Pharmaceutical Processing articles from April 2006

Pharmaceutical Processing archives from April 2006

Direct-to-consumer marketing--changes afoot?(From the Editor)
April 1, 2006... It is not news to hear about the issues facing the U.S. pharmaceutical industry: shrinking pipelines, high costs of R&D, increased competition from both here and abroad, public perception of a greedy industry, drug safety issues, the cost and...

Tank cleaner complies with cGMP guidelines and FDA requirements.(What's Hot)
April 1, 2006... The SaniJet 25 cleaning device is designed for use in ultra-hygienic industries that follow European Hygienic Engineering and Design Group Guidelines (EHEDG). It is suitable for use in fermentation, mixing, processing and storage tanks and...

Smooth bore hose eliminates particle entrapment.(What's Hot)
April 1, 2006... FlexPro[TM] PTFE fluoropolymer hose is specifically engineered for a smooth bore ID with ultra-flexibility. The smooth ID surface results in an unimpeded flow with no particle entrapment. The hose is sterilizable for high purity and steamable...

Sample coolers designed for pharmaceutical applications.(What's Hot)
April 1, 2006... Sanitary sample coolers are specifically designed for the safe taking of samples for chemistry/ TOC, conductivity and microbiological studies from steam or heated water systems. Units are specifically designed to be used in pharmaceutical...

Dust containment cabinets ideal for hazardous materials and biosafety applications.(What's Hot)
April 1, 2006... The Series 1522 Inflow Dust Containment Cabinets are available in a variety of sizes and styles, with a painted steel finish compatible with all typical cleanroom environments. Features and benefits include an acrylic hood for durability and...

Disposables: pushing on an open door.(Cover story)
April 1, 2006... As little as three years ago disposables were often seen as the preserve of the bio contract manufacturer--a useful item in the "flexibility" toolbox. Today, the market in disposables and single-use systems in cell culture applications is...

Disposable clamps made from reinforced nylon.(Cool Technology: Filtration & Separation)
April 1, 2006... The lightweight and easily manipulated Bio Clamp can be autoclaved repeatedly and gamma irradiated It also has a perforated wing nut to facilitate a tamper proof tie. It is supplied in sizes from 1/2" to 4". The Bio Clamp, together with the...

Water treatment/ purification systems.(Cool Technology: Filtration & Separation)
April 1, 2006... The "PS" line of high-pressure and high-flow pilot operated solenoid valves is now available in an extended range of sizes and materials. With PTFE bellows seal, pressure ratings to 140 PSI and Cv's to 80, the PS series is designed for...

Separators protect product purity and equipment.(Cool Technology: Filtration & Separation)
April 1, 2006... Sanitary-grade separators are designed for use where products intended for human or animal consumption are handled in final form. Type 304 stainless steel is the standard material used for bodies and flanges. Type 316 stainless is an option All...

Nanofiltration elements ideal for selective rejection applications.(Cool Technology: Filtration & Separation)
April 1, 2006... Fluid Systems[R] TFC[R]] SPIRAPRO spiral nanofiltration elements lower operating costs for a wide variety of selective rejection applications, including desalting and organics concentration. The elements utilize a polyamide thin-film composite...

Innovative packaging of frozen dendritic cell vaccine.(Solutions)
April 1, 2006... Melanoma is a form of skin cancer. The American Cancer Society estimates that there will be 59,580 new cases of melanoma and 7,770 deaths from melanoma in 2005 (1) . Since 1999, Baylor Institute for Immunology Research in Dallas, TX has carried...

Pillow tanks made to user specifications.(Cool Technology: Disposable Manufacturing)
April 1, 2006... Flexible pillow tanks are made to the user's exact specifications. Units are available in almost any size and can be mixed and matched with 10 different materials, such as polyurethane, polyethylene, and reinforced polyethylene A wide variety...

Aseptic bag filling machine compliments line of bags and disposables.(Cool Technology: Disposable Manufacturing)
April 1, 2006... Company now offers aseptic bag filling to compliment its complete line of customer bags and disposables for use in pharmaceutical manufacturing. Filling machine is capable of filling from 100 ml to 20 liter bag sizes, with less than a minute...

Platinum-cured silicone tubing is reliable and cost-effective.(Cool Technology: Disposable Manufacturing)
April 1, 2006... PharmaFocus tubing been designed specifically for the pharmaceutical industry. The silicone undergoes a battery of biocompatibility tests appropriate for pharmaceutical applications, eliminating costly extended implant studies typically...

Filter assemblies available in disposable models for biomanufacturing.(Cool Technology: Disposable Manufacturing)
April 1, 2006... The UltraCap[R]Inline and T-style versions are available for disposable filtration in biomanufacturing. The UltraCap[R] assembly is an integrally sealed filter and housing system. This completely disposable system saves cleaning and cleaning...

Disposable bioreactors offer easy scalability from R&D to production.(Cool Technology: Disposable Manufacturing)
April 1, 2006... The NUNC Cell Factory is designed to meet increased demand for flexible, safer and low-investment solutions for bioproduction. Applications include production of vaccines, commercial cell lines, biopharmaceuticals, antibodies and antigens. All...

Disposable technology improves fluid handling in depth filtration.(Applications)
April 1, 2006... Conventional lenticular disc filters have long been the standard in clarification and prefiltration process steps. The effectiveness of the charged depth filtration media make these filters ideal for use in mammalian cell culture applications....

Snap-in module with probe can be panel mounted or stands alone.(Process Components)
April 1, 2006... Traceable[R] snap-in module features a stainless steel probe with an extended 10 foot cable and easy-to-grab handle. Unit records minimum and maximum energy reading over any time period. Temperature range encompasses virtually all testing...

Conduit adapters offer quick disconnect compatability.(Process Components)
April 1, 2006... Company's variety of conduit adapters is designed for transitioning from conduit to 7/8-16UN minifast, M12 eurofast and M23 multifast connectors. The front of the adapter provides quick disconnect compatability, while the back provides screw...

FEP hose is kink, crush and abrasion-resistant.(Process Components)
April 1, 2006... Hose is made of virgin-grade FEP with a smooth liner that provides excellent chemical resistance, unrestricted flow, and zero moisture absorption. Reinforced with multi-layered rubber, polyester cord and a double helix wire for optimum support,...

Variable flow static mixer features automatic modulation.(Process Components)
April 1, 2006... The Model 2900 Variable Flow Static Mixer uses two in-line wafer type mixers: one fixed and one variable that adjusts incrementally to adapt to changing flow conditions. Featuring automatic modulation to maintain 3 psi, regardless of flow rate,...

Big pharma and biotechs in buying mode at INTERPHEX2006.(INTERPHEX2006 Wrap-Up)
April 1, 2006... Usually trade shows represent the beginning of the sales cycle, when products are introduced to the market for the first time, and the sales team identifies new prospects and potential customers they have not had the opportunity to meet before....

FDA initiative helps expedite development of flu vaccines.(Industry News)
April 1, 2006... The FDA recently issued recommendations to aid manufacturers in developing seasonal and pandemic influenza vaccines. FDA's goal is to expedite the development and availability of safe and effective vaccines needed to protect against influenza....

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

Biomarker guidance to require fit for use validation.(Regulatory Update)
April 1, 2006... FDA's biomarker qualification guidance will establish a "fitness for use" standard for marker validation, Deputy Commissioner for Operations Janet Woodcock said. The Pink Sheet reports. The guidance would make the evidentiary standard for...

FDA to provide updates on critical path opportunities list projects.(Regulatory Update)
April 1, 2006... FDA will highlight the agency's involvement in Critical Path projects in the coming months, Deputy Commissioner for Operations Janet Woodcock said March 16. "We are going to issue a report on what projects we're involved in--probably...

Expedited decision on Tysabri?(Noted)
April 1, 2006... FDA says it is trying to complete its review of Biogen Idec/Elan's Tysabri before the new June 28, 2006 review deadline. Natalizumab's user fee date is being extended 90 days to review changes to the drug's risk management plan. The Tysabri...

IMS global Rx sales.(Noted)
April 1, 2006... North American pharmaceutical sales growth was outpaced by all other markets in 2005, IMS Health reports. For the year, sales in North America grew 5.2% (to $265.7 bil.), compared to 7.1% growth in Europe (to $169.5 bil.), 6.8% growth in Japan...

PhRMA is moving.(Noted)
April 1, 2006... PhRMA is relocating its offices effective April 1 to 950 F Street NW, Suite 300, Washington, D.C. 20004. The new office will have additional space and will allow the trade group to consolidate its departments under one roof. Included in the...