USP <71> sterility testing
Sterility is the release test for anything injected. We run it in this building on two MilliporeSigma Steritest systems, not through a subcontractor, and publish the result on the same accession as the chemistry.
How the test is run
The sample is filtered through a 0.45 µm membrane inside a closed Steritest canister so the membrane is never exposed to room air. The canister is rinsed, then filled with tryptic soy broth for aerobes and fungi or fluid thioglycollate medium for anaerobes, and incubated fourteen days at the temperatures USP <71> specifies. Any turbidity in any canister is a failure, and the organism is identified. Media growth promotion is verified per lot, and a method suitability test confirms the product itself does not inhibit growth. The work happens in a SterilGARD II class II biosafety cabinet in the sterility suite.
What it costs and what to send
| Price | $195 per sample |
|---|---|
| Turnaround | 14-day incubation plus reporting; about three weeks from receipt |
| Sample | One extra sealed vial from the same lot. Endotoxin and sterility share that vial. |
| Matrices | Injectable peptides, sterile raw materials, ophthalmics, cosmetics claiming sterility |
| Reported as | Sterile or Not sterile for the units tested, with method suitability and media lot on the certificate |
Sterility is not bioburden
A bioburden count (USP <61>/<62>) tells you how many organisms a non-sterile product carries. It cannot release an injectable: a low count before the final filter says nothing about whether the filter worked. Sterility asks the release question directly, and the fourteen-day incubation exists because slow-growing organisms do not show in five. The full explanation is in USP <71> sterility vs bioburden.
Order it with endotoxin
Endotoxin (USP <85>) is the other release test for an injectable, and it shares the vial. The two together are $394 on top of identity and purity, or choose the 7x testing level in the intake builder, which adds sterility to identity, purity, net content, endotoxin, heavy metals and conformity.
Questions
Can I order sterility alone?
Yes. Nothing is bundled. Select only sterility in the intake builder and send one sealed vial.
Why does it take fourteen days?
USP <71> specifies a minimum fourteen-day incubation so that slow-growing organisms have time to produce visible growth. There is no validated shortcut for the compendial test.
Do you subcontract it?
No. Sterility runs in our own sterility suite on MilliporeSigma Steritest systems in a SterilGARD II cabinet. The instrument and media lot are printed on the certificate.
What if the sample fails?
The organism is identified and the result publishes like any other, with the method suitability data. We do not repeat the test to obtain a pass; a second sample from the lot can be tested as a new accession.
Do you also run rapid sterility methods?
Not at present. We report the compendial fourteen-day result.
Related
Peptides testing · USP <85> endotoxin testing · USP <71> sterility vs bioburden · Peptides testing · SARMs testing · Kratom testing · Hemp testing
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