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Antimicrobial Effectiveness Testing
USP <51> antimicrobial effectiveness (preservative) testing for multi-dose products.
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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 Antimicrobial Effectiveness Testing Matters
Prove the preservative works
USP <51> challenges the product with microorganisms to confirm the preservative actually suppresses growth over the in-use period.
Essential for multidose vials
Every needle entry is a contamination opportunity — preservative effectiveness is what protects later doses.
Substantiate in-use dating
AET data supports how long a product stays protected once opened, backing the in-use period you assign.
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 2 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 1 vial 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
Challenge the product, then count survivors.
01
Qualify the method
Method suitability confirms the neutralizer recovers each organism from the product without inhibition.
02
Challenge and incubate
The product is inoculated with the five compendial organisms and held under controlled conditions.
03
Count over 28 days
Survivors are enumerated at Day 0, 7, 14, and 28, and log reduction is compared to the <51> category criteria.
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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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