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GMP Pharmaceutical Vacuum Freeze Dryer Machine Lyophilizer for Injection Powder
1. Working Principle of Vacuum Freeze Dryer:
Freeze Dryer, also known as Lyophilizer, is widely used for pharmaceutical and biological industries.
Freeze drying technology, also known as lyophilisation or cryodesiccation, is a low temperature dehydration process that involves freezing the product, lowering pressure, then removing the ice by sublimation. This is in contrast to dehydration by most conventional methods that evaporate water using heat.
A freeze-dryer consists of a vacuum chamber, shelves, process condenser, shelf-fluid system, refrigeration system, vacuum system, and control system.
There are four stages in the complete freeze drying process: pretreatment, freezing, primary drying, and secondary drying. Usually, the freezing temperatures are between −50 °C (−58 °F) and −80 °C (−112 °F).
2. Application of Lyophilizer in Pharmaceuticals and Biotechnology:
Common use of pharmaceutical freeze dryer is to produce lyophilized vials, that is using freeze-drying process to increase the shelf life of the products, such as live virus vaccines, biologics and other injectables(injection powders), by removing the water from the material and sealing the material in a glass vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection and for self-administration by a patient.
Freeze-dried biological products and bio-pharmaceuticals include many kinds of vaccines, antihemophilic factor VIII, anti-blood clot medicine, and wasp venom allergenic extract. Many bio-pharmaceutical products based on therapeutic proteins such as monoclonal antibodies require lyophilization for stability.
Freeze-dryers are also used in manufacturing of raw materials for pharmaceutical use. Active Pharmaceutical Ingredients (APIs) are lyophilized to achieve chemical stability under room temperature storage. Bulk lyophilization of APIs is typically conducted using trays instead of glass vials.
3. Features of Our Freeze Dryer:
All the parts of the vacuum freeze dryer contacting with the products are made of imported 316L stainless steel;
The surface roughness of the automated lyophilizer reaches Ra≤0.5um;
The inner Chamber of the pharmaceutical freeze dryer has a smooth transition without dead corner, no objects accumulated consider for user, the structure is easy to clean;
Option for steam sterilization or chemical sterilization for the biological freeze dryer;
Except for the above, it can also provide automatic running CIP and SIP to ensure high quality of cleaning and the sterilization of both laboratory freeze dryer and industrial production freeze dryer.
4. Advantages of Our Freeze Drying Equipment:
1. Targeted lab-to-production scale from 0.5sm-50sm for optimum manufacturing and cost efficiency;
2. Automatic loading/unloading of lyophilized products to minimize handling and microbial exposure;
3. Famous European and USA branded components to ensure high performance;
4. International advanced 3D design of spraying nozzles, which is in better accordance with the requirements of thorough sterilization;
5. Shelves cylinder is equipped with the AISI 316L stainless steel bellows which can prevent cylinder oil from spreading and has a integrated function of in-place inspection;
6. Temperature control accuracy±0.5ºC (adjusted by PID);
7. Chamber, shelves, flexible hoses are all carried out with leak test by helium mass spectrometer;
8. We accept customized design and provide user-friendly control system;
9. We have professional design and manufacturing teams and perfect after-sale service.
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