Pharmaceutical Processing articles from September 2006

Pharmaceutical Processing archives from September 2006

Mixer features explosion proof control panel.(What's Hot)
September 1, 2006... The Laboratory Triple Shaft VersaMix is completely enclosed. All components are shrouded for safety and to enhance the overall look of the unit. Included as standard features are many components that were once offered as optional features:...

Stainless steel servo/motor drive designed for use in sterile environments.(What's Hot)
September 1, 2006... The PacDrive Aseptic SCL-055 features an aseptic, acid and leach-resistant stainless steel housing with an easy-to-clean, smooth surface designed to prevent contaminant, bacteria and germ formation. The IP 67 rated PacDrive Aseptic SCL-055 is...

Stainless steel valves for simple liquid sampling.(What's Hot)
September 1, 2006... Range of hygienic fittings enables liquid samples to be taken both hygienically and safely. The valves, which have been designed so that they cannot be accidentally over tightened or the valve handle accidentally removed, can be...

Subminiature couplings offer RFID technology.(What's Hot)
September 1, 2006... The IdentiQuik[R] SMC coupling allows users to electronically verify connection accuracy. The connectors integrate RFID capability into coupling bodies or inserts. Before the final connection is made, the IdentiQuik coupling halves...

Lab processor ideal for small samples and optimizing product recovery.(What's Hot)
September 1, 2006... The M-110S Microfluidizer[R] is ideal for a range of applications including emulsions, dispersions, liposomes, cell disruption and liquid-liquid or liquid-solid processing applications. The unit features a 25 ml stainless steel reservoir with...

Water purification system removes alkaline phosphatase.(What's Hot)
September 1, 2006... The Elix[R] Clinical system with a BioPak final filter is a lab water purification system that removes alkaline phosphatase from purified water. The Elix Clinical system's design combines prefiltration, softening, reverse osmosis,...

Circulating water temperature control system offers stainless steel construction.(What's Hot)
September 1, 2006... The Hydrotherm II circulating water temperature control system features stainless steel construction as the main component for wetted surfaces. The system is compact and portable, occupying approximately 2 square feet of floor space and has a...

Aqueous effluent treatment system decontaminates organic and inorganic waste.(What's Hot)
September 1, 2006... The Sentinel aqueous effluent treatment system is used to decontaminate organic and inorganic waste in volumes ranging from as little as 20 liters, up to 50,000 liters per day. It uses a process that breaks the chemical bond between active...

IT infrastructure requirement: PAT is driving the convergence of technology and application integration.(Special Report: PAT)
September 1, 2006... Over the past few years, the FDA has increased pressure on the pharmaceutical and biotechnology industry to become more innovative in manufacturing. Through issuing new guidance to the industry in 2003 and 2004, the FDA encouraged the use of...

Portable UVC unit provides in-room decontamination.(Process Components)
September 1, 2006... The Remedial In-Room Decontamination System (RIDS) provides a safe and effective way to decontaminate surfaces infested with mold, viruses and bacteria. The user wheels the RDS unit into the infested area, leaves the room and turns on the unit...

Filters remove odors and can improve indoor air quality.(Process Components)
September 1, 2006... Camsorb[R] Riga-Carb filters remove strong nuisance odors and can improve indoor air quality in commercial buildings, while potentially reducing HVAC costs. The filters are designed to fit anywhere a regular or headered rigid filter can be...

Developing your science-based manufacturing strategy.(Special Report: PAT)
September 1, 2006... This month marks the two-year anniversary of FDA's release of its process analytical technology (PAT) guidance for industry. Since that time, life sciences companies have undertaken a multitude of PAT projects, from sensor development and data...

Data acquisition board features onboard processing.(Data Management)
September 1, 2006... The DAP 5000a/526 includes 16 analog inputs, 2 analog outputs, 16 digital inputs, and 16 digital outputs. External rack-mounted hardware can extend these channel counts to 512, 66, 128, and 1024 respectively. The board can acquire 14-bit data...

Data logger capable of withstanding up to 30 days of submersion in dry ice.(Data Management)
September 1, 2006... The In-Transit FlashLink Probe-less Dry Ice Data Loggers, Models 20061 (5-Day logging capacity) and 20062 (15-Day logging capacity) are designed to withstand up to 30 days of continuous submersion in dry ice. The units are especially well...

Ethernet based PLC with IP filter protects against unauthorized access.(Data Management)
September 1, 2006... The 750-841 Ethernet based programmable controller is now protected against unauthorized access by means of a built-in IP-filter. Configuration of the IP-filter is facilitated by means of web pages in the controller. When the security option is...

Data matrix decoder system operates under demanding conditions.(Data Management)
September 1, 2006... The PIATI_XPL is capable of operating in either area or line scan mode, and ensures outstanding decoding performance even when reading codes under challenging and demanding conditions. The unit is able to decipher codes in virtually all...

Is PAT leaving quality behind?(Special Report: PAT)
September 1, 2006... The recent emphasis on continuous improvement, operational excellence and Process Analytical Technology (PAT) within the pharmaceutical and biotech industries has driven us to evaluate the basic tenets of our approach to quality. Historically,...

Gravity-feed system provides accurate metal detection.(Process Equipment)
September 1, 2006... The Phantom Pipeline Metal Detector has a powerful digital signal processing system which eliminates noise interference. The detector features automatic set-up and operation, automatic self-test and diagnostics, multiple product changeovers,...

Portable tanks and kettles available in custom designs.(Process Equipment)
September 1, 2006... Portable vessels are available to accommodate specific processing and plant requirements. Tanks and kettles can be supplied with a variety of scraped-surface agitators with high shear mixers and propeller mixers for normal or heavy-duty...

Benefits of High-Resolution Ultrasonic Spectroscopy in a PAT installation.(Special Report: PAT)
September 1, 2006... Pharmaceutical manufacturing is a complex process often utilizing complex scientific and engineering principles. The new FDA initiative considers process analytical technology (PAT) to be a system for designing, analyzing, and controlling...

Brushless pump system offers low maintenance.(Process Components)
September 1, 2006... Masterflex[R] I/P Process Pump System features a 1/3 hp PWM brushless motor drive, roller and ball bearing construction and a non-chip, epoxy-coated IP55 washdown steel enclosure, making it well-suited for 24-hour continuous-duty operations....

Ball segment valves eliminates product build-up.(Process Components)
September 1, 2006... The LUNAR ball segment valves are able to handle liquid and dry products as well as fine powders to coarse abrasives. The valve is designed so that materials cannot easily build-up, accumulate, or be captured within the body. An inflatable seal...

Stainless steel check valves available in a full range of sizes.(Process Components)
September 1, 2006... Stainless steel poppet and ball check valves are available in sizes from 1/4" to 1" IPS. Spring loaded for 2 or 10 PSI they are rated for pressures to 2500 PSI. Poppet valves have a temperature range of -15F to +400F; ball valves have a -20F to...

Vibration meter troubleshoots and quantifies process vibrations.(Process Components)
September 1, 2006... The Model 205 hand-held, vibration meter can troubleshoot and quantify very small or large levels of intermittent and transient process vibration. The unit features sensitivity as low as 0.04 mils. It has a frequency range of .4 to 5000 Hz...

In-line ball valves constructed of 316 stainless steel.(Process Components)
September 1, 2006... Fluid Flow sanitary ball valves features the capacity to reach 450 psi and 350E The nominal full-port design and totally encapsulating seals create an unobstructed product flow. Valves can be modified for CIP, aseptic applications as well as...

Fused glass/metal windows offer sight and light in sanitary applications.(Process Components)
September 1, 2006... Metaglas[R] mechanically prestressed borosilicate glass windows are formed by fusing borosilicate glass inside a precisely formed stainless steel ring. Since steel has a much higher coefficient of thermal expansion than borosilicate glass it...

Are all metrology labs alike?(Applications)
September 1, 2006... Short answer--NO!!! In fact, to those of us in the industry who truly know what it takes to recalibrate instruments to objectively defined standards, a better question might be-- Are you using the equivalent of a meat thermometer to...

Lab incubator features forced air convection and cooling.(Lab Equipment)
September 1, 2006... Friocell incubators allow exact incubation processes for both variation and deviation. The units offer exact climate control, short recovery times and a unique cooling system which prevents samples from drying out. A high-performance lighting...

Tubing designed for a wide range of fluid applications.(Lab Equipment)
September 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...

Compact coriolis meters offer accuracy and stability.(Instrumentation)
September 1, 2006... Micro Motion F-Series meters offer [+ or -] 0.10% mass flow accuracy, [+ or -] 0.15% volume accuracy, [+ or -] 0.50% gas flow accuracy, and [+ or -] 0.001 g/cc density accuracy. Compact and drainable, the meters offer installation flexibility...

Compact oxygen transmitter ideal for field use.(Instrumentation)
September 1, 2006... The SPECTRACAP[R] Oxygen Transmitter OMT355 measures oxygen concentration optically by measuring the absorption of light from a tunable diode laser. For oxygen sensing the laser is tuned to a wavelength which is characteristic for the oxygen...

Data logger can record up to 16,383 measurements per channel.(Instrumentation)
September 1, 2006... The OCTVOLT is an eight channel, battery powered, stand alone recorder. The storage medium is nonvolatile solid-state memory, providing maximum data security even if the battery becomes discharged. The device can be started and stopped directly...

Single quadrupole mass spectrometers feature high sensitivity.(Instrumentation)
September 1, 2006... The 6100 Series of single quadrupole mass spectrometers comprises four new instruments, including a fast-scanning model. The 6140 Single Quad is a high-performance, fast-scanning model designed for high-throughput laboratories. The 6130 Single...

Pressure calibrator design protects calibration pump from contamination.(Instrumentation)
September 1, 2006... The company's 718 pressure calibrator's design protects the built-in pneumatic calibration pump from fluid contamination, allowing it to be serviced in the field. Measuring less than nine inches in length and weighing just over two pounds, the...

Software improves speed and accuracy of antibiotic sensitivity testing.(Instrumentation)
September 1, 2006... Software for AutoZONE, an automatic zone analyzer system, generates more accurate zone readings and saves valuable time. Using this new software, AutoZONE's computer controlled, high-resolution CCD camera can automatically begin zone...

Fluid system components available in a wide range sizes and styles.(Instrumentation)
September 1, 2006... Complete Fluid-System Solutions[TM] enhance product design and development by transforming the fluid component supply chain into a highly efficient, single-source design, development, and manufacturing process that assures full system...

HPLC electrochemical array detector features streamlined software.(Instrumentation)
September 1, 2006... CoulArray[R] Application Software--Version 3.0 is designed for more effective operation of the company's highly sensitive and selective CoulArray HPLC electrochemical array detector. The streamlined software features single window interface...

FDA announces plan to strengthen advisory committee processes.(Industry News)
September 1, 2006... The FDA has announced several steps to help make its advisory committee processes more effective at providing timely, top-tier, independent scientific advice to the agency and at reassuring the public about the basic integrity of this process....

Medical Director named for Emerging and Pandemic Threat Preparedness.(Industry News)
September 1, 2006... The FDA has appointed Mark Goldberger, MD, MPH, as Medical Director for Emerging and Pandemic Threat Preparedness in FDA's Center for Biologics Evaluation and Research (CBER). Dr. Goldberger was selected after a national search of eligible...

FDA approves Oncaspar for newly-diagnosed acute lymphoblastic leukemia.(Industry News)
September 1, 2006... The FDA recently expanded the approved use of Oncaspar to include treating children and adults with newly diagnosed acute lymphoblastic leukemia (ALL) as part of a multiple drug chemotherapy regimen. FDA previously approved Oncaspar in 1994...

Supplemental new drug application for Famvir[R] approved by FDA.(Industry News)
September 1, 2006... Novartis recently announced that the FDA approved prescription Famvir[R] (famciclovir) tablets as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH), based on a supplemental new drug application (sNDA)....

Proposed legislation aims to stem the flow of counterfeit prescription drugs.(Industry News)
September 1, 2006... Representative Mike Rogers (R-8-MI) recently held a Congressional briefing on counterfeit drugs and spoke about his recently introduced anti-counterfeiting legislation. In addition, representatives from the pharmaceutical industry and a leading...

American Lung Association collaborates with leading vaccine manufacturer on new initiative.(Industry News)
September 1, 2006... The American Lung Association recently announced that it will collaborate on a new, far-reaching influenza public awareness initiative with sanofi pasteur, a leading influenza vaccine manufacturer. As the nation's oldest voluntary health...

MedImmune shipping FluMist[R] for flu season.(Industry News)
September 1, 2006... MedImmune is now shipping FluMist (Influenza Virus Vaccine Live, lntranasal) to customers for the 2006-2007 influenza season. FluMist is MedImmune's live, attenuated influenza vaccine (LAIV) approved for use in healthy individuals between 5 and...

Selecting an effective pipette calibration frequency.(Perspectives on Instrumentation)
September 1, 2006... In the June 2006 issue of Pharmaceutical Processing, we discussed the most common methods for calibrating and verifying liquid delivery instrumentation. These methods are gravimetry, fluorometry, photometry and Ratiometric Photometry[TM], and...

Attend INTERPHEX2007 as a VIP Club member!(INTERPHEX2007 Update)
September 1, 2006... Let's face it, attending a trade show is serious business that involves some planning and effort if you want to get the most out of your visit. The industry has made great strides in developing technologies to simplify and streamline the...

Direct drive peristaltic pumps offer high volumes.(Process Components)
September 1, 2006... The Masterflex B/T[R] RapidLoad[R] line of pumps is designed for high volume, high accuracy bulk fluid transfer and dispensing applications. The line offers flow rate capacities to 9.5 GPM and is available in a wide range of models, including...

Stainless steel tube fittings fit a variety of applications.(Process Components)
September 1, 2006... Line of fittings includes ten different selections: male connector, male elbow, union, union elbow, union tee, nut, back ferrule, front ferrule, ferrule set and bulkhead union with many different sizes to choose from. Tube fittings function...

Micro Batching System ideal for the batching of minor ingredients.(Process Components)
September 1, 2006... The Micro Batching System is ideal for facilities that run the same recipe repeatedly, in different batch sizes. It can also be set up with modular ingredient dispensers to accommodate recipes and batch sizes that change continuously. Systems...

Holders available for forward- and reverse-acting discs.(Process Components)
September 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...

What does PAT have in store?(Pharma-IT)
September 1, 2006... Spectral Data The last article 1 wrote for Pharmaceutical Processing was a discussion about a significant component of a comprehensive PAT solution--universal instrument interface software, and its application for PAT. Universal instrument...

Application Server features an embedded data historian.(Process Control)
September 1, 2006... The ProLinx 7000 Application Server (AppSrvCE) delivers communication protocols and an embedded data historian in one package. The AppSrvCE is fully customizable and programmable (including 'C' programming), supporting multiple automation...

Handheld Pendant with live or dead man enable switches.(Process Control)
September 1, 2006... The MRI75 series Handheld Pendant Station for machine control offers excellent ergonomics, a full complement of control options, and choice of serial or hardwired interface. Controls include e-stop switch, left and right enable buttons, 2...

Power supplies feature easy installation and replacement.(Process Control)
September 1, 2006... Company has expanded their line of modular DIN rail mounted power supplies. The recent additions include units that provide 5 VDC 8 amps, 12-15 VDC 6 and 8 amps, 24 VDC 3 and 5 amps and 48 VDC at 2.5 amps all in space saving housings. The CSF...

Sensor expands the array of process control applications.(Process Control)
September 1, 2006... The Model 2400S transmitter with MVD technology is an integral transmitter designed for the Micro Motion[R] ELITE[R] Coriolis meter. The unit expands meter installation options to include integral mounting or remote mounting in the field, or...

Sensor provides high-speed position feedback for industrial Ethernet.(Process Control)
September 1, 2006... The R-Series EtherCAT sensor is a high-speed networking solution based on industrial Ethernet technology. The EtherCAT sensor, short for 'Ethernet for Control Automation Technology,' is an interface for industrial Ethernet that provides fast,...

Ultrasonic Positioning System improves QA and process reliability.(Process Control)
September 1, 2006... The UOS-100 Ultrasonic Positioning System consists of ultrasonic emitters, receivers and a control interface and is designed to significantly enhance error proofing in demanding applications. The UOS-100 is a complete system--from propagation...

Control units ideal for hygienic applications.(Process Control)
September 1, 2006... The 22.5mm HYGEIA Series "N" control units have been designed expressly to meet the emerging hygienic standards of the pharmaceutical and medical industries. Each meets the stringent requirements of EN 1672-2:2004 and ISO 14159 for cleaning and...

PLC offers features to support complex controls.(Process Control)
September 1, 2006... Programmable Logic Controller is compact in size but equipped with RISC base processor operating at 0.321[micro]sec/basic instruction. Features include super fast floating point calculation, built-in two axis of motion with linear/circular...

Communication controller can be placed on any HMI package.(Process Control)
September 1, 2006... ActiveX controls is a Microsoft Windows based object that provides the user with a graphical user interface (GUI) on their HMI package. With the ability to be placed into any new or existing HMI package, the ActiveX control provides immediate...

Maximizing enterprise-wide management of pharmaceutical wireless systems.(Solutions)
September 1, 2006... To help improve a multitude of results, the pharmaceutical industry the past few years has increasingly looked at and tapped into wireless technologies that automate production, process controls, security, safety, logistics, product...

Balancing compliance with economics: the new role of manufacturing.(Solutions)
September 1, 2006... Continuing pressures on life sciences manufacturing, from increased competition to expiring patents, are forcing organizations to achieve tighter operating efficiencies, while improving their ability to satisfy quality compliance standards. ...

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

Panel conflict waivers to stay; FDA to provide clarity.(Regulatory Update)
September 1, 2006... FDA's plan for improving its advisory committee member selection process focuses on increasing the transparency and consistency of the existing process rather than an overhaul of its practices, The Pink Sheet reports. "We will be revising...

FDA adjusts thinking on drug/diagnostic co-development draft guidance.(Regulatory Update)
September 1, 2006... FDA will be more flexible about the schedule it expects sponsors to follow for drug/diagnostic co-development than the agency suggests in a 2005 "concept paper" on the subject. "The concept paper was perhaps a little idealized in that it...

Manufacturers prevail in $340b lawsuit.(Noted)
September 1, 2006... Manufacturers prevail in $340b lawsuit: California federal Judge William Alsup recently cleared AstraZeneca, Aventis, Bayer, Bristol-Myers Squibb, GSK, Wyeth, Pfizer, TAP and ZLB Behring from Santa Clara county claims seeking undefined treble...

Division of Metabolic & Endocrine Products director.(Noted)
September 1, 2006... Division of Metabolic & Endocrine Products director: Acting Division of Metabolic & Endocrine Products Director Mary Parks has been named to the permanent position. Parks, former ODE II division deputy director and team leader for...

FY2007 user fee rates.(Noted)
September 1, 2006... FY2007 user fee rates: FDA increases its Prescription Drug User Fee Act rates 17% to $896,200 for an application requiring clinical data and $448,100 for an application not requiring clinical data or a supplement requiring clinical data. The...

From FDA to Quintiles.(Noted)
September 1, 2006... From FDA to Quintiles: Steven Niedelman, former FDA deputy associate commissioner for regulatory operations, has joined Quintiles Consulting as executive VP. Upon his departure from the agency Deputy ACRAs Diana Kolaitis and David Horowitz...