Exhibitors Showcase

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INTERPHEX 2007â„¢ Conference and Exhibition

Continuous thin-film dryer

LCI's "Contivac" continuous thin-film dryer lowers residence time by as much as 500 times for many batch-dryer applications, thereby reducing side reactions and color changes. The dryer permits high product quality and provides quick response time that reduces personnel and product-storage requirements. LCI Corp., Charlotte, NC www.lcicorp.com~ Tel. 704.394.8341 INTERPHEX Booth No. 2958

Constant-pressure system

Microfluidics offers its aseptic "M-7250CP" constant-pressure system. The processor integrates machine controls, functions, and data recording into a common platform. The unit includes a data-acquisition station that monitors temperature, pressure, and flow and allows users to record and print digital testing data. The system can be steamed in place for aseptic processing. Microfluidics, Newton, MA www.microfluidicscorp.com~ Tel. 800.370.5452 INTERPHEX Booth No. 2547

Liquid-filling and sealing system

Capsugel's "CFS 1200" liquid-filling and sealing system handles lipid-based formulations for poorly soluble compounds. The system is a fully automatic, CGMP-compliant machine that fills and seals as many as 1200 capsules/h and helps bring products to market quickly. Capsugel, Greenwood, SC www.capsugel.com~ Tel. 800.845.6973 INTERPHEX Booth No. 781

Software update

Sparta Systems offers an enhanced training-management functionality for its "TrackWise" software. The "TrainingManager" functionality adds automation and configurable business-rules capabilities to supplement the software's existing training-management capabilities. Sparta Systems, Holmdel, NJ www.sparta-systems.com~Tel. 888.261.5948 INTERPHEX Booth No. 3119

Compliance-management system

EtQ's "Reliance for Pharmaceuticals" is an integrated quality- and compliance-management system preconfigured to address the pharmaceutical industry's needs. EtQ's advanced quality-system methodology bridges the gap between systems, minimizes CAPAs, and initiates post-CAPA processes. EtQ's modules are integrated to deliver a closed-loop solution, including CAPA, risk management, and investigations. EtQ, Inc., Farmingdale, NY www.etq.com~ Tel. 800.354.4476 INTERPHEX Booth No. 3230

Powder-diffraction database

The "PDF-4/Organics 2007" database from the International Centre for Diffraction Data contains 312,355 organic and organometallic entries. The database enables rapid materials identification for the pharmaceutical and specialty chemicals industries. The product interfaces with diffractometers and data-analysis systems and has applications for consumer products, catalysis, analytical labs, drug discovery, and production. International Centre for Diffraction Data, Newtown Square, PA www.icdd.com~ Tel. 610.325.9814

Engineering data-management system

The "eCADinfo" engineering data-management system from CIMCON accelerates drawing approvals using "AutoCAD" file-comparison features and electronic workflows. The system manages AutoCAD drawings, equipment and instrument specifications, engineering data, and documentation with version control, security, redlining, Xref, view, and full-text search capabilities. Operators track GxP parameters using integrated "Excel" spreadsheets. CIMCON Software, Chelmsford, MA www.part11solutions.com~ Tel. 866.PART11.S INTERPHEX Booth No. 3220

Walk-on ceilings

MSS Pharma walk-on ceilings are designed to provide cost and schedule savings for manufacturers. The ceilings function as platforms so that work can be done above and below the cleanroom simultaneously, thus reducing requirements for catwalks. It also is not necessary to shut down operations to access space above ceiling equipment during maintenance. The walk-on ceiling is a component of the modular MSS Pharma "Cleanroom System," manufactured by AES Clean Technology. AES Clean Technology, Montgomeryville, PA www.aesclean.com~ Tel. 215.393.6810 INTERPHEX Booth No. 545

Contract pharmaceutical services

UPM Pharmaceuticals provides contract drug development, CGMP manufacturing, analytical testing, and regulatory support. The company specializes in oral solids, semisolids, and liquids. UPM's flexibility and responsiveness enable it to deliver customer-focused services for preclinical, clinical phases I–III, and small-scale commercial. UPM Pharmaceuticals, Baltimore, MD www.upm-inc.com~ Tel. 410.843.3700

Parenteral products

Hospira One 2 One is a world leader in the custom manufacture of parenteral products offering vials, flexible containers, cartridges, prefilled syringes, and ampules. Hospira's expertise comes from 70 years of quality manufacturing. One 2 One has been a reliable outsourcing partner to some of the world's largest pharmaceutical and biotechnology companies. Hospira One 2 One, Lake Forest, IL www.hospira.com~ Tel. 224.212.2267 INTERPHEX Booth No. 440

Contract services

Micron Technologies offers contract particle-size reduction and analytical services exclusively for the pharmaceutical industry. Primary capabilities include micronization (gram, kilo, and ton quantities) in addition to other particle-reduction techniques. Analytical services include particle-size analysis, materials characterization testing, and stability studies as well as methods development and validation. Facilities are FDA-registered and operate under CGMP requirements. Micron Technologies, Exton, PA www.microntechnologies.com~ Tel. 610.425.5100 INTERPHEX Booth No. 243

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Contract biomanufacturing services

Cook Pharmica provides CGMP manufacturing for cell culture-based biopharmaceuticals as well as CGMP cell banking and cell bank storage. Cook also offers development services for mammalian and microbial systems, including cell-line and strain development, media optimization, molecular biology, scale-up and process development, purification development, and analytical testing. Cook Pharmica, Bloomington, IN www.cookpharmica.com~ Tel. 877.312.2665 INTERPHEX Booth No. 132

Contract manufacturing

A brochure from Ben Venue Laboratories describes the company's contract manufacturing services. Capabilities include the development and production of dosage forms such as sterile suspension, emulsion, liposome, microsphere, lyophilized, and liquid injectables in aqueous or nonaqueous solvent systems. The company produces batch sizes from clinical to commercial scale. Ben Venue Laboratories, Bedford, OH www.benvenue.com~ Tel. 440.232.3320 INTERPHEX Booth No. 146

Contract services

Celsis Analytical Services is a CGMP contract-services laboratory that partners with customers to provide the technical resources needed to increase the efficiency and speed of clients' research. With a broad range of microbiology, chemistry, and ADME-Tox services, Celsis helps customers meet their workload testing deadlines on time and on budget. Celsis, Chicago, IL www.celsis.com~Tel. 312.476.1200 INTERPHEX Booth No. 121

Outsourcing services

Precision Pharma Services offers a brochure describing its biopharmaceutical outsourcing capabilities for a range of both clinical- and commercial-scale parenteral manufacturing. Precision offers both analytical and microbial quality control testing services, including raw materials, moisture content, and stability testing as well as product sterility, growth promotion, and endotoxin testing. Precision Pharma Services, Melville, NY www.precisionpharma.com~ Tel. 631.845.6112 INTERPHEX Booth No. 155

Drug-development services

Cyanta Drug Development Services helps pharmaceutical, biotechnology, and medical-device companies achieve their regulatory goals through extensive analytical testing and support services. Services include analytical method development, stability and method validation, extractables and leachables, custom synthesis, and formulation support. Cyanta Drug Development Services, Maryland Heights, MO www.cyanta.com~ Tel. 314.738.9600 INTERPHEX Booth No. 205

Contract manufacturing services

Schwarz Pharma offers full-service contract manufacturing services from product development to distribution. Technical services include solid-dose manufacturing. Schwarz Pharma invests in people, systems, procedures, process optimization, and infrastructure to achieve excellence. The company provides a well-trained team, modern facilities, and product quality that meets its clients' specifications. Schwarz Pharma Manufacturing, Seymour, IN www.schwarzusa.com~ Tel. 812.523.5490

Clinical services

Patheon's "Quick to Clinic" programs bring molecules to first-time-in-human studies rapidly and minimize the amounts of active pharmaceutical ingredients required. Patheon uses the experience and scientific knowledge of its multidisciplinary team of pharmaceutical-development services experts and its specialized equipment and development strategies to achieve these results. Patheon, Mississauga, Canada www.patheon.com~ Tel. 888.PATHEON INTERPHEX Booth No. 401

Pharmaceutical development

Azopharma is a contract pharmaceutical development organization that provides a range of chemistry, manufacturing, and controls solutions for the pharmaceutical industry. Azopharma has experience in formulations, custom synthesis, isolation, purification, elucidation, characterization, method development, and validation and clinical supplies for Phase I trials. Azopharma, Miramar, FL www.azopharma.com~ Tel. 954.433.7480 INTERPHEX Booth No. 224

Contract services

Powdersize offers a contract facility compliant with current good manufacturing practices for the micronizing, micropulverizing, and classification of dry powders. The company processes batch sizes from grams to metric tons and provides scale-up services. Powdersize's milling technologies include vertical or horizontal jet mills, fitz mills, and pin mills. Powdersize, Quakertown, PA www.powdersize.com~ Tel. 215.536.5605

Stability services

Lancaster Laboratories specializes in supporting stability studies, with services ranging from protocol writing to storage and testing through tracking and trending of data. The company is experienced in testing solid-dosage forms, liquids, suspensions, transdermals, aerosols, and comparator products. Stability storage consists of 22 different temperature and humidity conditions with more than 20,000 ft3 of storage space. Lancaster Laboratories, Lancaster, PA www.lancasterlabs.com~Tel. 717.656.2300 INTERPHEX Booth No. 213

Pulmonary formulations

Baxter offers an eight-page, full-color brochure highlighting the company's proprietary pulmonary drug-delivery technology. Baxter's "Promaxx" protein microsphere technology offers narrow particle-size distribution for delivery to and through the lungs. The platform can be applied to various drug classes and can improve starting material stability. Baxter Healthcare Corp., Round Lake, IL www.baxterbiopharmasolutions.com~Tel. 800.4.BAXTER INTERPHEX Booth No. 426

Solid dosage forms

Cardinal Health offers its oral solids facilities for production of finished dosage forms and services from process optimization to analytical testing support. The company provides dosage forms with modified-release and taste-masking coatings. Other services include scale-up studies, clinical batch manufacturing, quality control testing, and stability storage and testing. Cardinal Health, Somerset, NJ www.cardinal.com/pts~ Tel. 866.720.3148 INTERPHEX Booth No. 311

Contract manufacturing services

Lyne Laboratories provides pharmaceutical manufacturing services for dosage forms, including high-alcohol content or solvent-based drug products. An explosion-proof facility is available for high-concentration flammable products. Lyne also manufactures liquids, syrups, suspensions, semisolids, tablets, powders, and dropper bottles. Other services include technical transfer, analytical and validation services, stability programs, and regulatory support. Lyne Laboratories, Brockton, MA www.lyne.com~ Tel. 800.525.0450 INTERPHEX Booth No. 230

Contract manufacturing

Mallinckrodt Pharmaceuticals Outsourcing specializes in high-quality, solid-dose, and oral liquid products. The company's 250,000-ft2 facility is FDA-registered and licensed with the DEA for Schedule I–V narcotics. The company uses the synergy within its Pharmaceuticals Group to guide projects from API sourcing to commercial-product launches. Mallinckrodt Pharmaceutical Outsourcing, Hobart, NY www.pharmaceuticals.mallinckrodt.com/outsourcing~ Tel. 607.538.2093 INTERPHEX Booth No. 355

Contract manufacturing

DSM Pharmaceuticals offers contract manufacturing and development services.Capabilities include the manufacture and development of sterile liquids and lyophilized products to solid, semisolid, and liquid dosage forms. The company provides assistance with formulation and development, production scale-up, regulatory consultation, secondary manufacturing, and primary and secondary packaging. DSM Pharmaceuticals, Parsippany, NJ www.dsmpharmaceuticals.com~ Tel. 973.257.8011 INTERPHEX Booth No. 500

Contract services

Chemir provides nonroutine chemical analysis and materials testing for pharmaceutical and medical-device manufacturers. The company's services include failure analysis, materials characterization, deformulation, and contaminant identification. Chemir's staff also provides litigation support in intellectual-property and products-liability cases. Chemir Analytical Services, Maryland Heights, MO www.chemir.com~Tel. 800.659.7659

Contract services

Mikart offers contract development and manufacturing services from scale-up through full-scale commercial production. Mikart's 40,000-ft2 science center includes analytical laboratories, quality control, and a complete pilot-scale manufacturing suite. Services include preformulation and product approval as well as fluid-bed granulation, roller compacting, and film coating technologies. Mikart, Atlanta, GA www.mikart.com~ Tel. 888.4MIKART

Contract chemistry services

Chemic Laboratories provides contract chemistry services to the pharmaceutical, biotech, and specialty chemicals industries. Chemic offers expertise in methods development, validation, extractables and leachables assessment, bioanalytical services, small-scale CGMP organic synthesis, and formulation development. Chemic also provides a line of high-purity excipients manufactured through proprietary methodology. Chemic Laboratories, Canton, MA www.chemiclabs.com~ Tel. 781.821.5600 INTERPHEX Booth No. 137

Pelletization technology

Glatt offers its CPS technology for direct pelletization of active pharmaceutical ingredients with either immediate- or modified-release properties. It can produce dense, spherical, and uniform pellets with a high concentration of drug active (>90%) or with uniformly distributed low-dose actives within a narrow particle-size distribution over a range of median particle sizes (>100 μm). Glatt Contract Pharma Services, Ramsey, NJ www.glattair.com~ Tel. 201.825.8700 INTERPHEX Booth No. 418

Pharmaceutical ingredients

Danisco Sweeteners produces pharmaceutical excipients, intermediates, and actives based on proprietary specialty-carbohydrate systems. Danisco's excipients enable optimum performance and differentiation in many delivery systems, from tablets and rapid-melt products to syrups. Products include "Xylitol" sweetener and "Finlac DC" lactitol. Danisco USA, Elmsford, NY www.danisco.com~ Tel.800.255.6837

Matrix-tablet polymer

Degussa's "EUDRAGIT NM 30 D" polymer is suited for the formulation of matrix tablets for highly soluble drugs such as diltiazem. The polymer's positive tablet properties (e.g., weight constancy and mechanical stability) and release profiles allow it to be processed in a fluidized-bed system or a high-shear mixer. Degussa Pharma Polymers, Piscataway, NJ www.pharma-polymers.com~Tel. 732.981.5383

Excipients

JRS Pharma offers many branded excipients. The company's patented, high-functionality "ProSolv" excipient facilitates small tablet size, manufacturing efficiency, and economic advantage. JRS's major products are its "Emcocel," "VivaPur," "Explotab," and "Viva-Star" excipients. The product line consists of binders, fillers, disintegrants, and lubricants, primarily used for tableting. JRS Pharma, Patterson, NY www.jrspharma.com~ Tel. 845.878.3414

Pharmaceutical-ingredients brochure

Grain Processing Corporation offers an "Ingredients for the Pharmaceutical Industry" brochure that highlights high-quality excipients for tablets, capsules, granulations, coatings, liquids, and powders. The brochure describes "Spress," "INSTANT PURE-COTE," and "PURE-DENT" specialty starches and "MALTRIN" maltodextrins and corn-syrup solids. Grain Processing Corp., Muscatine, IA www.grainprocessing.com~ Tel. 563.264.4265 INTERPHEX Booth No. 241

Excipients

Asahi Kasei provides solutions for new drug formulations. The company offers high-performance excipients that comply with National Formulary standards, including highly compactible microcrystalline cellulose (MCC) "Ceolus KG-802" and MCC spherical seed core "Celphere." The company supports its products with technical service. Asahi Kasei, New York, NY www.ceolus.com~Tel. 212.371.9900 ext. 217 INTERPHEX Booth No. 337

Sodium phosphates

Jost Chemical Co. manufactures sodium phosphate monobasic and dibasic with various levels of hydration. The products are produced under CGMP-compliant systems that meet USP monograph specifications. These products were developed in response to requests from the pharmaceutical industry. Jost's manufacturing process produces chemical salts with low levels of impurities. Jost Chemical Co., St. Louis, MO www.jostchemical.com~ Tel. 314.428.4300

Excipients and polymers

Dow offers literature that introduces its "Methocel" methyl cellulose and hypromellose, "Ethocel" ethylcellulose, and "Polyox" water-soluble National Formulary resins. The literature describes the polymers, their functional properties, and Dow's excipient technologies such as granulation, tablet coating, controlled release, extrusion, and mucosal bioadhesion. The literature also includes an excipient polymer application overview. The Dow Chemical Co., Midland, MI www.dow.com~Tel. 800.232.2436 INTERPHEX Booth No. 4552

Polymers

Noveon's "Carbopol" polymers are efficient gel-matrix formers for controlling drug release in solid dosage forms. The polymers are available in both powder and granular forms and are suited for all types of tablet-manufacturing processes. "Carbopol 71G NF" polymer is a free-flowing granular product for direct-compression formulations. Noveon, Cleveland, OH www.noveon.com~Tel. 216.447.5000

Expanded kilo laboratory

ISP Fine Chemicals has completed the expansion of a kilo laboratory at its CGMP fine chemicals plant in Columbus, Ohio. The low-temperature system, designed in cooperation with Buchi AG, features a 60-L, glass-lined reactor with a self-contained heating and cooling system to operate at a temperature range of -85 to +200 °C. The laboratory also is equipped with a Nutsche filtration system for solid product handling. International Specialty Products, Wayne, NJ www.ispcorp.com~ Tel. 973.628.4000

Total organic carbon analyzer

The "Anatel TOC600" on-line total organic carbon analyzer is designed for pharmaceutical water measurement. Its patented stop-flow oxidation technology provides complete oxidation of an aliquot of water and fully complies with USP Chapter ‹643› and EP 2.2.44. The Anatel TOC600 unit's wide dynamic range allows for monitoring an array of water-system applications. Hach Ultra Analytics, Grants Pass, OR www.hachultra.com~Tel. 541.472.6500 INTERPHEX Booth No. 1563

Mass spectrometer

AMETEK's "ProMaxion" process mass spectrometer provides continuous real-time monitoring and control of solvent-drying processes. The instrument controls all aspects of the drying cycle from product entry to removal. It signals the end of the drying cycle, determines the optimum time for vacuum drying after filtration, and tracks process variables such as air entry into the drying chamber. AMETEK Process Instruments, Pittsburgh, PA www.ametekpi.com~ Tel. 412.828.9040

Weigh module

The "Ringmount" (Mettler Toledo, Columbus, OH) weigh module features a self-centering suspension that ensures a high degree of accuracy and repeatability. The unit's smooth, sanitary design resists corrosion, prevents moisture penetration, prevents bacteria growth, and facilitates clean-in-place processes. The module is designed for tank and vessel applications in the pharmaceutical, chemical, and biotech industries. Atlantic Scale Co., Nutley, NJ www.atlanticscale.com~ Tel. 973.661.7090 INTERPHEX Booth No. 3042

Solid-phase extraction

"GracePure" solid-phase extraction devices help clean up and concentrate problematic samples. Grace performs more than 30 tests on GracePure silica-based product batches and provides a quality certificate. The company produces everything from the silica particle to the finished product. Grace Davison Discovery Sciences, Columbia, MD www.discoverysciences.com~ Tel. 800.255.8324

Disposable laboratory capsule

ErtelAlsop offers the "Micro-Cap" disposable laboratory capsule for the filtration of pharmaceutical and biotech products. The Micro-Cap capsule provides 22.5 cm2 of area for as much as 500 mL. Inlet and outlet hose barbs accept leur fittings. Micro-Caps are available with ErtelAlsop's "XL" series and "Micro-Clear" carbon series of filter media. ErtelAlsop, Kingston, NY www.ertelalsop.com~ Tel. 800.553.7835 INTERPHEX Booth No. 1330

Water-delivery system

Caron's "Universal Condensate Recirculating System" is a water-delivery system for the company's humidity-controlled chamber. The system uses tap water and recycles chamber condensate, thereby eliminating the need for a floor drain. The device maintains water purity between 100-125 kΩ-cm to enhance the chamber's cleanliness and maximize component life. Caron Products and Services, Marietta, OH www.caronproducts.com~ Tel. 740.373.6809 INTERPHEX Booth No. 266

Charged-aerosol detector

ESA's "Corona" charged-aerosol detector provides universal high-performance liquid chromatography detection in degradation studies, impurity testing, cleaning validations, and excipient characterization. The system features high sensitivity, consistent response, and a wide dynamic range for use in drug development and manufacturing processes. ESA Biosciences, Chelmsford, MA www.esainc.com~ Tel. 978.250.7000

Analytical technology

Waters Corp. offers a range of products for sample preparation, chromatography, mass spectrometry, and laboratory informatics. Waters offers services in discovery, development, and manufacturing processes, including target discovery and identification; lead discovery; lead optimization; bioanalysis; safety assessment; chemical development; and quality assurance and control. Waters Corp., Milford, MA www.waters.com~ Tel. 508.478.2000

Automatic pycnometry system

Micromeritics's "AccuPyc II 1340 Series" pycnometers are fully automatic analyzers that provide high-speed, high-precision volume measurements and density calculations. The instruments can analyze various powders, solids, and slurries in volumes from 0.01 to 350 cm3. An integrated control and analysis module operates five additional external-analysis modules for high throughput. Micromeritics Instrument Corp., Norcross, GA www.micromeritics.com~ Tel. 770.662.3688 INTERPHEX Booth No. 324

Laboratory mixer

The "BenchMix" programmable high-shear laboratory mixer from Admix facilitates product development and formula optimization. The "OPLB-300" model's integrated touch panel allows users to select a digital readout of mixer speed and run time for as many as seven separate mix-head combinations, thus providing an accurate and repeatable method of scaling up from 1 L to more than 1000 gal. Admix, Manchester, NH www.admix.com~ Tel. 800.466.2369

TOC vials and CV kits

"Sievers" certified (<10 ppb) total-organic-carbon (TOC) vials are cleaned in an ISO 9001 quality environment using validated, automated equipment. The vials are certified for use in USP and EP water testing. The "Sievers" cleaning-validation kits include 72 certified TOC Vials and 100 "Alpha" sampling swabs. GE Analytical Instruments, Boulder, CO www.geinstruments.com~ Tel. 303.444.4491

Handheld chemical analyzer

The "TruScan" analyzer from Ahura Scientific is a handheld system for rapid, accurate chemical-identity verification. The device uses Raman spectroscopy to authenticate raw materials through packaging such as double bags and barrels. The analyzer weighs less than 4 lb. and is designed to withstand vibration, extreme temperatures, and humidity. Ahura Scientific, Wilmington, MA www.ahurascientific.com~ Tel. 978.657.5555 INTERPHEX Booth No. 176

Sealed container

The "SimpleMIX" system from Veltek Associates is a sealed multichamber container that, when activated, mixes two sterilizing solutions. The top part of the container holds the sterile concentrate disinfectant or sporicide and the bottom part contains sterile USP WFI-quality water. Veltek Associates, Malvern, PA www.sterile.com~ Tel. 610.983.4949 INTERPHEX Booth No. 719

Design and fabrication

DCI offers design, fabrication, and servicing of stainless steel storage and processing equipment. The company provides tanks, vessels, agitation systems, field service, modifications, parts, and components such as heads, manways, and lift assists. Parts meet ASME and BPE standards and feature CE marking. DCI, St. Cloud, MN www.dciinc.com~ Tel. 320.252.8200 INTERPHEX Booth No. 2955

Insulated packaging

Termika's insulated packaging protects against temperature fluctuations and can be custom-sized and -printed. "Criomed" and "Criomed Plus" packaging systems were developed to transport temperature-sensitive pharmaceuticals. Customized printing inscribes each package with a unique identifier to enable the tracking of shipments and purchases. Termika US, Roswell, GA www.termika.us~ Tel. 678.585.7767 INTERPHEX Booth No. 2879

Transfer packaging for prefillable syringes

BD has developed its "BD TSCF" packaging for the secure transfer of sterile prefillable syringe components into the pharmaceutical filling environment. The packaging is compatible with IDC "Biosafe" female doors for aseptic filling machines within isolator or barrier systems. This packaging is part of the "BD SCF" global offer, which features expertise in sterile processing of preservative-free drugs; secure, reliable, easy-to-use systems; sterile, ready-to-fill; and drug master file and technical dossier. BD Medical, Pharmaceutical Systems, Franklin Lakes, NJ www.bdpharma.com~ Tel. 800.225.3310 INTERPHEX Booth No. 458

Blow–fill–seal machine

Weiler's "Asep-Tech Model 628" blow–fill–seal machine features a two-piece stepped base design for easy maintenance and convenient product discharge. The device produces sterile, liquid-filled, tamper-evident containers in 0.5–250-mL sizes in full-scale production quantities. The model incorporates a product-buffer tank to meet tight fill tolerances. Weiler Engineering, Elgin, IL www.weilerengineering.com~ Tel. 847.697.4900 INTERPHEX Booth No. 444

Pharmaceutical detergent

"Solujet" detergent from Alconox features a surfactant system that performs on many residues. The product cleans at low concentrations without additives. The Solujet detergent cleans titanium dioxide, tablet coatings, and petrolatum. The company's Web site offers cleaning-validation references, certificates of analysis, technical data, and a Guide to Critical Cleaning. Alconox, White Plains, NY www.alconox.com~Tel. 914.948.4040 INTERPHEX Booth No. 3136

Heavy-duty disposable filter assembly

Meissner has introduced its "UltraCap H.D." high-capacity, disposable filter assembly for liquid, gas, and vent applications. The assembly is offered with T-style sanitary flange inlet and outlet connections with filter-media removal ratings from 0.04 μm to 100 μm. It is available with various membranes and media. Meissner Filtration Products, Camarillo, CA www.meissner.com~ Tel. 805.388.9911 INTERPHEX Booth No. 2401

High-containment filter unit

Fette's "CEPHIR" high-containment HEPA filter unit removes particulate matter from the exhaust air of pharmaceutical production machines. The device enables audit trails and data logging. The unit is easy to validate, and is designed according to good manufacturing practice guidelines. Fette America, Rockaway, NJ www.fetteamerica.com~Tel. 973.586.8722 INTERPHEX Booth No. 1327

Turnkey solutions

OPTIMA Group Pharma offers turnkey line solutions, including freeze drying and data-acquisition capabilities, for bottles, syringes, and vials. The company is a single-source pharmaceutical-equipment supplier. Its services include upstream preprocessing, downstream post-processing, filling, and closing. Optima Group Pharma, Green Bay, WI www.optima-usa.com~ Tel. 920.339.2222 INTERPHEX Booth No. 437

Lubricants

Natoli Engineering stocks an assortment of FDA-approved synthetic food- and nonfood-grade lubricants for application above or below the tablet-press compression zone. Natoli also carries an FDA-approved lubricant that is specially formulated for autolube systems as well as several lubricant applicators and helpful lubrication guides. Natoli Engineering, Saint Charles, MO www.natoli.com~Tel. 636.926.8900

Tableting equipment and services

Thomas Engineering provides tablet coaters, containment coaters, fully integrated continuous coaters, solution-prep skids, punch and die tooling, commissioning, validation, and maintenance. Together with KORSCH America, the company offers sales, service, spare parts, and engineering for tablet-compression equipment. KORSCH offers a line of research-and-development, scale-up, and production machinery. Thomas Engineering, Hoffman Estates, IL www.thomaseng.com~ Tel. 847.358.5800 INTERPHEX Booth No. 2006a

Pressure controller

Dwyer's "Digihelic II" pressure controller combines a differential pressure gage, switch, and transmitter with Modbus communications into a single, compact package. The controller can be combined with a flow sensor to calculate appropriate velocity and flow readings. The unit is designed for various pressure applications. Dwyer Instruments, Michigan City, IN www.dwyer-inst.com~ Tel. 800.872.9141 INTERPHEX Booth No. 2866

Peristaltic pumps

The "520," "620," and "720" series of peristaltic pumps accurately meter, dose, and transfer sensitive fluids in sanitary environments. The 720 series pump controls production speed and flow for high-capacity throughput. The 520 and 620 series pumps combine power and control in a compact and rugged package. Watson-Marlow Bredel, Wilmington, MA www.watson-marlow.com~ Tel. 800.282.8823 INTERPHEX Booth No. 1601

Sanitary pressure regulator

The "J-Pure" sanitary pressure regulator reduces the pressure of high-purity gases in biotechnology and pharmaceutical applications. The device is suited to various high-purity gas applications in biopharmaceutical plants, including clean filtered air, nitrogen-purge systems, process blanket, gas, and process gases. Steriflow Valve, Cincinnati, OH www.steriflowvalve.com~ Tel. 513.533.5600 INTERPHEX Booth No. 2758

Clinical vial filler

Bosch Packaging Technology offers its "FLT" small-scale vial filler for the preproduction clinical-trials market. The unit is a scaled-down version of a larger vial filler. It provides high quality and easy transition into production operations. The FLT vial filler features laminar flow, an isolator-friendly design, and a user-friendly operator interface. Bosch Packaging Technology, Minneapolis, MN www.boschpackaging.com~ Tel. 763.424.4700 INTERPHEX Booth No. 846

Validation services

SANYO offers various precise and in-depth validation services in addtion to high-quality equipment. Services include on-site validation, custom validation-support packages, factory-acceptance testing, critical-utility qualification, and NIST traceable calibration. Together, SANYO's equipment and validation services reduce the time and cost associated with new equipment. SANYO, Bensenville, IL www.sanyovalidation.com~ Tel. 800.858.8442

Coating systems

L.B. Bohle offers film, fluid-bed, and continuous-film coating systems. Film and fluid-bed coaters are available in both laboratory and production scale in 5–600-kg capacities. All systems provide high-quality coating with easy cleanup. Computerized controls offer both automatic and manual operation with complete batch documentation. L.B. Bohle, Warminster, PA www.lbbohle.com~ Tel. 215.957.1240 INTERPHEX Booth No. 1663

Vacuum mixer-homogenizer

Olsa's 1000-L vacuum mixer-homogenizer includes a mixing vessel that can be tilted to enable product discharge, cleaning inspection, and maintenance. The stainless steel unit features independently controlled inner and outer counter-rotating agitators and a bottom-entering high-speed homogenizing turbine. Its product-contact surfaces are mirror-polished. Olsa USA, Hauppauge, NY www.olsausa.com~ Tel. 877.657.2872 INTERPHEX Booth No. 2841

Tablet press

Specialty Measurements offers the "MiniTab" press, which is designed to manufacture tablets ranging from 0.5 to 4 mm in diameter. The introduction model can produce <300,000 tablets/h; larger models are capable of making >2 million tablets/h. The compact size of the machine, less than 250 × 500 × 500 mm, makes it ideal for glove-box applications. Specialty Measurements Inc. (SMI), Lebanon, NJ www.smitmc.com~ Tel. 908.534.1546 INTERPHEX Booth No. 2204

Vacuum conveying systems

All product-contact areas of VAC-U-MAX's vacuum conveying systems are 316L stainless steel and feature a polished surface to facilitate cleaning and product flow. The company's vacuum receivers are disassembled quickly without tools and can be designed for cleaning in place with the addition of a sprayball cover. VAC-U-MAX, Belleville, NJ www.vac-u-max.com~Tel. 800.vac.u.max INTERPHEX Booth No. 2573

Culturing set

SGM's "DriAmp" biological-indicator culturing set features "Releasat" medium and is designed for high-temperature, direct-air exposure or submersion in nonwater-based solutions. The "DriAmp BI" is a 1-mL, snap-top glass ampul containing inoculated silica. The Releasat medium provides a reduced incubation time of 72 h. A color change indicates positive test results. SGM Biotech, Inc., Bozeman, MT www.sgmbiotech.com~Tel. 406.585.9535 INTERPHEX Booth No. 438

Connecting solutions

Sartorius presents its "BioWelder" and "BioSealer" products for connecting or disconnecting thermoplastic tubing in biopharmaceutical manufacturing processes. The products accept various thermoplastic tubing types in diameters from ¼- to ¾-in. OD. The fully automated units provide short cycle times and allow flexible implementation into disposable manufacturing processes. Sartorius, Edgewood, NY www.sartorius.com~Tel. 800.635.2906 INTERPHEX Booth No. 2310

Interchangeable turret tablet press

The "Hata CVX" tablet press from The Elizabeth Companies features removable turret technology and an easy-clean design for quick parts removal and change-over between product runs. The press also has an easy-access press interior and fewer parts with less weight on heavier press components. The tablet press is mechanically designed to operate turret speeds as fast as 100 rpm on single-sided models. Other features include an optimized take-off area. The Elizabeth Companies, McKeesport, PA www.eliz.com~ Tel. 412.751.3000 INTERPHEX Booth No. 1829

Automatic tablet tester

An automatic tablet tester that is designed to test tablet weight, thickness, diameter, and hardness is available from Dr. Schleuniger Pharmatron. The "Autotest" 4 tester is 21 CFR Part 11–compliant and can maintain alignment of various tablet shapes and sizes and is controlled by Microsoft Windows–based software. Options include a 12-magazine feeder for QC environments and an in-line testing deduster–diverter with optional tablet air transport. Dr. Schleuniger Pharmatron, Manchester, NH www.pharmatron.com~ Tel. 603.645.6766 INTERPHEX Booth No. 2277

Peristaltic pump

Bioengineering's "Peripex" pump head features a six-roller planetary design for low-pulsation transport of sensitive cells. Peripex pumps offer variable-speed control, precise dosing, cascade connections with other controllers, and time-dependent flow-rate adjustment. Profibus or analog-digital interface enable remote control and integration into automated systems. Bioengineering, Waltham, MA www.bioengineering.ch~Tel. 781.672.2620 INTERPHEX Booth No. 1257

Fluid-bed processing system

Huettlin offers the "Unilab" fluid-bed processing system that reduces product-development and production costs by integrating the coating, granulating, and drying processes into one product container. The Unilab system can be scaled up 1–50 using the company's scale-up software program for fluid-bed systems. Huettlin, Ho-Ho-Kus, NJ www.huettlin.com~ Tel. 201.444.7756 INTERPHEX Booth No. 740

Fermentation system

GEA Liquid Processing has introduced the "GEA Diessel" series of modular fermentation systems. The unit maintains temperature, pH, and agitator speed automatically and is equipped with an open-architecture control system for flexible process parameter configuration. Sizes of 30–1500 L are available. The design compliments existing operations such as filtration ("GEA Filtration"), cell disruption (Niro "Soavi"), and CIP systems ("GEA LP"). GEA Liquid Processing, Niro, Columbia, MD www.niroinc.com~ Tel. 410.997.8700 INTERPHEX Booth No. 1629

Raidal diaphragm valves

Swagelok's "DR" series radial diaphragm valves minimize entrapment areas, drain easily, and maximize cleanability. The valves are manufactured in several configurations to include multiple valves and ports. Their versatility can lead to compact systems designs. Swagelok Co., Solon, OH www.swagelok.com~ Tel. 440.349.5934 INTERPHEX Booth No. 2137

Loading system

Cole-Parmer's redesigned loading system is designed for quick and easy tubing changes. "PerfectPosition" tubing features retention marks to indicate the exact alignment needed for optimal performance and tubing life. The system's cast-aluminum housing features an epoxy-powder coating to prevent chemical corrosion and facilitate cleanup. The front cover swings open for clean- or steam-in-place protocols. Cole-Parmer, Vernon Hills, IL www.coleparmer.com~ Tel. 800.323.4340 INTERPHEX Booth No. 431

Aseptic peristaltic dispensing pump

Flexicon's peristaltic pumps ensure gentle handling, closed fluid-path sterility, dispensing accuracy, flexibility, and speed. Product passes from the bulk tank directly into sterile medical-grade silicone tubing on a filling head. A gentle massaging motion compresses the tubing against a dual-roller rotor to achieve a smooth, nonpulsing flow. Flexicon America, Burlington, VT www.flexiconamerica.com~ Tel. 802.657.3232 INTERPHEX Booth No. 961

Stainless steel vessels

Allegheny Bradford designs and fabricates quality stainless-steel equipment, including process vessels and tanks, for sanitary applications. The company provides customized, sanitary process vessels designed for clients' specific requirements. Engineers assist in specifying ports, controls, and accessories. The company also offers electropolishing services, quality-control procedures, and a high-tech document-control department. Allegheny Bradford Corp., Bradford, PA www.abccorporate.com~ Tel. 800.542.0650 INTERPHEX Booth No. 1355

Single-use components

AdvantaPure offers single-use components to reduce contamination risk. Products include tubing, hose, manifolds, assemblies, stoppers, and sealing systems. Components are manufactured from Class VI, platinum-cured silicone. They contain no animal-derived ingredients and do not transfer taste or odor. The components can be used with radio-frequency identification for tracking from manufacture through disposal. AdvantaPure, Southampton, PA www.advantapure.com~ Tel. 215.526.2151 INTERPHEX Booth No. 1555