Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase.
Freeze drying is widely used in the pharmaceutical industry for vaccines, antibodies and other biological materials. According to their functions and applications, freeze dryers can be categorized into laboratory freeze dryers, pilot freeze dryers for research and small-scale production batches, industrial freeze dryers as well as freeze drying systems consisting of one or multiple modules.
Tofflon laboratory freeze dryers serve for pharmaceutical formulation or process development & optimization, and facilitate technology transfer from R&D to production. It is a high-performance unit which is designed according to GLP principles to comply with the strictest international standards.
Formulation & Freeze‐Drying Cycles Development
Tofflon laboratory freeze dryers are specially designed for freeze-drying cycle development.
Built-in standard recipe template
The freeze-drying cycle can be processed manually or semi-automatically according to the recipe profiles, which is easy for real-time adjustment in the process development
After the recipe setting is created, SCADA software can run automatically
Freeze‐Drying Cycles Scale‐Up
Tofflon laboratory freeze dryers are dedicated to design an optimized cycle including determination of process robustness in the laboratory, and save time and money during the scale‐up process.
Freeze‐Drying Cycles Optimization
Freeze drying is generally known to be time consuming and therefore expensive process. In order to lower costs during drugs production, the effective cycle time must be reduced. Tofflon laboratory freeze dryers can be used for freeze-drying cycle optimization during R&D stage.
Good physical appearance
Lower moisture containing
Shortest cycle time
Higher efficiency of drugs production
Lower cost
Vacuum Detection Solution
Freeze drying / lyophilization depends on vacuum to accommodate sublimation. The measurement and control of vacuum are critical for the success of the process. The capacitance vacuum manometer is the preferred option for vacuum detection with technical features as below:
Not affected by the humidity of the ambient environment
Measurement accuracy up to 0.5%
The voltage value and the actual vacuum degree change linearly, and the data processing is more convenient and more accurate
Eutectic Point Monitoring
In the freeze-drying process, if the freezing temperature is too low, the freezing time will be prolonged and then the production cost will be increased. If the freezing temperature is too high, quality problems such as local boiling and foaming will occur during the drying process. In this way Tofflon has launched an eutectic point tester to assist users to detect the eutectic point of products, and effectively control the freezing and sublimation process.
Dew point monitoring is used to monitor the freeze-drying process, to determine the end point of freeze drying and estimate the residual moisture content, which can effectively improve process development and optimization efficiency.
Residual Gas Analysis
The Lyoshot developed by Tofflon is a mass spectrometer. The mass spectrometer has features as below:
Analyze the moisture content in the production process of drugs, and judge the end point of the freeze-drying cycle
It can detect the invasion of silicone oil molecules in time to determine whether the drug is contaminated
Leak testing for the containers can be conducted under vacuum.
Controlled Crystallization During Freeze-Drying
Controlled crystallization technology can make the product in the chamber crystallize at the same time within a certain period of time (generally within 1~3mins). Thanks to DOE experiment design, we can find the best combination of process parameters suitable for this kind of product through less experiments.
Can improve batch-to-batch uniformity
Optimize freeze-drying process
It can also provide theoretical data support for process scale-up
Organic Solvent Trapping
The solvent trapping system can not only collect organic solvent for secondary use in the freeze-drying process, but also does not cause environmental pollution, it can ensure the continued sublimation and drying, shorten the freeze-drying cycle, and stabilize and protect the freeze-dried products. Vacuum pump oil has a positive effect without being emulsified.
Online Sampling for Vials
It can help users to take out the vials without interrupting the freeze-drying process and maintaining the original freeze-drying environment for further analysis and testing, optimizing the freeze-drying process, and analyzing changes in the characteristics of materials.
Summary
Besides the above typical functions mentioned above, Tofflon Laboratory Freeze Dryers can be customized designed as per your special requirements such as CIP and SIP, double shelf spacing, dry vacuum pump and proportional aeration. What’s more, Tofflon Lyophilization Lab can support you with the selection of the most suitable freeze dryer but also expert advice on how it should be used.