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"Authorized generics"--the next battle ground?(From the Editor)
April 1, 2004... A battle is brewing before the FDA to end the practice of "authorized" generics. What exactly is an "authorized" generic you might ask? Basically, under an authorized generic deal, a brand company licenses its product to a generic firm for...
Touch-Screen Controller for detectors features a backlit display.(What's Hot)
April 1, 2004... The Metron 05 Touch-Screen Controller features a backlit touch-screen display with an oscilloscope function that shows the signals coming from metal detector sensing coils. Viewing the signals makes adjusting detector sensitivity, time delays,...
Foil laminates added to unit-of-use packaging line.(What's Hot)
April 1, 2004... Foil laminate tubes are ideal for packaging numerous products. Tubes offer superior barrier protection against moisture transmission and UV light exposure. Company also offers contract filling and sample packaging.
Unette
Use InfoLINK...
Tamper-proof security seals ensure filtration product integrity.(What's Hot)
April 1, 2004... Located on the outer corrugated package, the security seal provides visible assurance of intact packaging. If the seal is broken after leaving Millipore facilities, white adhesive is left behind displaying the word "Opened" on the tape. In the...
Utility carts offer antimicrobial product protection.(What's Hot)
April 1, 2004... Deep Ledge and BC Series polymer utility carts are now available with Microban[R] antimicrobial product protection that helps keep the products "cleaner between cleanings" by inhibiting the growth of bacteria, mold and mildew that cause odors,...
PC-sized process control system offers all the features of a conventional system.(What's Hot)
April 1, 2004... The SIMATIC PCS 7 BOX provides all the features of a conventional process control system in the compact design of a single PC, making it a "DCS in a Box". Its integrated functionality and capability allow PCS 7 BOX Lobe used in new applications...
Mixer incorporates a special helical agitator and high-speed dispersion blade.(What's Hot)
April 1, 2004... The Dual-Shaft VersaMix design incorporates a special helical agitator and high speed dispersion blade. The new combination of agitators provides improved axial and radial turnover of the materials being mixed, as well as high shear of the...
Deep clearance locking clamps made entirely of stainless steel.(What's Hot)
April 1, 2004... Available in two sizes, both clamps have an overall length of 10 1/2" with a 2 1/2" reach. Model #10026 has 3 3/8" of vertical clearance and model #10027 has 1". For heavy-duty applications where corrosion resistance, sterility, and cleanliness...
Solenoid pivot valve manages complex flow operations.(What's Hot)
April 1, 2004... Manifold-mountable solenoid operated pivot valve features a low internal volume design in a 2-way or 3-way configuration that minimizes carryover during precision mixing or dispensing of high purity or aggressive fluids. Several wetted material...
Replacement turret and stand assembly meets or exceeds OEM design.(What's Hot)
April 1, 2004... Company now offers a direct OEM replacement turret and stand assembly to fit the 3090/3200 and 2090/2200 series of tablet presses The package is designed to be an affordable option for replacing or adding a turret and stand assembly to run on...
Selecting a vacuum conveying system.(Solutions)
April 1, 2004... Vacuum conveying technology has become an indispensable part of the pharmaceutical manufacturing process. It is being used for an increasingly wider array of tasks: moving materials through the drug processing line, blending ingredients, even...
Digital gauge allows "no tools" battery replacement.(Processing Components)
April 1, 2004... The 4 1/20 Ashcroft[R] gauge is designed for easy maintenance. Gauge comes apart with a quick twist of the front ring. Once the batteries are installed, the gauge can be hand tightened to fit securely back in its correct position. Unit is...
Air filters feature "bend-to-fit" flexibility.(Processing Components)
April 1, 2004... MagnaFlex Air Filters are designed for enclosures that cannot accepts rigid air filter frame because of enclosure obstructions. The magnetic sealing strip eliminates expensive mounting hardware and simultaneously locks the flexible filter in...
In-line flow sensors designed for limited space applications.(Processing Components)
April 1, 2004... Sensors feature a compact housing, with stainless steel wetted parts that are available with a 4 to 10 mm inner diameter. They can be installed into new and existing applications with fittings available from the company. Flow detection is...
Clear plastic basket strainer simplifies maintenance.(Processing Components)
April 1, 2004... Strainers are designed to protect piping system components such as nozzles, instrumentation, and pumps from damage caused by particulate matter in the system flow. They can also be used as a pre-filter before a bag or cartridge filter to extend...
Disposable manifolded filtration systems provide ease of use and reduction of cleaning requirements.(Filtration & Separation)
April 1, 2004... Systems provide increased security, while saving time and money. Security is increased since disposable systems are used once and discarded, so the risk of cross contamination is eliminated. Time is saved since the disposable units can be used...
Benchtop centrifuge offers a wide array of rotors.(Filtration & Separation)
April 1, 2004... The Universal 32/32R benchtop centrifuge utilizes one of the widest arrays of rotor selections and affords the user the ability to process a multitude of tubes, from microlitre tubes to 100mL bottles to microtitre plates, Utilizing its...
Depth filter reduces reverse osmosis pretreatment costs.(Filtration & Separation)
April 1, 2004... ROsave.Z high efficiency cartridge filters are engineered specifically for reverse osmosis (RO) pretreatment applications. The filters can reduce the costs for change-outs, equipment downtime and waste disposal Manufactured using Z.Plex...
Filter cleaning system keeps filters operating efficiently.(Filtration & Separation)
April 1, 2004... TEKRINSE screen-cleaning technology allows TEKLEEN filters to use less than two gallons of water per backwash cycle. The main flow remains uninterrupted, allowing operations to continue smoothly. The only requirement for automatic,...
Compact check-screener improves the purity of pharmaceutical powders.(Filtration & Separation)
April 1, 2004... Compact screener accurately check-screens pharmaceutical powders to remove any oversize contamination In one pass, materials can be screened and sized to safeguard the purity of pharmaceutical powders and ensure that the final product is of the...
Hollowshaft encoders feature quick disconnect.(Processing Components)
April 1, 2004... Encoders feature the eurofast[R] quick disconnect. Units are available in either incremental or absolute position sensing, with a hollowshaft construction. The entire series has all stainless steel housings; including receptacles. In...
Stainless steel load cells for specific applications.(Processing Components)
April 1, 2004... The LD360s is designed for high reliability in high-risk, high-cost biopharmaceutical sanitary CIP/SIP applications. It is available in capacities of 1,000 pounds through 25,000 pounds. The LD3xic was designed for standard high-value...
Lifting systems allows for faster screening frame cleaning.(Processing Components)
April 1, 2004... The Air-Lift consists of two vertically mounted air cylinders that are located on opposing sides of any circular separator and affixed to mounting brackets on the lower and upper screening frames. To operate, a quick-disconnect clamp connecting...
Container is ideal for in-process handling and organization.(Processing Components)
April 1, 2004... Cross-Stack Akro-Tubs are available in two sizes, each in heights of 8" and 12". These heavy-duty tubs feature size and bottom stacking grooves that allow stable, 90 stacks of loaded containers to provide efficient transport on pallets or...
Validation strategies for disposables.(Cover Story)
April 1, 2004... The adoption of disposable manufacturing in conventional biopharmaceutical processes has already demonstrated tremendous benefits for the industry in terms of process flexibility, economics and security. However, the regulatory and validation...
Pinch valves available for use with CMP distribution pipe systems.(Values & Fittings)
April 1, 2004... Dymatric PV Series Pinch Valves (PV) are available with Poly-Pro[R] butt-ends for CMP distribution pipe systems. The flow through design and long lasting tube material provides an extended life cycle, eliminating stress and particle cohesion....
High pressure mini-valves are compact and reliable.(Values & Fittings)
April 1, 2004... Miniature series of valves and fittings are designed for use with 1/16" and 1/8" high pressure tubing. With pressure ratings of 15,000 psi (1034 bar) and temperatures to 600[degrees]F (316[degrees]C) these compact and reliable components...
Catalog features mini valves, fittings, quick disconnects, etc.(Values & Fittings)
April 1, 2004... Catalog describes expanded line of miniature valves, fittings, cylinders, tubing, pressure regulators, orifice, quick disconnects and other fluid power devices. Company specializes in miniature "high-performance" fluid power components.
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Ball valve designed to streamline processes.(Values & Fittings)
April 1, 2004... The 337F ball valve is BPE compliant and made of 316L material. The valve is available in full port tube sizes from 1/2"-4" with clamp, tube butt weld, or the Thru-Weld end which provides a smoother finish, fewer hot spots, and better MTR...
Panel mount coupling body enhances connection flexibility.(Values & Fittings)
April 1, 2004... Panel mount coupling bodies for the APC product provides added flexibility and mounting options to create secure connections for numerous applications. The new panel mount coupling body enables tubing to be easily connected and disconnected...
Flush valves available in stainless steel.(Values & Fittings)
April 1, 2004... Perma-San[R] Flush Valve Series is available in highly polished stainless steel construction from 1-1/2" to 4" and in air actuation or electro-polished versions.
Viatec, Inc.
Use InfoLINK 4D1147 or Call 800-389-8814
[ILLUSTRATION...
Condensate recovery system for vented receivers and sumps.(Processing Components)
April 1, 2004... The GP14 provides high-pressure, high temperature condensate pumping services up to 392[degrees]F and 200 psig. Features include: durable Inconel compression spring; energy efficient contoured body design increases energy savings; and the...
Conveyors designed to prevent end-drive and pulley damage.(Processing Components)
April 1, 2004... The 6200 Series features the Wedge-Lok System that prevents conveyor end-drive and pulley damage. System protects conveyors from damage by locking the pulley end from moving during a sharp impact. Features include 10 diameter end-roller for...
AmerisourceBergen names Terrance P. Haas President of AmerisourceBergen Drug Corporation.(Industry News)
April 1, 2004... AmerisourceBergen Corporation, one of the largest pharmaceutical services companies in the U.S. dedicated solely to the pharmaceutical supply channel, has announced the promotion of Terrance (Terry) P. Haas, 38, to the new position of Corporate...
Fuji Chemical announces the formation of a new U.S. based subsidiary.(Industry News)
April 1, 2004... Fuji Chemical Industry Co., Ltd. has announced the formation of a new U.S. based subsidiary, FCI Health Science, Inc., located in Mount Laurel, NJ. The new company, headed by president, Charles DePrince, was formed on January 2, 2004 with the...
USP to hold first Annual Scientific Meeting.(Industry News)
April 1, 2004... The United States Pharmacopeia (USP) has announced that it will hold its first USP Annual Scientific Meeting at the Sheraton Woodbridge Place in Iselin, N.J. from Sept. 27 to 29, 2004. The new USP Annual Scientific Meeting, which replaces the...
Malvern Instruments enters distribution partnership with Parsum GmbH: Parsum in-line particle measurement systems further extend Malvern Process Systems range and applications.(Industry News)
April 1, 2004... Particle characterization and rheology company Malvern Instruments Ltd. has entered into a distribution partnership with Parsum GmbH. The agreement provides Malvern Instruments with worldwide distribution rights for Parsum in-line particle...
MetaWorks[R] and DrugLogic[TM] form strategic alliance.(Industry News)
April 1, 2004... MetaWorks[R], Inc. and DrugLogic[TM], Inc. have announced a strategic alliance to offer pharmacovigilance analyses, drug safety consultation and services for global pharmaceutical companies and related industries. Capitalizing on their skill...
Parker Hannifin forms new Life Sciences Business Unit.(Industry News)
April 1, 2004... Parker Hannifin Corporation has announced the formation of a new Life Sciences Business Unit to enable the development of technologies driving next-generation advancements in this fast growing market segment.
The new unit incorporates the...
Environmental sensors.(Web & Literature Review)(Advertisement)
April 1, 2004... Vaisala--a leader in environmental measurement develops, manufactures and markets state-of-the-art relative humidity, dewpoint, carbon dioxide, ammonia, barometer pressure, and wind transmitters, sensors, and hand-held meters for industrial...
Hand-Held C[O.sub.2] Meter.(Web & Literature Review)(Advertisement)
April 1, 2004... Vaisala's CARBOCAP[R] GM70 Hand-Held Carbon Dioxide Meter measures carbon dioxide from 0... 2000 ppm up to 20% concentrations of C[O.sub.2]. Featuring short warm-up time, high reliability, long-term stability, and optional diffusion or pump...
Process Automation solutions.(Web & Literature Review)(Advertisement)
April 1, 2004... TURCK Process Automation, a partnership of technology, expertise and products from TURCK and InterlinkBT offers a broad line of bus I/O stations, junctions, cordsets and components for device-level networks.
TURCK Process Automation
...
Material handling equipment.(Web & Literature Review)(Advertisement)
April 1, 2004... K-Tron International companies provide material handling equipment, systems and services to a wide variety of industries, including the plastics, food, chemical, detergent, pharmaceutical, electric utility and paper and pulp industries....
Silicone tubing and hose products.(Web & Literature Review)(Advertisement)
April 1, 2004... Amesil offers a complete line of high-purity, platinum-cured silicone products-tubing, hose, and associated aseptic fittings. Amesil also provides custom molded components--stoppers, bottle tops, "Ys," "Ts," manifolds, gaskets, and various...
Tablet presses and equipment.(Web & Literature Review)(Advertisement)
April 1, 2004... Thomas Engineering's website covers their line of Accela-Cota Tablet Presses, punch and die tooling, spare parts, support services, packaging equipment, and reconditioned equipment. The website presents extensive product offerings of coating...
Size reduction and fluid mixing.(Web & Literature Review)(Advertisement)
April 1, 2004... Website is targeted to processors in the pharmaceutical, food, cosmetic/personal care and fine chemical industries. The site features an expanded Products section with detailed specifications. The "Solutions For Industry" section offers case...
Endotoxin detection products.(Web & Literature Review)(Advertisement)
April 1, 2004... Cambrex BioScience Walkersville, Inc. is the industry leader in sales and innovations for endotoxin detection products, services and software. Their latest catalog is available in electronic form. For more information, Cambrex BioScience,
...
Pneumatic conveying.(Web & Literature Review)(Advertisement)
April 1, 2004... A leading supplier of pneumatic conveying equipment and industrial vacuum cleaners, company has launched a new Web site. Visitors can search by application or components or request a quote by filling out the Online Request for Quotation Form....
Fluid handling System Sourcebook.(Web & Literature Review)(Advertisement)
April 1, 2004... Cole-Parmer's new 192-page Fluid Handling System Sourcebook features the latest Masterflex[R] tubing pumps, new tubing and hose formulations, plus fittings, valves, flowmeters, mixers, filtration, and level control. Request your FREE catalog at...
Mixing equipment.(Web & Literature Review)(Advertisement)
April 1, 2004... Website offers solutions to mixing challenges that face your specific process along with information on our wide range of in-line and in-tank sanitary equipment to handle all your mixing, blending and particle size reduction needs. The "Find...
Processing technology.(Web & Literature Review)(Advertisement)
April 1, 2004... This comprehensive website outlines the company's various operating divisions and overall structure. Processing technology sections detail the company's processing equipment, which is serviced from sales and service offices throughout the...
Sanitary fittings and tubing.(Web & Literature Review)(Advertisement)
April 1, 2004... Central States Industrial provides a complete line of sanitary fittings and tubing in AL-6XN. This alloy provides superior corrosion resistance when 316L stainless steel components are inadequate. AL-6XN alloy is a super-austenitic" alloy...
Precision instrumentation.(Web & Literature Review)(Advertisement)
April 1, 2004... Mesa Laboratories, Inc., DataTrace Division develops, manufactures, and markets high-quality, precision instrumentation for monitoring temperature, humidity, and pressure. The DataTrace Tracers are available to accurately monitor many...
Solids metering technology.(Web & Literature Review)(Advertisement)
April 1, 2004... A leader in bulk solids metering technology for pharmaceutical and nutraceutical dry material handling, AccuRate[R] invites you to visit their web site for information on volumetric and gravimetric feeders, bulk bag discharging systems, solids...
Flooring products.(Web & Literature Review)(Advertisement)
April 1, 2004... SRS provides methacrylate products for use in commercial, industrial, institutional, research and civil engineering environments. Products offered by SRS. Include: DEGADUR[R] Flooring Systems, DEGADUR[R] Polymer Concrete, DEGAROUTE[R] Road...
Design and build services.(Web & Literature Review)(Advertisement)
April 1, 2004... R C Systems, Inc. has 30 years experience in the following design and build areas: pharmaceutical processing design and build systems for USP water, vision inspection, process and packaging --meeting Part 11 requirements; material handling...
Seal Master[R] inflatable seals.(Web & Literature Review)(Advertisement)
April 1, 2004... Improve production efficiency with versatile, custom-built, fabric-reinforced elastomeric seals. In addition to sealing, they are widely used for mixing, drying, cooling, granulating, coating, conveying and other applications. Require little...
Metal detectors.(Web & Literature Review)(Advertisement)
April 1, 2004... Eriez.com features more than 450 pages of magnetic plates, grates, traps and conveyors, as well as lifting magnets, metal detectors and vibratory feeders and screeners. With Eriez' new adlink, users can locate products seen in company...
Tablet press technology.(Web & Literature Review)(Advertisement)
April 1, 2004... FETTE, the worldwide leader in tablet press technology offers a wide range of information on products, services, parts and training on the website for its North American Headquarters at www.fetteamerica.com. Fette America
...
Checkweighing technology.(Web & Literature Review)(Advertisement)
April 1, 2004... OCS Checkweighers is a global company in the business of dynamic weighing technology and checkweighers. Quality and quantity verification of products is beginning to play a major role in every industry sector. In order to accommodate this need,...
Technical education for an evolving industry: BIOPHEX 2004 conference.(Biophex 2004 update)
April 1, 2004... As it nears the close of its third decade, biopharmaceutical industry appears to be moving into an exciting new phase of unprecedented growth and profitability. The industry entered 2004 on a high note, with 37 FDA approvals and more than $16...
Water filtration system finds new application.(Applications)
April 1, 2004... When the Schering Plough (Avondale) Company's pharmaceutical manufacturing facility in Ireland looked for a new way to provide process water to its manufacturing facility as well as feedwater to a purified water generation system, it turned to...
RH calibration system ideal for validation.(Quality Assurance)
April 1, 2004... The Model 2000 Humidity Calibrator provides an accurate and rapid means to calibrate portable instruments, transmitters, data loggers, chart recorders and critical RH/T devices. System features accuracy of +/-1.25% RH and chamber uniformity of...
Vortex flowmeter is intrinsically safe.(Quality Assurance)
April 1, 2004... The EF77 incorporates a highly durable, patented capacitive sensor, which generates accurate volumetric flow rate measurements of gases, liquids, saturated, and also superheated steam. Unit offers a wide measuring range, high resistance to...
Sterile visual flow indicators meet 3-A and FDA requirements.(Quality Assurance)
April 1, 2004... Designed to be mounted inline for high purity applications, these sterile-design visual flow indicators provide operators with a clear view of virtually any process pipeline fluid or powder. They feature an internal-flush style that meets FDA...
Data logger operates without external probes.(Quality Assurance)
April 1, 2004... The ebro[R] EBNI 85 has a compact, sturdy construction with compression strength of 20 bar. Rated to IP 68, it is totally submersible and can be cleaned quickly and easily. Unit measures temperature from -85[degrees]C to 85[degrees]C The unit...
FDA to announce when ANDAs are submitted.(Regulatory Update)
April 1, 2004... The FDA has announced that they will begin posting the date when Paragraph IV applications are filed.
The change, which is being made in response to two citizen petitions, will allow generic firms to better plan their filings and assess...
House bill calls for electronic pedigree for controlled substances by 2006.(Regulatory Update)
April 1, 2004... Legislation introduced by Representatives Charlie Norwood (R-Ga.) and Ted Strickland (D-Ohio) would require electronic coding for a "hot list" of controlled substances by 2006.
The "Prescription Drug Abuse Elimination Act" (HR 3870) would...
FDA office of generic drugs adding fourth team to handle increased ANDAs.(Regulatory Update)
April 1, 2004... The Center for Drug Evaluation & Research Office of Generic Drugs (OGD) is adding a fourth team within the Division of Bioequivalence to handle an increase in ANDA submissions. Review teams typically include six to seven reviewers and a team...
Import control efforts to be aided by trilateral working group.(Highlights)
April 1, 2004... A U.S.-Canada-Mexico working group will cooperate on controlling illegal importation of prescription drugs into the U.S.
The FDA recently announced that it had entered into a "Trialateral Cooperation Charter" with its North American...