Sterile, and the record to prove it.

Suitability before routine testing

A sterility test only means something if your product cannot suppress the organisms it is meant to reveal. Method suitability — the bacteriostasis and fungistasis study — challenges your product, in your chosen method, with low-level inoculum and proves recovery is not inhibited. It runs once up front, and again whenever the formulation, the container or the manufacturing process changes. Skipping it is the single most common finding on a sterility program.

Two methods, chosen by the product

Membrane filtration is the preferred method wherever the product can be filtered: the filtrate is rinsed to carry away antimicrobial residues, then the membrane is incubated in both media. Products that cannot be filtered — viscous preparations, ointments, devices, very small fills — go to direct inoculation, with the volume ratios the chapter prescribes so the product cannot inhibit the medium. We tell you which one applies before you ship.

• Fluid thioglycollate medium at 30–35 °C for anaerobes and aerobes
• Soybean–casein digest medium at 20–25 °C for fungi and aerobes
• Fourteen days of incubation, read throughout rather than only at the end
• Any recovery identified to species by MALDI-TOF and retained as an isolate

What you get back

• A sterility certificate stating the method, media, incubation record and result
• Your method suitability report, reusable until the product or process changes
• Species-level identification and an isolate record for any recovery
• Daily observation records rather than a single end-of-incubation reading
• Early notification if anything grows before day 14 — you hear it from us the day we see it