Medical Device Link.

Originally Published PMPN April 2005

SHOW COVERAGE

Record number of exhibitors expected at this year' installment of the pharmaceutical conference and exhibition.

Pharmaceutical professionals seeking new product offerings and a wide range of business information would do well to visit the Big Apple near the end of this month. That's because Interphex 2005, the 26th annual pharmaceutical conference and exhibition, will be showcasing 1000 companies from around the globe and numerous conference sessions at New York City's Jacob K. Javits Convention Center on April 26–28.

Equipment, technology, and services will be exhibited in the PharmaManufacturing, PharmaSourcing and Services, and PharmaIT forums, as well as the new PharmaFacilities forum.

In the PharmaManufacturing forum, exhibitors will be displaying products that enhance manufacturing productivity, including automation and process controls, packaging and processing equipment, tablet/capsule fillers, and validation.

The PharmaIT exhibition will feature business process and manufacturing applications, enterprise integration, computer hardware and software, and networking applications.

The PharmaSourcing and Services area will include analytical and testing solutions, contract manufacturing, packaging, and research organizations, business process outsourcing exhibitors, and a host of other companies that provide a wide range of diverse services.

The newly-added PharmaFacilities forum will contain exhibitors offering products and services that support the full life cycle of pharmaceutical development, including cleanrooms and contamination control, economic development and site selection, maintenance and warehousing, safety and security, and power and utilities. Within this forum will be the Rockwell Automation Partner Pavilion, which will feature automation solutions along with products and systems integrators.

The exhibition will also be joined by an application-oriented conference that is designed to help pharmaceutical and biotechnical professionals develop skills to increase performance.

Keynote sessions at this year's conference include a panel entitled "Strong Medicine: What's Next for Drug Development?" This roundtable discussion will include input from Nancy Hutson, PhD, senior vice president of global research and development for Pfizer; Irvin Modlin, MD, PhD, professor at Yale University School of Medicine; and Sarah W. Fuller, president of Decision Resources Inc., among others. In addition, John M. Taylor III, FDA associate commissioner for regulatory affairs, will lead a discussion called "Risk-Based Inspections: What's the FDA Looking for?" Finally, former New York City mayor Rudy Giuliani will discuss "Leadership in Challenging and Uncertain Times."

In addition, Interphex 2005 attendees will have the opportunity to be on hand as the winner of the Facility of the Year Award is announced. This award, in its first year, recognizes manufacturers who are using new technologies to improve the quality of their products and to reduce the cost of producing medicines. The five finalists for this award are as follows: Alkermes Inc. (Cambridge, MA), chosen for its Brickyard Square manufacturing facility; Apotex Inc. (Winnipeg, MB, Canada), nominated for its Etobicoke exapansion project; Kowa Company Ltd. (Nagoya, Japan), nominated for its Kowa Nagoya project; Lundbeck Pharmaceuticals Ltd. (Copenhagen, Denmark), chosen for its new manufacturing facility in the UK; and Novo Nordisk A/S (Hillerod, Denmark), selected as a finalist for its new NovoSeven facility.

The winner of the award will be introduced at 8:45 a.m. on Wednesday, April 27, prior to that day's keynote presentation. While at the show, attendees can meet with representatives of the finalists' facilities in the lower level of Hall 1A of the Javits Center.

EXHIBITOR PRODUCTS

Outsert System

A new outsert system can produce larger outserts with more panels and greater thicknesses. The MV-2005 Outsert System is designed and configured so the company can customize it according to the customer's expanding needs. The system is electronically controlled for ease of setup, operation, and changeovers, and comes equipped with a modem for off-site diagnostic analysis. Vijuk Equipment, Elmhurst, IL; 630/530-2203; www.vijukequip.com.

High-Barrier Foil Laminations

A company will feature its peelable and nonpeelable high-barrier foil laminations for new medication-delivery systems, such as nasal swabs, oral melt strips, and transdermal patches. Options include reverse-printed polyester, 4–6-color gravure or flexographic printing, child resistance, and various foil gauges to meet barrier requirements. Amcor Flexibles, Mundelein, IL; 800/447-0049; www.amcor.com/flexibles-healthcare.

Diagnostic Mailing Kits

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A company will showcase its two new flexible diagnostic mailing kits at its booth. The Model 570 and Model 571 include all required secondary and outer packaging components. Users of the kits only need to provide leak-proof primary specimen containers, such as tubes, vials, or cups. The kits are designed to accommodate any size and quantity of containers that fit inside the flexible secondary envelope along with the absorbent material. Both products fully comply with the USPS, DOT, and IATA regulations for air or ground transport of clinical and diagnostic specimens. ThermoSafe Brands, 1rlington Heights, IL; 847/398-0110; www.thermosafe.com.

Tablet Counter

A high-speed double tablet counter features two counting heads and a two-lane filling conveyor to maximize productivity within a space-saving footprint. The Cremer CF 1220D can fill up to 110 bottles per minute and can handle tablets, caplets, and hard or soft capsules ranging in size from 2 mm to 25 mm in diameter. In addition, the machine's spare set of product contact parts enables it to be changed over in less than 10 minutes with no additional tools. It also offers enhanced software with improved diagnostics that allows users to maximize production efficiency by identifying and correcting limiting factors during operation. NJM/CLI, Lebanon, NH; 800/432-2990; www.njmcli.com.

Dispensing Pump

A new dispensing pump will be introduced at booth #1709 at this year's Interphex. The 520Di combines the ability to perform in-process applications in the place of previous 520 versions, with dispensing and dosing programming built in to handle delicate laboratory environments. It features spring-loaded stainless-steel rollers and a larger swept-volume pump head, in addition to combining the gentle handling of fluids with increased capacity. The gentle nature of the peristaltic pumping action is ideal for fragile protein-string and enzyme-based vaccines which are easily damaged. Watson-Marlow Bredel, Falmouth, UK; 800/282-8823; www.watson-marlow.com.

Processing Cartridges

A manufacturer of membranes and systems will feature its SelRO nanofiltration elements and Romipro hollow-fiber ultrafiltration cartridges at Interphex. These two state-of-the-art membrane products are well-suited for pharmaceutical laboratory and production processes. The SelRO membranes provide solid chemical and thermal stability to satisfy the requirements of processes involving high and low pH, high temperature, and organic-solvents media. The Romipro cartridges provide cost-effective purification and concentration for separation of enzymes, proteins, and polypeptides. They are available in a number of sizes. Koch Membrane Systems Inc., Wilmington, MA; 888/677-5624; www.kochmembrane. com.

Desiccant System

A company will feature its newly-launched Desiccant Efficiency System Integration (DESI) program, which is designed to help companies save time and money when automating desiccant systems. Through the program, the company's experts holistically analyze relevant variables such as current volumes, line speeds, and anticipated growth before recommending the most efficient product, configuration, and insertion equipment for a particular company. Visitors to the company's booth will have the chance to speak with company representatives and schedule a free DESI program consultation designed to outline the solutions best suited to their specific needs. Süd-Chemie Performance Packaging, Colton, CA; 800/989-3374; www.s-cpp.com.

Rollstock Machine

A company is offering a fully automatic, space-saving thermoform-fill-seal rollstock machine. The R140 is ideal for small product and batch runs. In addition to viewing this machine, visitors to the company's booth will also be able to meet with company packaging experts and receive consultation on developing customized medical, pharmaceutical, and diagnostic packaging designs unique to their own business needs. Multivac Inc., Kansas City, MO; 800/800-8552; www.multivac.com.

Software System

A company will showcase a new version of its efficiency, quality, production, and batch-analysis software application. The Proficy Plant Applications Version 4.1 enables managers to gain clear insight into their operations to allow more efficient management of peak performance and compliance. The new version adds new capabilities to reduce overall implemenation time with improved ease of use and configuration, enhanced reporting, improved connectivity and extensibility, and more-expansive scheduling execution and production tracking. In addition, it has advanced analysis and drill-down improvements, enhanced security, and 21 CFR Part 11 and e-Signature features. GE Fanuc Automation Americas Inc., Charlottesville, VA; 800/433-2682; www.gefanuc.com.

Flow Meter

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A developer and manufacturer of flow-measurement products offers a new straight-tube mass flowmeter. The Optimass Series 7000 meets the most stringent hygienic requirements for pharmaceutical applications, and contains the Adaptive Sensor Technology (AST), which helps it produce an inherently balanced meter in the most demanding processes. The straight-tube design is resistant to blocking or fouling, allowing the meter to handle high-viscosity fluids while maintaining a high level of accuracy. Krohne Inc., Peabody, MA; 978/535-6060; www.krohne.com.

Blister Films

A company will display a wide range of pharmaceutical packaging films at its booth. Among the new products on display will be Pentapharm Aclar 400/02, Pentapharm Aclar S03, and Pentapharm Aclar G03 laminated barrier films. The 400/02 is a two-layer film that provides the highest moisture barrier available in a thermoformable film. It is ideal for standard pharmaceutical blister packaging, deep-draw packages, and products that are ultrasensitive to moisture. Additionally, the 400/02 films offer good optical clarity, allow for clear packages and product visibility, and offer excellent machinability on existing standard form/fill/seal packaging lines and tooling. Klöckner Pentaplast of America Inc., Gordonsville, VA; 434/293-7718; www.kpfilms.com.

Filling and Closing Machine

A company will feature a combination filling and closing monoblock machine for products with a liquid to paste consistency. The Flexofill has the capability to handle press-in, screw and crimp closures, spray pumps with dip tubes, roll-on, pipettes, measuring cups, and syringes. The GMP-compliant machine features a modular construction that offers a small footprint with quick, easy format changes. Kugler, div. of Optima Machinery Corp., Green Bay, WI; 920/339-2222; www. optima-usa.com

Documenting Calibrator

A new calibrator has been designed for air-handling processes in critical environments that require portable, high-accuracy and low-pressure document- ing calibration to certify pressure needs. The Micro-Cal Model 869 provides this capability by performing calibration checks on sensors with accuracies as high as .00025 in. The product was engineered to be portable, lightweight, and compact for use in cramped or remote locations. The battery-powered unit provides a minimum of 8 hours of operation and recorded calibration times as fast as 5 minutes per unit. Setra Systems Inc., Boxborough, MA; 800/257-3872; www.setra.com.

Automated Machines

A company will show several new products at its Interphex booth. The Corima AEC218 syringe plunger inserter and labeler checks for the presence of the needle-protection device, inserts the plunger, prints the appropriate details on the label, and applies it to the syringe. The Tonazzi Millenium 200 tube-filling machine has a cantilever structure and is suitable for sterile environments. Its dosing units can be transferred from the working area to the washing and sterilization zone mounted in a single block using a special trolley. The Vasquali VB02 mechanical counting machine has a capacity of 120 bottles per minute and is able to count up to 600,000 tablets, 450,000 capsules, and 1.5 million coated tablets per hour. The BL400TE continuous automatic labeler is a tamper-evident machine that applies two seals on the corners of erected cartons and checks precision application of seals. Marchesini Packaging Machinery Inc., West Caldwell, NJ; 973/575-7445; www.marchesini.com.

Anticounterfeiting Technology

A company will introduce its new comprehensive anticounterfeiting technologies at its booth. The RxTrackNSecure and its protective products utilize the latest printing methods to provide durable, easy-to-apply, and affordable ways to guard against pharmaceutical product fraud. The system features holography, taggants, serialization, color shift, security printing, tamper evidence, and substrates to help companies protect their brands. New Jersey Packaging, Fairfield, NJ; 973/808-8000; www.newjerseypackaging.com.

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