3 replies to this topic

[matthewcc]

Hello, I have a question that I don't think I saw come up in the forums.

 

We sample incoming components that will get used in the manufacture of finished dietary supplements. We normally sample in non-sterile bags such as Ziploc bags. Under ordinary circumstances, this seems fine, since they are appropriate for food-contact and the components they hold might have an aerobic plate count (APC) limit on the order of millions of cfu/g. However, for some components, where the APC limit is going to be much lower, such as <1000 cfu/g, then it gets closer to needing a sterile bag. In fact, a third-party laboratory brought this up; we sent them a sample in a non-sterile bag, and it was for testing to an APC limit of <1000 cfu/g and eventual use in identification of microorganisms.

 

Ziploc seems like it is low-risk for the reasons I mentioned and it seems to me they would almost certainly have a documented hazard evaluation (HACCP) for the materials they use.

 

Are Ziploc or other non-sterile bags acceptable for component-contact or product-contact, or, as the APC specification limit gets lower, closer to sterility, is a sterile bag such as a Whirl-Pak bag needed? Additionally, for simplicity, are bags such as this normally Whirl-Pak across the board to avoid having to choose which bag is needed for a particular component/product sample?

 

We are regulated in the United States under 21 CFR Part 111 and 117 and we have SQF and NSF GMP certifications for manufacturing dietary supplements. 

 

Thank you,

Matthew

[Scampi]

I wouldn't risk it, ever

 

Whirpak bags are cheap and remain sterile til you open them

[G M]

Most of our samples end up in stomacher bags, which also come sterilized.

[jfrey123]

I don't like it.  That said, my old spice company used them a lot when the companies who owned the product wanted us to pull composite samples at higher amounts.  We traditionally kept our in-house retains in whirlpack bags because we didn't want the argument of a contaminated ziplock to be an issue if we saw any elevated micro counts.

 

My concern is that you have to touch both sides of the top of the bag with your hands over it to seal it.  Food residue can get stuck in the zipper mechanism.  And good luck getting a COA from Ziplock that the bags were sterile.  Also brings up that, unless you use enough to qualify for a pallets direct from Ziplock, you're unlikely to get the documentation needed for an approved supplier program (lab materials being something you want to be able to control).