Lyophilization Technology 03/2011. 03/03/2011Lyophilizer Tech. Summary | 03 March 20112 What is...
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Transcript of Lyophilization Technology 03/2011. 03/03/2011Lyophilizer Tech. Summary | 03 March 20112 What is...
Lyophilization Technology
03/2011
03/03/2011 Lyophilizer Tech. Summary | 03 March 2011 2
What is freeze-dryingWhy is it used
A means of preservationUsed to provide a stable product that may
be stored for a long time.Applied to products and materials that may
change if heat is applied.A dehydration processInvolves sublimationA batch process and can take a long time.
03/03/2011 Lyophilizer Tech. Summary | 03 March 2011 3
Advantages of Lyophilization
Proteins thermally sensitive can be dried. Products sensitive to oxygen can be sealed in N2. In a vial the fill volume is accurate giving better dosage
control than powder filling. The second drying step can be controlled to give
excellent long term storage properties. No change in moisture level during storage. More control of the environment compared with other
methods. Products are more stable after lyophilizing.
03/03/2011 Lyophilizer Tech. Summary | 03 March 2011 4
What kind of products can be freeze-driedNon-biological products
heat-labile chemicalsNon-living bio products (majority)
enzymes, hormones, antibiotics, vitamins, blood products, antibodies,
vaccines, pharmaceuticals bone and body tissues for surgical/medical use, foodstuffs
Living organismsMiscellaneous materials
03/03/2011 Lyophilizer Tech. Summary | 03 March 2011 5
Required from a lyophilized material?
Dried to the right moisture contentEthically acceptableCosmetically RefinedActive!StableCake likeClean
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-100
-80
-60
-40
-20
0
20
40
60
0 5 10 15 20 25 30
Refrigeration VacuumSystems
EquipmentFaultfinding
Tem
pera
ture
Freeze DryerDesign
CycleDevelopment
Critical temperature
Shelf temperature
Product temperature
Pre-Freezingstage
Holdingperiod Primary
dryingSecondaryDrying
Time
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The Process for lyophilization1. Solution preparation, Depth in a vial is 0.5 inch.
The water based products are typically < 10% solutions.
2. Freezing, Freeze to -40 0C. Freezing below a critical temperature before the drying process. Kept at its lowest temperature for a given period to ensure all the material is frozen. Form large, contiguous ice crystals. Be frozen quickly. Freeze rate is 10C/minute
3. Primary Drying. Supply of heat and the pressure used. Involve Sublimation
4. Secondary Drying5. Stoppering (vials)6. Final condition
03/03/2011 Lyophilizer Tech. Summary | 03 March 2011 8
Sublimation Solid (ice) to a vapor. An energy intensive process Latent heat of sublimation of ice
2800 kJ/kg (1200Btu/lb). In Lyophilizing step, product must go from a
solid form to a vapor. For sublimation to occur, supply the energy.
03/03/2011 Lyophilizer Tech. Summary | 03 March 2011 9
Phase Diagram for Pure Water760 torr
100 0C
4 torr
Liquid
Triple point
Vapor
Solid
Product Temp.
03/03/2011 Lyophilizer Tech. Summary | 03 March 2011 10