Regulatory Open Forum

Hi all,

I have a question regarding the sterile barrier symbol. We have an injectable device that is enclosed within a syringe via a cap and stopper. The syringe is sterilized and then placed into other levels of packaging. No other level of packaging is sterilized.

GSPR 23.3(a) requires that "sterile packaging be recognized as such"; as I understand it, this requirement is typically satisfied by applying one of the four sterile barrier symbols listed in ISO 15223-1 to the level of packaging that is sterilized. However, I am wondering how, if at all, the sterile fluid pathway symbol would interact with this requirement.

If our labeling includes the sterile fluid pathway symbol (thus making clear that the injectable formula is sterilized), does this in any way satisfy GSPR 23.3(a)? Does the fact that only the syringe (which is used to administer the device) is sterilized, and that other levels of packaging are not sterilized render GSPR 23.3(a) not applicable? Or, is the sterile barrier symbol always required when packaging is sterilized, whether it be primary packaging such as syringes, or otherwise?

Thanks!