MC-D73 Positive & Negative Pressure Leak Detector
The MC-D73 is specifically designed for sealing performance testing in the pharmaceutical industry that requires vacuuming or pressurization, such as dye ingress or microbial ingress method, and is suitable for sealing performance tests for various packaging containers such as vials, ampoules, eye dropper bottles, BFS, IV bags and pre-filled syringes.
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Test Method
Application
Pharmaceutical Parenterals
Vials (Glass/Plastic), Ampoules, Pre-filled Syringes (PFS), Cartridges
Ophthalmic & Small Volume Containers
Eye dropper bottles, BFS (Blow-Fill-Seal) ampoules and strips
Large Volume Parenterals (LVP)
Infusion bottles and flexible bags
Method Development & Validation
Determining MALL and supporting CCI method validation protocols
Altitude & Transport Simulation
Simulating low-pressure (high altitude) environments to challenge package seals
Features
01
Dual-Mode Pressure Control: Automatic switching between Vacuum (Negative Pressure) and Positive Pressure modes without manual valve reconfiguration
02
Method-Specific Design: Optimized exclusively for Dye Ingress and Microbial Ingress testing per pharmacopeial recommendations
03
Standalone Operation: Configurable with an integrated vacuum pump and air compressor; no external plant air supply required (optional configuration)
04
Altitude Simulation Capability: Adjustable vacuum range allows for simulation of high-altitude air transport conditions as part of distribution challenge studies
05
Broad Vessel Compatibility: Standard 20 L chamber with customizable stainless steel racks to accommodate various container sizes and formats
Technical Specifications
|
Parameter |
Specification |
|
Pressure Range |
Approx. 113 – 4000 mbar (Absolute) — Wider custom ranges available |
|
Chamber Volume |
20 Liters |
|
Pressure Control |
Automatic switching between Vacuum and Pressure |
|
Instrument Display |
Digital Pressure Gauge |
|
Certifications |
TUV |
|
Validation Package |
IQ/OQ Protocol Support |
|
Dimensions |
Diameter 430 mm × Height 430 mm (Custom dimensions available) |
|
Weight |
24 kg (Unloaded) |
More Information
How does ECA stipulate about visible particulates for injectable drugs?
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.
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.
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