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Solid-dosage forms and parenteral products benefit from next-generation packaging machines.
Packaging machines displayed at INTERPHEX (April 23-25, 2013, at the Javits Center in New York, NY) rely on advanced technology to handle solid-dosage forms or parenteral products.
For solid-dosage forms
Packaging equipment for solid-dosage forms tends to be integrated. BellatRx, for example, displayed a compact Packaging Cell designed to handle batches of less than 50,000 units. The flexible system consists of a container infeed turntable, infeed conveyor, counter, desiccant inserter, cotton inserter, and capper. A low-level vibratory bowl presents caps to the capper and can be equipped with an elevator for replenishment (see Figure 1). The Packaging Cell also may include an induction sealer, retorquer, bander, labeler, inspection modules and outfeed turntable. Rated at 60 bottles per minute, the cell can run up to 100 bottles per minute with the addition of a feedscrew. It also can be configured to handle liquids or powders.
Expanded functionality also is commonplace as demonstrated by the US introduction of the MV-11 Outsert System from G&K–Vijuk International. A patented, three-knife process increases insert size to 266 panels in response to regulatory requirements for more product and patient information. Operating at 14,000 cycles per hour, the unit folds printed sheets measuring 40 x 20 inches into 1 1/8 x 1 1/8-inch outserts.
For parenteral products
Compact, integrated systems also rule parenteral-product packaging. One example, the Da Vinci Loading/Unloading System from IMA Life North America, moves groups of vials in and out of lyophilization chambers using a battery-powered gear box and caterpillar drive system that recharges when parked (see Figure 2). An aluminum track and belt made of a material with a low coefficient of friction minimizes wear and particulate generation, enabling the unit to function in a Grade A (Class 100) cleanroom environment and move up to 600 vials per minute. Eliminating the actuating mechanisms usually found on the front and back of the machine shrinks the space required for loading and unloading and improves operator access. Patent-pending wireless communication eliminates cables between battery and programmable logic controller and further simplifies the design of the machine. Laser technology precisely controls positioning.
Many aseptic filling lines begin with washing. The GW24 Batch Washer from Cozzoli Machine cleans ampules and vials ranging from 1 to 500 mL with 180 °F water for injection (WFI) and jets of air. A programmable logic controller stores nine wash recipes with up to 18 steps each.
For low-volume and start-up applications, the RW-250 Vial Washer from PennTech Machinery operates the same way as its rotary RW-500 except the operator pushes vials into the cassette manually. Containers ranging from 1 to 100 mL are inverted to clean with WFI and sterile air and reoriented to exit the machine. Dwell times can be set as needed, and maximum output is 100 vials per minute.
A compact monoblock system from Chase-Logeman includes modules to fill, insert droppers, torque, label, and apply date and lot codes. The rotary, 12-station unit fills containers ranging from microtubes to 4-ounce bottles at rates of up to 60 per minute. A checkweighing option tares the container and weighs it again after filling. Peristaltic pump or other filling technologies can be specified. Other options include a disposable fluid pathway and disposable filling needles.
The all-electric ASEP-TECH Model 628 machine from Weiler Engineering blows, fills, and seals containers ranging from 0.5 to 500 mL. Standard features include a patented, electronically controlled fill system, automatic sterilization system with integral data collection, and filter integrity test system. A HEPA air shower maintains a Class 100 environment in the nozzle shroud area. A two-piece stepped base simplifies maintenance and product discharge.
—Hallie Forcinio is Pharmaceutical Technology's packaging editor, firstname.lastname@example.org.