Freeze drying is a critical process for producing biological drugs in vials within the pharmaceutical industry. The FDA estimates that more than 45% of all approved biological drugs produced today are manufactured using this approach.
Each of these vials hold a high life-sustaining and monetary value, making the act of preserving every single batch extremely vital. When combined with the immense energy consumption, a production batch of 50-100,000 vials could easily represent millions of dollars/euros – so failure is not an option.
To avoid batch loss, the freeze drying process must be accurately validated and the batch must be carefully monitored. Achieving this requires following FDA, GMP(A) and ISO guidelines, and using high-end validation and monitoring equipment, like LyoPro.
The LyoPro data logger is uniquely designed for freeze drying, addressing all the challenges this valuable process has to offer. The data logger itself can be configured to fit the size of the vials in question and comes with several specially designed fittings to ensure trouble-free operation for any vial size. Even if the vials are as small as 2R or as large as 100R – or anything in between.
The thermocouple sensor attached to LyoPro is easily replaceable with a spare, and the very thin tip (0.55 x 0.95 mm) ensures little to no impact on the sample. The complete TrackSense LyoPro data logger can also be user-calibrated, thereby maintaining the industry leading measuring accuracy.
TrackSense LyoPro eliminates data gaps with its high capacity battery and internal memory, providing a complete and trustworthy study from start to finish.
LyoPro can be sterilized at 121 °C for 30 minutes to ensure clean room compliance.
One Data Logger for All Vial Sizes
TrackSense LyoPro’s ‘train concept’ is what truly sets it apart from the rest. While the data loggers themselves are designed to fit the exact size of a standard vial, the specialized accessories made for LyoPro allows the wireless data logger to fit any vial size.
A LyoPro system comes with the following options to ensure a perfect fit and an effortless transition into the process:
LoggerNests: The LoggerNests allow you adjust the height of your LyoPro data logger to fit the exact height of your vial
Connection Clips: The Clips come in two variants, one for the sample vial and one for the buffer vial, allowing you to keep the LyoPro ‘train’ together and flexible
LyoStoppers: Keep your measuring point fixed and repeatable with the LyoStopper for your sample vial
All the Measuring Points You’ll Need Covering your entire freezer dryer with the required measurements points is easily achievable with TrackSense LyoPro. While on a wireless live connection, up to 100 data loggers can be run simultaneously in a single study – ensuring that you will never have to split-up your studies or fill in data gaps.