0
yes
Only If the process is followed by standards and protocol.
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.
Source.. FDA
link
Wiki User
∙ 7y ago
Add your answer:
Earn +20 pts
Is lyophilization a method of dry heat sterilization?
If we limit our discussion to the enveloped viruses HIV, HCV and HBV, then lyophilization is a sterilization method as explained in my recent article [Cell Tissue Bank (2011) 12:99-104]. Desiccation of the lipid envelops inactivates these viruses.
The concentration of glycerol used for lyophilization?
Not compatable with lyophilization. Not volatile
What is the difference between sterilization and canning?
The canning process is to preserve the food in the can. Sterilization is the process of killing bacteria that is normally heat resistant.
What is food sterilization?
Sterilization is the process of destroying microorganisms from food, medical instruments, etc.
What kills most microbes?
Sterilization is the process that destroys and or removes all microorganisms. It also removes microbial forms such as bacterial endospores.
Is lyophilization a method of dry heat sterilization?
If we limit our discussion to the enveloped viruses HIV, HCV and HBV, then lyophilization is a sterilization method as explained in my recent article [Cell Tissue Bank (2011) 12:99-104]. Desiccation of the lipid envelops inactivates these viruses.
What is sterilization process?
The sterilization process is to have something completely clean
The concentration of glycerol used for lyophilization?
Not compatable with lyophilization. Not volatile
What is the difference between sterilization and canning?
The canning process is to preserve the food in the can. Sterilization is the process of killing bacteria that is normally heat resistant.
What is the process by which all microrganisms are destroyed?
sterilization
Process that destroys or kills pathogens?
disinfection
What is the heat process which reduces pathogens to a safe level?
sterilization
What is flash sterilization?
Flash sterilization is a process used to clean objects. Rapid penetration of steam is used to sterilize and clean the items.
What is food sterilization?
Sterilization is the process of destroying microorganisms from food, medical instruments, etc.
What is the difference between lyophilization and freeze drying?
4
What is the difference between sterilize and disinfect?
Disinfection and sterilization are both decontamination processes. Disinfection is the process of eliminating or reducing harmful microorganisms from inanimate objects and surfaces. Sterilization is the process of killing all microorganisms.
What is female sterilization?
Sterilization means to make a person/animal be unable to ever have babies. Female sterilization refers to carrying out the process in a female. This may be done by tubal ligation, removal of the uterus, or removal of the ovaries.
