MC-DUO(VP) Dual System Packaging Leak Detector
The MC-DUO(VP) is a non-destructive leak detection system designed for both vacuum decay and pressure decay testing methods. The system is easy to switch between these two modes. This versatile equipment is ideal for drug development, QC lab, and production line.
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Test Method
Application of Dual System Packaging Leak Detector
Flexible packaging
Infusion soft bag, etc.
Rigid packaging
Vials for filling powder, lyophilized or medicinal liquid, pre-filled syringes, ampoules, infusion bottles, etc.
Features of Dual System Packaging Leak Detector
01
Utilizes imported high-precision sensors for excellent sensitivity (down to 1 μm), fast cycle times, and high repeatability.
02
Employs non-destructive technology, safeguarding product and package stability.
03
Developed in accordance with the FDA-recognized ASTM F2338 test standard.
04
Compliant with FDA 21 CFR Part 11 requirements, featuring access controls, audit trail, and electronic signature capabilities.
05
Enables quick, user-friendly switching between vacuum and pressure decay modes.
Technical Specifications
|
Sensors |
Imported dual-sensor system |
|
Pressure Resolution |
0.1 Pa |
|
Vacuum/Pressure Source |
Vacuum: External pump; Pressure: External air compressor |
|
Validation Package |
IQ/OQ Documentation Available |
|
Calibration |
Via micro-flow meter or standard leak artifacts |
|
Dimensions |
440 × 410 × 270 mm(LxWxH) |
|
Weight |
19 kg |
|
Power Supply |
100-240 VAC, 50/60 Hz |
Combines two deterministic test methods in one instrument
Reduces the need to purchase separate testing systems
Supports both rigid and flexible pharmaceutical packages
Provides non-destructive package testing
Delivers quantitative and repeatable test results
Offers 0.1 Pa pressure resolution
Supports rapid switching between test modes
Complies with FDA 21 CFR Part 11 requirements
Developed according to ASTM F2338
Supports calibration and IQ/OQ qualification
Suitable for R&D, quality control and production applications
| Equipment Type | Vacuum Decay | Pressure Decay | Suitable Applications |
| Vacuum Decay Leak Detector | Yes | No | Rigid and semi-rigid packages |
| Pressure Decay Leak Detector | No | Yes | Flexible and pressurized packages |
| MC-DUO(VP) Dual System | Yes | Yes | Laboratories testing multiple package types |
The Zholion MC-DUO(VP) Dual System Packaging Leak Detector is particularly suitable for pharmaceutical companies, testing laboratories and packaging developers that need to test both rigid and flexible packaging using one platform.
The MC-DUO(VP) Dual System Packaging Leak Detector is developed in accordance with ASTM F2338, a deterministic test method for non-destructive detection of leaks in packages using vacuum decay technology.
The Dual System Packaging Leak Detector system also supports FDA 21 CFR Part 11 requirements through functions such as:
Testing methods and acceptance limits should be developed according to the package type, product requirements and applicable quality standards.
Not sure whether vacuum decay or pressure decay is more suitable for your package?
Send Zholion your package samples, dimensions, product state and target leak requirements. Our technical team can help evaluate the application, recommend the appropriate testing mode and configure a suitable test chamber.
Contact Us for MC-DUO(VP) Product Details and a Testing Solution
More Information
What is a dual system packaging leak detector?
A dual system packaging leak detector integrates two leak testing technologies into one instrument. The MC-DUO(VP) combines vacuum decay and pressure decay testing, allowing it to test a wider range of rigid and flexible packages.
Can one instrument test different package sizes?
Yes. Different package sizes and shapes can be tested by changing the test chamber, fixture or sample holder.
Can the system test pharmaceutical vials?
Yes. Vacuum decay testing can be configured for vials containing powder, lyophilized products or medicinal liquids. A package-specific chamber is normally required.
Which mode should be used for flexible packaging?
Pressure decay is generally more suitable for flexible packages that may deform significantly when exposed to vacuum. The final method should be confirmed through package evaluation and feasibility testing.
What is the difference between vacuum decay and pressure decay?
Vacuum decay detects leakage by monitoring pressure changes after a vacuum is applied around the package. Pressure decay applies positive pressure and detects leakage by measuring pressure loss.
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