Pharmaceutical Processing articles from November 2006

Pharmaceutical Processing archives from November 2006

Printhead can withstand daily washdowns.(What's Hot)
November 1, 2006... The IV9-Dot Printhead is driven by the company's Ij3000 Ink Jet System. Features of the printhead include: environmentally sealed printhead; robust metal housing over entire printhead; LED ink pressure display; electronic dot size setting;...

Single use, pre-calibrated conductivity, temperature and pressure sensors offered in many sizes.(What's Hot)
November 1, 2006... Family of single use, pre-calibrated sensors offer stored ID, stored calibration data, and stored lot number and tamper-resistant digital credentials. Sensors identify themselves and dump real-time documentation/graphing into spreadsheets or...

Colloid Mills tailored to wet-mixing and milling.(What's Hot)
November 1, 2006... Colloid Mills have a milling head which features a standard rotor and stator with working surfaces that can be tailored to meet user requirements for emulsifying, dispersion, and particle size reduction. Ideally suited for applications where...

AC powered explosion proof scale pallet truck handles a variety of containers.(What's Hot)
November 1, 2006... The Model D-170S-XP/ASM is a US Certified Explosion Proof Scale Pallet Truck. The truck offers a 7000 lb. capacity and 3.4" lowered fork height that enables it to transport and weigh GMA pallets, IBC's and totes easily. The RAVAS intrinsically...

Reverse osmosis spiral elements offer lower operating costs.(What's Hot)
November 1, 2006... The SPIRAPRO[TM] TFC[R] SR[R]3 and reverse osmosis spiral elements are designed specifically for pharmaceutical and fine chemicals applications. Ideally suited for desalting and separation of antibiotics and APIs, the SPIRAPRO TFC elements...

Intrinsically safe respirator offers high safety rating.(What's Hot)
November 1, 2006... The PA30IS intrinsically safe (IS) Powered Air Purifying Respirator (PAPR), is rated Class 1, Div. 1, Group C by Factory Mutual (FM). The PA30IS can be configured with the user's choice of hood, breathing tube, blower assembly and purifying...

Dissolved ozone sensor features stainless steel housing.(What's Hot)
November 1, 2006... Dissolved ozone meter offers a stainless steel housing that provides high corrosion resistance for minimal maintenance in pharmaceutical water production environments. The housing features pre-drilled mounting holes for quick and easy...

Top 10 things to consider when purchasing an isolator: ten often overlooked mechanical and operational considerations that are important to investigate when selecting an isolator.(Special Report: Keep It Clean)
November 1, 2006... Companies are beginning to understand the advantages of performing aseptic operations within isolators. Regulators, as well, are promoting the technology primarily for the separation of personnel from the processes that can occur within...

How to specify equipment for high-purity processes: the right combination of pumps, valves and seals is crucial to the design of fluid motion and control systems.(Special Report: Keep It Clean)
November 1, 2006... Specifying the proper equipment and ensuring that this equipment works together in an efficient system can yield virtually contamination-free operation in high-purity processes. Coupling the right system of pumps, valves and seals with highly...

Selecting the proper apparel for a cleanroom environment: how to pick the best apparel based on job function.(Special Report: Keep It Clean)
November 1, 2006... If you work in a cleanroom or sterile manufacturing environment, chances are you wear some sort of protective apparel on a daily basis. But are you wearing the best protective apparel for your job? The task of selecting personal protective...

Small footprint lyophilizer can accommodate a wide variety of vials.(Freeze Drying: Cool Technology)
November 1, 2006... VirTual Lyophilizers feature a small footprint, robust condensing capabilities and multiple shelf design. Units can be designed to accommodate a wide variety of vial sizes and bulk product along with condenser and shelf temperatures to handle...

Production freeze dryers meet 21 CFR Part 11 requirements.(Freeze Drying: Cool Technology)
November 1, 2006... Line of production freeze dryers meets the rigid criteria of the FDA's 21CFR Part 11 regulation and GMP's. Systems are available with options for sterile processing and offer a broad range of control features. All systems include a radiant heat...

Freeze drying system ideal for R&D applications.(Freeze Drying: Cool Technology)
November 1, 2006... The LyoStar II features an enhanced cascade refrigeration system that has more horsepower to provide ample cooling to -70[degrees]C. The use of RTD's for temperature measurement ensures shelf temperature stability and accuracy of [+ or -]...

Freeze dryers offer flexible process integration.(Freeze Drying: Cool Technology)
November 1, 2006... LYOVAC[R] freeze-drying systems feature a space-saving design that allows for flexible integration into a pharmaceutical processing system. Models include the: LYOVAC[R] FCM 10 and FCM 30, for pilot lyophilization and small-scale production...

Office of Generic Drugs moves to the Division File System.(Industry News)
November 1, 2006... The Office of Generic Drugs (OGD) in the FDA has adopted a new information technology system for reviewing and archiving Abbreviated New Drug Applications (generic drug applications or ANDAs) electronically. OGD recently began using the...

The market need for reconstitution systems: manufacturers and consumers can benefit from these advanced systems.(Applications)
November 1, 2006... As the number of lyophilized, or freeze-dried, drug products on the market and in development increases, so, too, does the need for systems and devices to administer these drugs. Many new drugs, especially those developed by...

Questions & answers on liquid handling QA/QC: our expert answers your questions and discusses your concerns relating to liquid delivery quality assurance programs.(Perspectives on Instrumentation)
November 1, 2006... Laboratories often assume that their liquid delivery instruments, from pipettes to automated liquid handlers, are operating within specification. But given that data integrity for applications from drug discovery to quality control relies on...

Congress appropriates $1 million for continued development of Valortim.(Industry News)
November 1, 2006... Medarex, Inc. and PharmAthene, Inc., a privately held biotechnology company, have announced that the FY 2007 Department of Defense (DoD) appropriations law includes $1.0 million payable to PharmAthene to support ongoing development of Valortim,...

Low-priced generics likely to attract large share of prescription drug sales.(Industry News)
November 1, 2006... A Wall Street Journal Online/Harris Interactive Health-Care Poll suggests that the low-priced generic drugs soon to be sold by stores such as Wal-Mart, Target and Kmart are likely to attract a big share of the prescription drug market. Two...

FDA approves new treatment for advanced head and neck cancer.(Industry News)
November 1, 2006... The FDA has approved Taxotere (docetaxel) Injection Concentrate for use in combination with cisplatin and fluorouracil prior to radiotherapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and...

Vacuum tray dryer offered with attached isolator.(Parenteral Manufacturing: Cool Technology)
November 1, 2006... The Vacuum Tray Dryer (VSD) offers a joint-free product compartment, which is 100 percent verifiable. The loading chambers are heated in the floor and ceiling areas, evenly and simultaneously. The isolator allows the operator to apply the wet...

Automatic labeling system designed for front/back or wraparound applications.(Parenteral Manufacturing: Cool Technology)
November 1, 2006... The EconoLine is a simple, economically-priced pressure-sensitive labeling system that may be configured for front/back or wraparound applications for speeds up to 100 ppm. The unit utilizes a six foot long conveyor with adjustable conveyor...

Sterile packaging products available in various configurations.(Parenteral Manufacturing: Cool Technology)
November 1, 2006... Line of sterile packaging products for pharmaceutical packaging includes more than 100 sterile, leakproof, biologically tested products including: PETG and PET Media Bottles, [B.sup.3] Media Bags[TM], HDPE Narrow-Mouth Bottles, PETG Serum...

Liquid filler fills vials/infusion bottles at up to 320 cpm.(Parenteral Manufacturing: Cool Technology)
November 1, 2006... The FLC fills vials and infusion bottles at up to 320 cpm in continuous motion, with fill volumes between 0.5 and 500 milliliters. The infeed turntable meets aseptic production requirements. it guides the containers on a single track to the...

Vial inspection machine operates at up to 24,000 vials per hour.(Parenteral Manufacturing: Cool Technology)
November 1, 2006... The HDB Series Pinhole Inspector is a high-speed electronic leak detection system capable of inspecting up to 24,000 vials per hour. The non-destructive high voltage inspection allows defects such as cracks, pinholes or incomplete seals under...

Cobra signs agreement with US Naval Medical Research Center to evaluate oral vaccine delivery platform.(Industry News)
November 1, 2006... UK based Cobra Biomanufacturing Plc has signed a Cooperative Research and Development Agreement (CRADA) with the Naval Medical Research Center of the US Navy to construct and test a vaccine against malaria using Cobra's proprietary ORT-VAC oral...

Phase 3 clinical trial costs exceed $26,000 per patient.(Industry News)
November 1, 2006... The cost per patient of running Phase 3 clinical studies exceeds $26,000, on average, according to a new benchmarking report, "Clinical Operations: Accelerating Trials, Allocating Resources and Measuring Performance" published by business...

Millipore opens $50 million R&D Center.(Industry News)
November 1, 2006... Millipore Corporation recently announced the opening of a new $50 million research and development center in Bedford, Massachusetts. The center will enable Millipore to leverage cutting edge technologies, further extending its applications...

Next-generation contraceptive patch in development.(Industry News)
November 1, 2006... Agile Therapeutics, a pharmaceutical development company focused on transdermal products, is developing the next generation of contraceptive patches, one that is designed to deliver low doses of birth control hormones over a seven-day period....

FDA approves expanded use of treatment for patients with severe Alzheimer's.(Industry News)
November 1, 2006... The FDA has approved Aricept (donepezil hydrochloride) for the treatment of severe dementia in patients with Alzheimer's Disease. Aricept was previously approved for the treatment of mild to moderate dementia of the Alzheimer's type. It now...

Zolinza approved for skin cancer.(Industry News)
November 1, 2006... The FDA has approved Zolinza (vorinostat) capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines. ...

Combination lung cancer therapy approved by FDA.(Industry News)
November 1, 2006... The FDA has approved the use of Avastin (bevacizumab) in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung...

FDA approves NEXIUM for the Treatment of Zollinger-Ellison Syndrome.(Industry News)
November 1, 2006... AstraZeneca has announced that the FDA has approved a new indication for the prescription proton pump inhibitor NEXIUM[R] (esomeprazole magnesium) for the treatment of Zollinger-Ellison Syndrome (ZES). NEXIUM already is indicated for the...

NOXAFIL approved for prevention of fungal infections in high-risk patients.(Industry News)
November 1, 2006... Schering-Plough has received FDA approval for NOXAFIL (posaconazole) Oral Suspension for prevention of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to...

Par begins shipment of pravastatin tablets.(Industry News)
November 1, 2006... Par Pharmaceutical Companies, Inc. has announced that it's partner, Genpharm Inc. of Toronto, Canada, has received final approval from the FDA for its Abbreviated New Drug Application for pravastatin 10 mg, 20 mg, and 40 mg tablets. Pravastatin...

Sanofi pasteur to deliver 50 million doses of flu vaccine for 2006-2007 season.(Industry News)
November 1, 2006... Sanofi pasteur is on track to deliver its entire projected supply of 50 million doses by the end of November. The company is distributing all of its vaccine as soon as it completes final testing and expects to ship the major part during October...

FDA approves new treatment for diabetes.(Industry News)
November 1, 2006... The FDA has announced the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DPP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar. FDA...

Web seminars from INTERPHEX provide year-round learning.(INTERPHEX 2007 Update)
November 1, 2006... For more than two and a half decades now, INTERPHEX has been the pharmaceutical industry's unchallenged leader in one on one, face to face product and technical education. Thousands of pharmaceutical and biotechnology manufacturing...

The latest pharmaceutical processing news from FDC reports.(Regulatory Update)
November 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...

CMS/FDA data sharing a one way street, Gottlieb says.(Regulatory Update)
November 1, 2006... Current data sharing efforts between FDA and CMS are largely a "one way street," FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb said during a recent Citigroup conference. The Pink Sheet reports. "I don't think FDA...

FDA needs to put meaning behind "clinically meaningful," Lipicky Saysh1.(Regulatory Update)
November 1, 2006... FDA's increasing requirements for clinical meaningfulness in efficacy measures make it more difficult to predict the agency's regulatory actions, former division director Ray Lipicky says. "I think FDA is getting harder to predict and is...

Consumer attitudes on Wal-Mart generics.(Noted)
November 1, 2006... Consumer attitudes on Wal-Mart generics: Fifty percent of prescription drug purchasers are absolutely certain, very likely or likely to fill prescriptions with generic drugs purchased at Wal-Mart, Target or Kmart, according to a Wall Street...

Statineffects.com.(Noted)
November 1, 2006... Statineffects.com: Adverse events associated with statins will be compiled in a new website at the University of California, San Diego School of Medicine. Statineffects.com will "enable people from around the world to self-report adverse...

J&J appoints new CFO.(Noted)
November 1, 2006... J&J appoints new CFO: Johnson & Johnson VP-Group Finance Dominic Caruso will replace Chief Financial Officer Robert Darretta following Darretta's retirement early next year. Effective Jan. 1, Caruso will take over as CFO and Corporate...