Every sterility method the compendia recognize.
Sterility is a validated microbiological answer, not a quick read — the matrix must first be shown not to inhibit microbial growth (method suitability), then filtered or inoculated into two media and watched for 14 days.
Published. Per-test.
No quote calls.
Every assay a la carte, every panel bundled. Bulk discount at 5+ samples. Prices below reflect a single-compound submission.
Membrane filtration or direct inoculation, 14-day dual-media incubation, and method-suitability validation. The standard compendial sterility panel on a public COA.
- USP <71> membrane filtration / direct inoculation
- 14-day dual-media incubation
- Method-suitability (B/F) validation
- Public COA + accession #
The injectable-grade pair — USP <71> sterility plus USP <85> LAL endotoxin on one public COA, the receipt research buyers and compounders ask for.
- Sterility (USP <71>)
- Endotoxin (LAL, USP <85>)
- Numeric EU/mL + pass/fail
- Public COA + accession #
Sterility + endotoxin + bioburden (USP <61>) on one COA — the full microbiological safety picture for a parenteral lot.
- Sterility (USP <71>)
- Endotoxin (LAL, USP <85>)
- Bioburden (USP <61> TAMC + TYMC)
- Public COA + accession #
Where sterility QC fails.
Most flagged sterility results trace to inhibitory matrices that were never validated, false growth from environmental contamination during setup, or a container that couldn't hold the barrier.
USP <71>, USP <1211>, ISO 17025 Aligned, 21 CFR Part 11.
Sterility testing is anchored by the compendial chapter and sterility-assurance guidance — here's what we map to on every sterility COA.
The compendial method — membrane filtration or direct inoculation into fluid thioglycollate (anaerobic/facultative) and soybean-casein digest (aerobic/fungal) media, 14-day incubation, with method-suitability validation required before any claim.
The informational chapter on sterility-assurance principles — sterility is a probability established by process design and validated testing, not proven absolutely by a single article.
Bioburden enumeration and specified-organism screens that set the pre-sterilization baseline and support the sterility program.
The cGMP requirement that sterile products carry sterility testing; as an analytical contract lab we generate the data your QA team files inside its own GMP release package (we are not the sterile-drug release filer).
Incubation logs, growth reads, and analyst records retained per 21 CFR Part 11-style data-integrity principles; available to the client of record on request.
USP <71> sterility testing detects viable microorganisms by incubating the article — or a membrane the article was filtered through — in two growth media for 14 days. It's used for injectables, sterile APIs, compounded sterile preparations, and medical devices. No growth in either medium over the full incubation is a pass; any recovered growth is a fail pending investigation.