Product Description
The LF-SMH is a laboratory-scale, multi-head, non-destructive container closure integrity testing (CCIT) system designed for off-line and in-process quality control applications in the pharmaceutical industry. Utilizing the Vacuum Decay Method, it detects microleaks in a wide range of containers, including ampoules, vials, pouches, MDPI, MDI, IV bags, flowwrapped devices, flowpacks, carpoules, and bottles. The system accommodates containers ranging from 5 x 30 x 5 mm to 86 x 86 x 250 mm and operates at speeds up to 20 cycles per minute. Its compact and robust design ensures ease of maintenance, quick changeovers, and low power consumption. The intuitive HMI provides real-time testing cycle diagrams and stores historical data, including production, raw data, events, and alarms. Compliant with FDA 21 CFR Part 11, EU Annex 11, and ASTM F2338-09, the LF-SMH offers a cost-effective solution for ensuring the integrity of pharmaceutical packaging.
Main Features and Benefits
- Quick and sensitive test
- Zero alteration of container features
- Vacuum and positive pressure testing
- Fast, reliable and repeatable results
- Highly functional, intuitive HMI
- Cost-effective solution
- System autodiagnostics available
- Compact and robust design
- Maintenance-free
- Quick change over
- Low power consumption
- Storage, maintenance, and download of historical data (production, raw data, events, alarms)
- HMI Real Time display of Testing Cycle diagram
- Computerised system is designed to comply with FDA 21 CFR Part 11 and EU Annex 11
- Validation Package guarantees complete and efficient regulatory compliance
