Pharmaceutical Processing articles from May 2008

Pharmaceutical Processing archives from May 2008

The river of denial runs deep.(From The Editor)
May 1, 2008... This month's column is about me. If you're not interested or don't care you can move on--I won't hold it against you. Here's my tale: Back in January, my family and I joined the local Y. While none of us were particularly out of...

Lab balances offer precise operation.(What's Hot)
May 1, 2008... [ILLUSTRATION OMITTED] The CPA Series of laboratory balances feature automatic internal calibration via an integrated calibration weight at the touch of the CAL key. Also, if the ambient temperature fluctuates outside of a user-defined...

Retractable spray ball features innovative seals.(What's Hot)
May 1, 2008... [ILLUSTRATION OMITTED] The Retract-A-Ball consists of a number of seals of various types and materials dependent on their position and function including an O-Ring fitted on the neck of the ball treated with an FDA compliant PTFE coating...

Regulator offers extended pressure range.(What's Hot)
May 1, 2008... [ILLUSTRATION OMITTED] The Series PRHM thermoplastic pressure regulator is capable of converting inlet pressures up to 150 psi to a pre-determined maximum downstream pressure ranging from 5 to 125 psi settings. Unique to these regulators...

Rupture disc features packaging allowing it to be taken into sanitary environments.(What's Hot)
May 1, 2008... New packaging allows sanitary rupture discs to be taken into hygienic/sanitary environments while protecting the rupture disc right up to the moment of installation. The form-fitting packaging features a unique, easy to open pop-top; no need to...

Boehringer Ingelheim's pharmaceutical R&D building wins Facility of the Year Award for facility integration: building being eyed as a model for R&D sites by major global pharmaceutical companies.(Facility Of The Year Award)(Company overview)
May 1, 2008... An independent, blue-ribbon panel of judges comprised of global representatives from the pharmaceutical design, construction, and manufacturing sectors declared the new Pharmaceutical R&D building of Boehringer Ingelheim Pharma GmbH & Co. KG,...

Turning art into science: advances in double-layer tablet manufacturing.(Tabletting Technology)
May 1, 2008... Pharmaceutical tablet manufacturers have long sought to refine and optimize the processes utilized for producing double-layer tablets. Whether driven by capacity requirements, marketing-based ideas or simple physics, there are always unique...

Understanding the pharmaceutical manufacturing process: tools and techniques to integrate PAT into your process.(Pharma-IT: PAT Update)
May 1, 2008... In an effort to support innovation and efficiency in drug manufacturing, the U.S. Food and Drug Administration (FDA)introduced the Process Analytical Technology (PAT) initiative in 2003. Ever since, pharmaceutical manufacturers around the...

Pharmaceutical manufacturer increases yield with response surface methods: design of experiments software handles complex manufacturing variables.(Scale-Up & Manufacturing)
May 1, 2008... Pharmaceutical manufacturing typically involves a series of process steps, each with many variables that can have a major impact on critical responses such as product yield. It's often difficult to gain an understanding of the impact of these...

Harnessing new possibilities in health care: the role of emerging economies--a case for India.(Emerging Markets)(Company overview)
May 1, 2008... [ILLUSTRATION OMITTED] There is an emerging consensus worldwide that the healthcare industry has to be transformed in a way in which the "globalizing economy" could indeed make healthcare solutions accessible to all, while ensuring that...

Global sourcing for comparator studies: the emergence of Asia in the global clinical trials market.(Emerging Markets)(Industry overview)
May 1, 2008... With a growing number of clinical trials underway worldwide and an increasing demand for comparator products used for these trials, the pressure is on to not only find the drug of choice, but to find it at the right time, in the right amounts...

FDA embarks on major hiring initiative.(Industry News)
May 1, 2008... Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the FDA begins a multi-year hiring initiative. The FDA is hiring hundreds of individuals with science and medical...

Genzyme and FDA at odds over Myozyme manufacturing.(Industry News)
May 1, 2008... Genzyme recently announced that the FDA informed the company of its opinion that Myozyme[R] produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in...

A window into the Chinese pharmaceutical market: Hu Kun Ping, Vice President, Reed Sinopharm Exhibitions makes the case for doing business in China.(Emerging Markets)(Industry overview)(Interview)
May 1, 2008... [ILLUSTRATION OMITTED] In an interview with Pharmaceutical Processing, Hu Kun Ping, Vice President, Reed Sinopharm Exhibitions, discusses key trends, opportunities and challenges in the Chinese pharmaceutical market, while citing important...

FDA approves Cimzia to treat Crohn's disease.(Industry News)
May 1, 2008... The FDA has granted approval to Cimzia (certolizumab pegol) for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide. Crohn's disease is a...

Meda settles U.S. Astelin[R] patent litigation with Apotex.(Industry News)
May 1, 2008... Meda, through its wholly owned U.S. subsidiary, Meda Pharma-ceuticals Inc., has entered into a settlement agreement with Apotex that resolves the U.S. patent litigation between the companies regarding Apotex's proposed generic versions of...

Biometric Authentication Technology provides product and brand protection and security.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] Biometric Authentication Technology represents a new level of product security and brand protection that delivers an anti-counterfeiting solution based on the unique natural microstructures found in the substrate of...

Steel pallet is cleanroom compatible.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] Unit is a lightweight, flame-resistant steel pallet designed to meet Grocery Manufacturers Association (GMA) capacity and compatibility standards. The pallet is 100% cleanroom compatible, is washable, does not...

Software streamlines change management.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] Built on the FactoryTalk Services Platform, FactoryTalk AssetCentre provides manufacturers with a centralized tool for gathering, managing and securing data on automation assets such as control systems, drives and...

Tangential Flow Filtration system for process development and sample prep.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] The Cogent[R] [micro]Scale Tangential Flow Filtration (TFF) system for both process development and low volume sample preparation is an easy-touse, semi-automated bench top solution that has been designed to fully...

Contamination detection system operates quickly.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] The Growth Direct[TM] System is an automated system for rapid microbial detection that addresses key testing applications and fits with current regulatory practice. The Growth Direct[TM] System greatly reduces...

Containment system provides safe filter change-outs.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] Filter Capsules is ideally suited for the processing of potent active pharmaceutical ingredients (APIs) by providing safe, easy-to-use, flexible protection for filter change-outs--dramatically reducing the capital...

Connector allows for connections outside the cleanroom.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] The patent-pending PureFit[R] SC (which stands for sterile connection) is a new connective technology that makes sterile connections possible outside of the clean-room environment. The silicone valve design of the...

Manifold Sampling Systems designed for single-use applications.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] Bio-Simplex[TM] Manifold Sampling Systems, available in four and eight 60ml bottle configurations, are designed for single-use applications where fluid sampling or storage to multiple containers is desired. One-piece...

Small-batch fine grinder offers scaleable results.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] The MicroCer, with Yttria Zirconia grinding zone parts for metal/contamination free grinding, offers precise, repeatable and completely scaleable results to test small batches (75-400 mI) of high-quality, high-cost...

Automation products offered with WirelessHART[TM] standard.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] Smart Wireless range of pressure, flow, level, temperature, and vibration transmitters and gateways are now available with WirelessHART standard communications, as is AMS[R] Suite predictive maintenance software and...

Feeder features expanded hopper design.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] New version of the KT20 Pharmaceutical Feeder includes a specially expanded hopper design. Due to the higher open area directly at the base of the hopper, this design lends itself particularly well for cohesive...

Aseptic sampling device is completely disposable.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] Aseptic sampling device is a fully disposable, completely assembled system for biopharmaceutical fluid sampling. It provides a simple means for biopharmaceutical manufacturers to safely and cost-effectively monitor...

Low-flow hygienic diaphragm valves available in fractional sizes.(INTERPHEX2008 Wrap-Up)
May 1, 2008... The Bio-Pure valve platform, available in sizes from 1/4"-1/2" features the Advantage[R] Excel series S pneumatic actuator, providing years of trouble-free operation in a maintenance-free autoclave capable design. Advantage Excel series S are...

Capsule filling machine designed for highly potent substances.(INTERPHEX2008 Wrap-Up)
May 1, 2008... [ILLUSTRATION OMITTED] The GKF HiProTect series is a fully integrated containment capsule filling system for processing potent substances. The design of the GKF HiProTect prevents contact between the operator and potent substances,...

Hose assemblies increase flexibility in pharma/biotech applications.(INTERPHEX2008 Wrap-Up)
May 1, 2008... PAGE-flex SBF[TM] PFA Hose assemblies utilize a smoothbore PFA tube and a bonded wire braid--silicone--textile braided composite, giving the product superior bend radius, kink and vacuum resistance. Hoses can be supplied with a conductive liner...

Full line of solid dosage equipment available.(Cool Technology: Tabletting)
May 1, 2008... [ILLUSTRATION OMITTED] Company offers the: OYSTAR Manesty XPRESS[R] 300 Range Tablet Press suitable for small to medium batch sizes. The compact XPRESS[R] 300 offers numerous benefits including: high yields and excellent weight consistency...

Friability tester handles the hardest solid dosage forms.(Cool Technology: Tabletting)
May 1, 2008... [ILLUSTRATION OMITTED] The Friabimat SA-400 delivers friability testing for even the hardest, most robust solid dosage forms. With tests taking an average of just 2 to 4 minutes, the system is suitable for both QC and research...

Tablet counter assists with batch verification.(Cool Technology: Tabletting)
May 1, 2008... Line of automated tablet/capsule counters are the ideal complement to QA/QC processes, batch verification, accuracy checks and repackaging for clinical trials. The KL25 is designed for low-volume counting; the KL50ic and KL50icf provide add/on...

Tablet Deduster offers features that eliminate cross-contamination.(Cool Technology: Tabletting)
May 1, 2008... The Kramer E4000 Tablet Deduster has a jumbo gap-welded helix designed to eliminate product cross contamination, accommodate higher throughputs and easy cleaning. The E4000 deduster is shown with a Ceia metal detector and the Kramer automated...

Straight-tube coriolis mass meter can adapt to varying applications.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] The OPTIMASS 1300 straight tube coriolis mass meter reliably records mass flow, density, temperature and concentration of both liquids and gases. In addition, the OPTIMASS 1000 sensor offers secondary containment as...

UV tunnel provides significant pathogen reduction.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] The UVGI packaging disinfection tunnel demonstrates a 7 log inactivation of key microorganisms. 7 log inactivation was achieved on the following pathogens: Enterobacter sakazakii, Enterobacter cloacae, Salmonella...

Ultra-compact pressure transmitter ideal for use when a digital protocol is not required.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] The new GC51 and GC52 gauge and differential pressure transmitters feature an ultra-compact NEMA 4X/IP65 enclosure measuring only 2.65" in diameter. Stainless steel wetted parts accommodate either wet or dry media....

Painted stainless steel enclosure offers cost-effective thermal management.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] The Type 4X stainless steel wall-mount enclosure is painted with a white polyester powder finish inside and out to reduce solar radiation absorption and keep internal components cooler. Its stainless steel...

Coulometric Titrator is ideal for most trace moisture applications.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] The AQUACOUNTER[R] Karl Fischer Coulometric Titrator model AQ-2100S features convenient,' quick, electrode cable attachment; fritless ceil, and an innovative cell design. Unit is available in 2 channel configurations...

Stainless steel adjustable levers offered in metric and inch sizes.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] These adjustable levers feature a solid, all stainless steel handle with a sand blasted satin finish. Inserts, screws and springs are also stainless steel. Levers are available in a variety of sizes, in tapped, blind...

Pulse jet filters handle high loads economically.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] Pulse jet air filters are custom built for efficient, economical operation in demanding applications. Particulate-laden air is directed toward a deflector that causes heavier particles to fall directly into the...

Flexible screw conveyors ideal for various dry solids.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] FlexFlite flexible screw conveyors use steel augers and flexible tubes up to 100 feet long to move materials at rates as high as 3,600 lbs. per hour. They are portable and ideal for conveying product from bags, bins,...

Conveyors feature counterweighted lift mechanism.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] Line of reciprocating vertical conveyors feature counterweighted lift mechanisms that cut the effective unit load weight in half, thereby reducing horsepower and power requirements. Standard models are available with...

Remote Mount thermal mass Flow Meter for hard to reach locations.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] The ST50 Remote Mount Flow Meter measures air flow from 1 to 125 SFPS (0.3 to 38 NMPS), nitrogen from 1 to 150 SFPS (0.3 to 46 NMPS) and compressed air from 4 to 400 SFPS (1.2 to 122 NMPS). Accuracy is +1% of...

Vision sensors are easy to configure.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] The multi-purpose VOS300 Series vision sensors combines a camera, illumination, digital outputs, process data and five powerful evaluation methods into a single sensor housing. The vision sensing unit is easily...

Robot designed for use in aseptic processes.(New Products)
May 1, 2008... [ILLUSTRATION OMITTED] The STERICLEAN robot is designed to work in barrier isolator systems used in aseptic processes. The robot is designed to eliminate the highest source of contamination--human operators. The unit also addresses...

Feds seize more than $100,000 of unapproved drugs marketed as "natural supplements".(FDA Update: A monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration.)
May 1, 2008... At the request of the FDA, U.S. Marshals recently seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturale Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were...

FDA appoints Dr. Frank M. Torti to senior leadership position.(FDA Update: A monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration.)
May 1, 2008... Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. recently announced the appointment of Frank M. Torti, M.D., M.P.H. as the FDA's Principal Deputy Commissioner and first Chief Scientist. The newly created Chief Scientist...

FDA approves vaccine to prevent gastroenteritis caused by rotavirus.(RECENT APPROVALS)
May 1, 2008... The FDA has announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a...

FDA approves over-the-counter Children's Cetirizine Oral Solution.(RECENT APPROVALS)
May 1, 2008... FDA has given final approval to Perrigo Company to manufacture and market over-the-counter (OTC) Children's Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1mg/mL. * The...