If you are looking for a high-yield investment in the pharmaceutical field and have sufficient knowledge in this area, we recommend reading this article to become familiar with the pharmaceutical freeze dryer and its applications in the production of various pharmaceutical products. The pharmaceutical freeze dryer, due to its high quality, has been ordered by the largest pharmaceutical companies in Iran in several series in less than a few years and has been produced by Takvin Azmayesh Parseh Company.

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Introduction

   Drying at low temperatures and under vacuum is one of the most widely used methods to increase the shelf life and consequently store pharmaceutical products and other biological materials by removing the cold chain. With this method, specific, unstable, or heat-sensitive drugs and biological materials can be dried at low temperatures without causing damage to their physical structure and properties. These products can be quickly and easily reconstituted, which is valuable for emergency vaccines and antibodies that need to be administered promptly. Among the materials stored using this method are vaccines and antibodies, penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria.

   The pharmaceutical freeze dryer of Takvin Azmayesh Parseh Company includes two categories. The first category is named based on the PH prefix, which is used for injectable drugs. The second category is for probiotic and edible drugs, named with the BIO prefix.

  1. Injectable drug series are named with the PH prefix and include models: PHS1-PHS2-PHS3-PHS4-PHS5.
  2. Edible drug series are named with the BIO prefix and include models: BIO12-BIO120-BIO240-BIO360-BIO600-BIO1000.

What is Freeze Drying?

   Freeze-drying, or lyophilization, performed by the pharmaceutical freeze dryer, is a preservation and drying process in which the water present in the sample is sublimated (direct conversion from a solid to a gas) without going through the liquid state. This method is used to preserve drugs, food substances, biological materials, and other moisture-sensitive materials.

   This method, compared to other heat-based drying methods, removes the moisture from drugs without altering their properties. Therefore, it is considered the best option for producing high-quality products, especially in the pharmaceutical industry. Additionally, the freeze-drying process using the pharmaceutical freeze dryer can effectively prevent chemical changes and contaminants present in the sample, protecting sensitive materials from degradation and contamination.

Applications of Pharmaceutical Freeze Dryer

The pharmaceutical freeze dryer is used in the pharmaceutical industry for various processes. Below are some important applications of this technology in pharmaceuticals:

  1. Drying Drugs: One of the main applications of the pharmaceutical freeze dryer is drying drugs. This process is used to remove water from drugs and produce dry and more stable samples, significantly increasing their quality and shelf life.
  2. Production of Powdered Drugs: The pharmaceutical freeze dryer can be used to produce powdered drugs. In this process, drugs are first dried and then converted into powder, which can be used for the preparation of tablets, capsules, and other pharmaceutical forms.
  3. Preservation and Storage of Enzymes and Biological Reactions: Some pharmaceutical processes require the use of enzymes and biological reactions. The pharmaceutical freeze dryer can be used to preserve and store enzymes and biological reactions to maintain their activity, ensuring better quality when used.
  4. Pharmaceutical Research and Development: The pharmaceutical freeze dryer plays a crucial role in pharmaceutical research and development. This technology allows researchers to test new formulations, examine specific drugs, and optimize drug production processes.

Examples of pharmaceutical products prepared using freeze-drying technology:

  • Vaccines
  • Antibodies
  • Red blood cells
  • Plasma (for easy transfer during severe blood loss or hemorrhagic shock)
  • Hormones
  • Bacteria
  • Viruses
  • Enzymes
  • Controlled-release drug tablets
  • Probiotics
  • Vitamins and minerals
  • Collagen peptides
  • Electrolytes (e.g., coconut water powder)
  • Active pharmaceutical ingredients (substances active in drugs, such as acetaminophen in Tylenol)

Components of Pharmaceutical Freeze Dryerفریز درایر دارویی

This device is composed of several components, each playing a crucial role in the operation and execution of the freeze-drying process. Some of the main components of the pharmaceutical freeze dryer include:

  • Main reservoir system and steam trap reservoir
  • Refrigeration system
  • Heat transfer system and shelves
  • Vacuum system
  • Power, precision instruments, and control system
  • CIP & SIP system
  • Stoppering system
  • Pizza door system
  • Auto loading and unloading system
  • Pharmaceutical freeze-drying process

The Pharmaceutical Freeze-Drying Process by the Machine

  1. Freezing: The desired product undergoes freezing, and this is done slowly to prevent the formation of large crystals that may rupture the cellular walls of the materials.
  2. Primary Drying (Sublimation): This second stage of the freeze-drying process involves reducing the pressure, and heat is applied to sublimate the frozen water. Completing this process takes about 10 hours, but depending on the sample, it can take several days. After completing the primary drying, 93 to 95 percent of the water has been removed through the sublimation process.
  3. Secondary Drying (Absorption): This final stage increases the temperature even further to remove the remaining moisture. Care must be taken to prevent under or over-drying. This stage is usually performed for samples intended for long-term storage. Secondary drying reduces the residual moisture in the product to only 1 to 2 percent.

   The dried drugs are then packaged in the pharmaceutical freeze dryer using various packaging options. For example, glass vials with rubber stoppers and aluminum crimped caps, as well as dual-chamber systems that can be syringes or cartridges.

Advantages of Pharmaceutical Freeze Dryer

   The pharmaceutical freeze dryer, like any other technology, has its specific advantages and disadvantages. Below are the most important advantages of this technology in pharmaceuticals:

  1. Preservation of Drug Quality: While freeze-drying requires heat for sublimating frozen water, it prevents excessive heat to protect the integrity of the product. By removing water from drugs and storing them at low temperatures, the pharmaceutical freeze dryer can preserve the quality and properties of the drugs, preventing undesirable changes in their lifespan.
  2. Increased Shelf Life of Drugs: Using the pharmaceutical freeze dryer can increase the shelf life of drugs. Keeping drugs at low temperatures and drying them can extend the useful life of drugs. For example, antibodies can have a shelf life of up to 5 years with proper storage conditions.
  3. Less Restriction in Storage and Transportation: When a product undergoes freeze-drying, it can be stored at room temperature for a longer period. This significantly reduces transportation costs, especially during long-distance exports, as there is no longer a need for a cold chain.
  4. Quick Access to Drug Formulations: Drug formulations prepared with the pharmaceutical freeze dryer, such as vaccines and antibodies, often require immediate administration. These products can be quickly reconstituted by adding distilled water or a specific solvent and are ready for use in the shortest possible time.

The standard for the Pharmaceutical Freeze Dryer by Parseh Experiment Formation Company.

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