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NJM, a ProMach product brand, showcases the Dara SYX-E-OR aseptic filling and closing machine for vials and bottles at Interphex Booth #2353. Featuring direct drive servo-motion controls, a starwheel-driven design and a compact footprint, the Dara SYX-E-OR offers accurate operation and quick changeover. Its modular configuration and a wide variety of options enable each system to be custom built to handle the exact products, containers and closures that satisfy each customer’s specific needs.
“This system offers the best technology available in the smallest footprint. With so many available modules to choose from, the SYX-E-OR can be designed to handle pharmaceuticals, biotech, cosmetics, perfumes and more,” said Thomas Kessler, Regional Sales Manager at NJM. “Among other things, the SYX-E-OR is ideal for Aptar Pharma’s unit-dose and biodose systems, which are increasingly used for everything from Naloxone sprays for opioid overdoses to vaccines and medications for children and others who dislike needles and tablets.”
The servo-driven, rotary, intermittent-motion Dara SYX-E-OR fills liquid or powder products in vials or bottles made from glass, plastic or metal, with dose volumes from 0.1 mL to 1 L. The SYX-E-OR can be equipped with stainless steel or ceramic rotary piston pumps to achieve +/- 0.5 percent accuracy or with peristaltic pumps to achieve +/- 1 percent accuracy or with a powder doser to achieve +/-2 percent accuracy. New product changeovers can be completed in 20 minutes with no tools required.
Containers can be closed with snap-on caps, screw caps, childproof caps, aluminum caps, stoppers, spray/dosing pumps and droppers. The caps and droppers are fed automatically by vibrating feeders made of AISI-316L stainless steel. A pick and place station places the caps and droppers onto bottles sequentially using a vacuum. The closing station is equipped with a servo head to handle even difficult screw closures. The closing torque can be managed either electronically or magnetically.
The Dara SYX-E-OR can be built as a single-head system – the SYX-E-OR/S – to run at production speeds of up to 100 units per minute or as a dual-head system – the SYX-E-OR/D – which features two filling, two plugging and two closing stations to handle throughputs of up to 183 units per hour.
To meet the needs of each application, the Dara SYX-E-OR is capable of filling in a variety of ways – with nozzles lowered to the bottom of the containers, half way up or from above. Stations detect fill levels and missing/raised stoppers and trigger an automatic reject device to remove out-of-tolerance containers.
For sterile applications, the Dara SYX-E-OR can be equipped with a laminar air flow (LAF) or an open or closed restricted access barrier system (ORABS/CRABS). Optional clean-in-place (CIP), sterilization-in-place (SIP) and gas flushing are also available. Statistical process control (SPC) and in-process control (IPC) are options to help ensure final product quality.
Fully servo-driven, the Dara SYX-E-OR provides repeatable performance, low maintenance, simple troubleshooting, fast changeovers and easy adaptability to future applications and new package formats such as adding new container sizes. An Allen-Bradley PLC controls machine functions and a 15-inch (38 cm) color touchscreen presents a large and intuitive user interface. All production parameters can be programed into the PC, including the height of each station, dosing volumes, kinematics of the filling / pick-and-place / closing stations and output speed.
The Dara SYX-E-OR is equipped with data recording software to export the production data in compliance with 21 CFR Part 11. Designed in compliance with cGMP, the SYX-E-OR features a 304 stainless steel frame and electro-polished 316 stainless steel product contact parts that meet FDA approval for use with pharmaceutical and biopharmaceutical products.
NJM offers a “total solution” approach that includes IQ, OQ, FDS, SDS, SAT and HDS validation support as well as turnkey line integration services to seamlessly combine best-in-class technologies. NJM’s world-class aftersales support includes standard and extended warranties, preventative maintenance programs and onsite installation, training and ongoing service.