New Dara Moduline Model NFL achieves a class 100 cleanroom working environment when operating the system in a class 100,000 cleanroom
The Model NFL combines a decontamination module, which accommodates nests or trays of prepackaged ready-to-use (RTU) vials, with a vial filling/stoppering/capping module
US packaging machinery company NJM Packaging has launched the Dara Moduline Model NFL, a nest filling line inside an isolator. The new system seamlessly integrates Dara’s aseptic fill-finish system with Getinge La Calhene’s isolator technology to achieve a class 100 cleanroom working environment when operating the system in a class 100,000 cleanroom.
By designing the top plate of the filler into the isolator and manufacturing them simultaneously rather than sequentially, Dara speeds up delivery and reduces capital costs.
Moduline is a family of compact and modular solutions for filling liquids and powders into vials, syringes and cartridges at speeds of up to 100 units per minute in a footprint only 1,150mm wide and 3,200mm long. It doses volumes from 0.1 to 100 ml for liquids and from 2 to 1,500 mg for powders while maintaining an accuracy of +/- 0.5%.
The Model NFL combines a decontamination module, which accommodates nests or trays of prepackaged ready-to-use (RTU) vials, with a vial filling/stoppering/capping module. A single front window with automatic opening and closing offers good ergonomics and easy access.
Transfers are achieved without violating the system’s sterility via mouse holes, transfer modules with rapid bio-contamination, a sterilisation tunnel and/or a bag-out system. Alternatively, materials can be supplied in bulk by integrating Moduline washer and depyrogenation modules with the fill-finish module.
Dara Moduline Model NFL
The new partnership between Dara and Getinge La Calhene offers standardised designs and streamlined manufacturing processes that reduce the cost of ownership and speed delivery. The fill-finish system and the isolator are built simultaneously so equipment delivery can be as fast as eight months, depending on the configuration.
A single HMI (human machine interface), which can be accessed locally on the unit and/or remotely from the customer’s SCADA system, controls both the fill-finish system and the isolator. The GAMP-compliant software monitors air velocity, differential pressure, relative humidity, temperature, non-viable particulate, microbes and more. It can be equipped with data acquisition software that complies with FDA 21CFR Part 11.
Dara can equip Moduline with stainless steel or ceramic rotary piston pumps and/or peristaltic pumps for liquids and/or vacuum pressure fill for powders. Both VHP (vapour hydrogen peroxide) and NO2 (nitrogen dioxide) sterilisation methods are available. Dara can also equip the system with a micro-scale for 100% weight control.
Partially or fully servo-driven, depending on the specific configuration, the Moduline filling lines offer repeatable performance, low maintenance, simple troubleshooting, fast changeovers with no tools required and easy adaptability to future applications and new package formats. An Allen-Bradley PLC controls machine functions and an Allen-Bradley color touchscreen presents a simple user interface.
Featuring 304 stainless steel and glass on all external materials and 316 stainless steel and polymers on all internal materials, Moduline has been designed in compliance with cGMP. The isolator and bio-decontamination cycle are pre-validated. Microbiological cycle development and/or PQ (performance qualification) are available.