Question 1

What is the typical turnaround time for sterility testing?

Accepted Answer

Standard USP <71> / ISO 11737-2 sterility testing requires a 14-day incubation. The clock starts the day samples are received. For Boulder Sterilization clients, samples are received the same day the cycle ends — eliminating the 2-5 day inbound transit window typical of national labs.

Question 2

Do you offer rapid sterility / fast cycle release?

Accepted Answer

Yes — Boulder BioLabs offers 4-hour cycle release using rapid-readout biological indicators (BIs). Compared to national contract labs' 6-day rapid microbiological method (RMM) or traditional 7-day BI incubation, the rapid-readout 4-hour platform confirms sterilization cycle efficacy via fluorescence detection within four hours of cycle end. For BI-based release programs (common in EO, CD, and steam sterilization release), devices can be released within hours of cycle completion — not days, and certainly not the 6 days national labs typically advertise. For programs requiring USP <71> product sterility testing, traditional 14-day incubation still applies.

Question 3

Are Boulder BioLabs methods compliant with ISO 11737 and USP standards?

Accepted Answer

Boulder BioLabs executes microbiology testing protocols aligned with ISO 11737-1, ISO 11737-2, USP <71>, USP <85>, and ISO 10993-7, operating under the Boulder BioMed ISO 13485 quality management system. Lab-level method accreditations (A2LA, ISO 17025) are in progress.

Question 4

Do I need a method suitability study before sterility testing?

Accepted Answer

Yes. Method suitability (bacteriostasis/fungistasis, or B/F) is a regulatory prerequisite under ISO 11737-2 and USP <71>. Without a documented method suitability study, your sterility test result is not defensible to FDA or a Notified Body inspector. We bundle method suitability into every new sterility program by default.

Question 5

Can you test devices sterilized at another contract sterilizer?

Accepted Answer

Yes. While our co-location advantage is strongest for Boulder Sterilization clients, we accept devices sterilized at other contract sterilizers via temperature-controlled freight. Chain of custody is documented in our LIMS at receipt.

Question 6

What's the difference between EO residuals and CD residuals testing?

Accepted Answer

EO residuals testing measures ethylene oxide, ethylene chlorohydrin (ECH), and ethylene glycol (EG) using GC-FID analysis, aligned with ISO 10993-7. CD residuals testing measures residual chlorine dioxide plus its degradation products (chlorite, chlorate) using ion chromatography and spectrophotometric methods. The two are completely different analytical workflows.

Question 7

How many samples do I need to submit?

Accepted Answer

Sample quantities vary by test and program type. For routine bioburden monitoring, the validated sampling plan typically calls for 10 devices per lot. For EO sterilization validation under ISO 11135, sample sizes are larger and depend on the validation protocol (half-cycle, full-cycle, PCD studies). Sterility testing for validation typically requires 10+ samples. We'll quote exact quantities based on your specific program scope.

Question 8

Do you provide bioburden trend reports for routine monitoring?

Accepted Answer

Yes. Clients on quarterly or recurring bioburden monitoring programs receive rolling trend data alongside individual lot reports. Trend visibility helps detect process drift before it triggers a sterility failure.

Question 9

What endotoxin limits should I use for my device?

Accepted Answer

FDA guidance sets typical limits at 0.5 EU/mL or 20 EU/device for most blood-contacting devices, with stricter thresholds for CSF-contacting devices (2.15 EU/device) and ophthalmic devices. Your specific limit depends on patient contact route and duration. Our LAL/BET team will help confirm the appropriate limit during quote scoping.

Question 10

Which LAL method should I use?

Accepted Answer

We support gel-clot, kinetic turbidimetric, and kinetic chromogenic LAL methods. Method selection depends on device material, expected endotoxin range, and prior inhibition/enhancement data. For high-volume routine release, kinetic chromogenic is typically fastest. For low-volume one-off testing, gel-clot may be most cost-effective.

Question 11

Can you support 510(k) submissions?

Accepted Answer

Yes. Our reports are formatted for inclusion in 510(k) submissions and prior approval supplements. For full regulatory submission support — pre-sub meetings, predicate selection, narrative drafting — we partner with Boulder Regulatory and Quality (Boulder RA/QA), our sister company in the Boulder BioMed family.

Question 12

How much does sterility testing cost?

Accepted Answer

Pricing varies by test type, sample count, method (direct inoculation vs. membrane filtration), and whether method suitability is included. We send detailed scope and price quotes within one business day of receiving your project description.

Question 13

What if my sterility test fails?

Accepted Answer

Positive sterility results are sub-cultured and identified to genus level (or species, on request) to support root cause investigation. We'll work with your QA team and, if relevant, with the Boulder Sterilization cycle development team to identify whether the failure was a process issue, sample contamination, or laboratory artifact. Investigation reports are issued under our ISO 13485 QMS.

Question 14

Are you A2LA accredited or ISO 17025 accredited?

Accepted Answer

Not yet. Boulder BioLabs operates under the Boulder BioMed ISO 13485 quality management system, with microbiology testing protocols aligned with ISO 11737, USP, and ISO 10993 standards. Lab-level A2LA and ISO 17025 accreditation are in progress. We disclose this transparently rather than implying accreditations we don't hold.

Question 15

How do I request a quote?

Accepted Answer

Tell us your device, sterilization method, tests needed, sample quantity, and timeline. We respond with scope and price within one business day.

Frequently Asked Questions