Pharmaceutical Processing articles from June 2008

Pharmaceutical Processing archives from June 2008

A sentinel for the industry: proposed two years ago by the Institute of Medicine, the Sentinel product safety system is now coming on-line. Will it be what the industry needs to restore faith in its drug safety monitoring procedures?(From The Editor)
June 1, 2008... As someone who has a vested interest in the pharmaceutical industry, I often check out the FDA's website. In addition, I subscribed to their e-newsletter which comes out about once a week. I find both the website and e-newsletters valuable...

Deduster allows tablets to be moved vertically.(What's Hot)
June 1, 2008... [ILLUSTRATION OMITTED] The VDS-150 is an upward conveying and dedusting system for tablets and capsules. The unit can be connected to the right or left side of a tableting machine. Outlet can be positioned 90, 180 or 270 deg. to the inlet....

Management Suite maximizes sensor performance.(What's Hot)
June 1, 2008... [ILLUSTRATION OMITTED] The iSense[TM] Asset Management Suite is designed for the maintenance, documentation and the management of pH and Dissolved Oxygen (DO) sensors. With iSense[TM], sensors used in the process are highly accurate, more...

Pneumatic drum inverter is easy to maneuver.(What's Hot)
June 1, 2008... [ILLUSTRATION OMITTED] Portable pneumatic drum inverter is designed to allow operators the ability to discharge drums into a variety of receiving vessels such as mix tanks, reactors, etc. The drum clamping system is custom designed to fit...

BMS's pharmaceutical development center of excellence wins Facility of the Year Award for equipment innovation: company creates first GMP operational clinical sterile continuous process isolation facility in the United States.(Facility Of The Year Award)
June 1, 2008... [ILLUSTRATION OMITTED] When Bristol-Myers Squibb conceptualized its new, more than $90 million pharmaceutical development center at its New Brunswick, New Jersey campus, the idea was to bring early and late phase clinical manufacturing and...

How to determine monitoring instrument calibration schedules: don't let your monitoring instruments put you at risk.(Instrumentation)
June 1, 2008... Ask yourself--"How long can we afford to have out of range conditions that go undetected by our monitoring instruments?" Most pharmaceutical processors endeavoring for full FDA compliance would answer that there is a zero tolerance for...

The track and trace challenge of the global pharmaceutical supply chain: electronic tracking is essential to meet regulatory and marketplace requirements.(Supply Chain)
June 1, 2008... The pharmaceutical industry's supply chain has become the focus of daily headlines, and often not in a positive way. Today's pharmaceutical products rely on ingredients and material from across the globe, and require the tightest, safest, and...

RFID in pharmaceutical applications: is it causing headaches or relieving them?(RFID)
June 1, 2008... [ILLUSTRATION OMITTED] On one hand, the pharmaceutical industry is no different than any other. Products are made at high speed, are subject to cost pressures and require better and better traceability to address possible recall issues. On...

Cutting edge batch production keeps pace with demand: CSL Behring AG keeps pace with demand and quality concerns.(Process Control)
June 1, 2008... CSL Behring AG in Bern, Switzerland, is a specialist in the production of plasma products such as immunoglobulin and albumin. The whole production process, from the blood plasma stage through to the usable drug, is subject to strict quality and...

Syringe assembly machine offers quick size changeovers.(New Products)
June 1, 2008... [ILLUSTRATION OMITTED] The compact Type 211 machine works with all marketed safety devices and offers quick and easy size changeovers. The continuous motion, single belt transport system provides smooth, precise and efficient handling...

Quick change sparger system for bioreactors and fermentors.(New Products)
June 1, 2008... [ILLUSTRATION OMITTED] Quick change sparger design reduces the time and effort it takes to replace sparger elements in bioreactors and fermentors. The porous metal element is available with a uniquely designed adapter that allows easy...

Agitators available in numerous styles.(New Products)
June 1, 2008... Single-motion, dual-motion, and counterrotating agitators, including inclined agitators, are designed specifically to handle a wide range of specialty products. Agitators can be designed for viscosities up to 2,000,000 CPS. Single-motion...

Tablet sample prep system enables higher lab throughput.(Cool Technology)
June 1, 2008... [ILLUSTRATION OMITTED] The RTS SolidPrep TM provides high speed preparation of tablets and other solid dose pharmaceuticals for assay, impurity and dose content uniformity applications. Using the SolidPrep TM most laboratories will be able...

Hydraulic calibration pump features damage-proof design.(Cool Technology)
June 1, 2008... [ILLUSTRATION OMITTED] The Magnum Pro M-10 features a range from 0 to 10,000 psi and can be used with either water or oil. The unit features a shatter proof reservoir, as well as other significant enhancements to eliminate the chance of...

Conductivity/TDS meter with RS232 output.(Cool Technology)
June 1, 2008... [ILLUSTRATION OMITTED] The CDH221 and CDH222 meters feature a splash-proof front, are portable, and can recognize and compensate for electrode offset and slope. This makes them ideal for quality control and other applications. Omega...

Magnetic flowmeter offers highly accurate dosing/filling control.(Cool Technology)
June 1, 2008... [ILLUSTRATION OMITTED] Type 8055 Full-Bore Magflowmeter permits precise, highly accurate dosing/filling con-across a wide array of flow applications. The continuous or batch control Type 8055 incorporates two transistor outputs (40VDC,...

Low permeability tubing is designed for high purity fluid transfer and is flexible and weldable.(New Products)
June 1, 2008... [ILLUSTRATION OMITTED] AdvantaFlex[TM], tubing is designed specifically for high purity fluid transfer. AdvantaFlex is manufactured from a biopharmaceutical-grade TPE (thermoplastic elastomer) and is flexible, weldable, and heat sealable...

Ultrapure water system is an alternative to centralized water purification/distribution loops.(New Products)
June 1, 2008... [ILLUSTRATION OMITTED] The Milli-Q Integral water purification system provides labs with an innovative alternative to centralized "loop" configurations. The Milli-Q Integral system's single water production unit produces pressurized pure...

Cambridge Major Laboratories breaks ground on manufacturing site.(Industry News)
June 1, 2008... Cambridge Major Laboratories has announced a major expansion into large scale API manufacturing. On June 5, 2008 the company broke ground on a new 120,000 sf, state-of-the-art API manufacturing site next to its headquarters in Germantown,...

Negron to lead Pall's manufacturing and supply chain operations.(Industry News)
June 1, 2008... Pall Corporation has appointed Senior Vice President Felix M. Negron to lead global manufacturing and supply chain operations for the company's Life Sciences business. Negron, a 20-year pharmaceutical operations and quality assurance...

Manufacturer removes remaining stocks of Trasylol from the U.S. market.(Industry News)
June 1, 2008... Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the US. market, most of which is in warehouses and hospital or physician's stock. The FDA will work with Bayer to...

Medimetriks Pharmaceuticals, Inc. begins operations.(Industry News)
June 1, 2008... Medimetriks Pharmaceuticals, Inc. recently announced that it has commenced operations. The newly-formed company, led by the founder and the key Senior Management Team of the former Bradley Pharmaceuticals, will develop, license and...

FDA obtains permanent injunction against Scientific Laboratories, Inc.(FDA Update: A monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration)
June 1, 2008... The FDA recently announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing...

FDA requests recall of Xiadafil VIP Tabs.(FDA Update: A monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration)
June 1, 2008... The FDA has requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared...

Barr announces approval of generic Yasmin.(FDA: RECENT APPROVALS)
June 1, 2008... * Barr Pharmaceuticals, Inc. recently announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin [R]...

FDA approves Amitiza for IBS-C.(FDA: RECENT APPROVALS)
June 1, 2008... * The FDA has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza...