IV Bag Leak Testing: High Voltage Leak Detection vs Vacuum Decay Leak Detection

In pharmaceutical packaging integrity testing, choosing the right Container Closure Integrity Test (CCIT) method can make all the difference in ensuring sterility, regulatory compliance, and production efficiency.

Two widely recognized approaches, High Voltage Leak Detection (HVLD) and Vacuum Decay (VD), both aim to detect container leaks that could compromise product safety. However, these testing methods do not perform equally across container types.

This comparison explores how HVLD and Vacuum Decay work, their advantages and drawbacks, and why many pharmaceutical manufacturers are transitioning toward Vacuum Decay for flexible and large-volume packaging applications.

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What is High Voltage Leak Detection (HVLD)?

High Voltage Leak Detection (HVLD) is a probabilistic test method that applies a high-voltage potential across a liquid-filled container to detect electrical conductivity changes caused by leaks.

When a defect is present, a measurable current passes through the package where there should be none, indicating a breach in the container.

HVLD is often used for rigid containers like:

Pre-filled syringes
Glass or plastic vials
Ampoules

However, its performance is highly dependent on the conductivity of the solution inside the container and the stability of the container shape, making it less suitable for flexible, large-volume packaging, like IV bags.

The Limitations of HVLD with IV Bags

HVLD works by passing a microcurrent through a liquid-filled container and monitoring for conductivity changes caused by a leak.

While effective in certain formats like vials and syringes, HVLD struggles when applied to IV bags.

Seam and Weld Limitations. Most IV bag failures occur at seams or fused welds. HVLD often misses these defects because they may not create the conductive path needed for detection.
Dependence on Fluid Conductivity. HVLD requires conductive solutions. Bags containing viscous products, plasma derivatives, or non-conductive formulations are much harder to test reliably.
Instability with Flexible Bags. IV bags are large, pliable, and filled with moving liquid. HVLD signals can become unstable, making repeatable and consistent detection challenging.

“HVLD may offer speed in some applications, but for IV bags it introduces blind spots that manufacturers cannot afford." - Gianmarco Pincelli, Technical Sales Manager

What is Vacuum Decay Leak Detection?

Vacuum decay leak detection is a deterministic, non-destructive CCIT method that places a filled container (such as an IV bag) in a vacuum chamber. The chamber is evacuated to a set pressure, and sensors monitor for changes over time. If a leak is present, gas escapes from the container, causing a measurable pressure rise.

The process is simple, repeatable, and compliant with regulatory standards including:

USP <1207>
ASTM F2338
EU GMP Annex 1

Vacuum Decay is suitable for a wide variety of packaging, including: flexible IV bags, pouches, blister packs and rigid containers where non-destructive testing is required.

How does Vacuum Decay testing work? Let us show you here!

Why Vacuum Decay Outperforms HVLD for IV Bag Leak Testing

When it comes to IV bag integrity, not all test methods perform equally. Both High Voltage Leak Detection (HVLD) and Vacuum Decay are recognized CCIT methods, but when applied to flexible IV bags, Vacuum Decay has clear advantages that manufacturers cannot overlook.

Seam and Weld Coverage. Unlike HVLD, Vacuum Decay detects leaks across the entire bag, including welds, seams, and ports, where most integrity failures occur.
Resilient to Liquid Movement. Because the method measures pressure over time, Vacuum Decay is not disrupted by shifting liquid inside the bag. The result is a stable, repeatable test even for large or partially filled bags.
Validated and Compliant. Vacuum Decay is an established, deterministic, non-destructive method referenced in USP <1207>, ASTM F2338, and EU Annex 1. It provides the regulatory confidence manufacturers require.

Learn more about Vacuum Decay testing and validation now.

Moisture Sensitivity and False Rejects

Both HVLD and Vacuum Decay can be affected by surface moisture on IV bags, which may lead to high false reject rates—a costly challenge in pharmaceutical manufacturing.

However, ongoing innovations such as neural network-based anomaly detection in Vacuum Decay systems are changing this landscape. These advanced capabilities help:

Stabilize test results under varying moisture and humidity conditions.
Significantly reduce false rejects by distinguishing borderline cases more accurately.
Eliminate workarounds—such as excluding certain bag areas from inspection—that can compromise integrity and throughput.

This means manufacturers can achieve both maximum inspection coverage and higher process efficiency.

Operational Impact: Throughput and Efficiency

By delivering more sensitive, stable, and adaptive leak detection, Vacuum Decay systems can:

Maintain or improve throughput by reducing false rejects and unnecessary downtime.
Ensure full inspection coverage without compromising output.
Provide consistent data for process validation and control.

The result is higher productivity without sacrificing quality or compliance.

High Voltage Leak Detection vs. Vacuum Decay (Comparison Chart)

Category	High Voltage Leak Detection (HVLD)	Vacuum Decay (VD)
Test Method	Probabilistic – Detects conductivity when a leak allows microcurrent to pass through a defect	Deterministic – Measures pressure changes in a vacuum chamber due to gas leakage
Container Compatibility	Best for rigid, conductive liquid-filled containers like pre-filled syringes and glass vials	Ideal for flexible and rigid packaging, including IV bags, pouches, blisters, and non-conductive fluids
Leak Detection Sensitivity	Limited sensitivity, especially for non-conductive or viscous solutions	High sensitivity to microleaks, even with plasma or non-conductive fluids
Suitability for IV Bags	Poor – struggles with seams, welds, and liquid movement in flexible bags	Excellent – detects leaks in welds, seams, ports; unaffected by bag flexibility or fluid dynamics
Impact of Solution Conductivity	Requires conductive solutions for accurate results	Not dependent on liquid conductivity
Repeatability and Stability	Can be unstable in flexible containers with shifting liquids	Stable, repeatable results regardless of fill level or movement
Regulatory Compliance	Not referenced in USP <1207> or Annex 1	Referenced in USP <1207>, ASTM F2338, and EU GMP Annex 1
Audit Trail and Data Traceability	Limited – typically lacks built-in reporting or digital documentation	Robust – supports 21 CFR Part 11, digital audit trail, and electronic reporting

Learn more about High Voltage Leak Detection vs Vacuum Decay.

Why The Right Testing Method Matters

Pharmaceutical professionals, especially those responsible for sterile fill-finish, QA, R&D, and packaging engineering, face increasing pressure to adopt deterministic, regulatory-aligned, and non-destructive testing methods.

For products like IV bags, the choice of leak detection method directly impacts product integrity, compliance, and operational efficiency. Manufacturers in injectables, biologics, parenterals, and plasma derivatives are shifting toward methods like Vacuum Decay that ensure full seam, weld, and port inspection while reducing waste and rework.

View products designed to support pharmaceutical industry testing.

Vacuum Decay Testing: The Reliable Choice for IV Bags

While HVLD remains a recognized technique in pharmaceutical leak detection, its limitations with flexible IV bags particularly around seams, liquid variability, and conductivity make it a risky choice.

Vacuum Decay, especially when enhanced with AI-driven analytics, offers superior sensitivity, stability, and operational efficiency.

For pharmaceutical manufacturers seeking to maximize product safety, regulatory compliance, and line performance, Vacuum Decay-based systems, like Bonfiglioli Engineering’s IVB Flex, represent the most compelling solution.

Learn more about the IVB Flex now, or contact our team directly to discuss your unique needs.

FAQ

What is the difference between High Voltage Leak Detection (HVLD) and Vacuum Decay?

HVLD is a probabilistic leak test method that relies on detecting electrical conductivity in liquid-filled containers. In contrast, Vacuum Decay is a deterministic method that detects leaks by monitoring pressure changes in a vacuum chamber. Vacuum Decay testing is more sensitive and reliable for flexible containers like IV bags, whereas HVLD is best suited for rigid, conductive formats such as glass vials or ampoules. Learn more here.

Is Vacuum Decay testing better than HVLD for IV bags?

Yes. Vacuum Decay outperforms HVLD when testing IV bags due to its ability to detect leaks across seams, welds, and ports—areas where HVLD often struggles. Vacuum Decay is also not affected by fluid conductivity or bag flexibility, making it a more stable and repeatable option for large, pliable containers.

Why does HVLD struggle with IV bag testing?

HVLD relies on conductive paths formed by a leak and the liquid inside the container. In IV bags, which are flexible and may contain non-conductive or plasma-based solutions, these conductive paths are often inconsistent or absent, especially along seams and welds. This leads to missed defects and unreliable test results.

Is Vacuum Decay considered a regulatory-compliant method?

Yes. Vacuum Decay is a deterministic and non-destructive CCIT method referenced in USP <1207>, ASTM F2338, and EU GMP Annex 1. It meets global regulatory expectations for container closure integrity and is compliant with 21 CFR Part 11 when paired with digital audit trails and electronic reporting.

Can Vacuum Decay detect microleaks?

Yes. Vacuum Decay systems can detect micron-level leaks—even in non-conductive, viscous, or plasma-based formulations—making it ideal for high-assurance pharmaceutical applications. Advanced versions enhanced with neural network-based anomaly detection further improve sensitivity and reduce false rejects.

How does moisture affect HVLD and Vacuum Decay?

Both HVLD and Vacuum Decay can experience false rejects if surface moisture interferes with test signals. However, modern Vacuum Decay systems use AI-driven algorithms to compensate for humidity variability, delivering more accurate results and significantly reducing false positives caused by wet surfaces.

Is Vacuum Decay suitable for automated or high-speed testing?

Vacuum Decay is best suited for lab-scale, low-to-mid-volume, or batch testing environments where accuracy, repeatability, and regulatory traceability are top priorities. For high-speed, inline inspection, other deterministic methods like tracer gas leak detection may be more appropriate.

What kind of containers can Vacuum Decay test?

Vacuum Decay is highly versatile. It can test flexible IV bags, pouches, blister packs, syringes, vials, and other rigid or semi-rigid containers—especially when non-destructive testing is required. This makes it ideal for pharmaceutical and biologics manufacturers dealing with complex packaging formats.