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Visual Inspection
USP <790> inspection for visible particulates in injectable products.
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Compendial standard this method is validated to.
Business days from sample receipt to report.
WHY YOU NEED IT
Why Visual Inspection Matters
Keep particles out of injections
Injectable products should be essentially free of visible particulates; USP <790> is the compendial basis for inspecting units against that standard.
Visible matter is a real risk
Foreign particles injected into the bloodstream can cause embolism, inflammation, or immune reactions — risks inspection is meant to prevent.
A clear acceptance basis
<790> defines the standard injectable products must meet, giving a defensible, documented acceptance criterion.
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.
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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.
N/A
Stability Studies
Across your stability timeline
The same test run at each stability timepoint — for example, to support a longer beyond-use date (BUD).
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TECHNOLOGY
Every unit, under controlled light.
01
Controlled lighting
Each unit is inspected under a metered light flux against both black and white backgrounds — the standard conditions for spotting particulates.
02
Inspect every unit
Containers are swirled and examined for 5 seconds each so both light and dark particles become visible.
03
Segregate and assess
Units with visible particulates are recorded with notes, and the batch is judged against the <790> criteria.
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.
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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
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