External Sterilization of Aseptically Filled Pre-filled Syringes

O

orittal

#1
Looking for information regarding any requirements for sterilization of the external surface of aseptically filled syringes. This is a medical device prodcut that can't be terminally sterilized (protein in nature) and is intedned for surgical use/implantation. DOes anyone have experience with similarily sterile product that did not require surface sterilization of the syringe and secondary packaging within an operating room environment ?
Thanks
 
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Ajit Basrur

Staff member
Admin
#2
Looking for information regarding any requirements for sterilization of the external surface of aseptically filled syringes. This is a medical device prodcut that can't be terminally sterilized (protein in nature) and is intedned for surgical use/implantation. DOes anyone have experience with similarily sterile product that did not require surface sterilization of the syringe and secondary packaging within an operating room environment ?
Thanks
Welcome to the Cove :bigwave:

Can you pl be more specific as to what is the medical device ?
 

pkost

Trusted Information Resource
#3
For specific requirements I am unaware of any other than the requirement that if you label it as sterile then it has to have an SAL of 10^-6.

Is sterilising a pre filled device the only option available? Could you not place the protein in a bottle that remains outside the sterile field; then from within the sterile field fill a sterile syringe?

Failing that, I don't know much about the process of keeping sterile through aseptic techniques however, could you not sterilise the syringe then fill and pack it in an aseptic environment?
 
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