Can the whole 4X or 8X panel be run on a single vial?
Not as an execution or release promise. Controlled Rapid-only accession reserves one sealed analytical container, but the laboratory may request supplemental material until a signed ledger proves every destructive preparation fits and the molecular platform is qualified. A "10 mg" active label is not proof of total usable cake. A conservative USP <71> submitted-container accession uses two dedicated culture containers, one for FTM and one for SCDM, plus one reserved analytical/Rapid container, for three total. USP <71> may be ordered and accessioned, while its sterility determination and COA release remain held until the signed procedure, exact product/matrix suitability, and media-control package are bound. Optional consistency vials answer a separate question about vial-to-vial consistency.
Does the sterility test need more than one vial?
Yes. The conservative USP <71> submitted-container accession uses both Fluid Thioglycollate Medium (FTM) and Soybean-Casein Digest Medium (SCDM), with one dedicated whole sealed container for each medium, plus one reserved analytical/Rapid container, for three total. A "10 mg" active label does not establish total physical fill, and the laboratory may request supplemental material until the exact analytical ledger is qualified. Required culture containers are included with the service and are not paid conformity repeats. A one-container Rapid DNA result remains a research screen, not a sterility test or viable-CFU claim.
Is a one-vial sterility result a lot-release pass under USP 71?
No, and we will not certify it as one. A one-container Rapid DNA result is not USP <71> at all. For a USP <71> production-batch claim, the chapter's parenteral sampling table applies per medium: for a lot up to 100 finished containers, at least 10% or 4 containers, whichever is greater, are tested in each medium. A 40-container lot therefore has a conservative minimum of eight culture containers: four for FTM and four for SCDM, plus the separately reserved analytical allocation. Axiom accepts the declared service into controlled accession, but the batch-representative sterility claim and COA release remain held until the laboratory qualification and exact material ledger are complete. Required culture containers are not paid conformity repeats.
Is conformity testing the same thing as cross-vial consistency?
Yes: one product, two names, and the naming is our fault. "Per-vial conformity" is the choice you make on a multi-vial submission (each vial is analysed separately instead of pooled); "cross-vial consistency" is what those extra vials are billed as, starting at $95 and stepping down per vial. The mechanics: send at least two vials from one lot in a single submission, each vial's purity and net content are run independently, the lot mean must be on target, and the vial-to-vial coefficient of variation must sit inside the 5% default limit (tightenable per lot). Two vials is the minimum because a single vial has no uniformity to measure.
What does "Containers tested" on the certificate mean?
For a USP <71> execution, it is the observed number of physical containers allocated to the two-media sterility determination, locked from the accepted service plan and verified against vial intake before release. It is not automatically the shipment's total physical-vial count and does not include analytical containers established by the signed panel material budget or optional consistency vials. The count prints face up so a no-growth result cannot be read as covering containers that were never tested. The Rapid DNA research screen does not use a USP <71> containers-tested claim.