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
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.
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