Automated container closure integrity tester for pharmaceutical packaging
Ensure the integrity of your pharmaceutical packaging with a high-speed solution that performs precise leak testing across a variety of container types, safeguarding product sterility and patient safety in demanding production environments.
Performs Leak and Integrity Testing
The R DPX from WILCO AG is an automated Container Closure Integrity (CCI) tester designed for pharmaceutical manufacturers and contract manufacturing organizations (CMOs) focused on maintaining product sterility and integrity. This system employs state-of-the-art vacuum and pressure decay testing procedures for reliable detection of leaks across various packaging formats, including vials, ampoules, cartridges, and blow-fill-seal (BFS) containers.
With a capacity to test up to 600 samples per minute, the R DPX seamlessly integrates into high-speed, continuous production lines. Its robust design adheres to GMP guidelines, ensuring compliance with global pharmaceutical standards. The equipment is versatile, handling a wide range of containers from 1ml to 250ml, and is suited for solids, liquids, powders, lyophilized products, and non-conductive liquids.
Operating with the proprietary LFC method®, R DPX provides non-destructive, deterministic testing in accordance with ASTM F2338 and USP<1207> standards. The system is engineered for reliable product handling and features a toolless format changeover, minimizing downtime and enhancing operational flexibility. Designed for easy integration, it supports data handling in compliance with 21 CFR Part 11, offering comprehensive traceability and quality assurance.
Benefits
- Ensures product sterility by detecting leaks with high sensitivity.
- Increases productivity with testing speeds of up to 600 samples per minute.
- Minimizes operational downtime through quick, toolless format changeovers.
- Enhances quality control with GMP-compliant design and 21 CFR Part 11 data handling.
- Accommodates diverse production needs by testing a wide range of packaging types and product states.
- Applications
- Liquid formulations,Bfs bottles,Blow-fill-seal containers,Iv bags,Lyophilized products,Vials,Bfs cards,Biopharmaceuticals,Ampoules,Solid products,Cartridges,Small volume parenterals,Large volume parenterals,Pharmaceuticals
- End products
- Sterile injectable drugs,Bfs packaged oral suspensions,Nutritional supplements in iv bags,Antibiotic vials,Vaccines,Bfs packaged inhalation solution,Blood plasma components,Plasma-derived therapies,Cancer treatment formulations,Iv saline solutions,Chemotherapy drugs,Ophthalmic solutions,Parenteral nutrition solutions,Hormonal treatments in ampoules,Insulin cartridges,Anti-inflammatory lyophilizates
- Steps before
- Filling,Sealing,Container formation
- Steps after
- Packaging,Sterilization,Quality assurance
- Input ingredients
- small volume parenterals,large volume parenterals,BFS cards,BFS bottles,IV bags,glass vials,plastic vials,ampoules,cartridges,liquid products,lyophilized products,solid products
- Output ingredients
- cci tested parenterals,cci tested BFS containers,cci tested IV bags,cci tested vials,cci tested ampoules,cci tested cartridges
- Market info
- Speed
- Up to 600 samples/min
- Format Range
- 1 ml up to 250 ml
- Testing Method
- LFC method®
- Leak Sensitivity
- 5 microns
- Automation
- Automated CCI Testing
- Container Compatibility
- Glass and Plastic Vials
- Product Compatibility
- Liquid,Lyophilized,and Solid
- Non-Destructive Testing
- Yes
- Design Compliance
- GMP Guidelines
- Data Handling Compliance
- 21 CFR part 11
- Toolless Format Changeover
- Yes
- Capacity
- Up to 60,000/h (specific context)
- Automation level
- High-speed automated testing
- Batch vs. continuous operation
- Inline Continuous
- Changeover time
- Toolless format changeover
- Product handling
- Gentle and reliable
- Sensitivity level
- High sensitivity with LFC method®
- Integration capability
- Integrated with robotic handling system
- Testing capability
- Non-destructive,deterministic test method
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Machine footprint
- Dependent on test sample size
- Applicable container types
- Vials,ampoules,cartridges
- Format range
- 1ml up to 250ml
- GMP design
- Designed for use in GMP environments
- Control panel type
- HMI / Touchscreen
- Integration possibilities
- SCADA / MES compatible
- Format changeover
- Toolless
- Product handling versatility
- Glass / Plastic containers