Pharmaceutical Processing articles from August 2006

Pharmaceutical Processing archives from August 2006

Clinical trials get the once over.(From the Editor)
August 1, 2006... I believe in synchronicity. What is synchronicity you ask? Synchronicity is a term developed by Carl Jung to describe "temporally coincident occurrences of a causal events". To put it into plain English and based on Wikipedia's entry on the...

Magnetic metal separators offer continuous protection.(What's Hot)
August 1, 2006... Magnetic metal separators offer continuous permanent-magnet protection against ferrous debris, capturing even small ferrous particles and weakly magnetic or work-hardened 300-series stainless steel fragments. Cartridge-style magnetic liquid...

Washer equipped with modular process control system.(What's Hot)
August 1, 2006... The Reliance 9800 is intended for thorough cleaning of various materials and components such as large vessels, containers, drums, Integrated Bulk Containers (IBC's), pallets, blenders, hoppers, and other large items. The washer can also be used...

Photostability Test Chamber is ideal for stress testing.(What's Hot)
August 1, 2006... The Q-Sun Xenon Test Chamber is ideal for stress testing and photostability testing in accordance with ICH guidelines. The Q-Sun meets ICH guidelines, which specify 200 watt hours per square meter of UV for 1.2 million lux hours of visible...

Direct compressible starch offers strong binding.(What's Hot)
August 1, 2006... C*PharmGel DC 93000 is a direct compressible starch, which offers strong binding capabilities and fast tablet disintegration. Its unique flowability allows manufacturers to run tabletting machines at a higher speed thus giving a greater output....

Increasing the speed and flexibility of tangential flow filtration processing.(Cover story)
August 1, 2006... Tangential flow filtration (TFF) is a separation technique used for clarifying, concentrating and purifying proteins. In TFF, the fluid is pumped tangentially along the membrane surface. Particles or molecules which are too large to pass...

Liquid dispenser simplifies cleaning validation.(Cool Technology: Aseptic Processing & Packaging)
August 1, 2006... Liquid dispenser simplifies pharmaceutical and biotechnology cleaning validation with a new state-of-the-art peristaltic pump technology that results in significant cost savings. 100% security against product cross contamination is attained...

Fused glass cover/manway prevents particle accumulation.(Cool Technology: Aseptic Processing & Packaging)
August 1, 2006... Fused glass to metal sightglass can be used as a tank cover or manway. One piece construction offers reliability, safety and ease of opening and closing. Units are offered with ASME or without ASME approval. Material of construction is 316L...

Filling line systems offered with non-contact check weighing capability.(Cool Technology: Aseptic Processing & Packaging)
August 1, 2006... Company now offers BOC Edwards' 100% non-contact check weighing inspection equipment as part of a complete line. Benefits include: increased quality control and efficiency in accordance with the FDA's PAT initiative; and improved process...

High-speed cap crimper designed for aseptic environments.(Cool Technology: Aseptic Processing & Packaging)
August 1, 2006... The Road Runner Pharma high-speed aluminum cap crimper is suitable for clean room environments and is easily adapted for crimping aluminum caps on vials. It can process at speeds up to 400 BPM. Vial change parts require no tools. Capmatic...

Rupture panel prevents product build-up and contamination.(New Products)
August 1, 2006... The MVRB rupture panel is specifically designed to protect dust collectors, conveyor systems, dryers, and other equipment that requires precise overpressure protection. The smooth surface of the panel makes it well-suited for hygienic and...

Magnetic liquid gage ensures operator safety.(New Products)
August 1, 2006... The MagneStar non-intrusive liquid level gage provides accurate, level indications in a wide range of applications. The unit also protects operators from high pressure and/or high temperature fluids in a tank, process vessel or boiler while...

Transitioning from stainless steel to disposable connections.(Solutions)
August 1, 2006... The incorporation of disposable components into bioprocessing provides operational and safety advantages. Therefore, important question in the industry today is how to integrate single-use technologies with traditional stainless steel...

Glove is latex-free, hand specific and powder-free.(Cool Technology: Cleanroom Apparel & Accessories)
August 1, 2006... The DermaShield poly-chloroprene glove is designed as an alternative to latex products as it contains no vulcanization accelerators known to cause Type IV allergies. DermaShield features excellent flexibility and softness for extended wear...

Clean bench prevents contamination from entering work zone.(Cool Technology: Cleanroom Apparel & Accessories)
August 1, 2006... The Series 305 Horizontal Laminar Flow Clean Bench features a stainless steel table top with a white painted-steel shell, front access and interior lighting. The cabinet features "clean edge" construction that puts the hood and tabletop in...

Wipe is abrasion resistant and virtually free of particle generation.(Cool Technology: Cleanroom Apparel & Accessories)
August 1, 2006... The SYNERGY wipe is tough, abrasion resistant, very absorbent, and virtually free of particle generation. It is comprised of a blend of virgin polypropylene and cellulose that is layered and ultrasonically bonded into a uniform, super-tough...

Powered air purifying system offers unobstructed vision.(Cool Technology: Cleanroom Apparel & Accessories)
August 1, 2006... The RT Hood/PA30 PAPR system offers performance achieving fit factors above 100,000 (2004 RDECOM study), comfort offering unobstructed visibility without requiring a head band, and advanced NiMH battery technology and longer service life...

Polymeric microporous membrane characteristics--indicators for pharmaceutical performance.(Perspectives on Filtration)
August 1, 2006... There are a wide variety of microporous membranes available in market place. They are composed of different polymers, morphology, thickness, surface treatments, philicity, ire size, and pore size distribution. Each of these characteristics...

ISPE, INTERPHEX and Pharmaceutical Processing are looking for the world's most outstanding production facilities.(INTERPHEX 2007 Update)
August 1, 2006... Pharmaceutical facilities are critical assets that can have a significant impact on the success of a new or existing drug. At a time when the timely and cost-effective delivery of innovative new medicines to the marketplace is more crucial than...

Glassware washing: a look at your options.(Solutions)
August 1, 2006... Glassware washing techniques vary from lab to lab and can depend on the soil type inside the glassware, types of glassware and technique required by the laboratory's standard operating procedure. The three types of glassware washing we'll...

FDA announces new initiative to modernize clinical trials regulation.(Industry News)
August 1, 2006... The FDA recently announced a series of new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency's approach...

Javelin Pharmaceuticals wins Phase II SBIR grant.(Industry News)
August 1, 2006... Javelin Pharmaceuticals, Inc., a specialty pharmaceutical company with three late-stage pain drug candidates, recently announced it has been selected to receive a grant to advance clinical development of PMI-150 (intranasal ketamine) for pain...

Biologic treatment for wet age-related macular degeneration approved by FDA.(Industry News)
August 1, 2006... The FDA recently approved Lucentis (ranibizumab injection) for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD). Lucentis is the first treatment which, when dosed monthly, can maintain the vision of more...

Fiber optic luminaire is ex rated and CE compliant.(Process Components)
August 1, 2006... The Lumiflex provides an intense light output from 24, 120 or 230-volt halogen filament lamps through fiber optic guides for illumination ports. L.J. Star inc., Twinsburg, OH 44087. Call 330-405-3040. InfoLINK Enter 006-60801-104 at...

Supercritical fluid extraction system is highly accurate.(Process Components)
August 1, 2006... The SFT-]O0 is designed to perform extraction in a supercritical fluid media. Reliable, dual sapphire syringe pump technology rapidly and accurately pressurizes the unit's stainless steel vessel which is capable of containing supercritical...

Gas analysis sampling system for continuous monitoring.(Process Components)
August 1, 2006... The GASS-2040 conditions high-flow, high-moisture samples, eliminating acid mists or ammonia if present. It processes the toughest samples, with flows of up to 25 liters per minute and moisture contents in excess of 50%. The GASS-2040 can be...

Stainless steel tube fittings fit a variety of applications.(Process Components)
August 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...

FDA should fine companies with late studies, HHS OIG says.(Regulatory Update)
August 1, 2006... FDA should have the authority to sanction pharmaceutical manufacturers that are not adequately fulfilling their post-marketing commitments, the HHS Office of Inspector General suggests, The Pink Sheet reports. "Providing FDA reviewers with...

FDA needs bigger window to the public, say deputies.(Regulatory Update)
August 1, 2006... FDA may be looking to expand the scope of public discussion in the development of regulatory policy regarding emerging scientific issues. "I think there is an increasing desire to try to have more of a public discussion around some of the...

Merck U.S. Human Health management.(Noted)
August 1, 2006... Merck U.S. Human Health management: Merck/Schering Pharma-ceuticals General Manager Adam Schechter will succeed Brad Sheares as president of Merck's U.S. Human Health division, effective immediately. In his position heading the...

New OTR director.(Noted)
August 1, 2006... New OTR director: FDA appoints Vincent Vilker as director of the Office of Testing and Research, within the Office of Pharmaceutical Science. Vilker replaces Ajaz Hussain, who left FDA in October to become VP-biopharmaceutical development at...

Biogen Idec R&D president.(Noted)
August 1, 2006... Biogen Idec R&D president: Cecil Pickett will join Biogen Idec in September as president-R&D, a new position that combines the head of research and exec VP-development positions. His responsibilities will include discovery research, drug...