Company offers a total solution approach that includes full validation support and turnkey line integration services
NJM Packaging introduces the Dara SX-300-Lyo aseptic filling and stoppering machine for lyophilised products in vials. Dara can equip this system with stainless steel or ceramic rotary piston pumps or peristaltic pumps that utilise ‘single use’ tubing to achieve throughputs of up to 7200 vials per hour.
Featuring fully servo-driven automation and a compact footprint, the SX-300-Lyo offers accurate filling and precise stoppering, as well as low maintenance, fast and easy changeovers and simple set-up to add new vial sizes.
Ideal for suspensions, vaccines and cellular tissue, the Dara SX-300-Lyo aseptically fills glass or plastic vials with volumes from 1–100mL. It inserts rubber stoppers from 13–30mm in size half way into the vials for lyophilisation.
Dara can configure the SX-300-Lyo with rotary piston pumps or peristaltic pumps, with one or several filling heads, simple or multiple stoppering stations within a compact footprint. For sterile or cleanroom applications, the SX-300-Lyo can be equipped with a laminar air flow (LAF), open or closed restricted access barrier system (oRABS/cRABS) or with a high containment isolator system. Optional clean-in-place (CIP), sterilisation-in-place (SIP) or gas flushing are also available.
Ancillary equipment from Dara, such as automatic or manual denesting units, adapts this machine to any ready-to-fill vials. Trays of sterile vials can be manually fed to the SX-300-Lyo or the system can be integrated with an upstream vial washer and depyrogenation tunnel for continuous automated feeding. The system can be equipped with a checkweigher for 100% weight control or a statistical weighing mechanism. An optional particulate counter further ensures final product quality.
Partially or fully servo-driven, depending on the specific configuration, the SX-300-Lyo offers 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 an Allen-Bradley colour touchscreen presents a simple and unique user interface that includes dosing or weighing scales. All production parameters can be programmed into the PLC, including dosing volumes, dosing speeds, kinematics of the filling system, adjustment of automatic feeders and output.
The SX-300-Lyo can be equipped with data recording software to export the production data in compliance with 21 CFR Part 11. Featuring a 304 stainless steel frame and electropolished 316 stainless steel product contact parts that meet FDA approval for use by pharmaceutical and biotech manufacturers, the SX-300-Lyo has been designed to comply with cGMPs.