Automated Cci tester for primary packaging containers
Ensure the integrity of pharmaceutical packaging with precise and non-destructive testing, maintaining product safety and compliance with rigorous standards.
Performs Leak Testing on Pharmaceutical Containers
The R DPX from WILCO AG is an automated container closure integrity (CCI) tester designed exclusively for pharmaceutical and biotech industries. Utilizing advanced vacuum and pressure decay testing methods, it ensures high sensitivity and reliability in identifying leaks for a variety of packaging types, including vials, ampoules, and BFS containers. Capable of processing up to 600 containers per minute, this system integrates effortlessly into high-speed production lines, making it indispensable for manufacturers of injectable drugs and parenterals like vaccines and monoclonal antibodies. Engineered for efficiency, the R DPX offers toolless format changeover to minimize downtime and supports non-destructive testing under GMP conditions, adhering to USP 1207 standards for sterility. Ideal for operations requiring rigorous quality control without sacrificing throughput, it is a pivotal solution for companies striving to maintain stringent pharmaceutical packaging standards.
Benefits
- Maintains product sterility by detecting leaks with high sensitivity.
- Increases production speed, processing up to 600 containers per minute.
- Minimizes operational costs with toolless format changeover.
- Ensures regulatory compliance by adhering to GMP and USP 1207 standards.
- Versatile testing capability for various container shapes and materials.
- Applications
- Liquid formulations,Lyophilized products,Parenterals,Biopharmaceuticals,Injectable drugs,Pharmaceuticals
- End products
- Vials of vaccines,Liquid parenteral antibiotics,Injectable biologic drugs,Lyophilized chemotherapy drugs,Injectable hormone therapies,Bfs aseptic solutions,Ampoules of insulin,Glass containers of monoclonal antibodies,Lyophilized diagnostic enzymes,Prefilled syringes of heparin
- Steps before
- Filling,Sealing
- Steps after
- Packing,Sterilization
- Input ingredients
- liquid products,powder products,lyophilized products,glass vials,plastic vials,ampoules,cartridges,non-conductive products,low filling level products,BFS cards,BFS bottles,IV bags
- Output ingredients
- tested vials,tested ampoules,tested cartridges,leak detected products,non-leak detected products,tested BFS cards,tested BFS bottles,tested IV bags
- Market info
- Testing Speed
- Up to 600/min
- Format Range
- 1ml up to 250ml
- Leak Sensitivity
- Detection down to 5 microns
- Product Types Applicable
- Liquid,lyophilized,and solid
- Container Types Applicable
- Glass and plastic vials,ampoules,and cartridges
- Testing Method
- LFC method
- Operation Type
- Automated
- Test method Standard
- ASTM – F 2338
- Compliance
- GMP Guidelines
- Data Handling
- Compliance with 21 CFR part 11
- Test Method
- Non-destructive,deterministic preferred acc. USP1207
- Handling System
- Robust and reliable
- Format Changeover
- Toolless
- Throughput for BFS Containers
- Up to 60,000/h
- Bag Testing Speed
- Up to 150/min
- Automation level
- High-speed,up to 600 samples/min
- Batch vs. continuous operation
- Inline Continuous
- Changeover time
- Toolless,fast format changeover
- Cleaning method
- Non-destructive,CIP-ready
- Product handling
- Gentle product transfers
- Integration capabilities
- Combined with AVI systems
- Energy efficiency
- Optimized for high throughput
- Control panel type
- PLC-controlled
- Machine size
- Varies by sample size
- Format range
- 1ml up to 250ml
- Weight range
- 1–5kg
- Control interface
- Touchscreen,HMI
- Toolless format changeover
- Yes
- Reliable product handling
- Yes
- Modular System Integration
- Optional
- Data Handling compliance
- 21 CFR part 11