Pre-Interphex Showcase: Manufacturing

March 1, 2008

Pre-Interphex Showcase: Manufacturing

Guided-waveradar 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
www.magnetrol.com
tel. 800.624.8765

Leak-detection relay
The "Series DLD" leak-detection relays monitor the shaft seal of two submersible pumps to detect leaks before pumps fail. The relays sense the status of a float or conductivity switch installed in the seal cavity. An LED indicates when resistance drops below the set sensitivity.

Dwyer Instruments, Michigan City, IN
www.dwyer-inst.com
tel. 800.872.9141

Single-use process systems
AdvantaPure's single-use silicone components are designed to reduce costs, cross-contamination risks, and downtime. The components simplify cleaning-validation procedures and include tubing, hose, manifolds, process systems and assemblies, stoppers, and sealing systems. Parts are made of Class VI, platinum-cured silicone and are free of animal-derived ingredients.

AdvantaPure, Southampton, PA
www.advantapure.com
tel. 888.755.4370

Shell-and-tube heat exchangers
Allegheny Bradford's heat exchangers are designed to customers' process specifications. The units are manufactured to deliver superior performance and trouble-free operation. They are made of stainless steel and other alloys with state-of-the-art manufacturing procedures. Comprehensive documentation and turn-over packages are available with each unit.

Allegheny Bradford Corp., Bradford, PA
www.abccorporate.com
tel. 800.542.0650

Pump andtubing brochure
Watson-Marlow Bredel offers a brochure about its pumps and tubing products for the pharmaceutical and biotechnology industries. The products dispense delicate, viscous, corrosive, or abrasive fluids in research and production processes. They are designed for filtration, fermentation, disposable bioprocesses, and fill–finish dispensing applications.

Watson-Marlow Bredel, Wilmington, MA
www.watson-marlow.com
tel. 800.928.7786

Filter
Meissner’s "Protec RM" filter is available in 0.2-, 0.3-, and 0.5-mm absolute ratings. The filter
effectively protects downstream membrane filters and equipment. They consistently provide submicron contaminant removal, high dirt-holding capacity and high flow rates, while removing colloids, aggregated and non-product proteins, and lipids.

Meissner Filtration Products, Camarillo, CA
www.meissner.com
tel. 805.388.9911

Ribbon blenders
"B-Blender" units feature a modified design. The B designs blend as much as 32 lb/ft3 of materials. The blenders are available in 10-, 18-, and 36-ft3 capacities. The units are constructed in stainless steel and polished to an 80-grit finish on exterior and interior surfaces.

Charles Ross and Son, Hauppauge, NY
www.mixers.com
tel. 800.243.ROSS

Laboratory coater
The "BFC 5" laboratory coater is suitable for contained coating applications. Its versatile design allows the simple integration of isolator technology and ensures operator safety during the handling of toxic and potent substances. For nonhazardous applications, the coater can be used without an isolator.

L.B. Bohle, Warminster, PA
www.lbbohle.com
tel. 215.957.124

Sterileconnector
Saint-Gobain offers its "Pure-Fit SC" connector to enable sterile connections outside the cleanroom environment. The connector uses the company’s patented "SIB" technology to ensure a completely smooth inner-bore flow path. The unit’s silicone valve design facilitates assembly. All components are made of fully characterized animal-free materials.

Saint-Gobain Performance Plastics, Mickleton, NJ
www.biopharm.saint-gobain.com
tel. 888.387.0067

Bioreactor-fermentorsystems
DCI-Biolafitte
designs and builds aseptic process equipment and laboratory and pilot bioreactors, in 2–40,000-L capacities, for the pharmaceutical and biotechnology industries. The company offers a full-service approach that includes equipment quotations, product installation, and supports to meet clients' expectations.

DCI-Biolafitte, St. Cloud, MN
www.dci-bio.com
tel. 320.257.4378

Tablet press
KORSCH offers a flexible tablet press with single-layer, bilayer, trilayer, five-layer, and tablet-in-tablet technology. The unit is suitable for any drug-delivery application. The company's wash-in-place and high-containment capabilities enhance its tablet-compression technology.

Thomas Engineering, Hoffman Estates, IL
www.thomaseng.com
tel. 847.358.5800

Modular air-atomizing manifold
The "54000" modular-spray manifold simplifies the installation and maintenance of air-atomizing nozzles in tablet-coating applications. The unit is compact and lightweight. The manifold facilitates disassembly and assembly by eliminating multiple connections. The product is designed to increase production efficiency and save money.

Spraying Systems, Wheaton, IL
www.spray.com
tel. 630.665.5000

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

Vacuum mixer–homogenizer
Olsa's 1000-L
vacuum mixer–
homogenizer is a standalone unit. The machine features
independently controlled inner and outer counterrotating agitators and a bottom-entering, high-speed homogenizing turbine. Product-contact surfaces are mirror polished, and exterior surfaces are stainless steel. All utilities are integrated into the monoblock structure.

Olsa USA, Hauppauge, NY
www.olsa.com
tel. 877.657.2872

Water and steam systems
Stilmas designs, constructs, and installs pharmaceutical pure-water and pure-steam systems. The company has more than 100 years of experience and is qualified to provide turnkey and custom-designed systems that meet high engineering standards. Capabilities include water pretreatment plants, pure steam generators, and water for injection production plants.

Stilmas USA, Hauppauge, NY
www.olsa.com
tel. 877.657.2872

Tilt switchcontrol units
Dwyer's "Series LTC" tilt switch control units feature an adjustable time delay and a logic-selector switch. The box cover opens to allow access to signal lights, the relay, and the transformer. The controller transmits through a relay, which provides a change in contacts as the probe moves from vertical to tilt and vice versa.

DwyerInstruments, Michigan City, IN
www.dwyer-inst.com
tel. 800.872.9141

Tablet compressionaccessories catalog
Natoli's accessories catalog describes the company's durable, state-of-the art equipment and products. The catalog is a resource with references about set-up, inspection, maintenance, and other topics. The company accepts all
orders, and immediate worldwide shipment is available. The catalog can be downloaded from Natoli's website.

Natoli Engineering, St. Charles, MO
www.natoli.com
tel. 636.926.8900

Shear rheometer
Metropolitan Computing Corp. offers a shear rheometer designed to analyze the role of shear on the lubrication process and on drug products’ mechanical properties. The unit has a speed-controlled, 0.4-L capacity Couette cell with uniformly spaced shear pins. It offers a total shear magnitude of as much as 15,000 total shear units.

Metropolitan Computing, East Hanover, NJ
www.mcc-online.com
tel. 973.887.7800

Extractablesand leachables testing
Sartorius Stedim Biotech offers specialized analytical techniques that detect low levels of extractables. Solvents such as water and ethanol characterize the extractables in pharmaceutical formulations. Leachables testing is conducted with the test component in contact with the pharmaceutical formulation based on custom protocols.

Sartorius Stedim Biotech, Edgewood, NY
www.sartorius-stedim.com
tel. 800.635.2906

Dispensers and metering pumps
The "OEM" line of dispensers and pumps consists models offer outputs from 500 nL/dispense to 1.28 mL/revolution. Custom models can be designed for users’ applications. The units are suitable for analytical-instrumentation applications. The devices provide 61% accuracy. Stepper control kits are available for precision fluid control.

Fluid Metering, Syosset, NY
www.fmipump.com
tel. 800.223.3388

Filter-housing heaters
The "Series 48" filter-housing heaters from MKS are
designed for biopharmaceutical processes that
require advanced thermal control of material viscosities and vapor condensation. The heaters are easily removed, reduce maintenance time, and provide a cost-effective solution that replaces heat-trace tape, steam jackets, and supporting hardware.

MKS Instruments, Andover, MA
www.mksinst.com
tel. 978.645.5500

Syringe closure system
Vetter’s "V-OVS NS" closure system for prefilled syringes is designed to provide safety for users. The system is suited for syringes with a staked needle and features mechanisms to prevent tampering and counterfeiting. The system includes a sealing ring and a solid plastic protective cap with a soft rubber needle-protection element.

Vetter Pharma-Fertigung, Ravensburg, Germany
www.vetter-pharma.com
tel. +49 751 3700 0

Pilot-scale blender
The "MAXIBLEND 1-2-3" pilot-scale blender is a portable, stainless steel, self-contained tumble blender for powders. The blender features interchangeable 1-, 2-, and 3-ft3 V-shells and bins made of 316L stainless steel. The unit incorporates built-in lift system and I-bars for both V-shells and bins.

GlobePharma, New Brunswick, NJ
www.globepharma.com
tel. 732.819.0381

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.dwyer-inst.com
tel. 406.585.9535

Retention valve
3M’s pressure-
fillable retention valve features all-metal construction and a clean elastomer. The valve is designed to minimize moisture ingression, leakage, extractables, and leachables. The device is suitable for various pressurized metered dose inhaler formulations. The valve is designed to retain the prime for more than seven days and ensure uniform performance.

3M Drug Delivery Systems, St. Paul, MN
www.3m.com/dds
tel. 800.643.8086

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

Centrifugal pumps
Swagelok’s centrifugal-model pumps are suited for pharmaceutical and biopharmaceutical products. The pumps’ wetted parts are electropolished 316 stainless steel. All models can be cleaned in place easily. Swagelok’s centrifugal pumps are 3-A sanitary compliant.

Swagelok Biopharm Services, Solon, OH
www.swagelok.com
tel. 440.349.5934

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

Tablet press
Natoli presents its “NP-500 Series” double-sided, single-footprint, rotary tablet presses. The units are designed to compress tablets
requiring extra fill and extended dwell time. The heavy-duty machines are available in semiautomatic and automatic models. Replacement parts are available.

NatoliEngineering Company, St. Charles, MO
www.natoli.com
tel. 636.926.8900

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 will be capable of making .2 million tablets/h. The compact size of the machine, less than 250 3 500 3 500 mm, makes it ideal for glove-box applications.

SMI, Lebanon, NJ
www.smitmc.com
tel. 908.534.1546

Tablet-coating system
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
www.glattair.com
tel. 201.825.8700

Depositremover
The "ScaleBlaster" product prevents the formation of limescale
deposits in water pipes and cooling towers without requiring water-softening equipment, salts, chemicals, or maintenance. The integrated circuitry system destroys calcium carbonate molecules’ adhesive properties. The unit removes existing scale and stops new formation.

Clearwater Enviro Technologies, Clearwater, FL
http://scaleblaster.com
tel. 800.756.7946

Pharmaceuticaldetergent
"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
www.alconox.com
tel. 914.948.4040

High-containmentfilter 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 designedaccording to good manufacturing practice guidelines.

Fette America, Rockaway, NJ
www.fetteamerica.com
tel. 973.586.8722

Loadingsystems
Vac-U-Max offers packaged conveying systems designed for the direct charge loading of blenders, mixers, reactors, and other vessels that can withstand vacuum conditions. The systems include timing controls and vacuum-pump packages. The systems are available in stainless steel, arecapable of automatic transfer, and can be washed easily.

Vac-U-Max, Belleville, NJ
www.vac-u-max.com
tel. 800.822.8629

Water-production systems
MECO offers equipment for the production of water for injection and US Pharmacopeia purified water for biopharmaceutical processes. Technologies include filtration, reverse osmosis, electrodeionization, multiple-effect distillation, vapor compression distillation, and pure steam generation. MECO designs and constructs complete water systems for customers.

MECO, Sugar Land, TX
www.meco.com
tel. 800.421.1798

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

Steamsterilizers
Steris has expanded its "Finn-Aqua" line of steam sterilizers. The company offers its "Finn-Aqua" GMP biopharma sterilizers in sizes of 9.7–294 ft3 with various lengths for specific biopharmaceutical applications. All units offer a choice between Allen Bradley and Siemens programmable logic controls and feature several sterilization-cycle options for hard goods or liquids.

Steris, Mentor, OH
www.steris.com
tel. 800.JIT.4.USE

Capsule-filling system
Schaefer’s wet-in-place, isolated "IN-CAP" capsule-filling system is designed for small-volume capsule-filling projects. Applications include research and development and clinical trials. The system is portable and allows for easy relocation and storage.

SchaeferTechnologies, Indianapolis, IN
www.schaefer-technologies.com
tel. 800.435.7174

Pressure-reducing valves
The "Mark 96A Series" air-loaded, sanitary, pressure-reducing valves are designed to enable remote setpoint modification. Users change setpoints through a cabinet or panel-mounted air regulator, or through a distributed control system using a transducer. The valves’ air-loaded design reduces the units’ size and weight.

Steriflow Valve, Cincinnati, OH
www.steriflowvalve.com
tel. 800.543.7311

Integratedblock valve
ITT Pure-Flo's line of integrated block valves meets the demands of the biopharma-ceutical processing industry. The line includes an array of valves specifically designed to achieve process efficiency. Integrated-block technology optimizes drainability, hold-up volume, deadlegs, and cleanability. Combining multiple valves into a single body can reduce installation and validation costs.

ITT Pure-Flo, Lancaster, PA
www.ittpureflo.com
tel. 717.509.2200