Pharmaceutical Processing articles from February 2007

Pharmaceutical Processing archives from February 2007

Too much information?(From The Editor)
February 1, 2007... Are you a label reader? Do you read everything on the back of every bottle? Do you read all the extra "stuff" they give you when you take your prescription home? I don't. Oh sure, I'll read the dosing information, and take a cursory glance at...

Drive/control system reduces installation costs.(What's Hot)
February 1, 2007... The IndraDrive is a complete drive, motion control, and logic control mounted directly on the motor. The IndraDrive Mi electronic control is now mounted flush onto the motor, using the motor casing surface as the heat sink. The motor casing...

Tank mounted viscosity sensor unaffected by level, mix or turbulence.(What's Hot)
February 1, 2007... The MXBO Viscosity Sensor uses the proven "piston time-of-fall" method for measuring viscosities from 0.1 to 100,000 CPS and is PLC compatible for use with the firm's process controllers. Featuring all stainless steel wetted parts and open rod...

Multi-Axis Controllers and drives offer high performance computing and control.(What's Hot)
February 1, 2007... The SEC-AC-SMLC Multi-Axis Controllers are designed to meet motion control, logic, and I/O needs. The SMLC is a fully-integrated control solution providing hardware and software building blocks that are engineered to easily plug together and...

Containment valve system ideal for areas where operator exposure levels are limited.(What's Hot)
February 1, 2007... Containment valves are suitable for operation in areas where Operator Exposure Levels are limited and high containment operations are essential. The compact valve is designed in two sections, active and passive, and is air operated using only a...

Quality by design: myth or reality? Can the FDA's initiative move the industry to a more efficient state?(QBD)(Cover story)
February 1, 2007... In the United States, the FDA's initiative on nudging the pharmaceutical industry to invent, develop and commercialize products using technologies that will result in product quality by design (QbD) is a challenging task. It is also a noble...

Allergenic source materials: considerations and challenges for biopharmaceutical product or assay development.(Product Development)
February 1, 2007... With over 50 million Americans suffering from allergies, the diagnosis, treatment and prevention of allergic reactions has grown into a $5.3 billion industry. Until recently, most allergy treatments were designed to treat common symptoms of...

Bio to business at INTERPHEX: new biotech initiative bridges people, opportunities and technologies.(INTERPHEX2007 UPDATE)
February 1, 2007... In today's life sciences industry, biotechnology companies are looking very much like peers, rather than junior partners, of Big Pharma. And it's not surprising that, with more biologics coming into the market, biotech companies are attending...

PAT searches for its identity: PAT's been around for almost 2 years--where are the improvements?(PAT Update)
February 1, 2007... Two years ago, the Food and Drug Administration issued its landmark guidance document on Process Analytical Technology (PAT), articulating an alternative vision to the inspection-based quality control systems that have governed pharmaceutical...

Keeping flies (and other pests) out of the ointment: is your facility as impervious to pests as you think it is?(Facility Maintenance)
February 1, 2007... Are you adequately protected against pest infestations? Shaken by widespread and growing public health concerns including foodborne illness, bio-terrorism, and avian flu, consumers are experiencing a crisis of confidence and are gravitating...

The challenges of testing combination products: pharmaceutical labs struggle to cope with new testing guidelines.(Lab Testing)
February 1, 2007... By any measure, the combination products market--is booming. Navigant Consulting estimated the market at $5.9 billion in 2004 and predicted a 10 percent compound annual growth rate that will have it reach approximately $9.5 billion in 2009. ...

Sterilizing-grade filters: comparing performance in large volume parenteral applications.(Filtration)
February 1, 2007... Large volume parenterals (LVPs) are intravenous fluid products provided to patients at >100 mL doses. An LVP manufacturing process is typically comprised of mixing a sugar compound, various amino acids and salts (electrolytes) in water,...

Nanofiltration membrane ideal for water softening and organics removal.(Cool Technology: Filtration & Separation)
February 1, 2007... The FLUID SYSTEMS[R] TFC[R]- SR[R]2 spiral nanofiltration (NF) element significantly lowers operating costs for a wide variety of selective rejection applications, including water softening, lactose reduction, protein recovery, and antibiotic...

Filter efficiency test allows NIST traceability.(Filtration & Separation: Cool Technology)
February 1, 2007... Using fine silica glass beads of 1.5, 2, 3, 4.5, 5 and 6 [micro]m diameter, the new test enables measurement down to very fine pore sizes. To perform the test, standards are made into a dilute aqueous suspension which is drawn through the...

Filter assembly saves cleaning/validation costs.(Filtration & Separation: Cool Technology)
February 1, 2007... The inline UltraCap[R] filter assembly is an integrally sealed filter and housing system. This completely disposable system saves cleaning and cleaning validation costs and provides fast and convenient filter change-outs. The filter assembly is...

Reverse osmosis spiral elements lower operating costs.(Filtration & Separation: Cool Technology)
February 1, 2007... FLUID SYSTEMS[R] SPIRAPRO TFC[R] line of spiral wound membrane elements lower operating costs for a wide variety of applications, including selective rejection, desalting and organics concentration. Ideally suited for desalting and separation...

FDA proposes labeling changes to OTC pain relievers.(Industry News)
February 1, 2007... The FDA has proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and...

FDA proposes measures to strengthen drug safety under PDUFA reauthorized user fee.(Industry News)
February 1, 2007... The FDA has proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review...

Crimping solution allows for secure and easy separation of sterile disposable assemblies.(Single Use Products: Cool Technology)
February 1, 2007... The NovaSeal crimping solution is designed for use with single-use disposable assemblies. The NovaSeal solution is a simple and practical crimping approach that is easy to handle and use. The patented design of the manual crimping tool first...

Clamp eliminates distortion in non-metallic sanitary flanges.(Single Use Products: Cool Technology)
February 1, 2007... The Bio Clamp is constructed of a glass reinforced nylon resin and does not promote distortion in non-metallic sanitary flanges as do stainless steel clamps. Due to its light weight they do not stress connection points and are easily...

Aseptic bag filler eliminates cross contamination.(Single Use Products: Cool Technology)
February 1, 2007... The AFL 1000 aseptic bag filler is a sterile single use disposable fill line. Features and benefits include: eliminates possibility of cross contamination; disposable filter part of the fill line; eliminates CIP/SIP and associated chemicals;...

Printed peristaltic tubing offers easy part identification and batch traceability.(Single Use Products: Cool Technology)
February 1, 2007... Coded peristaltic tubing is designed for optimum performance, part identification and batch traceability. Clearly printed markings present highly visible batch and part numbers to facilitate traceability requirements. Tubing is selected...

Astellas Pharma announces availability of MYCAMINE[R] 100mg vial.(Industry News)
February 1, 2007... Astellas Pharma US, Inc. has announced the availability of their antifungal agent MYCAMINE[R] (micafungin sodium) for injection in a 100mg vial format. Approved in 2005 for the treatment of patients with esophageal candidiasis and prophylaxis...

AstraZeneca announce RECENTIN[TM] as global trademark for AZD2171.(Industry News)
February 1, 2007... AstraZeneca has announced RECENTIN[TM] as the global trademark for AZD2171, its oral, highly potent and selective vascular endothelial growth factor (VEGF) signaling inhibitor. AZD2171 is currently in Phase II/III development for advanced...

FDA approves first generic Ondansetron tablets.(Industry News)
February 1, 2007... The FDA has approved the first generic versions of Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy....

Genzyme reports strong fourth-quarter revenue growth.(Industry News)(Financial report)
February 1, 2007... Genzyme Corp. recently announced that revenue increased 17 percent in the fourth quarter of 2006 to $852 million, up from $729 million in the fourth quarter a year earlier. For the year, revenue grew 16 percent to $3.2 billion from $2.7 billion...

FDA approves new drug for schizophrenia.(Industry News)
February 1, 2007... The FDA has approved Invega (paliperidone) extended-release tablets for the treatment of schizophrenia. Paliperidone is a new molecular entity, which means this medication contains an active substance that has never before been approved for...

Bristol-Myers Squibb and AstraZeneca announce worldwide collaboration to develop and commercialize diabetes compounds.(Industry News)
February 1, 2007... Bristol-Myers Squibb Company and AstraZeneca recently announced a collaboration to develop and commercialize two investigational compounds being studied for the treatment of Type 2 diabetes. Both compounds were discovered by Bristol-Myers...

Defining accuracy and precision.(Perspectives on Instrumentation)
February 1, 2007... The 2007 Perspectives on Instrumentation column will offer guidance and insight into the use, maintenance and application of liquid handling instruments. Liquid delivery is a common lab process, and this critical function is often overlooked....

High shear processor operates at up to 30,000 PSI.(New Products)
February 1, 2007... The M-110EH-30 is beneficial to the production of nano-suspensions and nano-emulsions as well as cell disruption with the least number of passes. IN addition, the unit is ideal for efficient processing of pharmaceutical formulations, fine...

Bulk bag conditioner loosens solidified bulk solid material.(New Products)
February 1, 2007... Unit loosens bulk solid material that has solidified during storage and shipment, enabling bulk bag unloaders to discharge it through bag spouts The conditioner features two hydraulic rams with specially-contoured end plates to press opposing...

Wet-Mix process systems feature colloid mill and feed pump.(New Products)
February 1, 2007... Wet-mix process systems are designed for applications including emulsifying, dispersion, and particle size reduction. Systems provide users with a finished product that is homogeneous, has repeatable viscosity and dispersion down to one micron,...

Ultra-sanitary, double-deck screener meets sanitary standards.(New Products)
February 1, 2007... The Vibroscreen[R] is designed for scalping, de-dusting and dewatering of contamination-sensitive materials and meets cGMP, 3-A, USDA and FDA standards. The unit features gap-free screen frames, quick-release "U" clamps, radius corners, a domed...

Double-digit growth drives oral drug delivery market to $52 billion by 2010.(Industry News)
February 1, 2007... As the largest sector within the total drug delivery arena, the oral drug delivery market-made up of both pharmaceuticals utilizing oral delivery technologies as well as the technologies themselves--is expected to grow at a compound annual...

Droxidopa granted Orphan Drug designation.(Industry News)
February 1, 2007... Chelsea Therapeutics International, Ltd. has announced that the FDA has granted Orphan Drug designation to its drug candidate Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic...

Floor and wall systems ideal for sterile, controlled environments.(New Products)
February 1, 2007... Company offers seamless, sanitary, long lasting and easy to maintain floor and wall systems for the pharmaceutical industry. Systems are available for processing, wash down, chemical storage and research areas as well as locker rooms and...

Case/tray packer speeds up production for low volume packagers.(New Products)
February 1, 2007... The Invex Low Speed Case/Tray Packer speeds up production for low volume packagers by incorporating all the flexibility of electronic motion controls in an economical, 12 case/tray per minute, small footprint format. Benefits include: smooth,...

The latest pharmaceutical processing news from FDC reports.(Regulatory Update)
February 1, 2007... 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...

PDUFA to continue as FDA incubator for new regs.(Regulatory Update)
February 1, 2007... FDA's proposals for renewal of the Prescription Drug User Fee Act will continue the program's function as an incubator of new regulatory approaches by the agency. The Pink Sheet reports. While some of the changes proposed are technical...

Drug safety "virtual" surveillance sought by FDA.(NOTED)
February 1, 2007... Drug safety "virtual" surveillance sought by FDA: FDA will hold a meeting to examine the feasibility of public-private partnerships to create a "virtual" product safety surveillance system based on existing datasets and collection activities....

Calling all COTS.(NOTED)
February 1, 2007... Calling all COTS: FDA is requesting to meet with commercial providers of pharmacovigilance risk management and product safety computer system products. FDA is interested in conducting market research of "commercial-off-the-shelf" products and...

OMB to review FDA guidance.(NOTED)
February 1, 2007... OMB to review FDA guidance: The Office of Management and Budget issued a bulletin to executive branch departments and agencies establishing policies and procedures for the development of significant guidance documents using FDA's guidance...

Safety reporting for combo products to be clarified in FDA proposed rule.(Regulatory Update)
February 1, 2007... A proposed rule wending its way through regulatory review at FDA would clarify post-market safety reporting requirements for combination products. While the reporting requirements for devices, drugs and biologics have many similarities,...