we will be aseptically manufacure eye ointments in multi-dose.
but i don`t know aseptically manufacture.
examply,tube(gamma?) and API is being supplied sterile material
But how InActive Pharmaceutical Ingredients should aseptic?
In Active Pharmaceutical Ingredients should not also sterile filtration
How should I sterilization?
Please advise.
It sounds as though you will need a sterile product.
The best way to do this is through terminal sterilization, if your product can handle the sterilization process.
If it cannot be terminally sterilized, then can it be sterile filtered, then aseptically filled?
If not, then you will need to purchase raw materials that are sterile, and/or you will have to sterilize them yourselves (such as autoclave/depyrogenate), and you will have to design an aseptic suite and perform aseptic operations. Aseptic operations are expected now to be done using isolators (ideally) or sterile process trains.
This is probably the most difficult type of product to do, with the highest risk, and the most regulatory scrutiny. I think you’re going to have to hire some additional people or consultant to get this off the ground. This is a HUGE topic.
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Dear JH_RYU,
You may use one of the following techniques:
1- If API can’t be sterilized through sterile filtration, then you can sterilize the API through autoclaving or use sterile API (gamma irradiated) and and then aseptically add the API in the base which may be previously sterilized by sterile filtration. Fill the product in the previously sterilized (gamma irradiated) tubes.
2-Terminally sterilize the filled product through irradiation. Terminal sterilization through steam is very difficult and require special techniques to withstand the pressure inside the tube.
Regards