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Compendial Sterility Testing
Rapid sterility testing validated under USP <1223> — for compounding pharmacies that can’t afford a two-week wait on batch release.
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Compendial standard this method is validated to.
Business days from sample receipt to report.
Compounded formulations supported to date.
WHY YOU NEED IT
Why Rapid Sterility Testing Matters
Catch contamination fast
Viable bacteria or fungi in a sterile preparation can cause life-threatening bloodstream infections — a rapid method flags them in about a day instead of two weeks.
Release within the BUD
Compounded sterile preparations often carry short beyond-use dates; results in ~1–2 days let you release product while it's still usable.
Fast, but still validated
Rapid microbial methods are held to USP <1223> equivalence criteria, so quicker results detect the same contamination the compendial test would.
OUR PROCESS
How we run this test for you
METHOD SUITABILITY
Proving the method first
Before any lot release, we validate that the test method performs reliably for your product — the compliance step that comes first.
Typically 35 vials per study
LOT RELEASE
Releasing every batch
Our core service — we run the test on each lot so you can release the batch to patients with confidence.
Typically 35 vials per lot
STABILITY STUDIES
Across your stability timeline
The same test run at each stability timepoint — for example, to support a longer beyond-use date (BUD).
Usually [X] vials per timepoint
TECHNOLOGY
We detect what's alive at the molecular level.
01
RNA Detection
Targets RNA from living bacteria and fungi, a direct indicator of active contamination.
02
qPCR Workflow
Runs on existing quantitative PCR machines already present in most pharmaceutical labs.
03
No Proprietary Hardware
Lower cost to adopt, easier to scale, less friction for your operations team.
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TALK TO A SCIENTIST
Tell us what you need tested
Whether you need testing guidance, a quote, or just have questions — we’re here. A scientist will follow up within one business day.
USP-compliant, validated methods
Response within one business day
No obligation — guidance and quotes welcome
For service requests, quotes, or technical questions, email our support team.
info@saphobio.com
Phone
Available Monday to Friday, 9:00 AM – 6:00 PM (Pacific Time).
Text us: +1 (929) 437-6148
Site Visit
Visits by appointment only. Please contact us to schedule.
1068 Washington St. STE B, San Carlos, CA 94070
1068 Washington St Ste B, San Carlos, CA 94070
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