MC-Duo(vp) leak Detector
Mc-duo (VP) leak detector is suitable for rigid packaging containers such as infusion bottles, filling powder,
lyophilized or liquid vial, prefilled syringe, ampoule or flexible packaging (such as soft infusion bags）, easy to operate, fast test speed, repeatable test results, high sensitivity, measurement The testing process is non-destructive to packaging and does not require sample preparation. The device is the best choice of alternative to traditional dyeing water bath and bubble method.
The Mc-duo (VP)
leak detector is based on the ASTMF2338 test standard which approved by FDA, with the addition of pressure decay testing capabilities to expand the testing capabilities of the device.
Mc-duo (VP) leak detector is assembled with advanced high precision sensors to ensure fast test speed, high test accuracy and repeatable test results.
Characteristics
Model：MC-Duo(VP)
Vacuum decay and pressure decay Due system
The best detection sensitivity is 1 ~ 2 microns
In line with FDA, EU, China CDE regulations, in line with ASTM test standards
Fast test speed
Flexible packaging, including rigid packaging and infusion bags, conforms to FDA 21 CFR Part 11 requirements, with access control, audit trace and electronic signature functions
Vacuum decay and pressure decay integrated design
Vacuum attenuation and pressure attenuation quickly switch, easy to operate.
| Model | MC-DUO（VP） |
| System or Work principle | Vacuum decay and pressure decay double system |
| Sensor | Double sensor |
| Sensitivity | The equipment is best up to 1 ~ 2 microns, and the sample sensitivity depends，on the specific packaging and product. |
| Package Type | Rigid packaging containers or flexible packaging (such as infusion soft bags)，for powder, freeze-dried or liquid filling vials, prefilled syringes, ampoules and infusion bottles in the pharmaceutical industry。 |
| Product | Powder, lyophilized or liquid |
| Use | R&d, QC quality control or off-line spot check in production shop |
| Compliance | Comply with FDA, EU, China CDE regulations, ASTM F2338 test standard, meet FDA 21CFR Part 11 requirements |
| Data integrity | Compliance with FDA 21CFR Part 11 requirements, with access control,audit trail, electronic signature and database management capabilities |
| Parameters and data storage | The storage capacity is nearly unlimited in the database |
| Test results | Pass/fail sum different pressurevalue |
| Differential pressure value resolution | 0.1Pa |
| A vacuum or pressure source | Vacuum source: external dry vacuum pump; Pressure source: external air compressor |
| Verify the package | IQ/OQ/and methodology development validation package |
| Check | Miniature flowmeter or standard leak hole |
| The power supply | 100-240VAC，50/60Hz |
