Expo Preview: Interphex 2009
March 17-19, New York, NY
Terminal Weighs Samples in Hazardous Areas
The IND226x weighing terminal has an IP66-protected stainless steel housing that allows it to withstand very tough operating and cleaning conditions in chemical and pharmaceutical facilities. The terminal features a seven-segment LED display and is equipped with a mountable IND serial data interface and ACM200 interface converter, which enable its connection to PCs or printers via an RS232 interface. Its various power-supply options allow it to be used in a wide range of applications, including mobile weighing with a rechargeable battery. It has received certifications for use in the hazardous area of zone 1/21 from the Organisation Internationale de MÈtrologie LÈgale (OIML), the National Type Evaluation Program (NTEP) metrological approvals, and International Ex.
Appeared In Issue: March 2009
Mettler Toledo
www.mt.com
Water Distribution System Sanitizes and Monitors
Nexus is a range of standard, packaged, pre-validated distribution systems that are designed for purified water and water-for-injection applications with flowrates up to 30 m3/h (132 gal/min). Each package comes with an inverter-driven pump, ASME BPE pipework, a heat exchanger, and a control panel. The hygienic design and Type 316L stainless steel fabrication are fully compliant with GAMP, ISPE, cGMP and FDA requirements. Standard instrumentation consists of conductivity monitoring, temperature control, and a loop return flowmeter, with options for total organic carbon and ozone monitoring. For sanitization, users can select electrolytically generated ozone with UV ozone destruction or hot water at 85°C (185°F). Every Nexus is supplied with a full validation package, including functional design specification, design qualification, installation qualification, and factory acceptance-test documentation.
Appeared In Issue: March 2009
Veolia Water Solutions and Technologies
www.veoliawater.com
These Machines Fill, Stopper and Crimp Vials
The Type 550 machine achieves aseptic filling and stoppering of pharmaceutical vials. The Type 551 crimping machine can be used directly inline with the Type 550 or on its own as a stand-alone unit. Used together, the machines offer repeatable precision and can handle up to 600 vials per minute. Their balcony design is compliant with cGMP guidelines, and the complete separation of the drive from the filling area optimizes the laminar airflow throughout the stations. Their mechanical areas are accessible from the back for easy maintenance, and their reduced widths offer easy access for operators. Both systems are suitable for through-the-wall installation.
Appeared In Issue: March 2009
Bausch Advanced Technology Group
www.bauschtech.com
Portable Clean-in-Place System Saves Time and Money
The self-contained UltraFlow clean-in-place system has been designed for use in a variety of wash cycles. Its eductor draws solution back without the need for a return pump, reducing both chemicals and water while eliminating air from all return solutions and saving both time and money. Its most recent upgrade includes: a unit width of 33 in., making it portable enough to fit through standard doorways; a heating element on the recirculating line, which allows solution to be heated before delivery to the lines or tanks; no static welded diaphragm valves; and quick disconnects for chemical reserves. All systems meet cGMP and ASME BPE standards.
Appeared In Issue: March 2009
Sanimatic
www.sanimatic.com
Rapid Microbial ID Uses DNA Sequencing
State-of-the-art microbial identification is performed via comparative DNA sequen_cing and the company’s MicroSeq technology. This genomics-based approach is accurate and rapid, taking less than 24 h to determine the source of microbial contamination to the species level. Other services offered include USP microbiological testing, environmental monitoring, and analytical testing.
Appeared In Issue: March 2009
Boston Analytical
www.bostonanalytical.com
Accessories Calibrate UV Sensors
This complete NIST-traceable calibration package is comprised of nonintrusive calibration accessories that have been designed for the manufacturer’s inline UV sensors AF45 and AF46. Similar to features afforded to spectro_photometer calibrations, these filters test: photometric accuracy and linearity, with an absorbance up to 2.4 available; stray radiant energy or blocking, which is the most important test in measuring photometrics; and wavelength verification and spectral stability, which ensures measurement consistency. The calibration cuvette FH03 allows nonintrusive introduction of product samples or liquid calibration standards for direct comparison to a laboratory spectrophotometer.
Appeared In Issue: March 2009
Optek-Danulat, Inc.
www.optek.com
Sintered Wire-Mesh Laminates Have Varied Filter Ratings
Products in this line of sintered (diffusion-bonded) multi-layer, woven-wire-mesh laminates are available in 48-in. by 48-in. sheets. They are designed for filtration, separation, screening, fluidization, and fluid-bed drying applications. Both the Poremet and Absolta models are diffusion-bonded 5-layer, surface-loading, rigid filter plates that are available with filter ratings ranging from 2 µm to 100 µm in Type 316L stainless steel and Hastelloy C-22. Their mesh layers are selected to achieve optimum levels of stability, fine-filtration capabilities, flowrate, and backwash properties. Both serve as replacements in most Nutsche filters and filter/dryers, and are ideal as chromatography bed supports.
Appeared In Issue: March 2009
G. Bopp USA, Inc.
www.bopp.com
Helical Dryer Is Compact and Mobile
The helical dryer model HD 40 is fully mobile and has a PLC-based control panel with wireless data logging for operation in hazardous areas. With a batch working capacity of 40 L, it can be used as a small production dryer or in trials for scale-up to production-size batch mixer/dryers. Its features include a heatable shaft/mixing assembly, bottom discharge, one mechanical seal, easy access for inspection, full cleanability with clean-in-place sprayers and compact dimensions so it can fit into kilo-labs and pilot-plants.
Appeared In Issue: March 2009
KMPT USA, Inc.
www.kmpt.com
Spray Drying System Has Many Optional and Standard Features
The SonoDry 1000 spray drying system incorporates the manufacturer’s nonclogging ultrasonic spray nozzles, and is suitable for aqueous and solvent feeds. It allows drop sizes to be customized by varying the frequency of the nozzle’s ultrasonic vibration. The system has a fully integrated hot plate and magnetic stirrer, as well as an ultrasonic atomizer and an air-spray two-fluid nozzle. Its control system features a built-in programmable logic controller (PLC), an RS 232/485 port with liquid-crystal graphic display, and an input/ monitoring control panel with audio-visual indicators and two-way communication between machine and computer. Data-logging functions include inlet/outlet temperature, hot air flowrate and feed pump flowrate, and recipe storage is virtually unlimited. Its optional Teflon membrane scrubber can achieve yields as high as 95% for fine-powder recovery. Optional features include a nitrogen inerting loop for drying organic solvents, dual liquid feed (for both the ultrasonic nozzle and the air-spray nozzle), a congealing nozzle for freeze drying, and a countercurrent nozzle that facilitates larger-diameter particles.
Appeared In Issue: March 2009
Sono-Tek Corp.
www.sono-tek.com
Smart Bulk-Solids Activator Eliminates Bridges and Rat-Holes
The ActiFlow smart bulk-solids activator is a non-product-contact device consisting of a vibratory drive and an intelligent control unit. Its use eliminates the need for mechanical agitators with secondary motors and gearboxes for applications involving difficult materials. The control module’s patent-pending self-tuning algorithm monitors the system, continuously adjusting the frequency and amplitude to maintain flow within the hopper, which prevents the formation of bridges and rat-holes.
Appeared In Issue: March 2009
K-Tron Process Group
www.ktron.com
Drug-Pelleting System Converts Continuously
The Continuous Drug Pelleting system fully integrates extrusion and spheronization processes to continuously convert drug formulations into free-flowing spheres of a controlled shape and size. Its compact Type 316 stainless steel design makes it suitable for use in good manufacturing practice (GMP) suites. Its components, which are easily accessible for cleaning and maintenance, include a PLC-based control system with the manufacturer’s XT-CDP CFR 21, Part 11-compliant controls.
Appeared In Issue: March 2009
LCI Corp.
www.lcicorp.com
High-Speed Wrapper Maintains Seal Integrity
The S-5680BX SuperWrapper can wrap protein-tyrosine phosphatase (PTP) blister-packs at a rate of 200 per minute. The unit creates reliable hermetic seals and minimizes unwarranted heat transfer. Its inverted film feed places the center-seal system above the product; if the machine stops for any reason, the sealer opens automatically and slides back to create an overlap upon restart, ensuring seal integrity. The wrapper functions automatically, and an operator may monitor product flow from the color touch-panel that includes self-diagnostics, data monitoring, and parameter setting for 100 products.
Appeared In Issue: March 2009
Omori Machinery Co.
www.omori.co.jp/english
Portable Processor Produces Nanosuspensions
The plug-and-play M-110P Microfluidizer processor operates reliably, quietly and efficiently at process pressures up to 30,000 psi. It requires only a standard electrical outlet and can be easily incorporated into any laboratory setting. It is a benchtop machine that requires no compressed air or cooling water for hydraulics. The processor uses the manufacturer’s fixed-geometry diamond interaction-chamber tech_nology and a ceramic plunger, enabling the production of nanosuspensions and nanoemulsions, as well as liposomal encapsulation and cell disruption, with relatively few passes. It handles flowrates of 110–115 mL/min, depending on process pressure. This flowrate allows for efficient processing of pharmaceutical formulations, fine chemicals, and biological materials.
Appeared In Issue: March 2009
Microfluidics
http://www.microfluidicscorp.com
Bioreactor Operates in Batch, Fed-Batch, or Perfusion Mode
This dockable, dual-use bioreactor offers process flexibility as a batch, fed-batch or perfusion system, and it can be used as a conventional, reusable, stirred-tank bioreactor or as a one-time-use bioreactor. Its design allows for the addition of various gases and liquid process supplements. The system has three subsystems: vessel, piping, and instrumentation. The vessel module is mobile and central to the product’s interchangeability for reuse and one-time use. The piping module provides the structure that houses and supports all elements that do not require portability. The instrumentation module is comprised of all programmable automation components and electronic devices used for measuring, controlling and making the system functional. The system’s scalable design accommodates working volumes from 30 L to 1,000 L.
Appeared In Issue: March 2009
Biozeen North America, Inc.
www.biozeen.com
Website Offers Daily Updates to the Interphex Community
ISPE and Interphex have joined to create interphex365.com — an online resource that provides on-demand insights, news, and product information, as well as education, networking, community, and career opportunities. Its professional elements and tools include a comprehensive global supplier directory. It will be updated daily, and user feedback will be incorporated into new functionalities to ensure that the tool remains valuable, useful and relevant.
Appeared In Issue: March 2009
ISPE
www.ispe.org
Reactor Technology Provides Continuous Processing
The ART plate reactor handles a continuous flow of reactants to create a safer process. Its reaction volume is up to 99% less than that for batch processing. The reactor’s design incorporates features typical of a continuous chemical reactor with those of a plate heat exchanger. It can handle capacities ranging from 0.25 L/h to 1,000 L/h, covering all steps from laboratory-scale R&D to full-scale production.
Appeared In Issue: March 2009
Alfa Laval
www.alfalaval.com
Lightweight, Alternative Mop Cleans Floors, Walls and Ceilings
The EasyCurve mop has a 14-in. flat, fabric-laminated head attached to a curved, stainless steel frame. It has been designed specifically to clean floors, walls and ceilings in cleanrooms and controlled environments, and all hardware and mop heads are autoclavable. The mop is compatible with a wide range of disinfectants, solvents and cleaning solutions. It uses a separate sling-style wringer that is installed over a 6.5-gal polypropylene bucket to completely and easily remove liquid from the mop head.
Appeared In Issue: March 2009
Contec, Inc.
www.contecinc.com
Feeder Handles Dry Pharmaceutical Materials
The AP-300 dry material feeder is available in volumetric and gravimetric configurations for pharmaceutical, nutraceutical and cosmetic applications involving feed rates from 0.5 kg/h to 150 kg/h. It is suitable for handling jet milling, continuous blending, medical-grade plastics compounding, packaging, coating, and ingredient weighing, as well as other applications that require quick disassembly. It features a dual-arm agitation system that maximizes material processing versatility, and an FDA-compliant ethylene propylene diene M-class rubber (EPDM) feed hopper that is both disposable and recyclable.
Appeared In Issue: March 2009
Schenck AccuRate
www.accuratefeeders.com
Weigh Boxes Provide a Barrier Against Hazardous Particulates
The XPert weigh box has inlet and outlet HEPA filters, and serves as a physical barrier to protect the operator from hazardous airborne particulates and powders in a leakfree environment. It has a static-pressure gage that monitors HEPA filter loading, an anti-static ionizer fan mounted on the interior of the box to reduce static charge, and a balance vibration isolator for delicate weighing operations. It also has a seamless one-piece, molded poly_ethylene shell that provides chemical resistance and can be cleaned easily. The viewing window is 0.25-in.-thick laminated safety glass that is removable for loading equipment. The inner and outer transfer chamber doors pivot upward and are counterbalanced and equipped with quick-latches. The main chamber interior is 13 ft3 and the transfer chamber has an 11-in.-nominal dia.
Appeared In Issue: March 2009
Labconco
www.labconco.com
Quick-Change Sparger System Boosts Mass-Transfer Rates
This sparger system reduces the time and effort needed to replace porous metal sparger elements in bioreactor and fermenter tanks. Its design allows a new tip to be installed at the end of the assembly after each batch is complete. Once installed, the sparger tip is ready for steam-in-place operation. It is removable for cleaning by a variety of methods, including ultrasonic cleaning or detergent and water flush. Changing to clean sparger tips after each batch provides an excellent method of maintaining GMP process validation while reducing the time and cost between batches. Using a porous metal sparger greatly increases mass-transfer rates in bioreactors and fermenters — the introduction of gases into stirred or unstirred reactor vessels via millions of tiny bubbles increases the gas-to-liquid contact areas, allowing for optimal mass-transfer rates. In-tank applications can be batch or continuous flow, with or without agitation.
Appeared In Issue: March 2009
Mott Corp.
www.mottcorp.com
Critical Fluid Transfer Tubing is Biopharmaceutical Grade
Suitable for media and viral filling and sampling applications, AdvantaFlex biopharmaceutical-grade tubing can be aseptically sealed in seconds. The material can be welded directly to biobag containers, which eliminates the need for silicone tubing grafts. It contains fewer extractables than other tubing and complies with USP Class VI, FDA, ISO and European Pharmacopoeia standards. It has been formulated for low permeability and is free of silicone oils and animal-derived ingredients. Complete validation and extractables test portfolios are available.
Appeared In Issue: March 2009
AdvantaPure/New Age Industries Inc.
http://www.advantapure.com
ISO Class 3 Cleanroom-Garment Service Expands
Cintas Cleanroom Resources has expanded its ISO Class 3 cleanroom-garment laundry services to Westland, MI. This joins its four other locations, which now collectively serve Pennsylvania, Ohio, Indiana, Illinois, Iowa, Michigan, Minnesota and Wisconsin. These laundries operate under the guidelines of the ISO 9001:2008-based quality management system to provide excellent service to industries requiring both sterile and nonsterile cleanroom garments and consumable supplies
Appeared In Issue: March 2009
Cintas Cleanroom Resources
www.cintas.com/CleanroomResources
Agitator Bead Mills Use Nanotechnology to Produce More-Effective Drugs
The MicroSeries agitator bead mills produce particles sized less than 100 nm, which increases their absorption and delivery efficiency in the human body. The mills perform wet-grinding of small batches (0.14–0.5 L) with resulting particles down to 10–20 nm in size. This laboratory-scale equipment is completely scalable to full production size. Because product loss is minimized, the mills are suitable for grinding high-quality, high-priced and scarce pharmaceutical materials.
Appeared In Issue: March 2009
NETZSCH Fine Particle Technology LLC
www.netzschusa.com
Testing System Automatically Measures Hundreds of Tablets
The SOTAX HT 100 automated tablet-testing system measures tablet weight, thickness, hardness, and dimensions (width, length and diameter). Its patented auto-alignment device is designed to place oblong tablets in the proper position for hardness testing. It can operate as a stand-alone system, processing hundreds of tablets with no operator intervention. The unit is controlled by Q-Doc Quality Management software; it can also be controlled via an external PC, a built-in PC, or a touch-screen monitor with built-in PC. All test results can be printed, stored, shared on a network, or transferred to a laboratory information management system (LIMS).
Appeared In Issue: March 2009
Sotax
www.sotax.com
Environmental Chamber Manages Humidity and Power
The 6020 environmental chamber is designed to ICH guidelines (Q1A) and is suitable for use in shelf-life studies, stability and package testing, and temperature- and humidity-elevation studies. It measures 25 ft3, and has onboard technology that provides precise temperature and humidity-controlled environmental conditions for numerous applications. Its gVAPOR humidity system delivers a controlled-humidity vapor as needed without wasting energy or generating heat. The gROD control system efficiently manages power consumption, saving electricity.
Appeared In Issue: March 2009
CARON Products & Services
http://www.caronproducts.com
These Small Electric Boilers Are Clean and Quiet
The Series SSB electric boilers are designed to produce clean steam up to 100 psig at rates from 36 lb/h to 540 lb/h. No flues, fuel lines or tanks are involved in their operation, and no onsite products of combustion are generated. They operate on electricity, can be located almost anywhere, and are compatible with distilled, demineralized, deionized, or reverse-osmosis-produced water. Small in size, they are quiet, provide high-quality steam, and are almost 100% efficient. Minimal heat is lost to the surrounding area. A secondary low-water cut-off is now standard, as well as passivated Type 316/316L stainless-steel pressure vessel construction. Typical applications include laboratory validation, moisturization, clean room humidification, sterilization, food processing and storage, cosmetics manufacturing, and tablet press-and-shrink tunnels.
Appeared In Issue: March 2009
Sussman Electric Boilers
www.sussmanboilers.com
Fabricated Tubing Reduces Contamination Risk
Custom-molded Pharma fabricated tubing assemblies simplify manufacturing. They are produced to the customer’s exact specifications, using silicone tubing with a variety of connectors, including the manufacturer’s Silastic biomedical-grade elastomer. Compared with assemblies fabricated onsite, these reduce costs and lower the risk of contamination.
Appeared In Issue: March 2009
Dow Corning Corp.
www.dowcorning.com
Diaphragm-Valve Actuator Reduces Spare Parts Inventory
This sanitary diaphragm-valve actuator comes standard with lightweight thermoplastic/stainless-steel hybrid construction. Optional full stainless-steel construction is available. Its three actuator heads cover sizes 0.5–2.0 in. The actuator has a swivel feature that allows a 360-deg. orientation of the air inlet — the actuator flips, allowing easy access for changing product functions.
Appeared In Issue: March 2009
Top Line Process Equipment Co.
www.toplineonline.com
Gasket is Designed For Sanitary Fittings
The Sta-Pure gasket provides excellent dimensional stability, which is crucial for increasing sealing reliability in critical bioprocess applications. Its design uses a patent-pending, 100% expanded polytetrafluoroethylene (EPTFE) microstructure that helps achieve the low particulation/spalation and leachable/extractable profiles required for aseptic processing. Its durable construction enables it to withstand repeated clean-in-place/sanitize-in-place (CIP/SIP) cycles. The gasket is suitable for use in ultrapure-water systems, media preparation, andupstream or downstream processing applications.
Appeared In Issue: March 2009
Gore Pharmbio Products
www.gore.com/pharmbio