Pharmaceutical Processing articles from June 2007

Pharmaceutical Processing archives from June 2007

Facilities in focus: pharmaceutical manufacturing facilities rarely get the attention they deserve--until now.(From The Editor)
June 1, 2007... Manufacturing facilities don't get much in the way of publicity. Not the way skyscrapers, museums, monuments, or even bridges do. Structures such as the Golden Gate Bridge, the Washington Monument and the Empire State building, for example,...

Bimetal temperature sensor provides local readout.(What's Hot)
June 1, 2007... Bimetal Dual-Mode Remote Thermometer provides on-site indication of process temperature conditions, and simultaneously provides a mV or ohm signal proportional to temperature for input to a transmitter, Remote Terminal Unit (RTU), controller,...

Rotor Detection System warns of metal-to-metal contact.(What's Hot)
June 1, 2007... The Rotor Detection System (RDS) is designed to immediately alert plant operators that a valve's rotor vanes have come into contact with the valve body. If a valve fails, the RDS sends a signal to the plants SCADA system and immediately shuts...

Spray Force Tester for nasal sprays and MDIs.(What's Hot)
June 1, 2007... The SFT 1000 is a cost-effective option for the measurement of maximum spray force, for both nasal sprays and metered dose inhalers (MDIs). It is highly suitable for quality control and research and development applications. The SFT1000's...

Butterfly valves enable sterile powder transfer.(What's Hot)
June 1, 2007... The aseptic Charge-Point high containment split butterfly valve system can be sterilized in place enabling powder transfer without risk of product contamination or operator exposure. The unit enables products to be transferred in a sterile...

Genentech wins the Project Execution Award with a facility that delivers gains in quality and cost: disparate partners collaborate, partner and execute as 'one company'.(Facility of the Year Award)(Cover story)
June 1, 2007... When a distinguished panel of judges on the annual Facility of the Year Awards competition, sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, declared Genentech's new biologics manufacturing plant in Oceanside, CA, the...

Pharmaceutical outsourcing's new frontiers: pharmacovigilance and clinical data management.(Outsourcing)
June 1, 2007... As companies in the pharmaceutical industry continue their drive to reduce costs and enhance efficiency by outsourcing various processes, they are increasingly pursuing newer areas, specifically pharmacovigilance and clinical data management....

Leveraging batch execution software to enable PAT: how to integrate software for a unified PAT approach.(Pharma IT)
June 1, 2007... Process Analytical Technology (PAT) focuses on understanding a given process, and identifying and controlling its variability, with the aim of accurately predicting it's outcome, Benefits of PAT include real time release of product, reduced...

Mass flow meters provide fast response in a compact instrument.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The Brooks[R] Model 4800 Series mass flow meters and controllers offer a broad flow range, fast response time, compact size and many other benefits for a variety of applications. Engineered with a Micro Electro Mechanical System (MEMS) based...

Process pump offered in eight additional sizes.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The Model 3700 API-610 10th edition process pump is now offered in 8 additional sizes, extending its hydraulic coverage to better fit user application requirements. The 3700 is designed with severe duty casing, pedestal support system and...

Disposable Mixing System reduces risk and speeds time-to-market.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The Mobius MIX200 Disposable Mixing System is a modular mixing solution that enables companies to improve their flexibility and reduce their downtime and contamination risk by using disposable rather than stainless steel components. The system...

Weir-style diaphragm valves available with custom block bodies.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... Custom block body weir-style diaphragm valves help minimize deadleg areas, reduce fitting assemblies, and streamline the sterilization process. Machined into a single, compact block, these multi-port or multi-valve assemblies are customized for...

MES consulting services expands to pre-project phase.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... Company now provides the most frequently requested services in the pre-project field including the initial Blueprinting Phase, the definition of Business Processes (including the system's architecture and the functional distribution between ERR...

Wall station offers a compact operator interface.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... Wall station provides a compact operator interface solution where space is a premium. Users can mix and match from the company's selection of displays, touchscreens, keyboards and pointers to create an interface that is optimized for their...

Tangential flow filtration capsule designed for single-use biopharmaceutical applications.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The Kleenpak[TM] TFF Microfiltration Capsule offers a high-flux rate with minimal hold-up volumes even under the most demanding bioprocessing conditions. The capsule is a self-enclosed unit, increasing worker safety by limiting exposure to...

Transfer system handles large and small components.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... BetaBag systems employing the DPTE Double Door Transfer Port are now available with a 270 mm or 105 mm disposable transfer port to accommodate the transfer of both larger and smaller components. Systems are designed to be autoclaved or gamma...

Powder rheometer offers automated bulk, shear and dynamic property measurement.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The FT4 Powder offers automated bulk, shear and dynamic property measurement. The data generated correlate directly with various aspects of processing behavior making the instrument ideal for formulation and process optimization, and effective...

Single-use trays and containers ideal for freeze drying applications.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... LYOGUARD[R] products allow manufacturers to maximize operational efficiencies without increasing risk of product contamination or worker exposure during freeze-drying processes. By using a proprietary ePTFE membrane, GORE LYQGUARD[R] trays...

High shear processor operates at up to 30,000 psi process pressure.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The model M-110EH Microfluidizer[R] is designed to operate reliably and efficiently at up to 30,000 psi process pressure. The unit is beneficial to the production of nano-suspensions and nano-emulsions as well as cell disruption with the least...

Anti-counterfeit film incorporates a hologram for better security.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... Perlalux[R]--Identity is an anti-counterfeit film product which offers a hologram safety feature. The hologram is visible oh the tablet side making Perlalux[R] Identity a unique safety and branding instrument for the pharmaceutical industry....

Laser coder matches high-speed production lines.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The 3320 creates consistent, crisp marks on high-speed production lines. The 3320 integrates into virtually any application that requires permanent marking of variable data on substrates such as glass, plastic, rubber, cardboard and labels....

Nitrile Gloves are latex-free.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... STERLING Nitrile Gloves are latex-free gloves that provide the protection of nitrile and the sensitivity of latex. Their textured fingertips offer excellent tactile sensitivity that allows easy handling of delicate instruments. The gloves are...

Robotic picker features integrated software.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... PickMaster software allows for the integration of picking, packaging and palletizing with the IRB 340 FlexPicker delta robot. The FlexPicker offers up to 150 picks per minute and a payload up to 2 kg. The FlexPicker's suspended mounting...

Outlet valves designed to be welded flush to vessel bottoms.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... Sanitary, flush-bottom "Fluid Flow" valves are designed to be welded to the bottom of vessels, eliminating any dead space between the valve and vessel enabling all product to be processed. Valves are available in sizes from 1 1/2"--4" and can...

Temperature control unit designed for critical processes.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The 2010 temperature control unit provides consistent temperatures for critical processes. The design features simplified internal cast or non-ferrous circuit with 40% fewer connections and 80% fewer mechanical parts. The 2010 series also...

Hoppers available for all types of drums.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... Stainless steel 304 and 316 hoppers are available for all types of drums. Units now feature rotary butterfly valves. Hoppers control the flow of powders from drums to processing machines. M.O. Industries, Inc., Whippany, NJ 07981....

Pharmaceutical feeder features all stainless steel material contact surfaces.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... The Model PHT20 and PHT35 feeders design improvements include adding an O-ring on screw shafts for a better seal and minimal leakage. Standard purge fittings on both models PHT20 and PHT35, assure no movement of product to bearing area and...

Drop-in and fit-in desiccants available for custom applications.(INTERPHEX 2007 Show Wrap-Up)
June 1, 2007... Company has developed drop-in and fit-in desiccant integration approaches for effective and customized moisture regulation in respiratory drug delivery (RDD) devices or dosage packaging. Dry Powder Inhalers (DPI), in particular, often require...

Clinical testing system demands tight-tolerance reagent packs: blow-molded containers offer the right combination of precision and efficiency.(Packaging)
June 1, 2007... Blow molding is rarely approached as a high-precision process, and most blow-molded containers have relatively wide tolerances. But these comparatively easy-going ways are inappropriate when the container will be used in an automated system...

CO2 incubator designed for cell cultivation without contamination.(New Products)
June 1, 2007... The C 150 offers as standard hot air sterilization at 180C. The seamless, deep-drawn inner chamber offers 27% less surface area reducing the potential for contamination. The unit can also be stacked in labs without sacrificing ease-of-use. ...

Sanitary ball valves meet strict 3-a specifications.(New Products)
June 1, 2007... Two-way and three-way diverter air actuated inline Fluid-Flow ball valves are designed for rigid corrosion-resistant, high sanitary applications. Standard fully encapsulating Mica-Filled Teflon seals provide the maximum reduction in product...

In-line high shear mixers offer extremely hygienic construction.(New Products)
June 1, 2007... Ultra sanitary in-line mixers feature interchangeable single or multi-stator rotor/stator arrangements as standard, resulting in fast mixing times and finer particle sizes. The unit's outlet can be configured for tangential self-draining or...

Parenteral packaging concerns for biotech drug products: as biotech grows, so does the need for effective packaging.(Perspectives on Packaging)
June 1, 2007... As biotechnology grows in importance, the science and engineering of primary packaging for injectible biopharmaceuticals has taken on new prominence. This article discusses the science, engineering, and regulation of primary packaging for...

Rectangular tablet bottles are easy to grip.(New Products)
June 1, 2007... HDPE bottles are available in 250 ml and 270 ml sizes, both with a 45-400 finish. Bottles are easy to grip and are available with tamper-evident, flip-top closures. Bottles are available with variety of deco rating options including custom...

Temperature monitor ideal for routine measurements.(New Products)
June 1, 2007... The Traceable[R] remote alarm RH/temperature monitor features a remote temperature/humidity sensor with a 7 foot cable. Unit is ideal for routine measurements, monitoring round-the-clock, all quality control needs, and critical experimental...

Microbial identification system also features kinetic characterization.(New Products)
June 1, 2007... The OmniLog[R] Combo System is capable of both microbial identification and kinetic characterization of cellular functions. The company's proprietary method for microbial identification allows labs to easily identify and characterize a wide...

Volumetric filling system increases productivity.(New Products)
June 1, 2007... Volumetric filling system is designed to control both weight and volume in dry filling applications. The design eliminates the need for a combination scale and includes a single Allen-Bradley PLC to control both the filler and the scale. Unit...

Digital weight indicator is washdown safe.(New Products)
June 1, 2007... The Model 2200 Advanced Weight Indicator is available as either a stand-alone unit or as part of a complete scale system. The full-function keypad allows for simple entry of digital tare, time and date, accumulator, eight product ID's, eight...

Blending vessels for liquids, creams and gels.(New Products)
June 1, 2007... Single shell and jacketed vessels are designed for a wide variety of applications including liquids, creams, and gels. Depending on the application, agitators can be furnished for viscosities from water-like to 2,000,000 CPS. Each system is...

Electric boilers offered with passivated pressure vessel.(New Products)
June 1, 2007... The Series SSB is designed to produce clean, efficient steam up to 100PSIG in a range from 36 pph to 540 pph. They operate on electricity, can be located almost anywhere and are compatible for use with distilled, demineralized, deionized or...

Industrial terminal designed for harsh environments.(New Products)
June 1, 2007... The ET41150 sealed industrial terminal features a 10.4" touch screen. Its face is sealed to IP65. The screen can be used with or without a glove and provides operators with a highly accurate touch screen for interface with host computers using...

Shrink labeler runs tamper evident neckbands and shrink sleeve labels.(New Products)
June 1, 2007... The R-200 Evolution Series is designed for continuous operation at speeds between 50 and 200 cpm. It provides precise graphic orientation, and accommodates sleeve diameters from 38 mm to 175 mm. Containers can filled or empty, and unit's...

Conveyor offers urethane belt.(New Products)
June 1, 2007... The AquaPruf 7600 Ultimate Conveyor Series features a positive-driven Mol Industries[R] USDA-approved solid urethane belt for smooth, consistent operation in wet, humid environments. The urethane belt has no bacteria-harboring hinges or pins....

Drum lifter/tilter offered with scale.(New Products)
June 1, 2007... The Model GBK features all polished 304 stainless steel construction. Unit clamps, lifts and tilts most drums via handle pump and hand wheels. Lifting capacity is 600 lbs. with a hydraulic cylinder stroke of 40 in. Fully powered model...

Batching system offers internet-based programming.(New Products)
June 1, 2007... Batching system feature internet-based programming, monitoring and diagnostics capabilities. System uses an Allen-Bradley PLC for the input of up to 100 recurring recipes, and a variety of QC functions. Weighing accuracy is .02 lb. per...

INTERPHEX2007 exceeds expectations--again.(INTERPHEX2007 Wrap-Up)
June 1, 2007... INTERPHEX 2007, the industry's largest annual event, once again exceeded growth expectations. Nearly 17,000 industry professionals were in attendance and over 1100 leading life sciences companies exhibited from around the globe. With the...

FDA committee finds substantial evidence to support Advair 500/50 in reducing COPD exacerbations.(Industry News)
June 1, 2007... An Advisory Committee to the FDA recently unanimously agreed (11 to 0) that GlaxoSmithKline's Advair Diskus[R] 500/50 (fluticasone propionate and salmeterol inhalation powder) demonstrated a significant reduction in the risk of exacerbations in...

FDA approves generic Ambien.(Industry News)
June 1, 2007... The FDA recently approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. Zolpidem (ZOLE-pi-dem) tartrate is a sedative-hypnotic drug indicated for the short-term treatment of insomnia. Zolpidem tartrate...

AstraZeneca to begin construction of $100m R&D expansion.(Industry News)
June 1, 2007... AstraZeneca has begun construction on a $100 million Research and Development expansion at the company's Waltham-based facility. The expansion of AstraZeneca's research facility will accommodate up to 100 additional researchers who will...

ANI Pharmaceuticals, Inc. acquires state-of-the-art Rx facilities.(Industry News)
June 1, 2007... ANI Pharmaceuticals has announced a major expansion of its Rx capabilities with the acquisition from Solvay Pharmaceuticals, Inc. of two manufacturing facilities located in Baudette, MN. The plants add 173,000 sq. ft, of manufacturing and...

Bristol-Myers Squibb breaks ground on new biologics manufacturing facility in Massachusetts.(Industry News)
June 1, 2007... Bristol-Myers Squibb recently held a groundbreaking ceremony at the site of the company's new biologics manufacturing facility in Devens, Massachusetts. The company announced the selection of Devens in June 2006 and recently began construction...

FDA approves first U.S. vaccine for humans against the avian flu virus.(Industry News)
June 1, 2007... The FDA has recently announced the first approval in the United States of a vaccine for humans against the H5N1 influenza virus, commonly known as avian or bird flu. The vaccine could be used in the event the current H5N1 avian virus were...

New critical path report highlights research needed to foster generic drug development.(Industry News)
June 1, 2007... The FDA recently issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs. The report is part of FDA's...

Count-up controllers used for timed shutdown or repeated on/off timing.(Cool Technology: QA/QC)
June 1, 2007... The Model 1 Walkaway Turn-Off Controller counts up and turns any piece of equipment off at the end of a set time period. It is programmable in three interval settings: .01 second to 99.99 seconds; 1 minute to 9999 minutes; or 1 hour to 9999...

Particle counter interfaces to mobile PCs.(Cool Technology: QA/QC)
June 1, 2007... The PC-GW3016 is a portable 6-channel particle counter that features exclusive data transfer and graphic software. Automated report generation software is also available to interface with mobile PCs which enhances on-site documentation of...

Supercritical fluid extract system useful for QA/QC applications.(Cool Technology: QA/QC)
June 1, 2007... The SFT-100 was developed to investigate the feasibility of applying supercritical fluid techniques to various analyses, processing challenges, and QA/QC applications. Reliable, dual sapphire syringe pump technology rapidly and accurately...

X-Ray Inspection System ensures product and package integrity.(Cool Technology: QA/QC)
June 1, 2007... The EZ Tec[R] XR Inspection System helps ensure product and pack age integrity by reliably identifying contaminants, scanning for missing or broken products, detecting packing voids, and confirming fill levels. The system offers a 15" touch...

Volumetric titrator has six built-in calibration modes.(Cool Technology: QA/QC)
June 1, 2007... The AQV-300 has six built-in calculation modes to accommodate solid, liquid and gas samples. It includes a statistics package with one-touch calculations. Four files with preset conditions can be stored in memory and allows instant recall of...

Metal detector ideal for cost conscious QA managers.(Cool Technology: QA/QC)
June 1, 2007... The APEX 100 features: integrated electronics with no external boxes to mount or wire; easy-to-use icon-driven interface; stainless steel and ABS plastic design endures factory applications and IP65 washdown; built-in Quality Assurance Test...

Circulating bath designed for kinematic viscosity testing.(Cool Technology: QA/QC)
June 1, 2007... Kinematic viscosity bath features a maximum temperature of 150[degrees]C and temperature stability of +/0.05[degrees]C. The unit comes equipped with a Teflon top plate that holds up to six 2" diameter glass capillary viscometers. The bath...

House Republicans challenge FDA on warning letters.(Regulatory Update)
June 1, 2007... Senior House Republicans are challenging FDA on the fairness of its warning letter appeals process, The Pink Sheet reports. In an April 18 letter to FDA Commissioner Andrew von Eschenbach, Reps. Joe Barton, R-Tex., and Ed Whitfield, R-Ky.,...

FDA needs new regulatory model in face of globalization, Woodcock says.(Regulatory Update)
June 1, 2007... The FDA requires a new regulatory model to confront issues presented by globalization, which will include reliance on foreign regulators, according to agency Chief Medical Officer Janet Woodcock "The global environment is very challenging...

Apotex/Mylan continue battle over Norvasc.(NOTED)
June 1, 2007... Apotex/Mylan continue battle over Norvasc: Apotex and Mylan are asking the D.C. federal court to reconsider its April 30 order denying motions over the marketing of generics of Pfizer's Norvasc (amlodipine besylate). Mylan seeks to delay...

FTC investigating Schering/Organon merger.(NOTED)
June 1, 2007... FTC investigating Schering/ Organon merger: The Federal Trade Commission is requesting additional information from Schering-Plough regarding its planned acquisition of Akzo Nobel's pharmaceutical and animal health business, Organon Biosciences....

Lilly leadership changes.(NOTED)
June 1, 2007... Lilly leadership changes: Alex Azar II will join Lilly as senior VP-corporate affairs and communications, the company announced on May 4. Previously, Azar served as HHS Deputy Secretary for two years ending in February. The company also...