Pharmaceutical Processing articles from November 2004

Pharmaceutical Processing archives from November 2004

2004's hot topics--a look back.(From the Editor)
November 1, 2004... As we look back on 2004, we can safely say that this year has been one of the most tumultuous as far as the pharmaceutical industry is concerned. Several topics that were simmering at the beginning of the year, bubbled over to grab their...

Laser marking system allows images to be marked directly into transparent materials.(What's Hot)
November 1, 2004... DataLase Clear enables images to be transferred into transparent media via a laser without interfering with the translucency of the substrate. System has the ability to form images directly between the layers of a clear laminate film, or...

Infrared thermometer re-engineered for improved accuracy.(What's Hot)
November 1, 2004... The ThermoTrace Infrared Thermometer, Model 15030, features a validated accuracy at [+ or -] 2[degrees]F (1[degrees]C) from 32[degrees]F (0[degrees]C) to 590[degrees]F (310[degrees]C). Unit features an 8:1 field of view and weighs only 4.5...

Particle shape measurement equipment uses digital image analysis.(What's Hot)
November 1, 2004... The FPIA-2100 analyzer for wet measurements and the PharmaVision 830 system for dry applications allow linking of subtle variations in particle form to final product performance. The FPIA-2100 is based on flow cytometry using a sheath flow...

Quick change feeder available in volumetric and gravimetric models.(What's Hot)
November 1, 2004... The Quick Change/Quick Clean T35/S60 feeder is a multi-purpose feeder designed to handle a range of materials and feed rates. Unit allows the user to quickly change from a single screw S60 screw configuration to a twin screw T35 screw...

Control system specifically designed for control of fermentation processes.(What's Hot)
November 1, 2004... The T800 Visual Supervisor is a multi-function unit providing all the features that are required to control and monitor units. It combines industrial control, data management and process automation into a single cost-effective unit. The Visual...

Bioburden reduction filter combines three technologies.(Cool Technology)
November 1, 2004... The Supor[R] UEAV 0.2 micron filter increases filter service life and protects sterilizing grade filters and other sensitive downstream processing equipment such as tangential flow filtration (TFF) and chromatography systems. It achieves this...

Prefilter combines benefits of membrane and depth filters.(Cool Technology)
November 1, 2004... Dual layer Protec RM0.5 is designed with an outer layer of glass fiber and an inner layer of hydrophilic PVDF membrane. This design combines the flow rates and dirt-holding capacity of a glass medium with the particle retention of a membrane...

Continuous backwash filter designed to treat different types of water.(Cool Technology)
November 1, 2004... The ASTRASAND[R] filter was developed for physical-chemical and/or biological treatment of different types of water, such as process, waste, surface, cooling and groundwater. Working as a continuous process, the filter bed is cleaned during the...

Filter housing is fully drainable.(Cool Technology)
November 1, 2004... Opti-Clean filter housings eliminate the collection chamber of conventional housings, and incorporates a specially machined, angled cartridge plate in the base which allows for complete drainage of any filtered and unfiltered product. The...

HEPA and ULPA filters engineered for stringent air purity requirements.(Cool Technology)
November 1, 2004... Microguard 99 filters are available in 99.97%, 99.99% and 99.999% efficiencies on 0.3 microns. Standard capacity, and high capacity models are available. A wide variety of cell side materials are offered, including, wood, steel and aluminum,...

Streamlining the clinical trials process.(Cover Story)
November 1, 2004... One of the most widely discussed and closely examined topics in the pharmaceutical industry today is the growing time and cost required to successfully complete clinical trials with the impact of this trend being most evident in the shortage of...

What is 21 CFR Part 820 and why should you care?(Pharma-IT)
November 1, 2004... It's time to get a copy of 21 CFR Part 820 and see what it says. As you rustle through that 820 regulation, you will likely see that it talks about things far better known in the industry than Part 11 Requirements were before they became the...

Project management shortens time-to-market.(Solutions)
November 1, 2004... Time waits for no man... or pharmaceutical company. This take on a familiar maxim is especially appropriate for drug makers. Every day counts in propelling the next blockbuster drug from the lab to pharmacy shelves. With hundreds of millions...

USP is now accepting applications for its 2005 fellowship and internship programs: application deadline for both programs is Dec. 31, 2004.(Industry News)
November 1, 2004... The United States Pharmacopeia (USP) is now seeking candidates for its 2005 internship and fellowship programs. USP's internship and fellowship programs provide students in the health field with the opportunity to conduct research and work in...

i3 Research acquires Statprobe.(Industry News)
November 1, 2004... i3 Research, a therapeutically specialized contract research organization (CRO), has acquired Statprobe, one of the largest providers of comprehensive data services, with five locations throughout the United States. The Statprobe...

ISP and Niro form strategic alliance to develop technology that enhances bioavailability: as part of the agreement, ISP acquires Niro's formulation development.(Industry News)
November 1, 2004... International Specialty Products (ISP, Wayne, New Jersey, USA) and Niro A/S (Niro, Soeberg, Denmark) have announced the signing of two agreements. The first agreement establishes a strategic alliance between the two companies and specifically...

CIP system eliminates cross contamination.(Washing)
November 1, 2004... The Ultra Flow CIP system offers efficient, cost-effective CIP of process tanks, vessels and lines. This serf-cleaning, single-use system provides shorter CIP cycles, minimal water and chemical use, and a fresh, clean solution for every cycle...

Portable Tank Cleaning system can replace CIP.(Washing)
November 1, 2004... The PTC Portable Tank Cleaner combines a pump, hoses, inlet adapters, filters and a choice of Gamajet Cleaning Machines, all mounted on an easily moved transport cart. Featuring high pressure cleaning at very low flow rates and 360[degrees]...

Glassware washer can handle multiple sizes simultaneously.(Washing)
November 1, 2004... The Reliance[R] 400 Washer can accommodate four manifold racks, and with the optional Universal Shelving System[TM], can clean multiple sizes of glassware simultaneously. The system provides fast glassware turnaround with a 30-minute cycle time...

Infrared Bin Washing Station increases washing efficiency.(Washing)
November 1, 2004... The Zanchetta IR Bin Washing Station features increased washing efficiency through a rotating platform with blade jet nozzles for outside washing, reducing the wash/dry cycle time to as little as 20 minutes. Infrared drying eliminates the...

Valve actuators meet sanitary processing requirements.(Processing Components)
November 1, 2004... Actuators possess field -rated performance characteristics. The aluminum rack and pinion actuators provide a double-stroke adjustment of +/-5 and are available in quarter turn and special 180[degrees] units. Rack and pinion actuators can be...

Pre-energized vee packing simplifies installation and maintenance.(Processing Components)
November 1, 2004... Seal features a unique geometry that guarantees a tight seal by simply installing it. There is no requirement to tighten a packing gland against the seal or to use adhesives at installation. In addition, the seal design does not rely on the...

Circulators provide precise temperature control.(Processing Components)
November 1, 2004... Designed with a 28 liter reservoir that accommodates large or multiple samples, the 9600 Series feature a -25 to 150[degrees]C temperature range and are available with a choice of three different controllers. The top of the line Model 9612...

GC/MS software upgrade increases productivity.(Processing Components)
November 1, 2004... Version 2.2 of the GCMS-solution software is designed for use with the QP-2010 GC/MS and incorporates features that increase productivity and throughput and provide simpler functionality for the user. Maintaining "One Window" design, new...

Air-operated transfer tubes resist clogging and are easy-to-install.(Processing Components)
November 1, 2004... TT Series Transfer Tubes are made from aluminum, with an anodized finish, and have a straight-thru bore to let materials pass freely without clogging. Featuring a new mounting clip for easy installation, these tubes are powered by compressed...

Sanitary conveyors easy to washdown.(Processing Components)
November 1, 2004... Conveyors feature all stainless steel construction, enabling users to wash down the conveyor with water, soap and other cleaning agents without the worry of rust or corrosion to critical components. Features include: roller widths between 6"...

Control system contributes to efficient WFI and clean steam.(Applications)
November 1, 2004... A new 'state-of-the-art' Pharmaceutical Manufacturing Unit (PMU) at Moorfields Eye Hospital NHS Trust (London, United Kingdom), features sophisticated Water for Injection (WFI) and Clean Steam generation systems for cleaning and sterilization...

Vacuum conveyor transfers powders from container to processes.(Material Handling)
November 1, 2004... The MiniVac[R] features a side access door for easy filter changing and/or cleaning; as well as an efficient regenerative blower. Discharge options include a rotary valve, slide gate or dump gate. Systems can handle up to 5,000 lbs/hr. Finishes...

Box filler ideal for wide variety of applications.(Material Handling)
November 1, 2004... Gaylord Box Filler includes a custom inlet tube and features a venturi bag inflation system, gain-in-weight load cells, vibration for production compaction and an inflatable bag spout seal. The discharge of the inlet tube accepts a...

Feeder provides sanitary solutions to pharmaceutical processors.(New Technology)(Advertisement)
November 1, 2004... The MECHATRON[R] 3-A feeder was designed for use in the pharmaceutical or other process industries where equipment must meet 3-A sanitary levels or equivalent. Available features include an FDA/USDA accepted "Con-Flex" flexible conical...

Compact portable data loggers offer multi-channel functionality.(New Technology)(Advertisement)
November 1, 2004... These small, electronic monitoring devices can record temperature, relative humidity, current, voltage, pressure, process signals, and much more. Data loggers offer high quality and reliability, large memory capacity, and multi-channel...

PTFE Teflon[R] hose assembled to user specifications.(New Technology)(Advertisement)
November 1, 2004... S-COR is specifically engineered to exceed the process needs for material transfer in pharmaceutical, biotech, semiconductor, food, dairy, beverage or cosmetic industries. The inner core is made from Dupont Teflon[R] T-62 PTFE with no...

Control system specifically designed for the fermentation process.(New Technology)(Advertisement)
November 1, 2004... The T800 Visual Supervisor is a multi-function unit providing all the features that are required to control and monitor units. It combines industrial control, data management and process automation into a single cost-effective unit. The Visual...

High flow sterile grade filters cut filtration time.(New Technology)(Advertisement)
November 1, 2004... The Sartopore 2 family of polyethersulfone filters has recently been expanded to include a high flow version. The Sartopore 2 HF is optimized to give the highest flow rate of any sterilizing grade filter. Filtration times can be reduced by...

In-line filters and strainers remove unwanted particles.(New Technology)(Advertisement)
November 1, 2004... In-line stainless steel filters and strainers are designed for the removal of unwanted particles from process line content, providing added protection for pumps, valves, heat exchangers and other processing equipment. Constructed of 316L...

Centrifugal extractors ideal for solvent extraction applications.(New Technology)(Advertisement)
November 1, 2004... Centrifugal extractors are the solution to challenging solvent extraction applications. Equipment range is designed to permit up to seven independent extraction stages installed in a single apparatus. Each stage is discrete in that it consists...

Modular process systems.(New Technology)(Advertisement)
November 1, 2004... Family of specialty companies provides quality equipment and components for hygienic industries with single source convenience. From stainless steel tanks, heat exchangers and filter housings manufactured by Allegheny Bradford Corporation, to...

Highly accurate checkweigher offers accuracies of 50 milligrams.(New Technology)(Advertisement)
November 1, 2004... The Ramsey AC9Rx is able to weigh, depending upon package weight and rate, with accuracies of 50 milligrams. Speeds up to 500 ppm are achievable. A completely enclosed t weighing area along with a loadcell and integrally mounted electronic...

Spiral mixer progressively divides and recombines product.(New Technology)(Advertisement)
November 1, 2004... The 130 Series Spiral Mixer consists of a series of helical interior elements, which progressively divide and recombine. The result is efficient in-line mixing, heating/cooling and dispersions. The mixers can be quickly installed in new or...

INTERPHEX Puerto Rico: the leading event for the world's leading pharmaceutical manufacturing center.(INTERPHEX Puerto Rico Update)
November 1, 2004... Over the past few decades, Puerto Rico has emerged as a global leader in pharmaceutical manufacturing. The island is home to 80 pharmaceutical plants that employ nearly 30,000 people. 19 of the world's top selling prescription drugs are...

The latest Pharmaceutical Processing news from FDC Reports.(Regulatory Update)
November 1, 2004... 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...

Drug R&D may depend on govt. funds if price disparities persist--Crawford.(Regulatory Update)
November 1, 2004... Drug price controls in the international market could lead to a reliance on government funds for R&D, FDA Acting Commissioner Lester Crawford said. "One inevitable consequence of [the drug pricing] disparity is that the U.S. and other countries...

PAT implementation poses challenge of industry-FDA collaboration.(Regulatory Update)
November 1, 2004... Collaborating with FDA will be the greatest challenge for industry in implementing the process analytical technology component of FDA's drug quality initiative, AstraZeneca Chemistry, Manufacturing & Controls Group Director Robert Timko said....

Berlex Bonefos review.(Noted)
November 1, 2004... Berlex Bonefos review: FDA's Oncologic Drugs Advisory Committee will discuss Berlex' NDA (21-776) for Bonefos (clodronate) as an adjuvant treatment for the reduction of occurrence of bone metastases in Stage II/III breast cancer patients on...

AHIP names policy center head.(Noted)
November 1, 2004... AHIP names policy center head: Economist Jeff Lemieux will lead America's Health Insurance Plans' new Center for Health Policy Research as of Oct. 18. He joins from the think tank Centrists.org, where he was executive director. The new research...

HHS IG subpoenas Procrit documents.(Noted)
November 1, 2004... HHS IG subpoenas Procrit documents: Johnson & Johnson is responding to a subpoena from HHS' Office of Inspector General for documents related to the sales and marketing or the anemia treatment Procrit (epoetin alfa). The company said it...

Plendil patent ruling.(Noted)
November 1, 2004... Plendil patent ruling: Mutual's ANDA for felodipine extended release does not infringe an AstraZeneca patent for the calcim blocker Plendil, a D.C. federal appeals court ruled Sept 30. The court reversed a Philadelphia federal judge's ruling...

Biovail names CEO.(Noted)
November 1, 2004... Biovail names CEO: Former MDS Pharma Services President John Squires, PhD, became Bioavail CEO on October 7th. Biovail's previous CEO Eugen Melnyk is continuing as chairman of the board.

From the editor.(Letter to the Editor)
November 1, 2004... Dear Reader, Welcome to Pharmaceutical Processing's 2005 Outsourcing Reference Guide. The pressure to lower drug prices and reduce operating costs continue to be major issues for the industry. Pharmaceutical companies are constantly...

Outsourcing reference guide 2005: the directory of contract services.
November 1, 2004... Clinical Packaging Clinical Services Clinical Packaging Advanced Scientifics Inc., Millersburg, PA Akorn Inc., Decatur, IL ALMEDICA International Inc., Allendale, NJ Bioserv Corporation, San Diego, CA BlisTech...

Outsourcing service providers.
November 1, 2004... A AAI Development Services, 2320 Scientific Park Drive, Wilmington, NC 28405; Tel: 910-254-7000, Fax: 910-815-2300, Toll Free: 800-575-4AAI URL: www.aaidevelopment.com Abbott Laboratories, Pharmaceutical Products Division, 200 Abbott...