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Magazine on the processing and handling of pharmaceuticals and related products.
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Is anyone listening?(From The Editor)
August 1, 2007... I have a relative--who shall remain nameless--who is a vegetarian and very pro all-natural food, lifestyle, etc. Recently, she got mad at me after I made a flip comment in reply to her diatribe about "milk with hormones" in it. Now, mind you,...
Correction.(Correction notice)
August 1, 2007... In our July issue on Shanghai Roche Pharmaceuticals Limited (SRPL) we inadvertently reported that isolation valves allow the transfer of product with a concentration in the air of less than 10 [micro]g per cubic liter instead of the actual 10...
Ball valves offer superior flow dynamics and control.(What's Hot)
August 1, 2007... TRIAC "V" Series Control Port Ball Valves deliver precise, consistent flow control with the simplicity and sealing features of a ball valve. The V-port valves are available with 30[degrees], 60[degrees] or 90[degrees] V notch. Control ports are...
Breathing simulator designed to test.(What's Hot)
August 1, 2007... The Breath Simulator BRS 1000 is a microprocessor-controlled instrument that generates an air flow profile which simulates adult tidal breathing. Its sinusoidal waveform and I:1 inhalation/exhalation ratio specifically conforms to a recently...
Pump design eliminates many diaphragm pump deficiencies.(What's Hot)
August 1, 2007... The Kobio pump design solves many of the critical problems of diaphragm pumps. Three pneumatically actuated diaphragm valves arranged in series are the only components of the pump. The pump operates in a defined sequence; it is self-priming and...
Cook Pharmica targets biopharm outsourcing and wins award for facility integration: goal to deliver innovative analytical, development and manufacturing services with an emphasis on quality realized with renovated facility.(Facility of the Year Award)(Cover story)(Company overview)
August 1, 2007... When Cook Pharmica completed Project Phoenix, its $70 million contract biopharmaceutical services facility in Bloomington, Indiana in late 2006, its impressive construction schedule--10 months versus the industry norm of 18-36...
Aseptic bag filler eliminates cross contamination.(Cool Technology: Single Use Products)
August 1, 2007... The AFLI000 aseptic bag filler is a sterile single use disposable fill line. Features and benefits include: eliminates possibility of cross contamination; disposable filter part of the fill line; eliminates CIP/SIP and associated chemicals;...
Disposable biocontainer optimizes process efficiency.(Cool Technology: Single Use Products)
August 1, 2007... Allegro biocontainers feature a unique combination of design and materials that help manufacturers maximize product recovery and minimize risk of contamination. Biocontainers are manufactured from an advanced film that reduces extractables and...
Clamp eliminates distortion in non-metallic sanitary flanges.(Cool Technology: Single Use Products)
August 1, 2007... The Bio clamp is constructed of a glass reinforced nylon resin and does not promote distortion in non-metallic sanitary flanges as do stainless steel clamps. Due to its light weight they do not stress connection points and are easily...
Crimping solution allows for secure and easy separation of sterile disposable assemblies.(Cool Technology: Single Use Products)
August 1, 2007... The NovaSeal crimping solution is designed for use with single-use disposable assemblies. As part of the Mobius family of disposable bioprocessing technologies, the unit is ideal for sampling, transporting or transferring fluid, while ensuring...
Hydrogels: a novel drug delivery system: applications and uses in pharmaceuticals.(Drug Delivery)
August 1, 2007... Hydrogels are hydrophilic, three-dimensional networks, which are able to imbibe large amounts of water or biological fluids. They are insoluble due to the presence of chemical and/or physical crosslinks such as entanglements and crystallites....
Enclosure washdown 101: how pharmaceutical manufacturers can help ensure product and operations integrity through proper enclosure washdown procedures.(Washing)
August 1, 2007... Cleanliness may indeed equate with godliness, but pharmaceutical manufacturers will need more than divine intervention to ensure that the nooks and crannies of their processing environments are clean and contaminant-free. Maintaining a sanitary...
Keeping your cool: pressure transducers help process cooling systems "cool down" customers' reliability concerns.(Process Control)
August 1, 2007... The use of cooling water is prevalent in many manufacturing industries. In fact, cooling water is important in various production processes, whether to chill plastic following heat treating or to cool down vats during chemical processing.
...
Portable vessels accommodate specific processing and plant requirements.(New Products)
August 1, 2007... Portable vessels are available starting at 1 gallon, allowing for product scaling, product development, and/or small scale production. Vessels can be supplied with single-, double-, or triple-motion agitation systems with viscosity rating to 2...
Vertically adjustable operator interface system ideal for plant floor and process area applications.(New Products)
August 1, 2007... The MiniStation[TM] features the company's Vertica[R] articulating arm, providing up to 30" of counterbalanced vertical adjustability. The MiniStation's diverse selection of displays, keyboards, and pointers allows the user to specify the exact...
Laser coding coming of age in pharmaceutical industry: manufacturers, co-packers enjoy code permanence and improved productivity.(Package Coding)
August 1, 2007... The pharmaceutical industry is facing substantial challenges caused by the growth of drug counterfeiting and diversion in recent years. Because of these and other factors, such as medication dispensing errors, the industry is seeking better...
Dust collectors with high-performance explosion vent.(New Products)
August 1, 2007... The "GOLD SERIES[R]" dust collector is available with a high performance explosion vent for applications involving the capture of explosive dusts. The new "X-vent" is NFPA approved and CD and ATEX certified for European use. The multi-ribbed...
FDA grants fast track designation to Cardium's Phase 3 angiogenic gene therapy for heart disease.(Industry News)
August 1, 2007... Cardium Therapeutics recently announced that the FDA has granted fast track designation to the company's lead product candidate, Generx[TM] for the potential treatment of myocardial ischemia. Myocardial ischemia, insufficient blood flow within...
PennTech Machinery and Shanghai Tofflon sign joint venture.(Industry News)
August 1, 2007... PennTech Machinery Corporation has announced the signing of a joint venture agreement between PennTech Machinery Corporation and Shanghai Tofflon Science and Technology Corporation. The joint venture, to be called PennTech-Tofflon, is located...
FDA approves first generic versions of Lamisil tablets.(Industry News)
August 1, 2007... The FDA has approved the first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). Such infections occur when fungi invade a fingernail or toenail or the skin...
Glatt to host solid dosage symposium.(Industry News)
August 1, 2007... Glatt Pharmaceutical Services will be hosting Industry Trends in Controlled Release Pharmaceutical Dosage Form Development Symposium September 18-20, 2007 in Mahwah, New Jersey.
Featuring a distinguished roster of speakers including Keynote...
Caraco announces tentative FDA approval for generic Provigil[R].(Industry News)
August 1, 2007... Caraco Pharmaceutical Laboratories, Ltd., has announced that the FDA has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Modafinil Tablets (modafinil), 100mg and 200mg.
Modafinil is indicated to...
New report offers a detailed analysis of the leading players in the Indian pharmaceutical market.(Industry News)
August 1, 2007... Research and Markets has announced the addition of "The Indian Pharmaceutical Market to 2011: Competitive Dynamics and Major Players" to their offering.
Traditionally, the Indian pharmaceutical industry has been characterized by a core...
Postmarket safety managers begin oversight roles.(Regulatory Update)
August 1, 2007... Associate directors for safety and safety-regulatory program managers have begun their postmarket drug safety oversight roles within FDA's Office of New Drugs' 17 drug review divisions, The Pink Sheet reports.
The positions were created as...
FDA reform bills grow similar as House/Senate conference nears.(Regulatory Update)(Conference news)
August 1, 2007... The recently passed House FDA reform bill (H.R. 2900) includes several last-minute changes that bring it closer to the Senate version (S. 1082), suggesting Congressional efforts to ease the prospective merge of the bills in the upcoming...
FDA brass paid to stay.(NOTED)
August 1, 2007... FDA brass paid to stay: FDA employees received $9.5 million in retention bonuses last year, leaving Congress asking why as much was spent on retention as on increased food safety oversight. At a July 17 House Energy and Commerce Committee...
Tampering with Medicaid prescriptions.(NOTED)
August 1, 2007... Tampering with Medicaid prescriptions: Pharmacy groups are appealing to Congress to delay implementation of a new law requiring Medicaid prescriptions to be written on tamper-proof pads in order for the drugs to be reimbursable. Concerned that...