Pharmaceutical Processing articles from July 2006

Pharmaceutical Processing archives from July 2006

FDA acts (again) to combat counterfeiting.(From the Editor)
July 1, 2006... Over the past years the industry has been struggling with its response to drug counterfeiting Public meetings with stakeholders have been held; task forces have been assembled to study possible solutions and make recommendations; technologies,...

Electromagnetic flowmeter available in a digital bus configuration.(What's Hot)
July 1, 2006... The BATCHCONTROL electromagnetic flowmeter is ideal for the batching and dosing of electrically conductive liquids and pastes in the pharmaceutical industry as it features an integrated control module and CAN open based network communication....

Data loggers offer built-in USB port.(What's Hot)
July 1, 2006... The Pro Series temperature and humidity data loggers feature LED alarms, 1-second sampling rates, and accuracy up to +/-0.5[degrees]C making them ideal for most critical applications. The TP125 Data Logger is a compact two-channel, low cost...

Stainless steel 1/4" drive sockets eliminate risk of contamination in critical processing.(What's Hot)
July 1, 2006... Sockets are designed for sterile and critical environment applications and are manufactured entirely from 17-4PH stainless steel, so no chrome plating is required on the surface. The new six point sockets are 2" in overall length and available...

Basket strainer ideal for corrosive or ultrapure service.(What's Hot)
July 1, 2006... Company has added a new 4" Eastar[R] Clear Polyester Basket Strainer to their existing lineup of 1/2" to 2" sizes. Ideal for straining applications in corrosive or ultrapure service, the new model will never rust or corrode, will not...

Lean Manufacturing, Gaining Efficiencies and Maintaining Compliance on the Plant Floor: will lean manufacturing techniques save the industry? Excerpts from our recent webcast shed light on many of the issues facing pharmaceutical manufacturers.(Cover story)
July 1, 2006... Recently, Pharmaceutical Processing's Editor-In-Chief Mike Auerbach moderated a live webcast titled Lean Manufacturing, Gaining Efficiencies and Maintaining Compliance on the Plant Floor. This webcast was designed to discuss lean manufacturing,...

High shear mixer improves dispersion prior to milling.(Manufacturing/Processing: Cool Technology)
July 1, 2006... The PreMax is a highly efficient mixer, often used to improve dispersion prior to milling. The PreMax contains a specially designed rotor/stator that creates high flow and shear rates. The PreMax has proven that it can in some cases eliminate...

Magnetostrictive position sensor offers fast and accurate operation.(Manufacturing/Processing: Cool Technology)
July 1, 2006... The R-Series Synchronous Serial encoder (SSI) Interface position sensor combines design and manufacturing enhancements resulting in a fast and accurate magnetostrictive position sensor. The unit includes options for synchronized 7500 kHz update...

Mixers designed for sanitary pharmaceutical/biotech applications.(Manufacturing/Processing: Cool Technology)
July 1, 2006... The high performance DT sanitary mixers are equipped with industry standard, off-the-shelf, NEMA electric or air motors. Many custom designs and options are available to meet specific applications for the bio/pharma market. The sanitary DT...

Air atomizing spray offers increased flexibility.(Manufacturing/Processing: Cool Technology)
July 1, 2006... The ViscoMist air atomizing spray nozzle has been redesigned to provide a cleaner look, improved performance, and increased spray flexibility. It has also been designed to operate with the company's spray controller, which more precisely...

Metal detectors provide equipment protection.(Manufacturing/Processing: Process Components)
July 1, 2006... E-Z-Tec[R] DSP Narrow Profile Liquid Line metal detectors are used to detect the presence of ferrous, non-ferrous and stainless metal contaminants in viscous products such as liquids, slurries, syrups, pastes and many other pumped materials....

Tabletop filling system offers gentle product handling.(Manufacturing/Processing: Process Components)
July 1, 2006... The programmable DF32 Tabletop Filling Machine features 1% accuracy to eliminate fill volume inconsistencies, embedded air, product waste and spillage for viscous oil and cream-based products. The automated, servo-controlled filling operation...

Tubing designed for a wide range of fluid applications.(Manufacturing/Processing: Process Components)
July 1, 2006... Tubing is extruded from Texfluor PTFE, FEP, PFA, ETFE, and ECTFE in sizes ranging from 1/8" to 4" I.D. as capillary, convoluted, and corrugated styles. Suitable for a wide range of fluid handling applications, special features such as wire-wrap...

Stainless steel gauge features protective diaphragm.(Manufacturing/Processing: Process Components)
July 1, 2006... Series SGO Gauges have dual English/metric scales with 1.6% accuracy. Units are designed with a 304 stainless steel chamber, and PTFE coated diaphragm for chemical compatibility. Gauges can withstand ambient temperatures up to 149F and process...

Rapid blending of nutraceuticals in a restricted space.(Solutions)(Cover story)
July 1, 2006... Although vitamins and minerals have long been a mainstay in health maintenance, a new category of health maintenance products has created an entirely new market over the last two decades. The term "nutraceutical" was first defined in 1989 by...

Holders available for forward-and reverse-acting discs.(Manufacturing/Processing: Process Components)
July 1, 2006... Holders, which are compatible with the company's complete rupture disc range, have been specifically designed to feature standard face-to-face dimensions to facilitate replacement of existing holders as users upgrade to the company's other...

Luminaire serves sight/light ports and area lighting needs.(Manufacturing/Processing: Process Components)
July 1, 2006... The USL 08-EX light provides 35 to 100 watts of illumination in a variety of sanitary applications. Equipped with a Metaglas[R] prestressed window and a MetaClamp[R] connection, they combine the characteristics of a rugged Ex-rated luminaire...

Enterprise Asset Management Technology: five ways to boost profits and regulatory compliance.(Solutions)(Company overview)
July 1, 2006... Pharmaceutical manufacturers often fear deploying new automation technologies due to the fatigue of adding more regulations to their already-hefty regulatory burden. New systems impose new validation requirements, they argue. It has put a tough...

FDA approves resumed marketing of Tysabri.(Industry News)
July 1, 2006... The FDA recently approved an application for resumed marketing of Tysabri (natalizumab) subject to a special restricted distribution program. Tysabri is a monoclonal antibody used to treat patients with relapsing forms of multiple sclerosis...

Azilect approved for treatment of Parkinson's.(Industry News)
July 1, 2006... The FDA recently approved Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson's disease. The drug is a monoamine oxidase type--B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that sends information...

FDA licenses vaccine for prevention of cervical cancer.(Industry News)
July 1, 2006... The FDA recently announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, pre-cancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is approved for...

GeoVax launches trials for its HIV/AIDS vaccine.(Industry News)
July 1, 2006... GeoVax, Inc. has announced that its HIV/AIDS human clinical trials have begun at several sites around the USA. These trials are made possible as a result of the recently received "Sale to Proceed" status for a new Investigational New Drug (IND)...

Zostavax licensed by FDA to reduce older Americans' risk of shingles.(Industry News)
July 1, 2006... The FDA recently licensed Zostavax, a new vaccine to reduce the risk of shingles (herpes zoster) for use in people 60 years of age and older. Shingles is a disease caused by the varicella-zoster virus, the same virus that causes...

INTERPHEX attendance mirrors industry trends: biotech, generics and services play increasingly important roles.(INTERPHEX 2007 Update)
July 1, 2006... For the past several years, we have contracted with a respected independent research firm to conduct audits of the INTERPHEX attendee base. Each year we receive detailed reports that give us an in-depth picture of who attends the show, their...

Packager packs tablet blisters into wallets then packs the wallet into a patient pack.(Manufacturing/Processing: Packaging)
July 1, 2006... The TLM packaging machine offers high levels of flexibility, with high-end controls, simple mechanics and exchangeable tooling. The unit is ideal for packaging individual units. Schubert Packaging Systems LLC, Addison, TX 75001. Call...

Blister pack feeder accommodates a wide range of tablets.(Manufacturing/Processing: Packaging)
July 1, 2006... The Variofill product feeding system is part of the TLT 2800 packaging line. The system is capable of handling products with a complex geometry at high speed while ensuring complete blister filling. With its thermoformed belt, the unit can even...

Colloid mills produce stable, consistent emulsions.(Mixing/Blending/Drying: Cool Technology)
July 1, 2006... Company's colloid mills are designed specifically to de-agglomerate solids and produce stable liquid emulsions in the micron particle range with consistent uniformity. These high-shear mixers are offered for continuous or batch emulsion or...

Tissue homogenizer assists with sample prep.(Mixing/Blending/Drying: Cool Technology)
July 1, 2006... These light-weight, high-torque homogenizers have variable speed, up to 30,000 rpm. The sealed tube chamber assemblies ensure safe operation. The homogenizer cannot operate when the blade is exposed, thus preventing injury and exposure to...

Planetary mixer incorporates Teflon coated blades.(Mixing/Blending/Drying: Cool Technology)
July 1, 2006... The DPM mixer with the HV Blade enables the mixing of ultra-high viscosity formulations. The new blade design offers other advantages including mixing products up to 8,000,000 cps; the rapid incorporation of light and difficult to wet solids...

Aerator increases the rate and consistency of dry bulk material flow.(Mixing/Blending/Drying: Cool Technology)
July 1, 2006... VibraPad Aerators eliminate the bridging, rat-holing, and compacting of dry bulk solids that can cause plugging, slow or erratic conveying, and processing downtime. VibraPads combine fluidizing air with mechanical vibration to set dry bulk...

The latest pharmaceutical processing news from FDC reports.(Regulatory Update)
July 1, 2006... FDC Reports, an Elsevier Science Company, produces several weekly and monthly news periodicals of significant interest to the Pharmaceutical Processing community. Each month, Pharmaceutical Processing magazine will offer select highlights from...

Phase III could be replaced with "targeted approval".(Regulatory Update)
July 1, 2006... The need for Phase III clinical trials would be reduced if sponsors use validated biomarkers in Phase II studies under a Manhattan Institute proposal. The proposal for a "targeted approval" process is part of a working paper authored by...

Pediatric wish list: longer exclusivity reviews, more public data.(Regulatory Update)
July 1, 2006... Future legislation should mandate increased public availability of pediatric trial data, Office of Pediatric Therapeutics Director Dianne Murphy said at a June 13 Institute of Medicine drug forum in Washington, D.C. "This data needs to be...

Tysabri price jumps.(Noted)
July 1, 2006... The price of Biogen Idec/Elan's multiple sclerosis treatment Tysabri (natalizumab) upon relaunch in July will be 20.8% higher than when it was first approved in November 2004, according to information on Elan's website. Tysabri's new wholesale...

Senators criticize iPLEDGE.(Noted)
July 1, 2006... A bipartisan group of senators, including Dick Durbin (D-Ill.), Judd Gregg (R-N.H.) and Orrin Hatch (R-Utah), are calling on FDA to fix the iPLEDGE risk management plan covering Roche's Accutane and isotretinoin generics. In a letter to FDA,...

AMA advocates DTC moratorium.(Noted)
July 1, 2006... The American Medical Association's new policy on direct-to-consumer advertising for prescription drugs includes an initial blackout period with a time length determined by FDA. The policy parallels PhRMA's DTC Guiding Principles on the issue of...