NJM Packaging introduces 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. It is low maintenance, achieves fast and easy changeover and has simple set-up for adding new container sizes in the future.
Ideal 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 to 250 mL for liquids and from 2 to 1,500 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 with no tools required.
Featuring two filling, two stoppering and two capping stations, the linear, intermittent-motion Dara SX-310-PP/D handles throughputs of up to 120 units/min within a compact footprint only 106 in. (270 cm) long and 30 in. (76 cm) wide. The rotary piston pumps achieve +/- 0.5% accuracy and the peristaltic pumps offer +/- 1 accuracy. The closing station features a servo-driven tangential rolling head to minimize particulate generation.
For sterile or clean room applications, the SX-310-PP/D can be equipped with a laminar air flow (LAF), open or closed restricted access barrier system (oRABS/cRABS) or a high containment isolator system. Optional clean-in-place (CIP), sterilization-in-place (SIP) 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.
Users can program the SX-310-PP/D to fill in a variety of ways—with nozzles lowered to the bottom of the containers, half way up or from above to meet the needs of each product. The system features a no bottle / no fill / no stopper safety device. Inspection stations detect fill levels, missing stoppers and raised stoppers and trigger an automatic reject to remove out-of-tolerance vials.
Optional vacuum-assisted stopper insertion reduces the oxygen in the headspace. An optional checkweigher maintains 100% weight control or a statistical weighing mechanism. An optional particulate counter further ensures final product quality.
Fully servo-driven, the SX-310-PP/D provides repeatable performance, low maintenance, simple troubleshooting, fast changeovers and easy adaptability to future applications and new package formats such as adding new vial sizes. An Allen-Bradley PLC controls machine functions and a Beckhoff PC-based color touchscreen presents a large and intuitive user interface. All production parameters can be programed into the PC, including dosing volumes, dosing speeds, kinematics of the filling system, adjustment of automatic feeders and output.
The SX-310-PP/D can be equipped with data recording software to export the production data in compliance with 21 CFR Part 11. Featuring 304 stainless-steel frame and electro-polished 316 stainless-steel product contact parts that meet FDA approval for use by pharmaceutical and biotech manufacturers, the SX-310-PP/D has been designed in compliance with cGMP.
NJM offers a “total solution” approach that includes full IQ / OQ validation support and turnkey line integration services to seamlessly combine best-in-class technologies.