Automated container closure integrity tester
Ensure the integrity of your sterile pharmaceutical containers with high-speed, non-destructive testing that detects leaks as small as 5 microns.
Performs High-Speed Leak Testing
The R DPX from WILCO AG is an automated Container Closure Integrity Tester engineered for stringent pharmaceutical and biotech applications. Leveraging the latest vacuum and pressure decay testing methods, it delivers high sensitivity leak detection for diverse primary containers, including vials, ampoules, and BFS products. Operating at speeds up to 600 samples per minute, it ensures seamless integration within high-speed production lines, adhering to GMP guidelines and utilizing the LFC method® for 100% non-destructive testing. Its toolless format changeover and compliance with 21 CFR part 11 streamline operations and data handling, while its adaptability to a wide range of product types—liquid, lyophilized, and solid—makes it indispensable for manufacturers focused on maintaining sterility and compliance.
Benefits
- Enhances product integrity by detecting leaks as small as 5 microns.
- Minimizes production stops with reliable and gentle product handling.
- Accelerates format changes with a tool-free system, reducing downtime.
- Ensures regulatory compliance with non-destructive, deterministic testing methods.
- Supports diverse production needs, handling various container shapes and product types.
- Applications
- Liquid formulations,Sterile containers,Iv bags,Blow-fill-seal products,Lyophilized products,Biopharmaceuticals,Parenterals,Auto-injectors,Bfs containers,Pharmaceuticals
- End products
- Sterile iv saline bags,Small volume parenteral drugs,Bfs plastic bottles,Liquid vaccines,Pre-filled syringes,Sterile auto-injectors,Sterile infusion solutions,Bfs ampoules,Lyophilized injectables,Large volume parenteral solutions
- Steps before
- Filling,Sealing,Lyophilization,Assemblage
- Steps after
- External Inspection,Labeling,Packaging,Sterilization
- Input ingredients
- glass vials,plastic vials,ampoules,cartridges,liquid products,powder products,lyophilized products,non-conductive products,low filling level products,fusion sealed sterile pharmaceutical containers,BFS bottles,LVP bottles,various shapes of BFS containers,conductive products,non-conductive liquids,flammable liquids,sensitive packaging,lyophilized and liquid filled vials
- Output ingredients
- tested vials,tested ampoules,tested cartridges,tested liquid products,tested powder products,tested lyophilized products,assured container closure integrity,leak-detected BFS bottles,leak-detected LVP bottles,containers with verified headspace conditions,inspected vials using Headspace Analysis
- Market info
- Speed
- Up to 600/min
- Sample Capacity
- 60,000/h
- Format Range
- 1ml - 250ml
- Leak Sensitivity
- Down to 5 microns
- Automation
- Non-destructive,automated
- Testing Method
- LFC method®
- Applicable for Container Type
- Glass and Plastic Containers
- Applicable for Product Type
- Liquid,Lyophilized,Solid
- Data Handling
- Compliance with 21 CFR part 11
- Changeover
- Toolless Format Changeover
- Automation level
- PLC / SCADA
- Batch vs. continuous operation
- Inline Continuous
- Changeover time
- Toolless format changeover
- Cleaning method
- Non-destructive
- Energy efficiency
- High-speed production
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- GMP Compliance
- Yes
- EU GMP Annex 1 Compliance
- Yes
- USP <1207> Compliance
- Yes
- 21 CFR Part 11 Compliance
- Yes
- Machine footprint
- Compact
- Format range
- 1ml up to 250ml
- Control panel type
- Integrated
- Machine size
- Variable based on samples
- Product handling
- Gentle transfer system
- Toolless format changeover
- Yes
- Material handling compatibility
- Glass and plastic vials,ampoules,cartridges
- Control panel type
- HMI with touchscreen interface
- Integration possibilities
- OPC server for network integration
- Toolless format changeover
- Yes
- Automation level
- PLC / SCADA
- Data Handling
- Compliance with 21 CFR part 11