Industry Pipeline

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 • 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

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 • 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