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FREEZE DRYER (1).pptx
Freeze drying, also known as lyophilization, uses sublimation to preserve the biological activity of thermolabile materials by removing water at low temperatures under vacuum. The process involves pre-freezing the product, primary drying where ice is sublimated under vacuum, secondary drying to remove residual moisture, and packing under inert gas. Freeze drying results in a dry, porous product that can be stored without refrigeration and reconstituted without loss of quality or activity. It is useful for drying heat-sensitive compounds and materials that require aseptic processing or long shelf life.
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FREEZE DRYER (1).pptx
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- 2. OBJECTIVES • To preservethe biological activity of a product • To reduce the product weight to lower the transportation cost • To extend the shelf life or stability • To dry thermo labile materials • To eliminate the need for refrigerated storage • To get accurate sterile dosing in to the final product container Sruthi’s Pharma World
- 3. PRINCIPLE • Freeze dryingis also known as lyophilization • lyophilisation is carried out using a simple principle of physics, sublimation • Sublimation is the transition of substance from the solid to the vapor state without passing through an intermediate liquid phase. Sruthi’s Pharma World
- 4. PRINCIPLE • The entireprocess is performed at a low temperature and pressure (usually below the triple point) by applying vacuum, hence it is suited for drying of thermolabile compounds Sruthi’s Pharma World
- 5. CONSTRUCTION • A dryingchamber in which trays are loaded • Heat source : radiation source, heating coils • Vapor condensing or adsorption system • Vacuum pump or steam ejector or both Sruthi’s Pharma World
- 6. CONSTRUCTION • The distancebetween subliming surface and condenser must be less than the mean path of the molecules • This increases the rate of drying Sruthi’s Pharma World
- 7. CONSTRUCTION • The temperatureof the condenser must be much lower than the evaporated surface of frozen substance (to maintain this condition condenser surface must be cleaned repeatedly) Sruthi’s Pharma World
- 8. WORKING 1. Preparation AndPretreatment 2.Prefreezing For Solidifying Water 3.Primary Drying(sublimation Of Ice Under Vacuum) 4.Secondary Drying(removal Of Residual Moisture Under High Vacuum) 5.Packing Sruthi’s Pharma World
- 9. PREPARATION AND PRETREATMENT •The solution is pre-concentrated under normal vacuum tray drying • This reduces the actual drying by 8-10 times Sruthi’s Pharma World
- 10. PRE-FREEZING TO SOLIDIFYWATER • The sample should be packed in vials, ampoules, or bottles • Kept in cold shelves (about-50°c) • During this stage cabinet is maintained at low temperature and pressure Sruthi’s Pharma World
- 11. PRIMARY DRYING • Afterfreezing, the product is placed under vacuum. • Heat is applied to frozen product to accelerate sublimation • The temperature and pressure should be below the triple point of water i.e., 0.0098°c and 0.533kilopascals for sublimation when water alone is present Sruthi’s Pharma World
- 12. PRIMARY DRYING • Vacuumis applied to the tune of 3mmhg • The temperature is increased to about 30°c in a span of 2 hours • The driving force for sublimation: the temperature and vapor pressure difference between evaporating surface and condenser Sruthi’s Pharma World
- 13. PRIMARY DRYING • Thisenables the frozen solvent in the product to vaporize without passing through liquid phase, a process known as sublimation • Easily removes moisture up to 98% to 99% Sruthi’s Pharma World
- 14. SECONDARY DRYING • Removalof residual moisture under high vacuum . • The temperature is raised to 50°c-60°c and vacuum is lowered about 50mmhg • Bound water is removed • Rate of drying is slow • It takes about 10-20 hrs Sruthi’s Pharma World
- 15. PACKING • After vacuumis replaced by inert gas, the bottles and vials are closed Sruthi’s Pharma World
- 16. CHARACTERISTICS OF FREEZEDRIED PRODUCT • Sufficient strength • Uniform color • Sufficiently dry • Sufficiently porous • Sterile • Free of pyrogens and particulates • Chemically stable both in dry and reconstitution Sruthi’s Pharma World
- 17. ADVANTAGES Removal of waterat low temperature Thermo labile materials can be dried Compatible with aseptic operations Sterility can be maintained Reconstitution is easy Loss of volatile material is less Sruthi’s Pharma World
- 18. DISADVANTAGES The product isprone to oxidation due to high porosity and large surface area Cost may be an issue depending on the product Long time process Sruthi’s Pharma World
- 19. USES • Used fordrying blood plasma and fractionated products bacterial and viral cultures human tissues Sruthi’s Pharma World
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