Dye Ingress leak test system DPS
CCIT – Container Closure Integrity Testing:
Dye Ingress method for increased product requirements.
CFR 21 Part 11 compliant IT system
Meets all normative requirements
(GMP, FDA, ISO etc.)
The Dye Ingress system from 3D innotec AG is an advanced system for the automated leak testing of aseptically prefilled units with a methylene-water mixture, also known as "Blue Dye liquid". These tests are performed under precise pressure cycles up to a maximum of -0.5/+1 bar relative to ambient pressure. The target pressure is maintained within +/- 0.01 bar to ensure high accuracy.
The Dye Ingress Leak Test
The Dye Ingress leak test system enables test sequences with a maximum of 5 cycles, each comprising 4 steps, which can be specified via a user-defined recipe. The pressure vessel is loaded with the samples to be tested and the Blue Dye liquid is pumped into the vessel to reveal leaks in the aseptically prefilled units under pressure and vacuum.
Upon completion of the test the system automatically generates a detailed test report. The parameters for vacuum, pressure and test times are individually adjustable and stored in the device. This guarantees that all tests are conducted under identical conditions, allowing for reproducible and documented results.
Advantages
- Mobile unit
- Low maintenance operation
- System availability 24/7
- Integration with customer domain possible
- User administration and user control of rights
- Holders, baskets, etc. are developed and manufactured to customer and requirement specifications
- Multi-stage filtration before each test cycle (200µm; 50µm; 1µm)
- High process reliability and process monitoring
- CFR 21 Part 11 compliant IT system
- PM-Control, PM-Quality and Audit-Trail integrated
- Meets all regulatory requirements (GMP, FDA, ISO etc.)
- Customer-specific adjustments are always possible
Pharmaceutical Leak Testing to the highest Standard
The complete system from 3D innotec AG is specifically designed to meet the high demands of the pharmaceutical industry and complies with all current GMP, FDA, ISO, and other regulations and standards.
Integrated Blue Dye preparation and IT connectivity
The closed system features integrated Blue Dye preparation, filtration, extensive data recording and documentation. It can be flexibly installed at any location and seamlessly integrated into existing IT environments. Moreover, the system is very low-maintenance and provides a high system availablility.
Comprehensive Qualification documentation and Compliance
3D innotec AG provides a wide range of qualification documentation including DQ, IQ, OQ, FAT, and SAT protocols. The system's control unit ensures compliance with CFR 21 Part 11 regulations. All events are recorded, secured and archived in an audit trail. Additionally, all recording sensors are delivered with corresponding calibration protocols.
Dimensions
- Length: 1670 mm
- Width: 930 mm
- Height: 1500 mm
- Empty weight: 350 kg
Electrical system
- Plug main cable: CEE Typ 5L 16A 6h 3x400V
- Power consumption: 1,8 kVA
Mechanics
- Total volume of pressure vessel: 70 liters
- Max. tank volume for Blue Dye liquid: 87 liters
- Max. pressure vessel volume for Blue Dye liquid up to overflow: 62 liters (without displacement from test samples)
Materials
- Machine frame: Aluminum profiles 40mm
- Paneling: Stainless steel 1.4404 electropolished
- Pressure vessel: Stainless steel 1.4404 electropolished
- Blue Dye tank: Stainless steel 1.4404
- Drip pan: Stainless steel 1.4404
Pneumatics
- Maximum pressure: - 0.5 ... +1 bar relative
- Max. set point deviation test pressure: +/- 0.01 bar (incl. overshoot)
- Max. time to reach test pressure: 3 minutes
- Test pressure recording interval: customer defined (default: 5 seconds)
- Display accuracy of process pressure: 0.01 bar
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