Who is actually filling all these 10 mL bac water vials?
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Genuine curiosity question, no agenda, no accusation. I can't figure this out and I'd like to know what people here actually know.
Nearly every vendor sells bac water in 10 mL, some in 3 mL and 5 mL. But the Hospira product everyone references is a 30 mL multiple dose vial, and it's plastic, not glass. Most vendor photos show glass with a rubber stopper and a crimped seal. Not the same object.
So where does the 10 mL come from? Possibilities I can think of:
- Someone buying 30 mL vials and drawing them down into aliquots, which is a sterile compounding operation.
- A registered repackager. The FDA NDC directory lists several labelers for bacteriostatic water that are distributors and repackagers, not original fillers.
- A compounding pharmacy or outsourcing facility filling to order.
- The vendor mixing and filling it themselves. Empty sterile 10 mL vials are sold off the shelf.
What I'm wondering:
- Has anyone found a manufacturer name, NDC, or lot number on a 10 mL vial, or is it always just vendor branding?
- Has any vendor told you who fills it when you asked?
Not trying to start a vendor pile-on. "Sterile" and "0.9% benzyl alcohol" on a label says nothing about who made it or how. If you know because you work in this space, I'd like to hear it.
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I ASSume it's automated...
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It’s almost certainly contracted out, the same as most beer and other stuff is. The capital costs to do it in house are prohibitive*, and keep in mind that the vast majority of peptide vendors are resellers operating out of a storage facility or mailboxes etc - regardless of how slick their web site is.
- Assuming you want to sell actual bac water, (insert concerns about maintaining sterility while personally decanting bac water in your spare bedroom).
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