MC-V12 Vacuum Decay Leak Detector

MC-V12 Vacuum Decay Leak Detector utilizes high-resolution absolute pressure sensor technology to detect both gross and fine leaks by monitoring vacuum level changes within a test chamber over a preset time. Its broad compatibility makes it suitable for most products and packaging types, widely used in pharmaceutical manufacturing.

The MC-V12 utilizes vacuum decay according to ASTM standard test method, the FDA, EMA, WHO, PIC/S, NMPA recognized consensus for non-destructive detection of leaks in packages by vacuum decay. The method is in line with new guidelines outlined in USP1207 preferring deterministic and objective methods that provide reliable and repeatable results.

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Test Method

Vacuum Decay

Application

Why Choose the MC-V12 Vacuum Decay Leak Tester?

Non-Destructive CCIT

The MC-V12 performs vacuum decay testing without opening or intentionally damaging suitable packages.

This allows samples to remain available for additional evaluation, stability studies or other laboratory testing.

Quantitative and Objective Measurement

Unlike subjective visual leak tests, the MC-V12 monitors measurable pressure changes inside the test chamber.

Test parameters and acceptance criteria can be developed for a specific product-package configuration to provide repeatable pass/fail evaluation.

High-Sensitivity Leak Detection

The high-resolution pressure measurement system is designed to identify small pressure changes associated with package leakage.

Under appropriate test conditions and package configurations, the MC-V12 can support micro leak detection. Detection capability should be established and validated for each specific product-package system.

Custom Test Chambers

Package dimensions and internal test volume can significantly affect vacuum decay test performance.

Zholion can provide package-specific test chambers and fixtures according to:

● Container dimensions
● Package geometry
● Closure configuration
● Product fill condition
● Expected leak location
● Required detection capability

Reducing unnecessary chamber volume can help improve test sensitivity and repeatability.

Applications of the Vacuum Decay Leak Tester

The MC-V12 pharmaceutical package leak tester can support different stages of package development and quality control.

Package Development

Evaluate different container materials, closure designs and sealing conditions before finalizing the packaging system.

CCIT Method Development

Use intact samples and positive controls to establish suitable test parameters, detection capability and acceptance criteria.

Process Validation

Evaluate whether the filling and sealing process can consistently produce packages with acceptable container closure integrity.

Routine Quality Control

Once a validated method has been established, the MC-V12 can be used for routine laboratory package integrity testing.

Stability Studies

Because vacuum decay is non-destructive for suitable packages, samples may remain available for subsequent evaluations according to the defined study protocol.

MC-V12 vs. RC-V12: Which Should You Choose?

Requirement	MC-V12	RC-V12
Vacuum decay testing	Yes	Yes
Laboratory CCIT	Recommended	Yes
Method development	Recommended	Yes
Routine QC	Yes	Recommended
Automated sample handling	No / limited	Yes
Higher testing throughput	Standard	Recommended
Package-specific fixtures	Yes	Yes

Choose the MC-V12 Vacuum Decay Leak Tester when you need a flexible laboratory system for CCIT development, validation support and routine testing.

Choose the RC-V12 auto vacuum leak detector when higher testing throughput and automated sample handling are important.

Need a Vacuum Decay Leak Tester for Your Package?

Send Zholion your package type, dimensions, product state and required leak detection level.

Our technical team can evaluate your application and recommend the appropriate MC-V12 Vacuum Decay Leak Tester, test chamber, positive controls and CCIT configuration.

Contact Zholion for MC-V12 Pricing & Technical Evaluation.

More Information

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Frequently Asked Questions

Q:
How does ECA stipulate about visible particulates for injectable drugs?

A:

4.3 What aspects should be considered when assessing artificially created test kits, and how should their suitability be justified?

Artificially created test kits are often used when representative production samples are unavailable, technically unsuitable, or cannot be obtained in sufficient quantity for qualification, training, or evaluation purposes.

Their suitability should be assessed based on the inspection technology used and the required level of representativeness. Artificially created defects and conforming units should exhibit optical, physical, and mechanical characteristics comparable to those of the real product under routine inspection conditions.

For AI-based inspection systems, higher requirements regarding representativeness may apply, as these systems often utilize very subtle features and characteristics to distinguish between acceptable and defective units. For example, a genuine lyophilized cake with crystalline reflective properties can generally be distinguished from a matte plaster-based imitation if these differences are visible in the image data.

If artificially created defects differ in relevant characteristics—such as texture, reflectivity, contrast, size, movement behaviour, or other optical or physical properties—there is a risk that the neural network learns features introduced by the artificial manufacturing process rather than the actual defect itself. Likewise, particle detection may be influenced by factors such as viscosity, turbidity, fill height particle size, or particle contrast. These factors should therefore be considered when assessing the suitability of artificially created test kits and may also affect the performance of conventional rule-based inspection systems.

Conventional rule-based systems are generally less susceptible to such effects because they evaluate predefined image features rather than learning complex representations. Although these approaches are often less selective and may be less suitable for highly challenging inspection tasks, they typically demonstrate greater robustness against variations or realism drifts within artificially created test kits.

Consequently, the suitability of artificially created test kits should always be justified and documented with regard to the inspection technology and the intended application. The decisive criterion is not whether defects are artificially created or taken from routine production, but whether the test kit reliably reproduces the behaviour of the final drug product under the selected inspection strategy.
Q:
Can one instrument test different package sizes?

A:

Yes. Different package sizes and shapes can be tested by changing the test chamber, fixture or sample holder.
Q:
Can the system test pharmaceutical vials?

A:

Yes. Vacuum decay testing can be configured for vials containing powder, lyophilized products or medicinal liquids. A package-specific chamber is normally required.

Parameter	Parameter Value
Interface	Touch Screen
Dimensions	390 × 350 × 390 mm (LxWxH)
Weight	21 kg
Power Supply	100-240 VAC, 50/60 Hz