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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.

TAT

Business days from test start to report, so schedules hold.

Vial formats supported today: 2R, 6R and 10R.

WHY YOU NEED IT

Why Container Closure Integrity Testing Matters

Prove the seal holds

A preparation stays sterile only while its container–closure system keeps microbes and gas out. USP <1207> evaluates whether the seal does that.

Deterministic leak detection

<1207> divides leak tests into deterministic and probabilistic. Vacuum decay is deterministic: objective quantitative data, without the large sample sizes.

Where <797> requires it

<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

How we run this test for you

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.

Typically 15 units per study

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.

Seal in the chamber

The container is placed in a format-specific chamber and a vacuum is drawn around it.

Monitor the decay

Pressure is tracked over time; a rise signals gas escaping through a leak in the seal.

Compare to the limit

The decay is measured against a validated threshold that rules out leaks large enough for microbial ingress.

OUR SERVICES

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Potency Testing

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18 calendar days

USP <71>

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The traditional USP <71> sterility method, accepted by every regulatory body.

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USP <51>

Antimicrobial Effectiveness Testing

USP ⟨51⟩ antimicrobial effectiveness (preservative) testing for multi-dose products.

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USP <788>

Particle Counting

USP <788> sub-visible particulate matter counting for injectable products.

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USP <790>

Visual Inspection

USP <790> inspection for visible particulates in injectable products.

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USP <697>

Fill Volume Testing

USP <697> fill-volume verification (container content) for injectable products.

2 business days

USP <791>

pH Testing

pH testing under USP <791> — a fast, low-touch check on each compounded lot.

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