Industry Pipeline

April 2, 2010
Pharmaceutical Technology, Pharmaceutical Technology-04-02-2010, Volume 34, Issue 4

Interphex Showcase 2010.

MANUFACTURING EQUIPMENT & SUPPLIES

Sanitary ball valve

Lee Industries's T-316 stainless-steel highly sanitary-ball valve meets the qualifications of the pharmaceutical industry. Rigid corrosion-resistant and solid construction provides reliability under extreme conditions. A simple fast-breakdown design helps reduce cleanup and maintenance costs. Lee Industries, Philipsburg, PA www.leeind.com tel. 814.342.0461

Fluid-path assemblies

One-Touch single-use fluid-path assemblies are designed for secure fluid transfer in critical biopharmaceutical processing applications. The products can be customized to end-user requirements and include combinations of connectivity, tubing, and other components. Fluid paths can be integrated with filter capsules in various surface areas, end-connection configurations, and media. Meissner Filtration Products, Camarillo, CA www.meissner.com tel. 805.388.9911

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

Visual inspection system

Eisai Machinery USA offers semiautomatic, semimanual, and manual VIS visual inspection systems. Eisai provides validation expertise to help implement VIS 1000 semiautomatic inspection machines. The company also provides a program of continuous service and technical support for its clients. The program monitors clients' machines to reduce downtime and improve production-line efficiency. Eisai Machinery USA, Hackensack, NJ www.eisaiusa.com tel.201.746.2111

Quality-control system

The FS-80 IP system reliably detects improperly sealed cans and twist-off bottle caps. The system improves final-product quality on assembly lines that fill containers under vacuum or pressure, including nitrogen-dosed cans, and it reliably detects low vacuum or pressure at speeds as high as 1300 bottles/min or 2000 cans/min. Industrial Dynamics/filtec, Torrance, CA www.filtec.com tel. 888.434.5832

Syringe-closing unit

A rotating, 16-head closing unit receives filled syringe bodies and pistons simultaneously. Because air must be vented during the closing process, each syringe is compressed into oval shape briefly, while air is vented at the piston seal. The process does not affect material or syringe properties, and it implements air evacuation under continuous operation. Optima Group Pharma, Green Bay, WI www.optima-usa.com tel. 920.339.2222

Sanitary clamping

Continental Disc Corporation introduces the SANI-TORQ clamping device to tighten sanitary clamps to a specified torque setting. The new device tightens a standard 1-1/2"–4" (40–100 mm) sanitary clamp with a standard wrench until the proper torque value is reached. An audible click indicates the correct inch-pounds force has been achieved, and a self-limiting feature stops tightening the clamp. SANI-TORQ is left in place until the clamp is removed. Continental Disc, Liberty, MO pressure@contdisc.com tel. 816.792.1500

Blow–fill–seal machine

The Asep-Tech Model 628 blow–fill–seal machine from Weiler features a two-piece stepped base design to facilitate maintenance and product discharge. Model 624 tooling can be used on the Model 628 machine. The Model 628 unit produces sterile, liquid-filled, tamper-evident containers ranging in size from 0.5 mL to 250 mL. Weiler Engineering, Elgin, IL www.weilerengineering.com tel. 847.697.4900

Tablet-compression accessories

Natoli's Tablet-Compression Accessories Catalog is a comprehensive catalog available to support the tablet-compression industry. The catalog is a resource that includes more than 150 pages of products, equipment, and references about setup, inspection, maintenance, and tablet analysis. All products listed in the catalog are available for worldwide shipment. Natoli, St. Charles MO, www.natoli.com tel. 636.926.8900

Level transmitter

The Enhanced Eclipse Model 705 is a loop-powered level transmitter based on guided-wave radar technology and is designed for easy configuration. The device is available with a 304 stainless-steel housing designed specifically for hygienic applications. The instrument meets requirements for wetted and nonwetted materials, process connections, and surface finishes for the sanitary industries. Magnetrol International, Downers Grove, IL www.magnetrol.com tel. 630.969.4000

Fluid-bed dryer bags

Kavon provides custom replacement fluid-bed dryer bags for US and European equipment models. The bags are appropriate for wet granulation, dry filtration, and wet and dry coating applications. The company offers flexible 1–4-bag systems in various fabrics choices and also repairs bags. Kavon Filter Products, Wall Township, NJ www.kavonfilter.com tel. 732.938.3135

Bulk-powder enclosures

XPert bulk-powder enclosures protect users from hazardous airborne particulates and fumes generated during powder-transfer operations. An electric hydraulic-lift mechanism raises the container to the proper ergonomic height. An electronic beam triggers the lift mechanism and automatically stops at the proper access height. Labconco, Kansas City, MO www.labconco.com tel. 800.732.0031

Dry-material feeder

The PureFeed AP-300 dry-material feeder was designed specifically for pharmaceutical processes. Users can disassemble the device quickly and easily. The machine includes a dual-arm agitation system for versatility in material handling. Its disposable and recyclable EPDM feed hopper complies with US Food and Drug Administration regulations. Schenck AccuRate, Whitewater, WI www.accuratefeeders.com tel. 888.232.4828

Top-entering agitators

The PharMix Series 3000 and 4000 top-entering agitators are specifically designed for demanding pharmaceutical and biotechnology mixing applications. The units' robust shaft designs run in free air for cleaning in place and eliminate the need for stabilizing rings. Each agitator comes with a complete prevalidation documentation package. DCI, St. Cloud, MN www.dciinc.com tel. 320.252.8200

Double rotary tablet press

Fette's 3200i double rotary tablet press is suitable for large to medium-sized nutritional batches. The press's segment technology helps increase productivity for single-layer and double-layer tablets.The unit's exchangeable segment turrets simplify cleaning, increase yield, and speed format change. The device also enables automatic process monitoring. Fette America, Rockaway, NJ www.fetteamerica.com tel. 973.586.8722

Sterile connector

The 1-in. Pure-Fit SC sterile connector is designed with the same features as Saint-Gobain's other connectors, but in a large, versatile size for great flow volume. The silicone valve design allows easy assembly, and the patented Pure-Fit SIB technology is designed to ensure a smooth inner bore. Saint-Gobain Performance Plastics, Clearwater, FL www.biopharm.saint-gobain.com tel. 800.541.6880

Powder filling

Capsugel's Xcelodose S system offers automated, programmable, and precise metering of drug powder into capsules or other containers by weight. The unit allows companies to fill capsules with drug substances alone, thereby eliminating the need for excipient compatibility and preformulation activities. The device weighs doses as low as 100 μg and greater than 100 mg with an accuracy of < 2%. Capsugel, Greenwood, SC www.capsugel.com tel. 800.845.6973

Tablet press

Specialty Measurement 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 will be 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. SMI, Lebanon, NJ www.smitmc.com tel. 908.534.1546

Single-use solutions

The FlexAct system focuses on biomanufacturing unit operations and can be used with preconfigured single-use equipment for upstream and downstream processing steps. The system allows users of stainless-steel equipment or individual disposable components to convert to single-use unit operations. Sartorius Stedim Biotech, Bohemia, NY www.sartorius-stedim.com tel. 800.368.7178

Weldable tubing

PureWeld weldable thermoplastic elastomer (TPE) tubing is suitable for biopharmaceutical processes from research to production. The product is designed to produce a quick, secure, and connector-free fluid path. The TPE contains no animal-derived material that could leach into products. Each piece of tubing displays its lot number and expiration date. Watson-Marlow, Wilmington, MA www.watson-marlow.com tel. 800.282.8823

Capsule filler

MG America offers its continuous-motion Planeta capsule filler achieves an output of 100,000 capsules/h. The Planeta has a modular design that allows for different dosing units to be fitted simultaneously for filling powders, pellets, microtablets, tablets, liquids, or herbal products in single or multiple doses and combinations. MG America, Fairfield, NJ www.mgamerica.comtel. 973.808.8185

Vacuum conveyor

Vac-U-Max has introduced a vacuum conveyor for capsules, gel caps, and coated tablets. The device conveys 2500 units/min and gently delivers the product to the capsule-filling or packaging machine. The system conveys the product to the process without damaging it or separating the empty caps. Vac-U-Max, Belleville, NJ www.vac-umax.comtel. 800.VAC.U.MAX

Fluid-bed dryer bags

Shaffer Products manufactures fluid-bed dryer bags for the pharmaceutical industry. The company offers various static-conductive fabrics in woven and screen cloths. Shaffer has introduced a range of innovative fabrics that combine submicrometer-level filtration with static conductivity and exceptional powder release. Shaffer Products, Union, NJ www.shafferproducts.com tel. 800.992.5684

Data logger

The Series DLP data logger records pressure and temperature in harsh and hazardous locations. The ¼-in. fitting allows the logger to be adapted to most pressure fittings. The internal temperature sensor provides accurate temperature measurements without the need of a separate temperature recorder. The logger can store more than 16,000 measurements per channel. Dwyer Instruments, Michigan City, IN www.dwyer-inst.com tel. 800.872.9141

Disinfection system

The TruCLEAN Deluxe disinfection system incorporates the bucket-in-bucket and has a specially designed sieve that can be used with or without the waste-containment bucket. The system quickly and effectively cleans controlled contamination zones whether the operator is isolating soiled contaminants from cleaning agents or applying a disinfectant. Perfex, Poland, NY www.perfexonline.com tel. 800.848.8483

Humidity and temperature generator

The HygroGen 2 instrument helps calibrate humidity- and temperature-measuring equipment. The unit is a self-contained, transportable generator designed to provide high chamber uniformity and stability. The instrument features a touch-screen interface and can generate relative humidities of 5 to 95% and temperatures of 0 to 60 °C. Rotronic, Huntington, NY www.rotronic-usa.com tel. 800.628.7101

Tangential-flow filtration systems

Cadence single-pass tangential-flow filtration (TFF) systems eliminate conventional TFF recirculation loops to optimize economic and operational benefits. The systems are designed to increase yield and achieve product recovery of greater than 98%. The systems also enable high concentration factors and improve the processing of highly shear-sensitive products. Pall Life Sciences, East Hills, NY www.pall.com tel. 516.484.5400

Power supply

The Swagelok welding system M200 power supply has an updated graphical interface. The high-resolution, 12.1-in., color, industrial touch screen features an improved weld-head graphic that shows progression, performance levels, and stop–start for each level of the weld in real time. Swagelok, Solon, OH www.swagelok.com tel. 440.349.5934

Powder-induction system

Ross's In-line SLIM system is designed to improve powder induction in a liquid stream. The system's rotor–stator generator includes progressive spiral porting, which produces high flow, high shear, and a high level of vacuum. This feature enables the system to operate without a pump and induct powders quickly. Charles Ross and Son, Hauppauge, NY www.highshearmixers.com tel. 800.243.ROSS

Vial-filling system

The compact MHI vial filler is designed to meet the specific needs of clinical and pilot production programs by offering a flexible platform in a compact package. The MHI unit can support various filling technologies, thus providing the versatility to explore different filling options on one machine. Bosch, Minneapolis, MN www.boschpharma-us.com tel. 763.424.4700

Tablet-coating platform

The Accela-Cota FLEX 500 tablet-coating platform features six exchangeable drums and provides an overall batch-size range of 50–820 L. Innovative gun positioning, a segmented exhaust plenum, and interchangeable mixing baffles configure the coater according to the requirements of the batch size and coating processes. Thomas Engineering, Hoffman Estates, IL www.thomaseng.com tel. 800.634.9910

Growth-media sterilization systems

ABC Actini manufactures and engineers a range of growth-media sterilization systems to meet stringent standards. The company's systems incorporate fully aseptic heat exchangers, single-pass systems, gravity drainability, high-purity seamless tubing, and a safe, indirect energy-recovery section. The systems are designed according to current good manufacturing practice and perform continuous treatment. ABC Actini, Lewis Run, PA www.abc-actini.com tel. 888.278.8544

Process valves

GEMÜ offers a broad range of aseptic diaphragm valves and multiport valves that comply with the US Food and Drug Administration's and the US Pharmacopeia's regulations. Automation options include communication and control modules that facilitate commissioning and optimize the diagnostic benefits of control-network architecture. GEMÜ Valves and Instrumentation, Atlanta, GA www.gemu.com tel. 678.553.3400

OUTSOURCING & CONSULTING SERVICES

Contract manufacturing

Cangene bioPharma (formerly Chesapeake Biological Laboratories) offers contract manufacturing for the aseptic fill–finish of liquid and lyophilized sterile injectables into vials and syringes. Cangene provides clinical- and commercial-scale manufacturing, and its clients distribute their products worldwide. Cangene's sites have received approvals from US, European, and Japanese regulatory authorities. Cangene bioPharma, Baltimore, MD www.cblinc.com tel. 800.441.4225

Protein identification

Orbitrap testing is a protein-identification platform with high sensitivity, rapid scan rate, high mass accuracy and resolution power as high as 100,000. The platform combines a linear, ion-trap mass spectrometer and Orbitrap mass analyzer. Lancaster Laboratories performs comprehensive, accurate identification of proteins in complex sample mixtures. Lancaster Laboratories,Lancaster, PA www.lancasterlabs.comtel. 717.656.2300

Regulatory services

Dow's strategic guidance early in a topical dermatological program helps speed timing and reduce costs. Dow designs specific nonclinical and chemistry, manufacturing, and controls programs to support applications, negotiates with the US Food and Drug Administration, and prepares submissions. The company recently brought five topical products from inception to approval. Dow Pharmaceutical Sciences, Petaluma, CA www.dowpharmsci.com tel. 877.369.7476

Manufacturing capabilities

Lyne Laboratories offers its explosion-proof manufacturing capabilities for high-concentration, flammable pharmaceuticals. Lyne's state-of-the-art facility was designed specifically for formulations high in alcohol content and for solvent-based drug products. Batch sizes range from 1000 to 8000 L. Lyne is registered with the US Food and Drug Administration and licensed by the Drug Enforcement Administration. Lyne Laboratories, Brockton, MA www.lyne.com tel. 800.525.0450

Contract Services

Chemic Laboratories is a contract facility that follows good manufacturing and laboratory practices. The company offers extractables-leachables analysis, methods development and validations, bioanalytical services, organic synthesis and formulation development, and stability testing. The independent Chemic Consulting Consortium advises clients throughout their product-development cycles. Chemic Laboratories, Canton, MA www.chemiclabs.com tel. 781.821.5600

Contract services

Mikart has provided contract development, manufacturing, and packaging services to the pharmaceutical industry since 1975. The company's capabilities include formulation development; analytical services; solid- and liquid-dose manufacturing; packaging in bottles, blisters, and multilaminate pouches; project management; and regulatory services. Mikart, Atlanta, GA www.mikart.com tel. 888.4MIKART

Drug-delivery solutions

For more than 50 years, companies have looked to 3M Drug Delivery Systems for solutions to help their products meet the market's needs. 3M offers inhalation and transdermal drug-delivery systems and components, including dry-powder inhaler and microneedle technologies, plus state-of-the-art contract manufacturing services to help ensure technical success. 3M Drug Delivery Systems, St. Paul, MN www.3m.com tel. 800.643.8086

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

Lyophilization services

Hospira's One 2 One business is a leading contract manufacturing organization specializing in injectable fill–finish services. The company meets clients' global manufacturing and supply demands with lyophilization capabilities at its three facilities located in Kansas, Milan, and Melbourne. Hospira One 2 One, Lake Forest, IL www.one2onecmo.com tel. 224.212.2267

Analytical pharmaceutical services

AAIPharma takes a customer-focused approach to solving drug-development and manufacturing challenges. The company's analytical pharmaceutical services include clinical packaging and distribution, sterile and solid-dose manufacturing, analytical services, validation, regulatory-affairs consulting, formulation development, and oral drug-delivery technologies. AAIPharma, Wilmington, NC www.aaipharma.com tel. 910.254.7000

Development and manufacturing services

Halo Pharma provides pharmaceutical development and commercial manufacturing services to help customers bring their products to market successfully and quickly. With integrated capabilities in various dosage forms, including tablets, capsules, powders, liquids, ointments, and suppositories, Halo can partner with clients from development through the commercial life of a product. Halo Pharma, Whippany, NJ www.halopharma.com tel. 973.428.4000

Dosage-form manufacturing

DSM is a global provider of finished dosage-form manufacturing and related services to the pharmaceutical and biopharmaceutical markets. The company performs aseptic filling of liquid and freeze-dried cytotoxic and noncytotoxic compounds; manufactures tablets and capsules; offers pharmaceutical development services; and performs clinical-trial-material manufacturing for solid and injectable dosage forms. DSM, Parsippany, NJ www.dsmpharmaceuticals.com tel. 973.257.8011

Quality-management system

Spectrum's Quality-Management System has achieved the International Organization for Standardization's (ISO) 9001:2008 standard. Since 1994, compliance with ISO standards and with the US Food and Drug Administration's current good manufacturing practice regulations have formed the foundation of Spectrum's Integrated Quality system, which is designed to help products get to market quickly. Spectrum Chemical, New Brunswick, NJ www.spectrumchemical.com tel. 800.901.5516

Powder-into-capsule services

Xcelience offers powder-into-capsule services that enable clients to fill small amounts of active pharmaceutical ingredients (APIs) directly into capsules and speed the time to first-in-human studies. The company's three dedicated systems provide flexibility, expertise, and high capacity. Xcelience has processed more than 30 APIs and 100 batches. Xcelience, Tampa, FL www.xcelience.com tel. 206.525.5852

Contract analytical services

Impact Analytical provides experienced scientists and state-of-the-art laboratories to provide pharmaceutical drug-development support and analytical services, including release testing, research support, methods validation and development, stability studies, actives quantitation, and raw-material testing. The company is certified by the International Organization for Standardization. Impact Analytical, Midland, MI www.impactanalytical.com tel. 989.832.5555

Contract manufacturing

Therapex is a contract manufacturer for oral liquid and topical healthcare products. The company offers turnkey services such as product development, technology transfer, and commercial manufacturing and packaging. In-house services include validation, quality control testing, method development, and stability testing. Therapex has more than 300 employees at its FDA-certified plant. Therapex, Anjou, Canada www.therapex.com tel. 800.465.5820

Development services

Vetter Development Service (VDS) supports drug-development projects from inception to market launch and beyond. The company offers clinical manufacturing from preclinical development through Phase II, with scale-up and transfer to its commercial manufacturing facilities. VDS fills clinical-trial materials under strict aseptic standards and according to good manufacturing practice. Vetter Pharma International, Ravensburg, Germany www.vetter-pharma.com tel. +49 751 3700 0

Pharmaceutical services

WellSpring Pharmaceutical is a full-service provider of clinical and commercial manufacturing and packaging, blinding, method development, analytical testing, and distribution services. Highly qualified managers and technical professionals work at the company's 100,000-ft2 facility to ensure that clients' clinical and commercial products meet high standards. WellSpring Pharmaceutical Canada, Oakville, Canada www.wpcoutsourcing.com tel. 866.337.4500

Contract services

Patheon is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. The company sells products and services to approximately 300 of the world's leading pharmaceutical and biotechnical companies. Through its fully integrated worldwide network, it aims to ensure that customers' products can be launched with confidence anywhere in the world. Patheon, Research Triangle Park, NC www.patheon.com tel. 905.821.4001

Contract services

Aptuit provides consulting expertise, facilities that comply with good manufacturing practices, technologies designed to expedite the development process, project-management capabilities, and regulatory-compliance services. Aptuit also offers a package for strategic and regulatory consulting, informatics, preclinical and clinical technologies, pharmaceutical sciences, clinical packaging and logistics, and active pharmaceutical ingredient development and manufacture. Aptuit, Greenwich, CT www.aptuit.com tel. 816.767.3900

Quality-assurance consulting

Compliance Insight offers US regulatory and quality-assurance (QA) consulting to pharmaceutical and biologic companies worldwide. The company provides consulting about good manufacturing practice, audits, training, and responding to the US Food and Drug Administration. Compliance Insight also offers design and QA review services for viral clearance and cleaning validation. Compliance Insight, Fairfield, OH www.compliance-insight.com tel. 513.860.3512

PACKAGING EQUIPMENT & SUPPLIES

Transfer packaging for prefillable syringes

BD TSCF packaging ensures the secure transfer of sterile prefillable syringe components into the pharmaceutical filling environment. The packaging is compatible with IDC Biosafe 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

Packaging solution

The NextBottle package from Catalent and One World Design and Manufacturing Group is designed to improve patient compliance. The product's dial mechanism dispenses one pill at a time and automatically reminds patients of the last day that a pill was taken. Catalent Pharma Solutions, Somerset, NJ www.catalent.com tel. 866.720.3148

Packaging technologies

Confab complements its modified-release expertise with dry-coated, core-centered tablets. The company is expanding its liquid unit-dose packaging, and new technologies allow it to package small containers with syringes or droppers into a carton. The company also has launched an updated, interactive website. Confab, Saint-Hubert, Canada www.confab.com tel. 450.443.6666

CHEMICALS, RAW MATERIALS, INTERMEDIATES, & EXCIPIENTS

Microcrystalline cellulose

Ceolus UF-711 is a highly compactible micro-crystalline cellulose with excellent powder flow. It comprises comparatively round and porous particles that contribute to high flow and compactibility. The product enables the creation of small tablets and challenging formulations. The ingredient is designed for direct compression using a gravity feeder. AsahiKASEI America, New York, NY www.ceolus.comtel. 212.371.9900

Sugars

Ferro Pfanstiehl manufactures sucrose, trehalose, galactose, and maltose according to the standards of the International Conference on Harmonization to help ensure compliance to active-ingredient standards for injectable products. The company uses validated endotoxin-removal processes and conducts final-product testing to ensure high purity through very low endotoxin levels. Ferro Pfanstiehl Laboratories, Waukegan, IL www.pfanstiehl.com tel. 800.383.0126

Gelatine properties

Eastman's gelatin formulations provide products for the changing needs of the pharmaceutical industry. The company offers compounds that withstand the degrading effects of light, moisture, and oxygen. Other gelatins mask tastes and odors and isolate irritant or unstable drugs for time-delivery products. Eastman Gelatine, Peabody, MA www.eastmangelatine.com tel. 978.767.6299

Excipient

The PanExcea MC200G performance excipient for oral disintegrating tablet applications combines two ingredients for rapid tablet disintegration and dispersion with good taste and texture. Designed for flexibility, PanExcea MC200G performance excipient enables high active-ingredient loading capacity and reduces tableting, licensing, and equipment expenses. Mallinckrodt Baker, Phillipsburg NJ www.mallbaker.com tel. 800.943.4747

CLEANROOM EQUIPMENT & SUPPLIES

Cleanroom cart pass-through

Terra's pass-through features dual-side, touchpad-activated roll-up doors that are designed to enhance cleanliness, eliminate clearance requirements, and simplify operation. Sealed motorized lifters and ultrasmooth polyethylene tracks ensure clean operation. Electronic interlocks prevent cross contamination, and infrared beams stop motion if an object protrudes into the door track. Terra Universal, Fullerton, CA www.terrauniversal.com tel. 714.578.6000

Sterile wipes

Veltek offers sodium-hypochlorite and hydrogen-peroxide wipes that are Class 10 laundered, filtered at 0.2 μm, and formulated with US Pharmacopeia water-for-injection. The products have laser-cut edges and are guaranteed sterile with lot-specific documentation. Veltek, Malvern, PA www.sterile.com tel. 610.644.8335

LABORATORY EQUIPMENT & SUPPLIES

Weighing terminal

The IND560 weighing terminal from Mettler Toledo allows users to choose between conventional strain gauge or high-precision, electromagnetic-force restoration weighing technologies. The unit is compatible with direct program logic controllers such as Profibus and DeviceNet, as well as Ethernet communication interfaces and internal and external digital I/O control. An IP65-rated panel and IP69k heavy-washdown mounting are available options. Atlantic Scale Co., Nutley, NJ www.atlanticscale.com tel. 973.661.7090

Near-infrared analyzer

The MB3600-PH Fourier transform-near infrared analyzer was designed for quality assurance, quality control, research, and at-line process analytical technologies applications. The instrument is maintenance-free and features a user-friendly software interface that enables operations that comply with 21 CFR Part 11. It analyzes solid and liquid samples nondestructively. ABB, Québec, Canada www.abb.com tel. 418.877.2944

On-line TOC analysis

To help pharmaceutical companies improve quality and reduce costs, GE Analytical Instruments offers a science- and risk-based program for achieving real-time release of pharmaceutical water. The program streamlines a complex process and helps companies move total organic carbon (TOC) testing from the laboratory to the production floor in approximately six months. GE Analytical Instruments, Boulder, CO www.geinstruments.com tel. 800.255.6964

Microbial identification

Accugenix provides leading-edge technologies for microbial identification and offers characterization services to the pharmaceutical industry. The company continuously updates its proprietary genotypic and proteotypic identification libraries to reflect current taxonomy and add newly described, relevant species. The company is registered with the US Food and Drug Administration. Accugenix, Newark, DE www.accugenix.com tel. 800.886.9654

Noncontact process analyzer

The XDS Process Analytics Direct Light is a noncontact process analyzer for real-time analysis in the pharmaceutical industry. The instrument performs nondestructive in-line near-infrared analysis of moving products. Noncontact reflectance measurements can provide in-depth chemical analysis for homogeneous or nonhomogeneous solid products directly in the product line. FOSS NIRSystems, Laurel, MD www.foss-nirsystems.com tel. 301.680.9600

Stackable stability chambers

Caron's 10-ft3 stability chambers were designed in accordance with ICH Guideline Q1A. The units are suited for applications such as new drug compound testing; product shelf life testing; stability and packaging testing; and temperature and relative humidity (RH) studies. The stackable configuration enables independent temperature and RH settings. Caron Products and Services, Marietta, OH www.caronproducts.comtel. 740.373.6809

Laboratory blenders

MaxiBlend and MiniBlend laboratory blenders are available in sizes from 0.5 to 16 qt. The units are made of 316-L stainless steel and supplied with V-shells, bins, or double cones. The units feature a tabletop design and include programmable logic controls and safety-interlocked guards. GlobePharma, New Brunswick, NJ www.globepharma.com tel. 732.819.0381

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

INFORMATION TECHNOLOGY

Quality and compliance management

EtQ for Pharmaceuticals is an integrated quality- and compliance-management system that is preconfigured to address the pharmaceutical industry's needs. EtQ's modular approach provides flexibility and automation. Key modules include corrective and preventive actions, document control, risk management, audits, training, and reporting. EtQ, Farmingdale, NY www.etq.com tel. 800.354.4476