Interphex 2009 Coverage
INTERPHEX is a trusted source for leading-edge technology, education, and sourcing of the products and services that drive scientific innovation for Life Sciences manufacturing from drug development to market – accelerating regulated products for patient care globally.
Exhibition Hours:
Tuesday, March 17 10:00 am – 5:00 pm
Wednesday, March 18 10:00 am – 5:00 pm
Thursday, March 19 10:00 am – 3:00 pm
Quick Facts
Interphex 2009
March 17-19, 2009
Jacob K. Javits Convention Center
New York, NY
Table of Contents
Videos and Podcasts
Audio: A Disposable V-Blender and Other Intriguing Possibilities
By Interphex 2009
Disposable Blendings Systems are plastic mixing vessels of nearly any size and shape—including V blenders. The systems were introduced in small labs as a means of eliminating cleaning validation, but are now being scaled up for commercial manufacturing. Mark Gaeta of Pharmaceutical Processing Technology, Inc. discusses what’s available at present, and what work is being done with industry partners. For more information, visit www.disposableblending.com.
Tube for the Times: Single-Use Tubing Meets Industry’s Needs for Sterility and Surety
By Interphex 2009
Single-use components often do not withstand autoclaving, gamma irradiation, welding and other demanding process steps. AdvantaPure CEO Ken Baker explains how AdvantaFlex tubing was designed with these demands in mind. He also gives us a first look at GammaTag, a gamma-safe RFID tag that can track the use of valuable process equipment and link data to critical process information systems.
Tracing and Authentication: On-Dose Protection at the Nano-Scale
By Interphex 2009
NanoGuardian’s proprietary technology reshapes the surface of a tablet, capsule, or vial cap to provide on-dose product security with, as they say in supermarket lingo, “no additives or preservatives.” Senior account executive Kirk Barnes shares some of the details of NanoGuardian’s work to get FDA’s endorsement of the technology, and a Doppler-like statistical model that predicts soft spots in a product’s global protection program.
Realizing the Value in Rapid Microbial Methods
By Interphex 2009
As USP updates its compendia and rapid microbial methods become more integral to industry practices, Celsis has expanded its service offerings, and its products (including an RNA-based rapid detection system). Cindy Lieberman, VP of marketing, talks about how manufacturers can stay current with, and realize value in, their rapid methods.
Akrimax Seeks to Leverage the Past and Present
By Interphex 2009
Akrimax Pharmaceuticals ventured into the CMO marketplace touting the skilled, experienced workforce it inherited from Wyeth in Rouses Point, N.Y., but has found that current global and economic forces make it appealing to domestic U.S. partners who may have traditionally looked overseas. We speak with executive associate Len DeCandia about today’s supply chain and operational challenges.
Is the (Completely) Wireless Pharma Plant Only 10 Years Away?
By Interphex 2009
It's possible, says Jane Lansing, VP of Marketing for Emerson Process Management. Sure, Emerson is heavily invested in enabling wireless in pharma, but the technology, standards and, yes, FDA support are all there to make the next decade the golden age in wireless for pharma, Lansing says.
Presentation: Managing Process Risk Through Application of FMEA to Batch Records
By Interphex 2009
In this detailed case study, Fred Greulich of Maxiom Group explores new ways to reduce manufacturing process risk and examines how failure mode and effects analysis (FMEA), when applied to batch records, can be a key tool for helping enterprises manage manufacturing process risk. For more information, visit www.maxiomgroup.com.
Bag Check: Transporting Biological Products in a Protective Shell
By Interphex 2009
How to safely transport single-use bags is a challenge for manufacturers of biological products. UFP Technologies strives to meet this need by designing customized, compression-molded bag protectors. Customers can have the size and shape they need of the clamshell-like products within 6 to 8 weeks, explains Tuna Sava, UFP Product Manager.
Presentation: Go Beyond Pedigree for Maximum Brand Security
By Interphex 2009
Scott Dicks of Maxiom Group offers a comprehensive brand security platform that looks beyond pedigree compliance and short-term regulatory matters towards a strategy that adds true business value while ensuring product safety. For more information, visit www.maxiomgroup.com.
Rough and Tumble Raman and FTIR Materials Analysis
By Interphex 2009
Taking sensitive analytical equipment into the field once risked damaging equipment and compromising results. Ahura Scientific’s Raman-based TruScan has eliminated those concerns, and its new FTIR field device is also “designed to be mistreated,” says VP of Product Management Duane Sword.
FMEA for Batch Records: Finding Success through Consensus
By Interphex 2009
Maxiom Group recently conducted a study with a large contract manufacturer on applying failure mode and effects analysis (FMEA) to batch records. What was learned, says Fred Greulich, Maxiom’s director of operational excellence, was that the process of having cross-functional teams analyze potential batch record failures was just as valuable as the solutions that were implemented. For more information, visit www.maxiomgroup.com.
Developing a Process Control Model for Mammalian Cell Culture Production
By Interphex 2009
Process development groups use modeling to improve the predictability of bioprocesses. Broadley-James Corp. and partners (Nova Biomedical, Emerson, Thermo Fisher, and others) are working to establish “black box” models—first for recombinant proteins and now for mammalian cell culture—that investigate control strategies to better inform process experimentation. Broadley-James’ Michael Boudreau explains.
Endress + Hauser Moves Further into Pharma
By Interphex 2009
Endress + Hauser continues to develop products specifically to meet pharmaceutical standards for sterility, compliance, and validation. Level product manager Gene Henry gives us a look at, and inside, the company’s latest Coriolis mass flow meter for pharma, which emphasizes “system accuracy”, as well as the latest guided radar level measurement devices.
Bringing Pasteurization (and Continuous-flow Thermal Processing) to Pharma
By Interphex 2009
Within the last decade, pharma has come to realize that pasteurization and sterilization techniques common in food and other industries make sense in pharma as well—and can be monitored in real-time. MicroThermics president John Miles explains how thermal technologies have matured to meet the needs of pharma, and how operating conditions can be modeled based on time-temperature histories to ensure safe, optimal heat-related processes.
Pall at Interphex: A Focus on Flexibility and Reliability
By Interphex 2009
Always making a big splash at Interphex, Pall Corp. announced advancements in a number of areas at the 2009 show. VP of Marketing Ian Sellick takes us through what’s new, including updates on mobile, scalable, single-use depth filter cartridges (Stax), single-use biocontainers (Allegro) and enhanced leachable analysis, optimized chromatography sorbents, accelerated separations technologies (PallSep) for clean allergen solutions and other applications, and developments in PCR-based microbial methods.
Vac-U-Max: What’s New in Pneumatic
By Interphex 2009
Doan Pendleton, the third generation to run the family-owned business, gives us a cook’s tour of his company’s latest equipment for pneumatic conveying (free-flowing materials and non-), tablet and capsule conveying, and filter separation for direct-charge blender loading.
Biopharma Mycoplasma Detection in Hours Rather than Days
By Interphex 2009
Greiner Bio-One’s PCR- and DNA-based microarray technology reduces the time of mycoplasma detection from weeks to a matter of hours, with a sensitivity that exceeds traditional QA/QC cell culture methods, says Amy McGhee, the company’s product manager for immunology. McGhee discusses the intricacies of the screening system, including how it avoids false positives and how its data can be integrated with LIMS and other systems.
Podcast: Can a Self-Calibrating pH Probe Simplify Inline Bioprocess Monitoring?
By Interphex 2009
A major headache with developing PAT for bioprocesses can be sensor drift, particularly for pH measurements. Sensorin addresses this problem with a self-calibrating technology. Founder Carolyn Kahn, PhD, explains in this podcast interview.
Back to TopArticles
A Risk-Based Approach to Energy Conservation
By Interphex 2009
Why can’t Quality by Design ideas serve as the foundation of corporate greening?
Interphex Stands Test of Time (and Economy)
By Interphex 2009
Despite a tough economy, few question the value of attending Interphex, and this year’s show promises to be as good as ever.
Back to TopProduct Preview
ABB, Inc.: Booth #2310
By Interphex 2009
ABB will showcase its Industrial IT eXtended PAT (process analytical technology) software. The latest generation of ABB’s PAT solutions, xPAT provides simplified engineering and streamlined integration with enterprise systems, as well as broad connectivity to a host of analyzers to help customers achieve continuous process improvement, real-time product release and Quality by Design. (QbD).
AdvantaPure/New Age Industries: Booth #1555: Premium Sanitary Hoses and Components. New AdvantaLabel and GammaTag RFID Solutions
By Interphex 2009
AdvantaPure manufactures sanitary hose, tubing, fittings, and silicone injection molded components such as single-use fill and sampling assemblies, stoppers and true unions. Products exhibited include: AdvantaFlex, a single-use biopharmaceutical grade tubing ideal for media and viral filling and sampling applications; AdvantaLabel hose identification solutions; and GammaTag, a new gamma-sterilizable RFID solution that can be attached to healthcare equipment and medical devices, as well as single-use products requiring gamma sterilization before use with no risk of data loss.
Ahura Scientific: Booth #258: Raw Material Identification in Less Than 30 Seconds
By Interphex 2009
Raw material identity verification is a critical step in the quality control process, with tremendous impact on customer safety as well as speed – and cost – of production. Global pharmaceutical manufacturers are seeking technology that will allow them to approach a 100 percent inspection goal, without prohibitive financial or staff investment.
With Ahura Scientific’s TruScan, pharmaceutical manufacturers can now obtain fast, accurate material identity verification – typically in less than 30 seconds – with the ease and convenience of a handheld Raman spectrometer. This cost-effective solution allows users to quickly develop methods, enabling immediate release of raw materials into production. Further, TruScan is designed to meet the stringent requirements of current good manufacturing practices (CGMP) and 21 CFR Part 11-compliant environments.
Akrimax Pharmaceuticals: Booth #954
By Interphex 2009
The Cranford, New Jersey-based Akrimax was founded in late 2007 by Joseph Krivulka and Leonard Mazur, who between them have nearly seven decades of industry experience. Akrimax is a next-generation specialty pharmaceutical company concentrating on acquiring marketed products and developing late-stage products to address disease states related to “metabolic syndrome.” The company also owns a world-class facility that enables the company to manufacture its own products and develop select manufacturing and packaging partnerships right here in the United States. Core capabilities include: manufacture of solids, liquids, creams, high-potency and controlled substances, technology transfer and development and diverse packaging requirements.
Badger Meter, Inc.: Booth #2077
By Interphex 2009
Badger Meter is a leading supplier of precision compact control valves. Badger Meters Research Control valves handle a variety of liquid, gas and steam applications in pharmaceutical research and manufacturing. Badger Meter offers sanitary valves from 1/2" to 3", cvs down to 0.05 and process valves from 1/4" to 2".
Bio-Reaction Industries: Booth # 384: Drastically Reduce Energy and Water Usage. Virtually Eliminate Greenhouse Gas Emissions
By Interphex 2009
Bio-Reaction Industries manufactures air pollution control systems that provide a new way of emission compliance. The company’s innovative Bio-Oxidation systems use microbes to digest industrial air pollutants. Compared to thermal solutions, Bio-Reaction systems enable businesses to save up to 90% in operating costs - even at a competitive capital cost.
Modular and customized for each customer’s application, Bio-Reaction systems dramatically reduce energy and water usage and virtually eliminate greenhouse gas emissions (such as CO2, NOx, SOx). This advanced bio-oxidation technology yields the highest removal efficiency of any air phase bio-technology in the world.
Budzar Industries Booth #1043
By Interphex 2009
Budzar offers custom-built heat transfer systems specific to pharma, whether temperature control modules, low temperature chillers, biowaste systems, process skid packages, or a portable vessel heating/cooling system. Each custom unit or system design includes approval drawings, choice of instrumentation, technical assistance and is factory tested prior to shipping.
Cashco, Inc.: Booth #2855
By Interphex 2009
A leading supplier of industrial control for over 75 years. We provide solutions for pharmaceutical applications by offering a full line of sanitary regulators & control valves. Our products offer general ease of maintenance and tighter controls to maintain industry needs. Cashco is a certified ISO 9001 manufacturer of sanitary process equipment.
Dwyer Instruments Inc.: Booth #2854
By Interphex 2009
New DH3 Series Digihelic Differential Pressure Controller provides a 4-20 mA process output, 2 SPDT relays with adjustable deadbands, and a large, bright backlit LCD display. It offers simplified programming via a menu key. The aluminum housing is rated NEMA 4X on the front face when properly installed in a control panel. The sensing element can detect low differential pressures down to 0.25˝ w.c. up to 100˝ w.c.. These features make the DH3 Digihelic Differential Pressure Controller the ideal instrument for monitoring pressures in various rooms, zones, and ducts in factories, laboratories, or buildings.
Emerson Process Management: Booth #2455: Improve Efficiencies and Reduce Operating Costs
By Interphex 2009
Emerson is a leader in helping businesses automate their production, processing and distribution in the life sciences and other industries. The company combines products and technology with engineering, consulting, project management and maintenance services.
Eriez: Booth #659
By Interphex 2009
Eriez manufactures the broadest range of metal detection equipment in the industry. Our E-Z Tec line is capable of finding ferrous, nonferrous and stainless steel metals by utilizing the highest level of sensitivities available for dry and liquid product processing.
Fette America, Inc.: Booth# 1819
By Interphex 2009
Fette will be exhibiting the 3090i Tablet Press; the 2090i Wash-in-Place Tablet Press; the 1200i Tablet Press; die table segments; the Checkmaster tablet measuring system; and the PKB Magnesium Stearate Spraying System.
Gamajet Cleaning Systems, Inc.: Booth # 2572: Save Time. Save Water. Improve Reliability. Increase Productivity.
By Interphex 2009
We can show you how to get 10x the cleaning power and save 80% of your water and chemicals.For over 50 years, Gamajet has been supplying a “Better Way to Clean” all types of tanks and vessels. Our rotary impingement cleaning method has become the first choice in cleaning for many of the world’s largest pharmaceutical operations. Industries throughout the world have recognized and utilize the benefits of cleaning with Gamajet.
In order to earn this trust and recognition, we constantly strive to design innovative products and techniques that make our customers cleaning jobs easier, faster, safer and less expensive. We are proud of the recognition the name Gamajet enjoys, and with it the acknowledgment of being an innovator – not a follower or copycat. We are equally proud of the fact that all Gamajet machines are built in America using U.S. manufactured parts, and have become the cleaning “standard” in many industries. In some markets the name Gamajet alone is instantly associated with tank cleaning, something none of our competitors can say.
In addition to our machines, we also strive to be a valued resource for our customers. As a small independently owned business, we are always available to help troubleshoot a cleaning problem, repair a machine or provide technical assistance. With Gamajet, you’ll receive individual attention directly from the owner.
GE Analytical Instruments: Booth #2300 : Science-Based Risk Management Via Real-Time TOC Analysis
By Interphex 2009
The Sievers 500 RL On-Line Total Organic Carbon (TOC) Analyzer is a reagentless analyzer designed for continuous monitoring of organics in ultrapure water for pharmaceutical, microelectronics, and power applications. The Sievers 500 RL provides the superior analytical accuracy and performance found in all Sievers TOC Analyzers, with a 0.03 ppb limit of detection and autozero capabilities for unsurpassed low-level performance. The 500 RL TOC Analyzer provides a range of options that can be customized to meet the specific needs of a wide variety of applications.
The Sievers 500 RL On-Line TOC Analyzer is designed to deliver science-based risk management capability to the production floor. This is largely achieved by integrating the trusted Sievers laboratory TOC analysis methodology into a reagentless on-line analyzer that delivers the same high level of analytical process capability associated with laboratory analyzers, but without the delay. The 500 RL thus supports pharmaceutical industry quality initiatives such as Process Automated Technology (PAT) and on-line Cleaning Validation (CV).
Greiner Bio-One: Booth #961: Rapid Contamination Source Determination in Cell Cultures
By Interphex 2009
Greiner Bio-One presents its CytoCheck mycoplasma detection and identification kit at Interphex 2009. CytoCheck uses DNA microarrays to identify mycoplasmas in cell cultures, and includes universal and species-specific probes that can identify 40 different mycoplasma species. This species-level identification allows rapid determination of the source of the contamination, allowing corrective and preventative measures to be implemented quickly. CytoCheck is suitable for quality assurance in the production of biologics, including vaccines, antibodies, and therapeutic proteins. The use of CytoCheck is consistent with CBER’s 1993 “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals” recommendations regarding mycoplasma testing.
Magnetrol International: Booth #2758: Enhanced Eclipse Guided Wave Radar Transmitters
By Interphex 2009
The Enhanced Eclipse Model 705 is a loop-powered, 24 VDC, level transmitter based upon Guided Wave Radar (GWR) technology and is the easiest transmitter to configure on the market. Eclipse is now available with a 304 stainless steel housing designed specifically for use in sanitary/hygienic applications. This instrument meets the needs and requirements for the wetted and non-wetted materials, process connections, and surface finishes for the sanitary industries.
Eclipse supports the FDT/DTM standard and a PACTware PC software package allows for additional configuration and trending flexibility.
MicroThermics, Inc.: Booth #1254: Reduce Operating Costs With Continuous Thermal Processors
By Interphex 2009
Reduce operating costs and produce the highest quality products with MTI BioPharm™ precision continuous thermal sterilizers, processors and reactors. We optimize our equipment for the development and production of your ingredients, pharmaceuticals, & fluid biotech products (or for the sterilization of production effluent). Our features include uniform heat exposure through a variety of heating methods (including patented continuous flow microwave heating), hold times, cooling, and more.
We have been designing and building precision continuous thermal processors for 20 years. Come to our booth, or contact us to learn how our newest technologies and precise control can increase your product quality and reduce your R&D and production costs.
NanoGuardian: Booth #3270: Layer Upon Layer of Brand Protection
By Interphex 2009
NanoGuardian is establishing itself as a pioneer in the brand protection industry with the introduction of its NanoEncryption technology, the only on-dose, multi-layered, brand protection technology that enables manufacturers to trace and authenticate every single dose from plant to patient. NanoGuardian’s NanoEncryption technology possesses intrinsic layered security features at the overt, covert, and forensic level and can be applied directly to tablets, capsules and vial caps. These multi-layered security features enable NanoGuardian to provide a dual-protective benefit to manufacturers with a single technology. The overt and covert security features enable authentication at any point in the supply chain, the forensic NanoCodes provide comprehensive tracing information on each and every dose.
Pall Life Sciences: Booth #2006: New Products to Improve Biopharmaceutical Manufacturing
By Interphex 2009
Pall Life Sciences is a leading provider of filtration, separation and purification technologies. New products featured at Interphex 2009 include a complete range of modular, disposable, self-contained high-performance depth filter capsules available from development scale through to systems that process tens of thousands of liters.
New high performance cartridge filters for Mycoplasma removal add to a range of featured contaminant removal products capable of removing bacteria, viruses, host cell protein, DNA and endotoxin. Both single-use systems featuring Allegro biocontainers and stainless steel-based systems may be applied for fluid management. At smaller scales, pre-packed chromatography columns, and additions to Pall’s extensive range of chromatography sorbents, will be demonstrated. Pharmaceutical quality control products feature rapid microbiology systems, including new developments in ready-to-use, simple, real time qPCR-based technologies.
Polychromix: Booth #127
By Interphex 2009
Polychromix is a leader in miniaturized and handheld NIR spectrometers and analyzers. Using our unique MEMS (Mirco-Electro-Mechanical-System) technology enables us to construct a new breed of handheld spectroscopic devices which are smaller, lighter and cheaper than ever possible before. The revolutionary PHAZIR and POD product lines are broadly used in a variety of quantitative and qualitative pharmaceutical applications including raw material inspection, at-line and online process control, moisture content analysis and more.
Siemens Water Technologies: Booth #2437: Reduce Water Usage and Production of Wastewater—Maintain Premium Quality
By Interphex 2009
Siemens Water Technologies offers the PreVUE purified water generation system, a comprehensive, fully tested standard product that is a proven, reliable system with world-wide installations. When the S3 technology (Sanitize/Start/Stop) option is selected, the system can drastically reduce the consumption of raw water, production of wastewater, and consumption of electricity while maintaining premium water quality performance. All Siemens process water systems go through a comprehensive fully-functional Factory Acceptance Test (FAT) and are supplied with world-class documentation packages that facilitate quick integration into your operation.
UFP Technologies, Inc.: Booth #2587
By Interphex 2009
BioShellTM is a revolutionary container system designed to protect contents of frozen bags during handling, storage and shipping. High-purity, dual-density foam construction can withstand multiple impacts at -60°C. Each BioShellTM is custom created to accommodate user’s bag design, freeze/thaw cycles and handling procedures. BioShellTM is of single piece construction with no “loose” internal components. Flexible and robust structure is reusable. Stackable and nestable designs reduce space in storage and transportation.
Vac-U-Max: Booth #1978: Pneumatic and Vacuum Conveying, Batching and Weighing Systems
By Interphex 2009
VAC-U-MAX Vacuum Conveying Systems for the food, pharmaceutical, chemical and industrial markets. With complete Stainless Steel construction all product contact areas are 316L with a polished surface for ease of cleaning and product flow. In addition Vacuum Receivers from VAC-U-MAX are quick take apart without tools. VAC-U-MAX Vacuum Conveying Systems Range from simple up and in systems to more complex PLC based multi-ingredient handling systems incorporating batch weighing. VAC-U-MAX is known in the industry for having the best built and most rugged construction with very little maintenance.
