New Aseptic Filling System Integrates with Getinge La Calhene for Standardization
Dara Pharmaceutical will be exhibiting the Moduline™ Aseptic Filling and Stoppering machine in New York in April.
The latest offering by Dara Pharmaceutical Packaging is here, ready to go for Interphex 2016. The Dara Moduline™ filling system for vials, syringes, and/or cartridges seamlessly integrates with Getinge LaCalhene’s isolator technology. For pharmaceutical manufacturers, this allows you to achieve a Class 100 cleanroom working environment when you operate the system in a Class 100,000 cleanroom.
The Moduline™ is compact and modular, perfect for filling liquids and powders at speeds of up to 100 units per minute. Its compact footprint is 1,150 mm (45 inches) by 3,200 mm (126 inches), allowing you to maximize your floor space while still filling doses from .01 to 100 ml for liquids and 2 to 1,500 mg for powders. Accuracy is +/- .05 percent, and the Moduline™ works well for volumes from small clinical trials to mass production of pharmaceuticals.
The most exciting part of the partnership is between Dara and Getinge La Calhene and the standardized designs and streamlined manufacturing processes, which decreases your cost of ownership while speeding delivery. Typically, it can take 18 months to build a traditional fill-finish system with an isolator, but the Moduline can be on your floor as quickly as eight months after ordering, depending on the configuration you choose.
Monitoring and control is simpler with a single HMI (human-machine interface) to control bot the fill-finish system and the isolator, which can be accessed on the unit or remotely from your SCADA system. You can monitor air velocity, differential pressure, relative humidity, temperature, and more, as well as equip the HMI with FDA 21 C.F.R. Part 11-compliant data acquisition software. A single front window means it’s ergonomically sound, and transfers through mouse holes, transfer modules with rapid bio-contamination, sterilization tunnels, and bag-out systems prevent the system’s sterility from being breached.
Dara Moduline™ Aseptic Filling & Stoppering