Terminal Sterilisation

Hi All,

We manufacture sterile empty stoppered & crimped vials. WE are looking at terminal sterilisation by steam sterilisation. However I do not believe this is possible as there is no guarantee the inside is sterile. Therefore gamma sterilisation could be am option.

We claim this vial to be sterile
We also have a sterile nitrogen filled vial that we need to terminally sterilise. I don’t know if steam sterilisation is appropriate here either

Does anyone have any recommendations.

Thank you.

You can acheive sterilization of empty bottles that are stoppered and crimped in an autoclave if you dispense a small amount ~0.5-1.0mL or more (depending on bottle size) of purified or WFI water into the bottle prior to stopper and crimp. Choose the water source based on the end use of the sterile bottle. The autoclave cycle for this would typically be an air overpressure. Heat transferred to the bottle from the cycle will turn the water to steam and sterilize the inside of the bottle. Load validation would be much like what is described in PDA Report #1.