Industry Pipeline - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

Industry Pipeline
Pre-Interphex 2010 Product Releases.

Pharmaceutical Technology
Volume 34, Issue 3, pp. 83-87

MANUFACTURING EQUIPMENT & SUPPLIES



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
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



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



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



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



Dual-shaft change-can mixers
Ross's dual-shaft change-can mixers each include an anchor and a high-speed disperser. Each agitator is driven independently by an inverter-duty, explosion-proof motor to enable variable-speed operation. Mixers are available in 2-, 10-, 50-, 100-, and 200-gal sizes. Change-can models are available in 2–1000-gal sizes. Charles Ross and Son, Hauppauge, NY http://mixers.com|~http://mixers.com/ tel. 800.243.ROSS



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



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



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



Gravimetric feeder
The PureFeed DP-4 gravimetric feeder accurately meters dry powders at feed rates as low as 20 g/h. A speed-controlled, inert, ceramic feed disc positioned at the base of a cylindrical, electropolished, stainless-steel material-storage chamber allows the feeder to discharge dry powders precisely, continuously, and without pulsation in a 20–2000-g feed-rate range. Schenck AccuRate, Whitewater, WI www.accuratefeeders.com tel. 888.742.1249



Product catalog
Cole-Parmer's Preferred Solutions catalog features equipment and instrumentation, fluid-handling products, electrochemistry items, and laboratory supplies. The catalog includes the latest Masterflex, Oakton, PolyStat, and StableTemp products to help ensure high-quality solutions for needs in the laboratory, field, or plant. Cole-Parmer, Vernon Hills, IL www.coleparmer.com tel. 800.323.4340



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



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



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



Container closures
BioClosure Systems are a line of container closures suited for clean pharmaceutical, biotechnology, and laboratory applications. The closures are practical for repeated or single use and work with flexible container systems, laboratory bottles and apparatuses, and sampling and storage receptacles of glass, plastics, or metal. AdvantaPure, Southampton, PA www.advantapure.com tel. 888.755.4370



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



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



Outsourced services
Pfizer CentreSource provides solutions for sterile manufacturing, high-containment manufacturing, and oral and solid dosage forms. Its capabilities draw upon Pfizer's global network of facilities, technologies, and expertise to fulfill a broad range of sourcing and outsourcing requirements, regardless of dosage form, batch size, or the complexity of the process. Pfizer CentreSource (PCS), Kalamazoo, MI www.pfizercentresource.com tel. 269.833.5844

OUTSOURCING & CONSULTING SERVICES



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



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



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



Prefilled water-for-injection syringes
Vetter offers a turnkey manufacturing solution for products that require prefilled water for injection (WFI) syringe. The ready-to-use WFI syringe offers high quality, pH stability, and purity for reconstituting lyophilized drug products. Vetter works directly with clients to provide high-quality WFI manufacturing service. Vetter Pharma International, Ravensburg, Germany www.vetter-pharma.com tel. +49 0 751 3700 0



Contract services
Patheon's services range from preclinical development through commercial manufacturing of a full array of dosage forms. Patheon uses innovative technologies, including single-use disposables, liquid-filled hard capsules, and various modified-release technologies. Its range of pharmaceutical development services includes preformulation, formulation, analytical development, clinical manufacturing, scale-up, and commercialization. Patheon, Research Triangle Park, NC www.patheon.com tel. 905.821.4001



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



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



Virology consulting services
Compliance Insight offers virology consulting services for biological pharmaceuticals and devices. Clients can benefit from various design and review services for viral clearance and cleaning validation, raw-materials testing, product-lot release testing, and product risk assessments for viral contamination. Compliance Insight, Fairfield, OH www.compliance-insight.com tel. 513.860.3512



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



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

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



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

CLEANROOM EQUIPMENT & SUPPLIES



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



Autosampler for total-organic-carbon analyzers
The GE Autosampler is controlled through DataPro 900 software and enables 24 h of unattended sample analysis. Users can load 120 17-mL vials, 63 40- or 60-mL vials, and 120 sample tubes in one protocol. The unit has high needle-to-position accuracy and allows users to define and modify sampling routines. GE Analytical Instruments, Boulder, CO www.geinstruments.com tel. 800.255.6964



Integrity-test tool
The Palltronic Flowstar IV instrument is an automated integrity-test tool designed primarily for use in laboratories or cleanrooms. It is available in various configurations, including a basic model and a version with wireless networking and full automation options. The instrument was developed in accordance with regulatory guidelines. Pall, East Hills, NY www.pall.com tel. 516.484.5400

PACKAGING EQUIPMENT & SUPPLIES



Brand-protection technology
NanoEncryption technology is on-dose brand-protection technology that enables manufacturers to trace and authenticate every dose from plant to patient. The technology possesses security features at the overt, covert, and forensic levels and can be applied directly to tablets, capsules, and vial caps. NanoGuardian, Skokie, IL www.nanoink.net tel. 847.679.6266



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



Integrated blister line
The Giant1 integrated blister line fully responds to sophisticated production requirements worldwide. The line is an alternative for the timely production of small and medium-sized batches. The unit produces as many as 350 blisters/min and 175 cartons/min. The machine provides flexible operation and changeover and easy cleaning. IMA Group, Bristol, PA www.ima.it tel. 215.826.8500

LABORATORY EQUIPMENT & SUPPLIES



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



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



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

CHEMICALS, RAW MATERIALS, INTERMEDIATES, & EXCIPIENTS



High-purity inorganic salts
Jost manufactures high-purity ammonium sulfate in several grades, and the company also provides sodium phosphate and dodecahydrate. These inorganic salts are appropriate as biological buffers and as process intermediates for synthesizing active pharmaceutical ingredients. Jost manufactures more than 250 chemical salts in a facility registered with the US Food and Drug Administration. Jost Chemical, St. Louis, MO www.jostchemical.com tel. 314.428.4300



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



Website
Roquette has launched a website for its pharmaceutical division. The site grants access to the company's excipient and active product lines and offers information about services. A formulation tool provides assistance to formulators from the product development cycle through to launch. The special services and support sections describe Roquette's application expertise. Roquette, Keokuk, IA www.roquette-pharma.com tel. 319-524-5757

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