NJM, a ProMach product brand based in Quebec, Canada, has introduced the Dara NFL/2-RDL aseptic filling and closing machine for ready-to-use vials utilizing the RayDyLyo® cap.
Handling groups of pre-sterilized vials and eliminating the crimping required with traditional aluminum closures, this servo-driven system streamlines the packaging operation to reduce capital costs, minimize footprint, and speed-up changeover.
Dara NFL/2-RDL was developed for biotech companies and 503B pharmacies. Utilizing ready-to-use vials simplifies small-scale production by eliminating the need for a washer and depyrogenation tunnel. Using the RayDyLyo cap further simplifies operations by eliminating crimping and the particulate generation that comes along with that process.
This NFL system is for customers with smaller capacity requirements that will benefit from this stopper/cap technology. The system provides the added value of syringe and cartridge processing capabilities in the same machine.
Standard features provide automatic loading and unloading of nested vials, while options facilitate either automated or semi-automated de-bagging and de-lidding.
Featuring a wide variety of options, NFL/2-RDL can be equipped with stainless steel or ceramic rotary piston pumps, which can achieve +/- 0.5% accuracy, or with peristaltic pumps, which can achieve +/- 1% accuracy.
The NFL/2-RDL 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 electro-polished 316 stainless-steel product contact parts that meet the Food and Drug Administration (FDA) approval for use by pharmaceutical and biotech manufacturers, the NFL/2-RDL is designed in compliance with current good manufacturing practice (CGMP).
Image courtesy of Healthcare Packaging