Alternatively, we also offer several other options to address your preferences and other parameters such as vacuum:
- TrackSense Vacuum Sensor: Qualify the vacuum of your freeze dryer to ensure the integrity of the chamber
- TrackSense Thermocouple Sensor: Replace and calibrate ultra-thin thermocouple sensors at will on a wireless device
- TrackSense Double SmartFlex Sensor: Get two measuring points per data logger to cover several areas of interest
- E-Val Pro Wired Thermocouple System: The traditional cable-based system with highly accurate thermocouple sensors
Delve into the most important features of Tracksense® LyoPro with our new product video
Alternative Solutions for Lyophilization
ValSuite® Software Reports
Lyophilization
