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Freeze-dryers in pharmaceutical companies

Freeze-drying has become a common practice in the pharmaceutical industry since its first applications in the 1940s. Since then, the freeze dryer has evolved from a simple vacuum drying equipment to a highly sophisticated and integrated system, which combines a series of processes to ensure systematic production according to technical and biological specifications.

Freeze-drying is a process that aims to separate the liquid (water or other solvent) from an organic material, or a solution, by freezing and then sublimation of ice under reduced pressure, thus generating a dehydrated product without altering its qualitative and quantitative composition, ie preserving the molecular structure of the substance to be preserved. This is achieved through the use of a freeze-dryer.

A freeze dryer consists of a dry chamber or freeze drying chamber, a condenser with a refrigeration circuit and a vacuum system.

Freeze-dried products include antibiotics, bacteria, sera, vaccines, diagnostic drugs, biotechnology products, proteins, as well as products containing cells, tissues and chemicals. The product is subjected to a freezing process at sub-atmospheric pressure. Then, in an initial drying phase defined as primary drying, water is removed (as ice) by sublimation; in the second phase, secondary drying is removed by desorption.

Freeze-drying is considered one of the safest and most widely used techniques for sample preparation in the pharmaceutical industry. It has been used in the preservation of biological materials such as blood plasma, serum, hormones and biologically complex pharmaceuticals such as vaccines, serums and antidotes, as well as in many diverse research projects in this industry, as this process offers excellent retention. .of molecular structures of biological samples.

This is why freeze-dryers are of vital importance in the pharmaceutical field, since the process implemented in these equipments aims at reducing the lability of these very delicate components present in the formulation.

A freeze-drying cycle can be divided primarily into four stages: freezing, evacuation, primary drying and secondary drying. Each of these steps is important in its own right, although the most critical factors to consider in the process occur during freezing and primary drying.

Advantages of freeze-drying

  • Maintains the chemical stability of the product, enzyme preparations do not undergo alterations.
  • Inhibits the growth of microorganisms.
  • Inhibits deterioration by chemical reactions. Oxidation phenomena are eliminated, since it is operated and conditioned under vacuum.
  • Facilitates the storage, transportation and preservation of products. As the remaining moisture is negligible, the product can be stored for an unlimited period of time, constituting products with long stability.
  • It allows to recover the properties of the preserved material only by rehydrating it. The high porosity facilitates a quick reconstitution by adding water or the appropriate solvent.
  • Prevents heat damage to the material to be preserved, as high temperatures are not used. The temperature to which the product is subjected is lower than those at which many unstable substances undergo chemical changes.
  • Reduction of additives and preservatives.

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