Aseptic Filling Machine for Vials for Fast Changeover

May 10, 2017
Pharmaceutical Technology Editors

The Dara SX-310-PP/D aseptic filling, stoppering, and capping machine for vials features full servo-driven automation and a compact footprint.

NJM Packaging has introduced the Dara SX-310-PP/D aseptic filling, stoppering, and capping machine for vials. Dara can equip this system with stainless steel or ceramic rotary piston pumps or peristaltic pumps that utilize single-use tubing. Featuring fully servo-driven automation and a compact footprint, the SX-310-PP/D offers accurate filling and precise stoppering and capping.

The Dara SX is suitable for the pharmaceutical, biotech, and cosmetic manufacturer filling suspensions, vaccines, or cellular tissue. The Dara SX-310-PP/D aseptically fills glass or plastic vials with dosing volumes from 0.1­–250 mL for liquids and from 2–1500 mg for powders. The system can be programmed for full stopper insertion, followed by aluminum/flip-off cap application, or half stopper insertion and no capping for lyophilization. It can be changed over to handle a new product in 15 minutes.

The machine includes two filling, two stoppering, and two capping stations. The linear, intermittent-motion Dara SX-310-PP/D handles throughputs of up to 120 units per minute within a compact footprint of only 106 inches (270 cm) long and 30 inches (76 cm) wide. The rotary piston pumps achieve +/- 0.5% accuracy, and the peristaltic pumps offer +/- 1 percent accuracy. The closing station features a servo-driven tangential rolling head to minimize particulate generation.

For sterile or cleanroom applications, the SX-310-PP/D can be equipped with a laminar air flow, open or closed restricted access barrier system, or a high containment isolator system. Optional clean-in-place, sterilization-in-place, or gas flushing are also available. Ancillary equipment from Dara, such as automatic or manual denesting units, adapts this machine for ready-to-fill vials. Trays can be manually fed to the SX-310-PP/D or the system can be integrated with an upstream washer and depyrogenation tunnel for continuous automated feeding. An integrated rotary table single files vials for presentation to the filling heads. Bags of stoppers are loaded into a vibratory hopper/circular feeder that delivers stoppers to a pick-and-place station that inserts the stoppers. Filled and closed vials are directed to output trays for manual unloading or they can be integrated with downstream equipment.

NJM Packaging will be attending the CPhI North America Conference from May 16–18, in Philadelphia, PA.

Source: NJM Packaging