Freeze-drying, also known as lyophilization, is a process used to preserve proteins by removing water from the product while keeping it in a solid state. It involves three main steps:
1) Freezing the liquid product to form ice crystals.
2) Drying the frozen product under vacuum to allow ice to sublimate directly from its solid to gas phase.
3) Secondary drying to remove remaining water and yield a dried, stable product.
This process is commonly used for foods, pharmaceuticals, and other products to extend shelf life without extreme heat that can damage components.
Freezing is a unit operation in which temperature of a food is reduced below its freezing point (removal of sensible & latent heat of fusion), and a proportion of the water undergoes a change in state to form ice-crystals. Immobilization of water to ice and the resulting concentration of
dissolved solutes in unfrozen water lowers the water activity of the food. Lowering of temperature, lowers the microbial activity as well as suppresses the chemical reactions in the food. Generally,
we find two type of freezing method, quick freezing and slow freezing. In slow freezing, food products are introduced to low temperature for relatively longer time duration and hence the ice crystal formed are of larger in size, which are sometimes not at all desirable depending on
characteristic of food product. In quick freezing, relatively even lower temperature is used for food product but exposure time is less. Hence the ice crystal formed are of smaller size. Even though small ice crystal formed during quick freezing helps in preserving the texture and other characteristic of product, sometimes it may cause to temperature shock to product. Choosing the method of freezing is hence of utmost importance.
Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes; freezing, primary drying (sublimation), and secondary drying (desorption).
The advantages of lyophilization include:
Ease of processing a liquid, which simplifies aseptic handling
Enhanced stability of a dry powder
Removal of water without excessive heating of the product
Enhanced product stability in a dry state
Rapid and easy dissolution of reconstituted product
Disadvantages of lyophilization include:
Increased handling and processing time
Need for sterile diluent upon reconstitution
Cost and complexity of equipment
The lyophilization process generally includes the following steps:
Dissolving the drug and excipients in a suitable solvent, generally water for injection (WFI).
Sterilizing the bulk solution by passing it through a 0.22 micron bacteria-retentive filter.
Filling into individual sterile containers and partially stoppering the containers under aseptic conditions.
Transporting the partially stoppered containers to the lyophilizer and loading into the chamber under aseptic conditions.
Freezing the solution by placing the partially stoppered containers on cooled shelves in a freeze-drying chamber or pre-freezing in another chamber.
Applying a vacuum to the chamber and heating the shelves in order to evaporate the water from the frozen state.
Complete stoppering of the vials usually by hydraulic or screw rod stoppering mechanisms installed in the lyophilizers.
There are many new parenteral products, including anti-infectives, biotechnology derived products, and in-vitro diagnostics which are manufactured as lyophilized products. Additionally, inspections have disclosed potency, sterility and stability problems associated with the manufacture and control of lyophilized products. In order to provide guidance and information to investigators, some industry procedures and deficiencies associated with lyophilized products are identified in this Inspection Guide.
It is recognized that there is complex technology associated with the manufacture and control of a lyophilized pharmaceutical dosage form. Some of the important aspects of these operations include: the formulation of solutions; filling of vials and validation of the filling operation; sterilization and engineering aspects of the lyophilizer; scale-up and validation of the lyophilization cycle; and testing of the end product. This discussion will address some of the problems associated with the manufacture and control of a lyophilized dosage form.
What is freeze-drying, advantages, areas where it is used, the principle of freeze-drying, processing method, and why this method to be chosen? (animations are used)
Freezing has been successfully employed for the long-term preservation of many foods, providing a significantly extended shelf life.
The process involves lowering the product temperature generally to -18 °C or below.The extreme cold simply retards the growth of microorganisms and slows
down the chemical changes that affect quality or cause food to spoil.
During freezing the cellular solution present in the food matrix is cooled to its initial freezing point, and further cooling causes the water molecule to
separate, forming ice crystal.
The migration of water molecules during crystallization led to an increase in osmotic pressure, further enhancing the water permeability of the cell membranes. This transport of water molecules, if not controlled, can eventually affect the microstructure of the frozen produce.
The freezing process occurs in two successive steps, i.e,
” NUCLEATION” and “CRYSTAL GROWTH”.
Freezing is a unit operation in which temperature of a food is reduced below its freezing point (removal of sensible & latent heat of fusion), and a proportion of the water undergoes a change in state to form ice-crystals. Immobilization of water to ice and the resulting concentration of
dissolved solutes in unfrozen water lowers the water activity of the food. Lowering of temperature, lowers the microbial activity as well as suppresses the chemical reactions in the food. Generally,
we find two type of freezing method, quick freezing and slow freezing. In slow freezing, food products are introduced to low temperature for relatively longer time duration and hence the ice crystal formed are of larger in size, which are sometimes not at all desirable depending on
characteristic of food product. In quick freezing, relatively even lower temperature is used for food product but exposure time is less. Hence the ice crystal formed are of smaller size. Even though small ice crystal formed during quick freezing helps in preserving the texture and other characteristic of product, sometimes it may cause to temperature shock to product. Choosing the method of freezing is hence of utmost importance.
Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes; freezing, primary drying (sublimation), and secondary drying (desorption).
The advantages of lyophilization include:
Ease of processing a liquid, which simplifies aseptic handling
Enhanced stability of a dry powder
Removal of water without excessive heating of the product
Enhanced product stability in a dry state
Rapid and easy dissolution of reconstituted product
Disadvantages of lyophilization include:
Increased handling and processing time
Need for sterile diluent upon reconstitution
Cost and complexity of equipment
The lyophilization process generally includes the following steps:
Dissolving the drug and excipients in a suitable solvent, generally water for injection (WFI).
Sterilizing the bulk solution by passing it through a 0.22 micron bacteria-retentive filter.
Filling into individual sterile containers and partially stoppering the containers under aseptic conditions.
Transporting the partially stoppered containers to the lyophilizer and loading into the chamber under aseptic conditions.
Freezing the solution by placing the partially stoppered containers on cooled shelves in a freeze-drying chamber or pre-freezing in another chamber.
Applying a vacuum to the chamber and heating the shelves in order to evaporate the water from the frozen state.
Complete stoppering of the vials usually by hydraulic or screw rod stoppering mechanisms installed in the lyophilizers.
There are many new parenteral products, including anti-infectives, biotechnology derived products, and in-vitro diagnostics which are manufactured as lyophilized products. Additionally, inspections have disclosed potency, sterility and stability problems associated with the manufacture and control of lyophilized products. In order to provide guidance and information to investigators, some industry procedures and deficiencies associated with lyophilized products are identified in this Inspection Guide.
It is recognized that there is complex technology associated with the manufacture and control of a lyophilized pharmaceutical dosage form. Some of the important aspects of these operations include: the formulation of solutions; filling of vials and validation of the filling operation; sterilization and engineering aspects of the lyophilizer; scale-up and validation of the lyophilization cycle; and testing of the end product. This discussion will address some of the problems associated with the manufacture and control of a lyophilized dosage form.
What is freeze-drying, advantages, areas where it is used, the principle of freeze-drying, processing method, and why this method to be chosen? (animations are used)
Freezing has been successfully employed for the long-term preservation of many foods, providing a significantly extended shelf life.
The process involves lowering the product temperature generally to -18 °C or below.The extreme cold simply retards the growth of microorganisms and slows
down the chemical changes that affect quality or cause food to spoil.
During freezing the cellular solution present in the food matrix is cooled to its initial freezing point, and further cooling causes the water molecule to
separate, forming ice crystal.
The migration of water molecules during crystallization led to an increase in osmotic pressure, further enhancing the water permeability of the cell membranes. This transport of water molecules, if not controlled, can eventually affect the microstructure of the frozen produce.
The freezing process occurs in two successive steps, i.e,
” NUCLEATION” and “CRYSTAL GROWTH”.
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3. INTRODUCTION
Freeze-drying stabilizes and preserves the
product’s proteins. The product begins in
liquid form, and is then frozen, causing
crystals to form. Next, the product is dried in a
vacuum before the temperature is increased.
9. Principle
Freeze drying also called as lyophilization. It is a low temperature
dehydration process that involves freezing. Process was first
applied to food products after the second world war. Coffee was
first freeze dried food products to be produced but now
vegetables, fruits, fishes, meats can be freeze dried.
10. Steps:
2. Freezing (Solidification):
- Low temperature and low atmospheric pressure.
- Ice crystallization
- (-50 degree celcius to -80 degree celcius)
1. Pre-treatment:
- This may include concentrating the product & formulation revision.
- Decrease high vapor pressure solvent.
- Increase the surface area
11. Steps:
4. Secondary Drying:
- Desorption
- Temperature increase with 50 degree celcius & Pressure decrease.
- Water stage not involved.
3. Primary Drying:
- Sublimation: Ice will be removed from the product which is freezed.
- Pressure decrease heat is supplied.
- 98% - 99% of moisture will be removed.
