Nov 18, 2007

Sterilization with a master carton or the product carton?

For some reason I can't remember now, my company has decided to ship product to sterilization in pallets of the final product carton instead of a master carton. Over the last three or so months I have come to the conclusion that this is a bad idea for a start up company and probably for all companies who don't have tight controls on the shipping and sterilization.

The master carton method consists of a few large, sectioned, pallet size boxes that the product is placed in, then onto a pallet, once the product is received back from the sterilizer the master carton has to be unpacked and product repackaged into the final product carton, the master carton can be reused. When you sterilize in the final product carton you just pile them all on a pallet, you can theoretically receive the product back from the sterilizer and quickly ship it out without the repacking.

The paperwork and inventory control are theoretically harder with the master carton method, as you have to document additional unpacking/packing as well as be sure to keep sterile and non-sterile loads separate. We are planning on selling only thousands of disposables a year for the foreseeable future, which also makes repacking not so horrible. Additionally, in practice the work required on the final product carton turns out to be just as bad as you have to repack (and document) some product if any boxes come back damaged from the sterilizer. Also, with the final carton method, you have to contend with short boxes due to sample pulling and the odd lot size. Another point to consider for the start up company is if you ever do change your final packaging carton, you will have to re-validate sterilization, or justify the change.

We still haven't done a final sterilization validation so we still have some wiggle room to make some changes- actually a lot of our packaging needs some minor redesign- this is one switch I'll hopefully be able to get to.


Jon said...

I recently learned there are more practical sterilization options. I posted about Andersen Products some time ago. Here is the link:
Andersen Products has a sister company, Andersen Scientific ( that is a real asset in small validation lots. I've been using them for a start-up client and it has been a wonderful option. We have also taken the approach of sterilization batch release versus a full sterilization validation. If you would like contacts for the Andersen organization, let me know. Coincidentally, I spent the day conducting a supplier audit of Andersen.

JCK said...

Jon, because of your mention of Anderson previously, my company is using them as well! I'm planning on going into more detail about our sterilization adventures, but am waiting for a few more details to shake out. Thank you for the recommendation as they have been very helpful.

Fred said...

Suppose I were to use Ansci as part of obtaining 510(k) clearance of an md. Is there any delay to the 510(k) process in comparison to traditional pallet sterilization? Sterility Review Guidance document K90-1 seems to indicate that it is a non-traditional, novel method that would trigger additional scrutiny by INCB.

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