A Profound Explanation of Freeze-Drying Technology and Freeze Dryer Technology
Nowadays, with the continuous development of freeze-drying techniques and freeze dryer technology, freeze-drying is increasingly widely used in the development process of sterile formulations. In the entire process of freeze-dried sterile formulations, freeze-drying technology is the most critical process, and the freeze dryer is the most crucial core equipment. Freeze-drying is a process, and how to produce high-quality freeze-dried products centers around freeze-drying technology and freeze dryer technology.
Freeze-Drying Protective Agents
To enable certain formulations to be successfully freeze-dried or to improve the solubility and stability of freeze-dried products, or to give freeze-dried products an attractive appearance, some additives need to be added to the liquid formulation. These are called protective agents, sometimes also referred to as fillers, excipients, buffers, or substrates. Protective agents must be chemically inert to the final product.
Functions of Freeze-Drying Protective Agents:
1. Serve as a microbial culture medium
2. Increase the concentration of freeze-dried formulations
3. Reduce damage to the product during freezing or sublimation
4. Raise the eutectic point of the product
5. Improve the stability of product storage and increase storage temperature
6. Eliminate free radicals, enhancing the stability of freeze-dried products
Three Important Stages of the Freeze-Drying Process:
1. Pre-freezing: Freezing speed; lowest temperature; thawing time;
2. Sublimation Drying Stage: Pc (dryer vacuum level), T (shelf temperature), Tp (product temperature)
3. Desorption Drying Stage: Pc (dryer vacuum level), Tp (product temperature)
Three Key Factors for Producing High-Quality Freeze-Dried Products:
1. A Good Freeze Dryer
- Meets GMP, cGMP, FDA requirements;
- Outstanding performance, good stability;
- Advanced technology, adjustable energy;
- Strong reproducibility;
It can be seen that the freeze-drying process is a complex one. From the selection of excipients, freezing speed, determination of product temperature to the choice of vacuum levels, all have significant effects on the appearance and quality of freeze-dried products. Only by thoroughly understanding the content of freeze-drying process research can issues related to the quality of freeze-dried pharmaceuticals be resolved.
Therefore, selecting a good freeze dryer suitable for your own products and knowing how to use a good freeze dryer to produce appropriate products becomes very important.
Article Tags: Freeze Dryer
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