Pharmaceutical Processing articles from September 2007

Pharmaceutical Processing archives from September 2007

It's just a word, but still ...(From The Editor)
September 1, 2007... "So expect more names to emerge, more legacies to fall, more stories on pharmaceuticals instead of far home runs." This quote, from a Yahoo sports columnist bothered me. He was referring to the latest steroids controversy in major league...

Flush valve offers CIP capability.(What's Hot)
September 1, 2007... [ILLUSTRATION OMITTED] Valve is a glass-lined, CIP flush valve for glass-lined reactors that features a flush port that allows sanitizing, sampling, back flushing of the tank and other functions without dismantling of the valve. The...

Sanitary lock-out clamp limits access to hazardous piping.(What's Hot)
September 1, 2007... [ILLUSTRATION OMITTED] Lock-out clamp is designed for use with otherwise hazardous high-temperature piping lines often associated with steam and CIP/SIP cleaning processes. The new locking clamp is an adaptation of the shrouded clamp--a...

Silicone tubing designed for long life.(What's Hot)
September 1, 2007... [ILLUSTRATION OMITTED] APSPG pump tubing is designed for the unique demands of peristaltic pumps. APSPG is made to withstand repeated compression and release for consistent, dependable performance. Manufactured in a certified Class 1000...

UV disinfection system for industrial process water.(What's Hot)
September 1, 2007... [ILLUSTRATION OMITTED] Designed for process water disinfection the AF3 amalgam UV disinfection system offers a high microbial kill rate with low power consumption and low hydraulic pressure drop. Designed using CFD modeling tools, it is...

Constant kaizen delivers Equipment Innovation Award for Taiyo Yakuhin: first to make and fill glass syringes in-house, Taiyo's success recognized with Facility of the Year Award.(Facility of the Year Award)(Cover story)(Company overview)
September 1, 2007... The combination of the time-honored Japanese operating philosophy of kaizen (constant improvement) with value engineering (VE) and value analysis (VA) principles has proven to be a potent formula for success at Taiyo Yakuhin, a privately-held...

Airborne dust containment & worker health: emerging technologies and solutions for the pharmaceutical industry.(Compound Containment)
September 1, 2007... In recent years, the pharmaceutical industry has seen a growing number of products that pose potential health risks to those working with them. Airborne dust, in particular, can put the equipment operator at risk, when a formulation containing...

Implementing a quality management process: bioMerieux realizes increased quality and regulatory compliance.(Quality Control)
September 1, 2007... For companies operating in the life sciences industry, a quality management process is critical, not only for regulatory compliance, but also for continuous improvement initiatives. And for a large, global company, the challenges are even...

The way out of the improvement wilderness: the Promise of Lean Six Sigma for Pharma.(Lean Six Sigma)
September 1, 2007... When it comes to process improvement, pharmaceutical manufacturers may be forgiven if they sometimes feel they can't see the forest for the trees. They face a bewildering variety of improvement methodologies, each with its competing claim to...

Calibration, adjustment and verification of measuring systems: defining terms to ensure accuracy.(Perspectives on Instrumentation)
September 1, 2007... The 2007 Perspectives on Instrumentation column has focused on several key liquid handling topics, including the Impact of One Microliter on critical pharmaceutical tasks and the difference between accuracy and precision. This article will...

Sealing challenges in the pharmaceutical industry: testing shows differences in materials and seal life.(CIP/SIP)
September 1, 2007... The acronyms may be short in the pharmaceutical, chemical processing, and food industries, but they pose big sealing challenges. CIP, Cleaning-in-Place, uses chemicals lethal to the majority of elastomer seals, while SIP, Sterilization-in-Place...

Mining for value, but where? R&D is the next area to come under scrutiny.(Research & Development)(Company overview)
September 1, 2007... After a dramatic increase in the use of Lean Six Sigma, basic planning and control, and other improvement techniques in manufacturing operations, life sciences companies could reap far greater gains by focusing these capabilities on Research...

Aligning data to achieve process understanding: to truly understand and predict how your process will operate ALL available data must be acquired and analyzed.(Pharma It)
September 1, 2007... Life Sciences companies are taking a variety of approaches to their PAT solutions and to how they acquire and analyze their data. Some companies are relying heavily on spectral data from instruments derived from a manufacturing process like...

Linear positioners offer flexible performance.(Process Control & Automation: Cool Technology)
September 1, 2007... [ILLUSTRATION OMITTED] Built around the 110 model of Trilogy's l-Force ironless motors, the TID and TIS include everything needed for motion except the drive and controller. The principal design goal for these ready-to-run positioners is...

High-density analog output module offers four independently programmable outputs.(Process Control & Automation: Cool Technology)
September 1, 2007... [ILLUSTRATION OMITTED] The model CSOUT, a high-density analog output module features four isolated, fully scalable outputs that are software configured and can be used in conjunction with any of the company's CS series modules. CSOUT...

Servo drive enables centralized control.(Process Control & Automation: Cool Technology)
September 1, 2007... [ILLUSTRATION OMITTED] EtherCAT-compatible Accelnet servo drives deliver 18A and 36A peak, respectively, combine Accelnet versatility and Ethernet speed for centralized control of multi-axis automation. The drives enhance the performance...

Signal conditioning and relay modules feature a system approach.(Process Control & Automation: Cool Technology)
September 1, 2007... [ILLUSTRATION OMITTED] Designated the 857 Series, UMPFLEX modules offer a ystem approach to signal switching and conditioning. Housed in a 6mm-wide package, the signal conditioning and relay modules also offer the same dimensional outline....

Reaping the benefits: single-use transfer lines in biopharmaceutical applications.(Single-Use Products)
September 1, 2007... Biopharmaceutical manufacturers face increased pressure to commercialize new drugs faster and at a lower cost. As a result, production demand is outpacing available manufacturing capacity. To meet existing and future demand and maintain a...

Healthcare organizations launch disaster response initiative.(Industry News)
September 1, 2007... Health care organizations involved in the manufacturing, distribution and dispensing of pharmaceutical products recently announced the creation of Rx Response--a program designed to help support the continued delivery of medicines during a...

Sanofi pasteur ships influenza vaccine for the 2007-2008 season.(Industry News)
September 1, 2007... Sanofi pasteur, the vaccines division of the sanofi-aventis Group, has begun shipment of influenza vaccine (Fluzone[R], Influenza Virus Vaccine) in the United States for the 2007-2008 season. The first doses of influenza vaccine are being...

Environmental Tectonics Corporation expands service offerings.(Industry News)
September 1, 2007... Environmental Tectonics Corporation's (ETC) Sterilization Systems Division has created a new Professional Services Group within the Sterilization Systems Group (SSG). This group will be responsible for the marketing, design, development and...

Position transmitters ideal for monitoring and feedback applications.(Data Management: Cool Technology)
September 1, 2007... [ILLUSTRATION OMITTED] The HSI/R 750 Series of hermetically sealed, loop-powered 4-20mA position transmitters are specifically designed for mechanical position measurement where a hard connection can be made to a test piece. The 4-20 mA...

Phase Monitor offers data acquisition package.(Data Management: Cool Technology)
September 1, 2007... [ILLUSTRATION OMITTED] A Data Acquisition Package (DAP) is now available as an option for the SFT Phase Monitor 11 instrument. The DAP provides real time image and data capture directly to a PC computer. The video image, along with the...

I/O Stations offer easy integration into PROFIBUS networks.(Data Management: Cool Technology)
September 1, 2007... [ILLUSTRATION OMITTED] PROFIBUS-DP[R] FDP20 I/O STATIONS are ideal for applications where I/O needs to be integrated onto PROFIBUS-DP networks. FDP20 stations are available in three versions: 16 inputs, 16 input/outputs, and 8 inputs...

Data logger software alerts users to out of spec conditions.(Data Management: Cool Technology)
September 1, 2007... [ILLUSTRATION OMITTED] The Alarm and Readout Tool plug-in software module for use with HOBOware Pro[R] software automatically notifies users via cell phone text messages or email when temperature, humidity and other conditions exceed...

Manufacturers of some diabetes drugs to strengthen warning on heart failure risk.(Industry News)
September 1, 2007... The FDA recently announced that manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The...

FDA approves updated warfarin (Coumadin) prescribing information.(Industry News)
September 1, 2007... The FDA recently announced the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people's genetic makeup may influence how they respond to the drug. Manufacturers of warfarin, the generic...

Millipore and Novo Nordisk expand agreement to supply recombinant human insulin.(Industry News)
September 1, 2007... Millipore Corporation recently announced an expansion of its agreement with Novo Nordisk to provide the biopharmaceutical market with recombinant human insulin, a key cell culture supplement used to manufacture biologic drugs. Under the...

Weight indicator is washdown safe.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] 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,...

Auger feeder features disposable flexible feed-hopper.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] The PureFeed[R] AP-300 Feeder is available in volumetric and gravimetric configurations for pharmaceutical, nutraceutical and other applications involving feed rates from 500 grams/hour to approximately 150 Kg/hour....

Fail-safe inductive sensor monitors critical safety applications.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] Fail-safe inductive sensor does not require a coded magnet or keyed target for safe operation. The wear-free, one-piece solution replaces traditional two-piece safety switches by integrating the company's patented,...

Split hopper offers easy product changeover.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] Unit offers 304 stainless steel construction and a patented sliding key tooling adapter that allows operators to easily install and remove tooling without tools. The elimination of set collars and Allen screws...

Industrial terminal designed for harsh environments.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] 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...

Sanitary conveyor system designed for tight spaces.(New Products)
September 1, 2007... The AquaPruf Motorized Pulley Conveyor Platform is designed with the gearbox and motor moved inside the pulley. This design streamlines the conveyor's profile, enabling it to fit into much tighter spaces. This design also enhances the unit's...

Blending vessels for liquids, creams and gels.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] 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...

Stackable hose mounting collars permit easy changeovers.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] Stackable mounting collars are two-piece designs with flats on one or both outside surfaces that are drilled and tapped for attachment to each other or to another surface. Collars securely hold hoses and tubing...

Stainless steel polyurethane paint touches up replacement parts.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] STEEL-IT[R] Anti-Rust Stainless Steel Polyurethane can be used on a variety of parts. Paint features a 316L stainless steel leafing pigment that creates a protective corrosion- and chip-resistant barrier. ...

High shear mixer promotes dual flow through a special rotor/stator.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] The PM Model incorporates a rotor/stator configuration that promotes dual flow through a special Delta rotor/stator. This higher flow promoted by this design is ideal for use in agglomerate reduction and the...

Volumetric filling system increases productivity.(New Products)
September 1, 2007... [ILLUSTRATION OMITTED] Volumetric filling system is designed to control both weight and volume in dry filling applications. Unit offers easy disassembly for clean-up and quick product changeover. Spee-Dee Packaging Machinery, Inc.,...

Stainless steel worktable ideal for various lab requirements.(New Products)
September 1, 2007... Worktables address a wide range of lab requirements while providing corrosion-proof performance, ensuring long life and maximum value. All stainless solid shelves and high temperature casters, are designed for cart wash and autoclave...

INTERPHEX Conference programming in full swing.(INTERPHEX 2008 UPDATE)(Conference news)
September 1, 2007... The INTERPHEX Conference Advisory Board recently met in Philadelphia to begin work on the 2008 INTERPHEX educational program. Reviewing and discussing the nearly 200 session submissions received since last April, the Board has created a stellar...

ODT draft guidance is too strict, industry tells FDA.(Regulatory Update)
September 1, 2007... FDA may face an uphill battle in finalizing a guidance limiting orally disintegrating tablets (ODT) to 500 mg and a 30-second dissolution time, industry comments on the draft indicate. The Pink Sheet reports. Most organizations that...

The latest Pharmaceutical Processing news from FDC reports.(Regulatory Update)
September 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...

Labeling guidance asks for too much detail--PhRMA.(Regulatory Update)
September 1, 2007... The amount of information to be included in the Dosage and Administration section of labeling under a recent draft guidance may be too detailed for certain drug products, the Pharmaceutical Research and Manufacturers of America say in comments...

ANDA question-based-review adherence.(NOTED)
September 1, 2007... ANDA question-based-review adherence: More than 90 percent of ANDA submissions include quality overall summaries as of July, FDA reports. The agency requested in January that generic drug applications include a quality overall summary that...

PTO turns down Pfizer request to reissue Lipitor patent.(NOTED)
September 1, 2007... PTO turns down Pfizer request to reissue Lipitor patent: The Patent and Trademark Office sent a "nonfinal rejection" notice to Pfizer in response to its request for the agency to reissue a key Lipitor (atorvastatin) patent. The PTO noted that...

Cardio-Renal panel to address Revatio, phosphate binders.(NOTED)
September 1, 2007... Cardio-Renal panel to address Revatio, phosphate binders: FDA's Cardiovascular and Renal Drugs Advisory Committee will meet Oct. 16 to discuss extending the use of phosphate binders to the pre-dialysis population. Shire, Genzyme and...