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Container Closure Integrity Testing
USP <1207> container closure integrity testing (vacuum decay) for sterile vials.
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WHY YOU NEED IT
A preparation stays sterile only while its container–closure system keeps microbes and gas out. USP <1207> evaluates whether the seal does that.
<1207> divides leak tests into deterministic and probabilistic. Vacuum decay is deterministic: objective quantitative data, without the large sample sizes.
<797> requires it for Category 3 CSPs and for any multiple-dose CSP — once per formulation, container and fill volume, demonstrated to the end of the BUD.
OUR PROCESS
Method Development
Proving the method first
Vacuum decay is specific to the container it runs on. For a format new to us, dimensions or a single unit are usually enough to confirm a method can be developed for it.
Dimensions, or a single unit
Method Suitability
Releasing every batch
Once a method exists, we establish that it performs reliably on your specific container — which takes a set of units rather than a single sample.
Stability Studies
Across your stability timeline
With development and suitability done, CCIT runs inside your stability program — <797> asks for integrity demonstrated to the end of the assigned BUD.
10 units per timepoint
TECHNOLOGY
Vacuum decay finds the leaks.
OUR SERVICES
STABILITY STUDIES
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
RELATED INFO
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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
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