How sterile depot parenteral products manufactured. Have any one of you worked on sterile injectable manufacturing especially depot and suspension injections. Can you please share process steps, and processing equipments required. Should we need sterile API for making injectable sterile suspension. What are the sterilization methodologies in commercial sterile suspension manufacturing.
yes we need sterile API to make sterile suspension injection , if filled product can not be terminally sterilized .
in case of terminaly sterilisable product we not require sterile API
Autoclave/ heat sterilization can be done at different cycle .
hi
It depends on the nature of your product, you should use sterile excipient and API's if you are producing oily suspension and if you are producing aqueous suspension you can terminally sterilize your product by heat (for non heat sensitive).
Regards
If suspension cannot be sterilized by filtration then it is compulsory to sterile the API and then process the whole step Aseptically. Or one phase of suspension is first dissolved and filtered to the another phase which is before sterilized by Autoclave or again by filtration and then suspension are prepared.
Parenteral suspension may have at least +/- 5 micron of particle size. It musn't be sterilzed by filtration, moreover if your A.P.I. is unstable in heat. So, you must choose the "STERILE" A.P.I and also "aseptic' process. For the solution which unavailable in sterile form, you may sterillize it using filtration and/or heat sterilization method.
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