The industry’s most comprehensive showcase of solutions and strategies for implementing 21st Century CGMPs
Ever since the FDA announced its new initiatives aimed at making the pharmaceutical manufacturing process more innovative and efficient, the industry has been buzzing with questions about how to meet the challenges of the new CGMPs for the 21st Century. Manufacturers are faced with exciting new opportunities, and new challenges. INTERPHEX2005 will bring the entire industry—manufacturers, suppliers, regulators, service providers and consultants—together under one roof to collaborate on a new, more proactive and science-based manufacturing paradigm. From April 26-28, New York’s Jacob K. Javits Convention Center will be packed with thousands of pharmaceutical industry professionals exploring new ideas, evaluating advanced technologies, sharing sophisticated strategies, developing productive partnerships and networking with peers from across the country and around the world.
Innovative suppliers and solutions
The innovations are obvious at the INTERPHEX exhibits, which provide an up-close, in-depth look at all that’s new, exciting and important in every aspect of pharmaceutical manufacturing, from processing and packaging to facility management, information technology and outsourcing partnerships. All of the leading equipment vendors will be demonstrating their newest products, including the Elizabeth Companies, Fette, IMA North America, ITT Pure-Flo, Korsch, Marchesini, MG America, Siemens, Thomas Engineering and many more. This year’s event also features an all new exhibit focused on pharmaceutical facilities, plus a new RFID Pavilion and Rockwell Automation Partner Pavilion.More than 950 of the industry’s leading suppliers will be showcasing their newest solutions and capabilities. The following is just a small sample of innovative products and services offered by INTERPHEX2005 exhibitors:AdvantaPure’s Hose Track Hose Lifecycle Analysis System identifies individual hose assemblies using RFID tags. The system records and stores critical information via a portable, handheld reader/writer. It tracks wear-related events, reduces wasted hose life and provides an audit trail to assist in FDA validation.
Entegris will announce its support of a new landmark cleanability study to be launched this year by a leading research university. The Entegris exhibit will feature demonstrations of BioPharm cleaning capabilities through advanced Entegris/ESC technology from Clean In Place (CIP) systems and fluoropolymer products, to engineering design services, RFID, spray and more.
Getinge’s innovative Closure Processing Systems provide a complete solution from sterilization, washing and siliconization to storage, distribution and transfer. During washing, rinsing and siliconizing steps, the closures are agitated by sterile air blown through water to reduce the presence of residual particles and prevent damage to delicate combi-seals and aluminum caps.
IMA North America will feature a new Conta electronic tablet counter that uses a series of cameras to verify tablet count, quality and uniformity. The system can identify defects and non-conformities including wrong color, wrong shape, partial or cracked tablets, and eject all non-conforming tablets to ensure that only 100% quality product exits the machine.
Integrated Service Solutions offers a cost effective, single-source solution for equipment calibration, validation, preventive/corrective maintenance and regulatory compliance services. The company’s full time, trained technicians specialize in a wide variety of equipment, ensuring prompt, reliable fixed fee service.
Irvine Analytical Laboratories will announce the addition of an 18,000 square foot building for expanded biopharmaceutical and inhalation testing services. The planned service expansion will support testing for large molecules, metered-dose inhalers, dry powder inhalers, nasal sprays and novel inhalation delivery systems. Korsch will showcase its new line of GMP oriented tablet presses for R&D and production applications. The XL 100 is a ten station, interchangeable turret tablet press that is ideal for small batch production. The XL 400, designed for fully automated, unmanned 3-shift production, is also offered with full wash-in-place capability and optional isolation for high containment applications.
Pharmadule supplies advanced modular production facilities at a fixed price, with average delivery time as much as a full year faster than conventional construction methods. Prequalification and GMP inspections are completed before shipment. Modular facilities can easily be extended or relocated to another site as needed.
St. Gobain Performance Plastics will feature its Sanitec silicone tubing that is permanently laser marked with both part numbers and lot numbers to provide complete traceability.
Sartorius offers single-source availability of gamma sterilized, custom and standard filter & bag assemblies that eliminate unnecessary aseptic connections, reduce contamination risk and enhance production efficiency. The company’s LA, ME and SE Series laboratory balances are compliant with USP regulations for measurement uncertainty and minimum sample determination.
For a complete, searchable database of INTERPHEX2005 exhibitors and product information, please visit www.interphex.com.
Innovative education
A fast-changing industry needs an innovative conference—and the INTERPHEX2005 Conference is focused on the front-burner issues that significantly impact performance and productivity. The program is organized in four major tracks—PharmaManufacturing, PharmaFacilities, PharmaSourcing and PharmaIT—and attendees can mix and match sessions from any and all tracks to create a curriculum geared to their specific objectives. Complete conference information, including session descriptions and convenient online registration, can be found at www.interphex.com.Each day of INTERPHEX2005 will open with a free keynote presentation, with high profile speakers including former New York Mayor Rudy Giuliani; John M Taylor III, the FDA’ Associate Commissioner for Regulatory Affairs; Professor Irvin Modlin MD, PhD., Yale University School of Medicine; Nancy Hutson, Senior Vice President, Global Reasearch & Development, Pfizer; Sarah W. Fuller, President, Decision Resources, Inc.; and Peter Barton Hutton, Senior Counsel, Covington & Burling.Additional special events include the first annual Facility of the Year Award, an Opening Night Reception on Tuesday, April 26th, and the opportunity to win a new MINI® Cooper.INTERPHEX2005, sponsored by ISPE and Pharmaceutical Processing magazine, will take place April 26-28, 2005 at the Jacob K. Javits Convention Center in New York City. For complete event details and online registration, visit www.interphex.com or call 1-888-334-8704 or 203-840-5648.
