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Rapid 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 40 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 10 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).
40 vials for MST, then 10 vials per timepoint
TECHNOLOGY
We detect what's alive at the molecular level.
01
Nucleic Acids Testing (NAT)
Targets Nucleic Acids from living bacteria and fungi, a direct indicator of active contamination.
02
qPCR Workflow
Quantitative PCR enables rapid and reliable turnaround time
03
Isolation and Identification of microorganisms
Non destructive method - results in reliable microbial species identification
OUR SERVICES
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STABILITY STUDIES
Planning a stability study?
See how this test can support a validated stability program and the data needed for extended beyond-use dating.
✓
Stability-indicating HPLC methods that separate API from degradation products
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Custom study designs for refrigerated, frozen and room-temperature storage conditions
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Defined pull points with potency, pH, appearance and container-closure assessment
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Documentation packages to support extended beyond-use dating under USP <797>
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Sterility and endotoxin testing integrated at study end points
Guide: USP <797> stability studies & extended beyond-use dating →
Request a Stability Study Quote
Starting at $10,000
CATEGORY 2
CATEGORY 3
These studies generate the stability data required to qualify for the extended beyond-use dates that USP <797> permits for Category 2 and Category 3 CSPs — going well beyond the default short-dating limits.
TYPICAL STUDY OUTLINE
What a stability program covers
Supports
USP <797> Cat 2 & Cat 3 extended BUD
Storage conditions
Refrigerated · Frozen · Controlled RT
Pull points
T0, then defined intervals to BUD
Assays per point
Potency · pH · Appearance
Method type
Stability-indicating HPLC
End-point testing
Sterility · Endotoxin
Deliverable
BUD support documentation
COMMON QUESTIONS
Frequently Asked Questions
RELATED INFO
Relevant Resources
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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 methods verified for suitability, alternatives validated
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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