EO Sterilization of Drugs in Custom Convenience Kits

[Victoria7]

We are a Repackager/Relabeler and I have been ask to search for guidance on putting drugs in our custom packs. One of our sales reps has came across another kit packer who is placing plastic mutidose flip top vials in their kits, then EO sterilizing and I dont think this is acceptable practice. We normally request this information from our suppliers but I was hoping to find documentation somewhere quickly. Can anyone in the forum help me out?:
Thanks,
Vicki

 

[Stijloor]

A Quick Bump!

Can someone help Vicki?

Thank you very much!!

 

[Scott Catron]

We are a Repackager/Relabeler and I have been ask to search for guidance on putting drugs in our custom packs. One of our sales reps has came across another kit packer who is placing plastic mutidose flip top vials in their kits, then EO sterilizing and I dont think this is acceptable practice. We normally request this information from our suppliers but I was hoping to find documentation somewhere quickly. Can anyone in the forum help me out?:
Thanks,
Vicki

A little more detail would be helpful. We were producing topical antiseptics in sponge applicators that were being placed into kits that were shipped to Mexico for EO sterilization.

What is it about the process you describe that makes you think it's not acceptable?

 

[Victoria7]

Thanks for the reply Steven. We currently will place sterile glass vials/ampules of Rx in our kits as the EO will not permeate the glass. If we have an Rx that is in a plastic vial or bottle we will piggyback it. The piggybacking process is when you place the sterile Rx in a separate bag that gets attached to the kit after it has been EO sterilized therefore the drug is never exposed. I have worked in the kit packing business for 4 years (previous was pharmaceuticals) and it has always been an understanding the EO will permeate plastic. I am not sure where this information comes from but that is what I have been told since working here. I have searched everywhere for data to support this but have had no luck. We depend on our suppliers through a questionnaire process to allow or not allow us to subject their components to EO.

 

[MIREGMGR]

A kit containing both a device and a drug is a combination product, and must be Listed as such (explicitly per the 2013 rules that apply beginning in a week) and coordinated through the Office of Combination Products.

My understanding is that in the case of a kit containing a drug, the CDER side of the clearance process will include a requirement that, if the external packaging has been exposed to EO, either a sufficient technical explanation (i.e. the drug's immediate packaging is of a type that has been shown to be impervious to EO penetration or other effect) or testing data must be provided to show that the drug has not been affected by the EO.

I think the Office of Combination Products would be the place to ask such questions. It's their job to be the information coordinator, and route questions to who will provide FDA's authoritative answer.

I would agree that packaging a drug in most plastics and then EO exposing would be highly undesirable.

 

[Victoria7]

Well have to admit I am embarrassed that this is the first I have heard of The Office of Combination Products. I am not sure that we fall in that catagory as it has never never been mentioned during a FDA or ISO Audit. Since our kits are convenience kits we do not hold 510K's. Thanks for the info. I am definatly checking it out.

 

[MIREGMGR]

http://www.fda.gov/AboutFDA/Centers...ofScienceandHealthCoordination/ucm2018184.htm