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Container Closure Integrity Testing
USP <1207> container closure integrity testing (vacuum decay) for sterile vials.
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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 Container Closure Integrity Testing Matters
Prove the seal holds
A product is only sterile if its container-closure system keeps microbes and gas out; USP <1207> evaluates whether the seal maintains integrity.
Deterministic leak detection
Physical methods like vacuum decay give sensitive, reproducible results rather than relying on microbial challenge alone.
Support dating and multidose use
Demonstrated integrity underpins stability and beyond-use dating — especially for multidose vials accessed repeatedly.
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
Vacuum decay finds the leaks.
01
Seal in the chamber
The container is placed in a format-specific chamber and a vacuum is drawn around it.
02
Monitor the decay
Pressure is tracked over time; a rise signals gas escaping through a leak in the seal.
03
Compare to the limit
The decay is measured against a validated threshold that rules out leaks large enough for microbial ingress.
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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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