2009 Pre-Interphex Showcase: Manufacturing Equipment & Supplies
Humidity and temperature measurement
Rotronic has introduced its “HygroClip2” and “AirChip3000” units to provide humidity and temperature measurement. The instruments include self-diagnosis and autocorrection abilities. The units respond quickly and accurately.
ROTRONIC Instrument, Huntington, NY
Allegheny Bradford offers process equipment that includes the company’s heat exchangers, filter housings, and tanks. Products arrive skid-mounted and preassembled to meet clients’ installation plans. Options include a choice of framing material, standard valve and instrument packages, and complete boundary piping for process or utility applications.
Allegheny Bradford, Lewis Run, PA
Continuous granulation and drying system
L.B. Bohle presents its “Easy Flow” system for pharmaceutical applications. The system is designed to increase overall equipment efficiency by facilitating continuous processing as suggested by the US Food and Drug Administration. The system’s controls are based in process analytical technology.
L.B. Bohle, Warminster, PA
The “Sartopore 2 XLG” and “XLI” filters offer significant performance benefits in many biopharmaceutical applications. The units combine effective prefilter layers with a 30% increase in effective filtration area. The products are heterogeneous, double-layer polyethersulfone membrane filters. The XLG has 0.8-µm prefilter, and the XLI has a 0.35-µm prefilter.
Sartorius Stedim Biotech, Edgewood, NY
MG America offers the “G250” capsule filler, which reaches outputs as high as 200,000 capsules/h. The unit’s features include precision handling and fill-weight accuracy for powder, single pellet, and dual-pellet applications. The company also offers end-of-line packaging equipment to the US and Canada.
MG America, Fairfield, NJ
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
Cole-Parmer published its 2009 Mixers Catalog, which includes the company’s latest overhead mixers. The 32-page catalog describes the company’s selection of mixers and overhead stirrers, including laboratory- and industrial-process scale mixers, static mixers, sanitary mixers, powder mixers, and process mixers. Mixer accessories are also available.
Cole-Parmer, Vernon Hills, IL
The “DAFM” series duct air flow measuring probes use evenly distributed total and static pressure measuring points to gauge air flow. The probe can be completely installed from outside of the fan, and the unit is appropriate for applications when proper duct locations are unavailable.
Dwyer Instruments, Michigan City, IN
The “SciPure 200” single-use system is a purification platform designed to automate, document, and optimize protein purification. The system performs automated concentration and diafiltration and uses disposable fluid pathways. Its disposable tangential-flow filtration tube manifold incorporates temperature, pressure, and conductivity sensors.
SciLog, Middleton, WI
Fette America offers tablet-press equipment for pharmaceutical manufacturing. The company’s line includes its “3090i” tablet press, “2090i” wash-in-place tablet press, “1200i” tablet press, die-table segments, “Checkmaster” tablet-measuring system, and “PKB” magnesium-stearate spraying system. Fette provides service and support for clients in the United States, Canada, and Puerto Rico.
Fette America, Rockaway, NJ
Ross offers a ribbon blender with a capacity of 515 ft3. The model is made of stainless steel and driven by a 200-hp drive. The blender includes a jacket for heating or cooling the product. The blender is also designed for internal-pressure operation.
Charles Ross and Son, Hauppauge, NY
Sanitary jet pulverizer
Jet Pulverizer has expanded the production range of its “Sanitary Micron-Master” jet pulverizers by introducing a 15-in. unit with a 50–400-pph processing range. The Sanitary family includes 1-in., 2-in., 4-in., 8-in., 12-in., and 15-in. mills. Units feature quick-disconnect assemblies and require no tools.
Jet Pulverizer, Moorestown, NJ
Filter cartridges with adapters
Meissner has introduced high-performance small flow element filter cartridges with optional -222 O-ring adapters. The filters are available in 2.5- and 5-in. lengths. The products are designed for point-of-use filtration and small-batch processing of liquids and gases, where flow requirements are less than 3 gal/min.
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
Aseptic sampling device
Gore’s “Aseptic Sampling Device” is a fully disposable, completely assembled system for biopharmaceutical fluid sampling. The customizable product is delivered as a preassembled, sterile, closed system. The unit incorporates intuitive lever-valve actuation, is easy to use, and enhances operator efficiency.
W.L. Gore and Associates, Newark, DE
Kraemer, a leader in dedusting technology for the pharmaceutical industry, provides precision-engineered dedusters designed to keep pharmaceutical tableting lines running cleanly and at peak efficiency. Kraemer’s US office serves the needs of the North American pharmaceutical industry with in-depth market expertise and a commitment to customer satisfaction.
Kraemer US, Towaco, NJ
Sterile respirator hoods
Bullard offers its “CC20” and “RT” respirator hoods and loose-fitting facepieces in sterile assemblies. These products have an assigned protection factor of 1000. The units are gamma-irradiated, preassembled with a breathing tube and clamp, and double-bagged to ensure sterility. Each assembly is validated and ships with a Certificate of Sterility.
E.D. Bullard, Cynthiana, KY
Pall’s “Allegro 2D” systems provide a high degree of flexibility for process designs. The systems are available in volumes from 50 mL to 50 L and are suited for applications such as cell-culture media preparation and storage and bulk-product storage before filling.
Pall, East Hills, NY
Semiautomated filling system
The “FPC50” semiautomated filling and plugging system provides accuracy, flexibility, and fast changeover in small-batch filling of clinical trial materials. The device is compact and saves space in the facility. The system also offers an easy transfer into a full- production scale-up operation.
Watson-Marlow Flexicond, Wilmington, MA
The “PureFeed AP-300” feeder was designed for quick and easy disassembly. The device includes a dual-arm agitation system to maximize material-handling versatility. Its EPDM feed hopper is disposable and recyclable, thus enabling shorter cleaning cycles and minimizing the potential for cross-contamination. The feeder is available in volumetric and gravimetric configurations.
Schenck AccuRate, Whitewater, WI
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 postprocessing, filling, and closing.
Optima Group Pharma, Green Bay, WI
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
Guided-wave radar transmitters
The “Enhanced Eclipse Model 705” guided-wave radar transmitter incorporates a 304 stainless steel housing designed for sanitary and hygienic applications. This instrument meets requirements for wetted and nonwetted materials, process connections, and surface finishes for sanitary industries. The device is loop-powered and easy to configure.
Magnetrol International, Downers Grove, IL
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
Tabletop powder blender
“MiniBlend” tabletop powder blender is a research-scale machine. The device can be used with 0.5, 1-, and 2-qt V-shells. A bottle-blending attachment permits operators to blend small quantities of powders directly in bottles or vials. Three batches can be made at a time using bottles.
GlobePharma, New Brunswick, NJ
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
Glatt Air Techniques has introduced the “GCSmart” line of tablet-coating systems. The tablet coater incorporates a fully perforated drum, Fischer baffle system for improved mixing, proprietary antibearding spray nozzle, washing-in-place cleaning, and Glatt’s “SmartScoop” discharge system. The coater is available in sizes of 125–700 L and features manual and fully automated process control.
Glatt Air Techniques, Ramsey, NJ
“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 website offers cleaning-validation references, certificates of analysis, technical data, and a Guide to Critical Cleaning.
Alconox, White Plains, NY
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
Swagelok’s “BPE” fittings meet 3-A sanitary standards and are inspected by an independent third party to verify compliance with regulatory requirements. The fittings are manufactured from 316L stainless steel in various configurations. The products are available with a “Kwik-Clamp” sanitary clamp or automatic tube-weld end connections in 0.5- to 6-in. sizes.
Swagelok, Solon, OH
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 will be capable of making >2 million tablets/h. The compact size of the machine, less than 250 X 500 X 500 mm, makes it ideal for glove-box applications.
SMI, Lebanon, NJ
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 changeover 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
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
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
Saint-Gobain presents “PharmaFluor” fluorinated ethylene propylene tubing. The ultrapure tubing is chemically inert, fully characterized to all current standards, and withstands temperatures from -100 °F to 400 °F. The product resists the absorption and adsorption of aqueous fluids and minimizes the risk of fluid alteration.
Saint-Gobain Performance Plastics, Mickleton, NJ