NJM, a ProMach product brand, introduces the Dara SX-310-RDL, an aseptic filling and closing machine for sterilized vials with RayDyLyo® caps. This system eliminates the crimping required with traditional aluminum closures to simplify the packaging operation and speed throughput, while offering fast and easy changeovers and new container size set-ups in the future.
The company’s engineering philosophy and modular designs allow it to quickly offer machines to accommodate new component technologies such as the RayDyLyo cap. This new cap/stopper combination led to the manufacture of a simpler and more compact machine based on the current SX-310 design, which has a high production rate compared to its footprint.
Featuring servo-driven automation, the linear, intermittent-motion Dara SX-310-RDL is ideal for 503B pharmacies and biotech manufacturers filling solutions, suspensions, diagnostics, vaccines or cellular tissue. Glass, plastic or metal vials are aseptically filled with dose volumes from 0.1 to 250 mL for liquids and from 2 to 1,500 mg for powders.
The dual-station SX-310-RDL/D handles vials up to 3 in. (75 mm) tall and 1.4 in. (36 mm) in diameter at speeds up to 120 containers/min. The single-station SX-310-RDL/S handles vials up to 8.3 in. (210 mm) tall and 2.5 in. (65 mm) in diameter at speeds up to 60 cpm.
Dara designed the new SX-310-RDL to seal vials with ARaymondlife’s patented RayDyLyo caps. As an alternative to aluminum caps, these pre-assembled plastic closures feature a rubber stopper within the cap. They minimize the “pop-off” effect and reduce the risk of stoppers adhering to freeze dryer plates. Available with Central Tear-Off (CTO) for injectable products and Total Tear-Off (TOO) for product reconstitution and mixing, RayDyLyo closures come in 13-mm and 20-mm sizes.
The SX-310-RDL seals the vials using simple vertical pressure on the caps. Eliminating the crimping station enables this filling and closing system to offer a smaller machine footprint, lower maintenance and less particulate generation compared to traditional filling, stoppering and capping systems.
The SX-310-RDL can be programmed for full stopper insertion for non-lyophilized products or half stopper insertion for lyophilizated products, a change made on the control panel in less than 5 min. The system can be changed over to handle a new vial size in 10 min, with no tools required.
Dara can equip the SX-310-RDL with stainless steel or ceramic rotary piston pumps or peristaltic pumps that utilize “single use” tubing for liquid products or vacuum-pressure fill guns for powdered products. The rotary piston pumps achieve +/- 0.5% accuracy, and the peristaltic pumps offer +/- 1% accuracy.
Featuring a footprint of only 100 in. (254 cm) long and 32 in. (82 cm) wide, the SX-310-RDL can be equipped with a laminar air flow (LAF), open or closed restricted access barrier system (oRABS/cRABS) or a high containment isolator system for sterile or clean room applications. 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-RDL 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 caps are loaded into a vibratory hopper/circular feeder that delivers them to a pick-and-place station that inserts them. Filled and closed vials are directed to output trays for manual unloading, or they can be integrated with downstream equipment.
To meet the needs of each product, users can program the SX-310-RDL to fill vials in a variety of ways – with nozzles lowered to the bottom of the containers, half way up or from above. The system features no bottle/no fill and no bottle/no cap safety devices. Inspection stations detect fill levels, missing caps and raised caps, which trigger an automatic reject to remove out-of-tolerance vials. 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-RDL 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 15-in. (38 cm) 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-RDL 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-RDL has been designed in compliance with cGMP.
NJM offers a “total solution” approach that includes full validation support and turnkey line integration services to seamlessly combine best-in-class technologies, including serialized and aggregated production lines comprised of primary and secondary packaging through bundling. NJM’s world-class aftersales support includes standard and extended warranties, preventative maintenance programs and onsite installation, training and ongoing service.
