Innovations at INTERPHEX

The annual INTERPHEX trade show returned to the Pennsylvania Convention Center in Philadelphia, Pennsylvania, this year and presented its usual rich mix of processing and packaging innovations. Attendees interested in packaging found new ideas on the show floor during the event, which took place Mar. 26–28.

Hallie Forcinio

Packagers looking for cold-chain management solutions, barrier materials, productivity-enhancing tools, reusable pallets, or contract packaging partners were well rewarded.

Barrier materials

New barrier materials included clear structures. A three-layer polyvinylidene chloride–polyvinyl chloride (PVdC–PVC) film provides an ultrahigh barrier to oxygen and water vapor. The high-crystallinity PVdC dispersion in the middle layer also delivers higher barrier properties. Compared with conventional PVdC-coated films, the symmetrical structure exhibits excellent mechanical stability. Blister packages that incorporate the film reportedly lay flat and are handled smoothly by cartoning equipment. Available in transparent clear and opaque colors, the multilayer film thermoforms in the same temperature range as monolayer PVC. The low coefficient of friction of the PVC outer layers prevents blocking in preheat plates and ensures a consistent material flow during thermoforming. The film is ultrasonically sealable to vinyl without coatings and heat-sealable to all standard vinyl-compatible lidstocks ("Pentapharm alfoil E S03," Klöckner Pentaplast, Gordonsville, VA).

Barrier films optimized for medical-device applications combine rigid polyethylene terephthalate (PET) glycol with an Aclar laminate. The choice of Aclar laminate determines the level of barrier properties. Designed for applications that combine a medical device with a moisture-sensitive pharmaceutical such as a prefilled syringe or inhaler, these films seal to all standard polyester- and vinyl-compatible lidstocks. The products are compatible with gamma, e-beam, and ethylene oxide sterilization and available in high-gloss clear and transparent colors ("Pentamed Aclar PA 300/12," "PA 200/12," and "PA 190/12" rigid barrier films, Klöckner Pentaplast).

Inksure's handheld reader authenticates items by scanning covert barcodes printed on packaging or documents. (COURTESY OF INKSURE)

A competitor to Aclar structures provides a high barrier to water-vapor transmission. The PVdC-based films also offer a good barrier to oxygen. Options include PVdC–polyethylene (PE)–PVC, PVdC–PE–polypropylene, and PVdC–PE–PET structures. The films also can incorporate security elements ("Perlalux-Tristar Ultra" film, Perlen Converting, Whippany, NJ).

Cold-chain management

Data loggers are one way to monitor shipments and provide alerts to shippers if temperature-sensitive products are exposed to excess heat or cold. One data logger relies on a USB port for configuration and data output. The system monitors multiple trips during a 400-day period, captures 16,000 temperature data points between -35 and 70 °C, and supports compliance with 21 CFR Part 11 requirements. An "X" or check mark in the corner of the screen instantly shows whether the product experienced acceptable conditions during the trip. An integral report generator presents the collected data as a PDF file and eliminates the need to install and qualify report software. Reports may be viewed, printed, e-mailed, or stored on a network ("PDF Datalogger," Elpro Services, Marietta, OH).

Contract packaging

Drugmakers seeking contract packaging services had many exhibitors to visit. One new 30,000-ft² facility offers aseptic vial filling and manufacturing that complies with current good manufacturing practices (CGMPs), plus a development area with multiple manufacturing and containment suites. The aseptic vial-filling line is designed to fill containment and high-potency products and will initially focus on filling small-molecule drugs. Designed for clinical supplies and niche commercial manufacturing, the operation includes a qualified, 60-ft² lyophilizer (Beaver Court complex, Pharmaceutics International, Hunt Valley, MD).

Easy-to-clean, multitrip aluminum pallets from LM Containers can be customized to user specifications. (COURTESY OF LM CONTAINERS.)

Productivity-enhancing tools

A stainless-steel accumulator–single filer moves small vials at rates faster than 800 vials/min. The patented conveying system handles vials as small as 2 mL with virtually no back pressure ("Infinity Rx" accumulator–single filer, Garvey, Blue Anchor, NJ).

Life cycle management software manages each step of a label's lifespan, including design, review, approval, printing, updates, revisions, and obsolescence across multisite operations. Software is compatible with barcode and radio-frequency identification labels and provides the comprehensive security and audit logs required for compliance with 21 CFR Part 11. An XML interface enables seamless integration with enterprise resource planning, product life cycle management and other enterprise systems ("ROBAR Enterprise Label Management System," Innovatum, Sugar Hill, GA).

Stainless-steel operator interface mountings improve efficiency, ease of use, and cleanability in sensitive pharmaceutical environments. Tightly integrated display and keyboard enclosures feature an industry-standard articulating arm for counterbalanced vertical adjustment and ergonomic flexibility. Durability and superior construction reduce data inaccuracies and unnecessary downtime ("MiniStations" operator interface mounting system, Strongarm Designs, Horsham, PA).

Statistical quality-control software for the packaging process integrates checkweighers, metal detectors, statistical balances, and other data-collection devices into a network. Test stations also can be established to measure and record product attributes such as cap torque, label placement, and lot numbers to unify all aspects of the quality process in one program. Extensive report and dashboard capabilities simplify the monitoring of important functions. An audit-trail module helps meet the requirements of 21 CFR Part 11 for electronic signatures, data management, and traceability. The program also can be provided with a full set of validation protocols to ensure CGMP-compliant monitoring ("FreeWeigh.Net" software, Mettler-Toledo Hi-Speed, Ithaca, NY).

"EQPac" software from Mettler-Toledo Hi-Speed expedites checkweigher qualification. (PHOTO: COURTESY OF METTLER-TOLEDO HI-SPEED.)

Software also can help expedite the equipment-qualification process. A fully documented process for checkweighers, for example, adheres to good testing and good documentation practices to deliver accuracy and consistency ("EQPac" software, Mettler Toledo Hi-Speed).

Product protection

Tablets and capsules are printed in a programmable, noncontact process to provide a readily visible, pill-level method of product identification and differentiation. The 12-lane system relies on an inkjet printer and pharmaceutical-grade black ink. A vision system provides 100% inspection ("EAM Tablet/Capsule Printing Machine," Efficient Automated Machine, Long Island City, NY, "Industrial Print System," Inc.Jet, Norwich, CT; "Pharma Black Ink," HP, Palo Alto, CA).

Machine-readable covert codes serve as a product-authentication tool and help prevent counterfeiting and diversion. Two-dimensional barcodes carry item or batch-level information and can be printed by existing equipment. Resulting codes are invisible to the naked eye and under ultraviolet light but are readily identified with an easy-to-use, handheld reader ("TrackSure" technology, Inksure Technologies, Fort Lauderdale, FL.)

Reusable pallets

Reusable steel or aluminum designs might be the answer for pharmaceutical manufacturers who want to eliminate wood pallets to comply with repair, cleaning, waste-disposal, or phytosanitary requirements put in place to eliminate the transport of woodborne pests. Metal pallets provide the highest strength-to-weight ratio, are fire-resistant, easy to clean, recyclable, and compatible with temperature extremes.

Heavy-duty aluminum pallets do not rust, feature sturdy welded construction, are easy to clean and sanitize, withstand high-temperature steam, and are nonabsorbent, thus easy to dry. Standard sizes include 40 × 48 in., 42 × 48 in., and 48 × 48 in. and 800 × 1200 mm and 1000 × 1200 mm with two- or four-way forklift access (aluminum pallets, LM Containers, Hayti, MO).

A lightweight, flame-retardant, 48 × 40 × 5.5-in. steel pallet reportedly ranks as first in meeting the capacity and compatibility standards of the Grocery Manufacturers Association. At 63 lb., the rust-resistant galvanized steel pallet weighs about 10 lb. less than a standard wood pallet. The product offers superior racking strength with more than 3500 lb of unsupported racking capacity and 40,000 lb of static load. Welded construction increases durability, reduces chances of damage, and helps maximize the number of trips the pallet can make before it is recycled. As a result, the steel pallet is said to cost less per trip than wood or plastic pallets ("Steelpac" pallet, Worthington Steelpac, Columbus, OH).

Stoppers, dosage cups, and other products

A fluorinated polyester coating fused to ultraclean rubber provides an inert stopper material with minimal levels of extractables and leachables. Available in ready-for-sterilization and ready-for-use formats, the barrier-coated, silicone-free stopper runs freely through equipment and provides maximum seal integrity even after exposure to storage temperatures of -78 °C ("Omniflex3G" stopper, Helvoet Pharma, Pennsauken, NJ).

A stock dosage cup for general and pediatric markets features readily visible milliliter and teaspoon calibration lines printed in black with food-grade ink. Printed lines permit more accurate measurement than engraved or embossed lines on traditional translucent dosage cups. The units also may be printed with custom calibrations, instructions, and logos. Cups fit over child-resistant closures ranging in diameter from 22 to 24 mm ("AccuCup," Comar, Buena, NJ).

A sanitary benchtop filler combines cleanroom design and touch-screen controls with servo-driven pump technology. Designed for developmental and short-run needs, the compact liquid-filling system can be equipped with piston, peristaltic, or lobe pumps to handle many viscosities. Fill sizes range from less than 0.05 mL to more than 1 L with ±0.5% accuracy (sanitary benchtop filler, Filamatic, Baltimore, MD).

Additional packaging news from the show floor can be found at PharmTech Talk. Meanwhile, it's not too early to begin thinking about participating in INTERPHEX 2009.

Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, editorhal@cs.com