Ideal for biotech companies and 503B pharmacies packaging suspensions, diagnostics, solutions, and/or vaccines, NJM’s NFL/2 handles nests of pre-sterilized syringes as well as vials and cartridges. This fully servo-driven system simplifies small scale production to reduce capital costs, minimize floorspace requirements, and speed up changeover.
The NFL/2 fills and seals syringes while they remain in the nest. A vibratory hopper/circular feeder delivers the plungers to the pick-and-place stations, which places the plungers into the syringes using direct drive, servo-motion control. Changeover to another syringe size can be completed in less than 15 min with no tools required.
As a dual station system, the NFL/2 can fill and close up to 4,500 syringes/hr in a compact footprint that’s only 6.6 ft long and 3.3 ft wide. For customers requiring faster throughput, the five-station NFL/5 handles up to 10,000 syringes/hr per hour.
To maximize production versatility, the NFL/2 is available with a wide variety of options. Automatic loading and unloading of nested syringes is available, as well as automatic and semi-automatic debagging and delidding. The NFL/2 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. If sterile or ISO 5 environments are needed, laminar air flow (LAF), open or closed restricted access barrier systems (oRABS/cRABS) or high containment isolator systems are available. Vacuum-assisted cap insertion and gas flushing reduce O2 levels in the container, if required. Optional statistical process control and particulate counters help ensure final product quality. Clean-in-place (CIP) or sterilization-in-place (SIP) modules are also available.
NFL/2 utilizes servo-driven, X-Y motion to achieve repeatable performance, low maintenance, simple troubleshooting, fast changeovers and easy addition of new formats. An Allen-Bradley PLC controls the machine functions and a Beckhoff PC-based 15-inch (38 cm) color touchscreen presents a large and intuitive user interface. All production parameters, including dosing volumes and speeds, can be programmed via the HMI.
The NFL/2 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 FDA approval for use by pharmaceutical and biotech manufacturers, the NFL/2 is designed in compliance with cGMP.