Pharmaceutical Processing articles from October 2007

Pharmaceutical Processing archives from October 2007

All talk--and finally some action? Advancements in healthcare have come at a high price. Most people can't afford the benefits of the latest technologies. We need to get more for our money.(From The Editor)
October 1, 2007... I recently had the pleasure to listen to Mark B. McClellan, M.D. former Commissioner of the FDA, deliver the keynote address at the inauguration and open house celebration at Glatt Pharmaceutical Services new solid dosage facility in Ramsey,...

Disposable bioreactor provides optimal balance in cell cultures.(What's Hot)
October 1, 2007... [ILLUSTRATION OMITTED] The disposable CELLine bioreactor provides optimal maintenance of cell cultures at near in vivo conditions, Two compartments are separated by a 10kDa MWCO membrane to provide continuous and optimal levels of oxygen...

UV/germicidal lamps sterilize without the use of chemicals.(What's Hot)
October 1, 2007... [ILLUSTRATION OMITTED] These safety-coated fluorescent lamps emit specific high-output UV radiation which destroys bacteria, viruses. spores and molds. By using a physical process-rather than chemical to inactivate pathogens, the lamps are...

cGMP labels incorporate RFID tags.(What's Hot)
October 1, 2007... These pressure sensitive labels with 100% readable RFID tags are delivered ready to use for a wide range of applications including item-level products, as well as case and pallet lots. The RFID labels are part of the company's RxTrackNSecure...

Misting booth reduces hazardous particulate exposure.(What's Hot)
October 1, 2007... [ILLUSTRATION OMITTED] Misting booth supplies a fine, low volume misting "fog" intended to fix any loose powder that may be on protective garments, reducing exposure to hazardous particulates. The standard booth accommodates one person and...

Vetter's RVS facility targets growth in aseptic prefilled devices and wins process innovation award: new plant maximizes automation while increasing both capacity and capability in manufacturing.(Facility of the year Award)(Cover story)(Company overview)
October 1, 2007... Automation to the maximum was uppermost on the drawing boards at Vetter Pharma-Fertigung GmbH & Co. when it conceptualized, designed and built its new 100 million [euro] capacity and capability expanding state-of-the-art aseptic prefilling...

Bulk container features both fork pockets and casters.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] The MOD P-333 Ship Shape bulk forklift container features both enclosed fork pockets and industrial strength casters. When fitted with these options, the bulk container enables lift truck operators to rotate, tilt...

Mill is ideal for glove box applications.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] The Comil[R] is ideal for containment milling due to several key design features. These features include; the generation of less fines than higher energy mills and the generation of an insignificant amount of airflow...

Butterfly valve available with multiple trim options.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] The LBF series of lined butterfly valves are available in sizes through 24-inch and in a variety of liner and disc materials. The valves are currently available in Dupont NXT molecularly enhanced Teflon[R] as a...

Business process outsourcing: is it the answer to what ails you?(Perspectives on Outsourcing)
October 1, 2007... For many people, a trip to the doctor's office for a physical often ends in a doctor's summary of, "your tests were pretty good, and you seem pretty healthy, but..." followed by a directive for a little more exercise, potential change in diet,...

Powder mixer and pump combo solves clumping problem: therapeutic products manufacturer realizes better quality and time savings.(Processing)
October 1, 2007... When global cosmetics maker Coats Aloe International sought a better way to mix its carbomer based body polish, their team found a solution that produced better product quality and substantial time savings. Coats Aloe manufactures...

The pharmaceutical cleanroom: today's reusable garments offer advantages.(Cleanrooms)
October 1, 2007... Among the many challenges of producing sterile fill pharmaceutical products is the need to provide workers in the protected environment with cleanroom garments that arrive on time, meet sterility requirements of the production process and...

Feeding and conveying in tablet press applications: tips to achieve an efficient and effective operation.(Tableting)
October 1, 2007... The introduction of both granulate as well as lubricant directly to tablet presses is of key interest to a wide variety of pharmaceutical, nutraceutical, and food manufacturers. The method of feed for both of these applications is of key...

FDA approves Coreg generic version.(Industry News)
October 1, 2007... The FDA has approved the first generic versions of Coreg (carvedilol). Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart...

FDA appoints Cote to head Orphan Products Development Office.(Industry News)
October 1, 2007... The FDA has named Timothy Cote, M.D., M.P.H., as the new director of the Office of Orphan Products Development. Dr. Cote will be responsible for promoting the development of products that demonstrate promise for the diagnosis or treatment of...

AHRQ and FDA to collaborate in largest study ever of possible heart risks with ADHD medications.(Industry News)
October 1, 2007... Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of...

Meditrina Pharmaceuticals, Inc. announces exclusive global manufacturing agreement with Pfizer CentreSource (PCS) for Femathina[TM].(Industry News)
October 1, 2007... Meditrina Pharmaceuticals, Inc., has completed a contract manufacturing agreement for drug product development and active pharmaceutical ingredient (API) supply with a unit of Pfizer CentreSource (PCS), a supplier of APIs and dosage form...

FDA approves new uses for Evista.(Industry News)
October 1, 2007... The FDA has approved Evista (raIoxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Evista is only the second drug...

New data show that GSK's Rotarix could be given with other routine infant vaccines in the U.S.(Industry News)(Conference news)
October 1, 2007... GlaxoSmithKline has released new study results that indicate that Rotarix[TM], an oral candidate vaccine for infants to prevent rotavirus gastroenteritis, could be co-administered with routine infant vaccines recommended in the U.S. at the two...

Batching system offers Internet-based programming.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] 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...

Volumetric filling system increases productivity.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] 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...

Microbial identification system also features kinetic characterization.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] 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...

Sanitary ball valves meet strict 3-A specifications.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] 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...

Hard gelatin capsules shaped like tablets for clinical trial use.(Cool Technology: Tableting & Encapsulation)
October 1, 2007... [ILLUSTRATION OMITTED] CT Caps are hard gelatin capsules shaped like a tablet. This configuration allows for encapsulation of 97% of tablets, essentially eliminating the need for double dummy design and significantly reducing the...

Filtration/containment dust collection unit removes high volume particulate matter.(Cool Technology: Tableting & Encapsulation)
October 1, 2007... [ILLUSTRATION OMITTED] The ABSOLUT Cephir High Filtration/ Containment System effectively and safely removes and contains high volumes of extremely fine dust particulates from the exhaust air of production machines in a variety of...

Capsule polishing machine offers continuous operation.(Cool Technology: Tableting & Encapsulation)
October 1, 2007... The Pulse-Scrubber is a continuous polishing system for softgel capsules. Unlike batch polishing systems that require manual loading and unloading, PulseScrubber operates unattended receiving, handling and discharging product continuously....

Double-sided press offers an exchangeable turret design.(Cool Technology: Tableting & Encapsulation)
October 1, 2007... [ILLUSTRATION OMITTED] The XL800 features an exchangeable turret design, offering 59 (IPD D), 71 (IPT B) and 87 (IPT BB) punch station configurations. With an internal turret lifting device, the XL800 eliminates the cost and space...

Membrane filtration systems can be customized in-house.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] Company has the ability to design, test, fabricate and commission customized and unique process membrane filtration systems in house. The company's filtration capabilities range from the design and build of mobile...

High pressure fittings permit direct connection to tubing.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] 360 [micro]m high pressure fitting design permits direct connection of 360 micron OD fused silica, PEEK, stainless, or electroformed nickel tubing without having to use troublesome liners. Because of the fitting's...

Temp transmitters ideal for general purpose applications.(New Products)
October 1, 2007... [ILLUSTRATION OMITTED] The T91 family of analog temperature transmitter are available with voltage or current output and in rail or head mounting versions. These analog temperature transmitters are characterized by fixed measuring ranges...

FDA grants orphan drug status to pafuramidine for treatment of African sleeping sickness.(Industry News)
October 1, 2007... Immtech Pharmaceuticals, Inc. has announced that the FDA has granted Orphan Drug Designation to pafuramidine (DB289) for treating Human African Trypanosomiasis (HAT), also known as African sleeping sickness. Orphan drug designation provides...

FDA warns Procter & Gamble about unlawful marketing of product for school children.(Industry News)
October 1, 2007... The FDA recently sent a warning letter to Procter & Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product. The agency says the product's claims and directions [or use cause it to be...

FDA proposing phase out of CFCs in metered-dose inhalers for epinephrine.(Industry News)
October 1, 2007... The FDA has proposed a change to its regulation on the use of chlorofluorocarbons or CFCs in metered dose inhalers (MDIs) for epinephrine. The rule would remove the "essential-use" designation that allows the use of CFCs in these medical...

PDUFA renewal might prompt FDARA action.(Regulatory Update)
October 1, 2007... A proposal circulated by House Democrats to renew user fee programs for three months while negotiations on FDA reform legislation continue is "not an option," Senate Health, Education, Labor and Pensions Committee Ranking Republican Michael...

Personalized medicine will require greater CDER, CDRH cooperation.(Regulatory Update)
October 1, 2007... Drug regulation during an era of personalized medicine will require cultural if not structural changes on the part of FDA. The agency's current structure of discrete review centers impedes a unified regulatory approach to the emerging...

Pfizer breathes easy with Exubera data.(NOTED)
October 1, 2007... Pfizer breathes easy with Exubera data: Type 1 and type 2 diabetes patients do not experience greater reductions in lung function with long-term use of Pfizer's inhaled insulin Exubera, the firm says. Data from an eight-year extension study of...

Bio VP-Health.(NOTED)
October 1, 2007... BIO VP-Health: The Biotechnology Industry Organization recently announced the appointment of former FDA official John Taylor as Exec VP-Health, where he will succeed Amit Sachdev. Since 2005 Taylor served at Abbott as Divisional VP-Federal...

First genetic test for warfarin sensitivity cleared.(NOTED)
October 1, 2007... First genetic test for warfarin sensitivity cleared: Nanosphere's Verigene multiplex nucleic acid test for genetic variations that influence metabolism of the common blood-thinner warfarin was 510(k)-cleared on Sept. 17. FDA updated the...