Visitors found new container options, child-resistant concepts, and serialization solutions. This article contains bonus online material.
This year's INTERPHEX show presented a wide range of packaging innovations. Many machines offered enhanced flexibility, modular design, and compatibility with single-use product paths.
Modular design enables a high-speed aseptic filling and stoppering machine to operate in intermittent or continuous motion and to accommodate various filling methods, including powder filling. It's also easy to add as many as 12 filling stations or quality-control points, such as checkweighing. Fill volumes range from 0.25 to 100 mL. The servo-controlled machine operates at 400 vials/min with 100% checkweighing, and 600 vials/min if only a sampling of containers is checkweighed (Xtrema F2000 filling and stoppering machine, IMA Life).
Another highly flexible line can be aseptic or nonaseptic, handles glass or plastic bottles or vials, and can accommodate different filling systems with as many as eight filling heads. Three closing stations can be set up to handle various fittings, stoppers, and cap styles. The system also can incorporate pre- and postfilling gas flushing, empty- and full-container checkweighing with feedback loop, 100% torque measurement, inspection cameras, and labeling. On its maximum fill of 1100 mL, output can reach 120 bottles/min. Changeover takes 15 min (Kugler Linoline, Optima Group).
The Xtrema F2000 high-speed filling and stoppering machine from IMA Life has automatic feedback that adjusts the dose if fill volumes drift out of specifications.
A blow-fill-seal machine designed for parenteral products eliminates hydraulics and the potential for oil leaks, related particulate generation, and cleanup issues. The 21 CFR Part 11-compliant equipment fills volumes from 0.2 to 500 mL and may be built with an isolator system. Container molds include from six to 30 cavities for outputs as high as 150 containers/min. Resin choices include low-density polyethylene, high-density polyethylene, and polypropylene. An optional ultrasonic cutoff system also helps minimize particulate generation (628 Asep-Tech blow-fill-seal packaging system, Weiler Engineering).
The touch-panel interface on Colanar's benchtop filler stores as many as 50 recipes in its memory.
Ionized hydrogen peroxide (H2O2) sterilizes cleanrooms and isolator interiors 50% faster than traditional spray systems. With a concentration of 7.5% versus the traditional 35%, the ionized H2O2 quickly fogs the interior of the room or enclosure; can be removed faster; and kills bacteria, viruses, mold, fungi, and spores on contact, thus achieving a six-log reduction in microorganisms. It's also less corrosive and doesn't rely on humidity to work. In operation, the H2O2 is aerosolized with house air or a compressor system and passes through a 17,000-volt electric arc to quickly fog spaces as large as 1500 ft3 (iHP 100 Mini Pod System, SixLog).
A washer for parenteral products cleans vial exteriors from the shoulder down to remove toxic product residue or improve label adhesion. The system replaces traditional vial-handling starwheels with parallel belts. Silicone cups along the bottom edge of the belts grip the vials by the cap and create a watertight seal that accommodates a high-pressure spray of water or detergent. Changeover between 13- and 20-mm vials requires no change parts. The washer contains only two moving parts and handles glass or plastic vials with volumes from 1 to 100 cm3 at 200 vials/min (EVW-100 External Vial Washer, PennTech Machinery).
With a built-in vacuum pump, Cozzoli's PF2TT powder filler needs only an air connection and 115-volt power supply.
At the other end of the line, an aluminum capping machine has been redesigned to reduce particulate generation with direct-drive motors located in the base of the unit. The machine caps vial sizes from 1 to 100 cm3 , operates at 200 vials/min, and changes over in less than 10 min (AC-6 Capping Machine, PennTech Machinery).
A modular system helps optimize packaging operations for syringes, vials, cartridges, and eye-drop or nasal-spray bottles. Once the process is fine tuned at speeds as high as 10 units/min, it transfers seamlessly to higher-volume equipment. The choice of modules begins with filling options, including single-use, and may include checkweighing, stopper or dropper insertion, needle-shield assembly, sealing, crimping, and capping (DPS Development and Production System, Groninger USA).
Another product-development-oriented system applies silicone to the inside of syringe bodies to determine how much is needed to ensure that the plunger moves smoothly. The semiautomatic unit can be loaded with 35 syringes and treats as many as 10 containers/min. Since the benchtop system is based on the same technology as the production-scale machine, the transition from laboratory or pilot line to full-scale production is seamless (SVS 9061 Silicone Spraying Unit, Bausch and Stroebel Machine).
Another benchtop system, a microprocessor-controlled powder filler with two heads, fills doses ranging from 50 mg to 75 g with ±1% accuracy. The filling process eliminates scraper blades and features a dual-level supply hopper and agitator. In operation, vacuum draws the powder into the dosing chamber. When it is full, the vacuum cuts off, and a pinch valve opens to create a pathway to the filling head. Positive pressure moves the powder through the dosing head into the container. After the fill is complete, a high-pressure pulse cleans residue from the chamber and filter, and deposits it into the container, thus eliminating waste (PF2TT Powder Filler, Cozzoli Machine).
A servo-driven benchtop filler fills liquids semiautomatically or automatically. Four rotary piston pump sizes handle fill ranges of 50 µL to 1.5 mL, 1–10 mL, 5–30 mL, or 10–100 mL. Models include single-, dual-, and five-head configurations. Systems can be cart-based, integrated with an X–Y table, or mounted on a vial or syringe filling machine (FSR 1000 single-head, FSR 1002 dual-head, FSR 1005 five-head benchtop filler, Colanar).
For solid dosage forms, a high-speed tablet counter fills 100-count bottles at as many as 120 bottles/min. The electronic system includes 20 central processing units (one per channel), can be set up quickly, needs no tools for changeover, and tracks downtime. A prehopper removes broken or damaged tablets. Good product moves into the pressure-free main hopper, where it is accelerated so that it drops single file into the bottle. With an optional communications package, the machine can send alerts through email or Smartphone (Street Fighter 100 tablet counter, Capmatic).
Because of growing interest, several exhibitors showcased single-use systems. A 50-cm3 peristaltic pump for single-use dosing systems has joined a 6-cm3 option. Tubing can be removed and replaced with one hand. Offset rollers minimize pulsation and improve fill accuracy to ±0.5 mL (PreVAS Single-use Dosing System, Bosch Packaging Technology).
At least four other firms offer peristaltic pumps for single-use systems (Bausch and Stroebel, Watson-Marlow, Flexicon Liquid Filling, and Colanar). But, peristaltic pumps are not the only style available for single-use systems. A single-use rolling-diaphragm pump built of polycarbonate with a platinum-cured silicone diaphragm is assembled in a cleanroom, 100% integrity tested, and delivered with custom tubing sets. The prevalidated, presterilized, and preassembled system offers accuracy of ±10 mg on fills equal to or less than 2 mL and ±0.5% on fills greater than 2 mL (PreVAS Dosing System).
A disposable turning valve pump also is supplied as part of a preassembled, presterilized system, which includes tubing and filling needles. Targeted for vials, eye-drop bottles, syringes, and cartridges, it offers high accuracy on fills from 0.1 to 3 mL and handles virtually any liquid, including highly viscous or shear-sensitive ones (Disposable Filling System, Groninger).
New inkjet coders
For coding needs, a 35 character/s continuous inkjet (CIJ) printer is reportedly 20% faster than competing systems. The IP65-rated unit is washdown compatible and recirculates solvent so that it consumes only 2 mL/h, compared with 4–7 mL for other systems. With only six moving parts and a simplified ink system, maintenance requirements are minimal. The printer also features a removable operator interface and uses volatile organic compound-free inks (alphaJET evo continuous inkjet printer, Oncode).
Another CIJ printer needs no preventative maintenance at all—just routine replacement of consumables, which are color-coded for easy identification. A modular design eliminates the traditional ink reservoir and separates ink and filters from pump and associated electronics so that ink disposal doesn't scrap viable mechanical and electrical components. Other features include a simplified operator interface and range of input–output options to simplify integration with other equipment (A320i printer, Domino North America).
As FDA requires more information in medication guides and patient information, the size of package leaflets and outserts is increasing. One of the biggest measures 630 in.2 , but folds into a 1.25 × 1.25-in. square with 210 panels, which is substantially more than the previous maximum of 170 panels (leaflet–outsert, Mini Graphics). Printed materials also may include 3-D graphics that rely on the same software used for 3-D imagery in video games and 3-D movies to create accurate color, texture, and size (3D Label Graphics, Mini Graphics).
It's possible to fold an insert to a size even smaller than 1.25 × 1.25 in. At 1.125-in.2 , the insert can be applied automatically and consist of approximately 200 panels (Glued Capsert, Arthur Press).
If one sheet isn't big enough, two or more inserts can be stacked together. One piggybacked concept compatible with automatic application features two 1.25-in.2 inserts with as many as 170 panels each (multiserts, Cortegra and Chesapeake Pharmaceutical and Healthcare Packaging; multipack bundles, The Challenge Printing).
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, firstname.lastname@example.org.