I've experimented sterilization with autoclave, but the melting point of used polymer polycaprolactone is 60 ° C and so it is not suitable for my formula...and so on sterilization with filtration because I have microparticles.
gamma radiation?
Have you tried gamma rays sterilization as done in surgery for implants. Provided that it does not affect your polymer ?
Dear Aida! in pharmaceutical practice in most cases microparticles were prepared under aseptic condition and other methods rarely used. As the size of microparticles are usually around 100 to 300 micometer (of course it is highly depended on your prepration method) so with filtration method you may lose some part of your formulation. Also as the irradiation may cause degradation in your polymer so you need to be sure of this exposure. So the best way is doing formulation under aseptic condition.
Ethylene oxide, Formaldehyde Fumes treatment and exposure to gamma rays.
You can go for surface sterilization by UV or gamma irradiation. Else, you can sterilize the ingredients individually and prepare the final formulation under aseptic conditions.
If the aseptic condition is not possible as mentioned by Ebrahim then you have left the only posibiliteis of filtration (Even 0.4Microm M can work) and radiation. UV low intensity and if the facility is available gaamma irradiation is the best one. Regards
Hi Aida. You can sterile-filter the water that you're using before you start, then try to work under a hood or biosafety cabinet. Try to test your microparticle in a Petri-dish agar culture before you start to confirm sterility. Gamma radiation was also found to be effective, and doesn't cause considerable deterioration of polymer integrity, but you need to test drug release before and after radiation. please check this out:
http://www.ncbi.nlm.nih.gov/pubmed/23515830
Regards
These can be sterilized by filtration sterilization technique if you wish to get particle sizes less than 220 nm
Nano filter like Syringe pump can remove Micron size pathogenic particles but some virus and macromolecules can pass through the filter.
May include gamma radiation of fumigation for killing bacteria and viruses but can not remove antigenic particle if contaminated before formulation.
Best Regards
PP
what if the polymer is damaged by heat? or by energy-containing methods, like beta (e-BEAM, which no-one has mentioned) or gamma radiation? Filtration affects the constituents of the polymer (e.g. solid content). Please stop repeating yourselves, and cutting and pasting, but THINK!
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