Interphex 2009 Coverage

 
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

Funny Pharm: You Write the Caption & Win: April 2011

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.

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Vital Links: Supplier Risk Monitoring

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.

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Therapeutic Dose: It Seemed Like a Good Idea at the Time

Saving money through outsourcing is really starting to cost us.

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Articles

Winning the cGMP Whistleblower Game

Respond fully to allegations, experts say; if you’re considering blowing the whistle, be sure the noncompliance is serious enough to threaten product integrity.

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Therapeutic Dose: Good Enough is Not Good Enough

As mom used to say on my report card: you could do better.

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Product Preview

ABB, Inc.: Booth #2310

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).

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AdvantaPure/New Age Industries: Booth #1555: Premium Sanitary Hoses and Components. New AdvantaLabel and GammaTag RFID Solutions

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.

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Ahura Scientific: Booth #258: Raw Material Identification in Less Than 30 Seconds

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.

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Akrimax Pharmaceuticals: Booth #954

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.

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Badger Meter, Inc.: Booth #2077

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".

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Bio-Reaction Industries: Booth # 384: Drastically Reduce Energy and Water Usage. Virtually Eliminate Greenhouse Gas Emissions

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.

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Budzar Industries Booth #1043

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.

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Cashco, Inc.: Booth #2855

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.

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Dwyer Instruments Inc.: Booth #2854

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.

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Emerson Process Management: Booth #2455: Improve Efficiencies and Reduce Operating Costs

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.

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Eriez: Booth #659

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.

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Fette America, Inc.: Booth# 1819

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.

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Gamajet Cleaning Systems, Inc.: Booth # 2572: Save Time. Save Water. Improve Reliability. Increase Productivity.

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.

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GE Analytical Instruments: Booth #2300 : Science-Based Risk Management Via Real-Time TOC Analysis

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).

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Greiner Bio-One: Booth #961: Rapid Contamination Source Determination in Cell Cultures

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.

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Magnetrol International: Booth #2758: Enhanced Eclipse Guided Wave Radar Transmitters

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.

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MicroThermics, Inc.: Booth #1254: Reduce Operating Costs With Continuous Thermal Processors

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.

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NanoGuardian: Booth #3270: Layer Upon Layer of Brand Protection

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.

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Pall Life Sciences: Booth #2006: New Products to Improve Biopharmaceutical Manufacturing

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.

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Polychromix: Booth #127

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.

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Siemens Water Technologies: Booth #2437: Reduce Water Usage and Production of Wastewater—Maintain Premium Quality

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.

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UFP Technologies, Inc.: Booth #2587

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.

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Vac-U-Max: Booth #1978: Pneumatic and Vacuum Conveying, Batching and Weighing Systems

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.

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