Freeze dryer

#FreezeDryer

1. GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY Presented by- Jinia Rina Ghosh (18601919065) Kaenat Faiz (18601919068) Ayan Sarkar (18601919072) Ahana Paul(18601919076) Piyali Basak (18601919088) Freeze Dryer

2. CONTENTS Introduction Principle Construction Working Advantages and Disadvantages Applications of freeze drying Desired characteristics of freeze dried products Practical aspects of freeze drying Maintenance Conclusion Reference

3. INTRODUCTION Drying: Drying is an important technique used in industry. Prevent deterioration. Improves solubility. Removes trace amount of water or liquid by heat. Equipments for drying: Tray dryer Spray dryer Fluid bed dryer Vacuum dryer Drum dryer Freeze dryer Freeze Drying: Lyophilisation Material is freeze then high pressure vacuum is applied First applied in food products. Most common unit process for manufacturing drug products too unstable to be marketed as solutions. Instrument used for freeze drying, is called freeze dryer. [1]

4. PRINCIPLE [1]

5. CONSTRUCTION [2]

6. WORKING [2]

7. Fig: Lyophilisation process Fig: Example of freeze-drying

8. ADVANTAGES 1. Thermolabile materials can be dried. 2. Denaturation does not occur. 3. Loss of volatile material is less. 4. Sterility can be maintained. 5. Material can be dried in its final container such as single does and multiple dose vials. 6. No need to refrigerate. 7. Less damage to the physical structures. 8. Constituents of the dried material remain homogenously dispersed. DISADVANTAGES 1. Expensive. 2. Time-consuming process. 3.Effective for selected items. 4. Difficult for solutions containing non-aqueous solvents. 5. Some issues associated with aseptic loading of vials into the chamber. 6. Volatile compounds may be removed by high vacuum. [2] [2]

9. APPLICATIONS OF FREEZE DRYING Industry Applications 1. Ceramics To create formable powder. 2. Pharmaceuticals Proteins, vaccines, enzymes, hormones etc. 3. Food processing Flavorings, juices, instant meals and soups etc. 4. Dairy industry High value proteins. 5. Technological Industry Chemically synthesized products, late stage purification procedures. 6. Research Stabilization and storage of biological materials. Fig: Food processing Fig: Ceramics Fig: pharmaceuticals [2,3]

10. DESIRED CHARACTERISTICS OF FREEZE DRIED PRODUCTS Intact cake Sufficient strength Uniform color Sufficiently dry Sufficiently porous Sterile Free of pyrogens Free of particulates Chemically stable Fig: Freeze-dried ice-cream Fig: Freeze-dried fruits Fig: Freeze-dried sterile pharmaceutical products [2]

11. PRACTICAL ASPECTS OF FREEZE-DRYING Have appropriate analytical tools and methods in place for formulation characterization and stability studies. Depend on literature, previous experience (if none, use consultants). Initial formulations should use commonly-known excipients used in freeze-drying. Solids content should be between 5% and 30% with a target of 10% to 15%. Should have several initial formulations to evaluate and compare. Determine appropriate processing parameters. Optimize formulation and process based on stability information. [3]

12. MAINTENANCE Freeze dryer PC maintenance when the system is running slow. Freeze dryer vacuum pumps maintenance. Refrigeration should be checked by functional tests every four months. Cleaning and calibration The condenser temperature should be 10 to 15°C below the sample’s eutectic point. Certain acids should not be used with bare stainless steel and should only be used with PTFE models. Defrost and drain the condenser after each standard run. Neutralize the chamber if acid is being used. Do not overload freeze dryer. Put completely frozen sample. [2]

13. CONCLUSION Freeze drying or lyophilization is process in which water is frozen, followed by its removal from a sample, initially by sublimation, then by desorption. The term lyophilisation describes a process to produce a product that loves the dry state. This is applicable in various pharmaceuticals, food industry, for thermolabile products, substances that are unstable in aqueous solutions etc. Maintaining all the steps uniformly, all the desired products can be obtained ensuring the maximum productivity. [1]

14. REFERENCE Lachman . L.; Liberman . H.A. Joseph.B.S . Pharmaceutical dosage form tablet.2,Marcell Dekker Vol.1 126-137 Remington. The science and practice of Pharmacy 20. Lipincott William and winkins . Vol.1 525-532 Martin. A.; Physical Pharmacy.4,B.I.Warly.pvt.ltd.NewDelhi.22-40 GEA Pharma & Healthcare - https://youtu.be/9iS0usklM58