A release decision made on independent data.
01 — Lot lifecycle
Receipt and quarantine
Each incoming shipment is assigned a TrueBac lot number, matched to the manufacturer’s batch record and certificate, counted and labeled. The lot enters our system in Quarantine. The order system will not allocate a quarantined lot to any order.
Sampling and independent testing
Samples are drawn from across the lot and sent to an independent laboratory in the United States accredited to ISO/IEC 17025. The laboratory is not affiliated with us or with the manufacturer.
Release or rejection
When the laboratory report is received, every result is recorded against its specification. A lot is Released only if every result conforms. Otherwise it is Rejected and never sold. Reports for rejected lots are retained and published too.
Traceability
Every order records the lot numbers it was filled from. The lot appears on your vial, your packing slip and your account, and each lot record lists its report and the report’s SHA-256 fingerprint.
Complaints and recall
Quality complaints are logged against the lot and reviewed. If a problem is attributable to a lot rather than a single unit, the lot is placed on hold or recalled. Our system identifies every order that received it, and we notify those customers directly.
02 — Test panel
Every lot is tested against the same panel. Exact specification limits appear on each report.
| Test | Method | Acceptance | Purpose |
|---|---|---|---|
| Sterility | USP <71> | No growth after the full incubation period | Detects viable microorganisms in the units tested. |
| Bacterial endotoxins | USP <85> (LAL) | Below the limit set for the lot specification, in EU/mL | Measures pyrogenic endotoxin from bacterial cell walls. |
| Particulate matter | USP <788> | Within limits for particles ≥10 µm and ≥25 µm | Counts sub-visible particles. |
| pH | USP <791> | Within the specified range | Confirms the solution has not drifted outside its range. |
| Benzyl alcohol assay | HPLC | 0.9% w/v nominal, within the specified tolerance | Confirms preservative concentration. |
| Identity | HPLC / reference standard | Conforms | Confirms the preservative is benzyl alcohol. |
03 — Limits of testing
We think you should know what a passing report does — and does not — establish.
That the units sampled from the lot met each specification when tested, by a qualified laboratory independent of us and of the manufacturer, using recognized compendial methods.
That every unit in the lot is sterile. Sterility testing examines a sample. A low rate of contamination can pass undetected by any practical sample size. Testing reduces uncertainty; it does not remove it. This is why we combine it with quarantine, traceability and recall, and why our products are supplied for laboratory use only.