Parenteral Packaging Equipment On Display at INTERPHEX

Interphex returns to the Javits Center in New York on March 21-23, 2017. Parenteral packaging will be well-represented especially technologies associated with fill/finish of ready-to-use vials, cartridges, and syringes.

For sterile or cleanroom applications, the NJM Packaging Dara SX-310-PP/D aseptic filling, stoppering, and capping machine can be equipped with a laminar air flow, an open or closed restricted access barrier system, or a high-containment isolator system.

NJM Packaging, for example, plans to introduce the Dara SX-310-PP/D machine. Pairs of filling, stoppering, and capping stations precisely aseptically fill, stopper, and cap glass or plastic vials with volumes from 0.1 to 250 mL for liquids and from 2 to 1500 mg for powders. Stainless steel or ceramic rotary piston pumps achieve +/- 0.5% accuracy. Optional peristaltic pumps, which utilize single-use tubing, deliver +/- 1% accuracy.

The compact, servo-driven machine can be programmed for full stopper insertion, followed by aluminum/flip-off cap application, or half stopper insertion, and no capping for lyophilization. A servo-driven, tangential rolling head minimizes particulate generation during closing. Inspection stations detect fill levels, missing stoppers, and raised stoppers and trigger an automatic reject to remove out-of-tolerance vials.

The machine achieves throughputs of up to 120 units per minute and is compatible with handling suspensions, vaccines, or cellular tissue. Changeover to a new product takes 15 minutes with no tools required.

Options include clean-in-place, sterilization-in-place, gas flushing, vacuum-assisted stopper insertion, onboard checkweigher, and ancillary equipment such as automatic or manual denesting units to adapt the machine for ready-to-fill vials.

OPTIMA Pharma’s MultiUse Filler Series fills and closes nested or bulk syringes, vials, or cartridges. The modular design of the transport system enables a wide range of vials to be handled without installation of format change parts. Visitors to the booth will also be able to view turnkey projects in 3D, including an isolator-equipped vial processing line capable of handling 400 vials/min with 100% in-process weight control.

Another system designed to handle nested, ready-to-use vials, cartridges, and syringes-the FlexPro 50 filling and closing machine from Groninger-now offers a single-use rotary piston pump option. The modular machine also handles vials in trays and bulk and can be integrated with an isolator and freeze dryer and supplied as a turnkey system.

Building on last year’s debut of its Extrafill robotic monobloc, Marchesini Group, which is celebrating the 25^th anniversary of its US office in West Caldwell, New Jersey, plans to introduce the Extrafill syringe filler. Developed to meet the growing demands of packaging disposable pre-filled syringes in the North American market, the compact Extrafill machine is designed to accommodate two to five filling and stoppering stations under one isolator and can produce up to 12,000 pieces per hour. A robotic arm, which features a gripper that moves like a human hand, peels off the Tyvek protective film and pushes the tub of syringes onto a loading belt for transport to the filling and stoppering stations. Batching precision is guaranteed by systems that center the syringes and completely protect them during the filling phase to avoid contamination and to ensure a sterile process.

Another robotic system, Steriline’s three-robot Robotic Filling Line for injectable products, is fully integrated under isolators. It handles vials sizes from 2 mL to 100 mL without change parts to minimize changeover time. “Zero-loss” inspection enables reprocessing of vials with missing stoppers or caps.  

Rommelag now offers a Disposable Filling System (DFS) alternative for its bottelpack aseptic blow-fill-seal machines. Simple to install and compatible with in-line sterilization, the DFS consists of pre-assembled disposable components and is based on a peristaltic feed.

On the sealing side, EMA Pharmaceuticals’ EMA Clean-Certified Caps provide “ready-to-be-sterilized” or “ready-to-be-used” overseals, processed to minimize particulate and bioburden and assembled in a cleanroom environment. Ready-to-be-used caps are packed in sealed polyethylene bags and gamma sterilized.