Pharmaceutical Processing articles from December 2008

Pharmaceutical Processing archives from December 2008

A triple win scenario.(FROM THE EDITOR)
December 1, 2008... Shocked, taken aback, briefly without words. This was my freshman public speaking professor's reaction to a fellow classmate's reply to a statement she had just made about the government. I don't recall the exact details of the discussion but...

Single-supplier sourcing in clinical trials: is the multiple supplier route the way to go? Perhaps not ...(CLINICAL TRIALS)
December 1, 2008... Fueled by longer life expectancies, new diagnostic technologies, advances in medical equipment, and the fluctuating world economy, the healthcare industry is in a state of evolution. As a result, the efficiency of clinical trials materials...

Contract manufacturing: new clarification technology provides disposable, flexible and scalable solution.(Cover story)
December 1, 2008... Addressing the Challenges Organizations Are Facing As the market for biopharmaceutical products rapidly expands, pharmaceutical and biotechnology companies are increasingly turning to Contract Manufacturing Organizations (CMOs) to help...

From a vision to a vial in twelve months: process development and cGMP manufacture for Cleveland BioLabs Inc. (CBLI).(SCALE-UP)
December 1, 2008... In September 2006, Cleveland BioLaps Inc. approached SynCo with a challenge--could they help to develop a production process, scale up, and manufacture a cGMP batch of their recombinant protein treatment for exposure to radiation (Protectan...

Multiple vessel processing system for research, development, pilot and clinical trial batches.(WHAT'S HOT)
December 1, 2008... [ILLUSTRATION OMITTED] The MVP-50 can replace multiple blending suites. By processing, transporting and storing material in the same vessel, operator and product exposure are reduced. From bins to Twin Shell[R]s, the system accommodates...

Iris diaphragm valve designed for precise flow control of powder and granular materials.(WHAT'S HOT)
December 1, 2008... [ILLUSTRATION OMITTED] The Mucon Iris Diaphragm Valve is available in manual, pneumatic and motorized operation and the dust tight design allows for infinite flow control from full bore to trickle feed. The valve comes in a variety of...

Gauges incorporate advanced features for pressure monitoring.(WHAT'S HOT)
December 1, 2008... [ILLUSTRATION OMITTED] Digital pressure gauges incorporate value-added features to advance the way users monitor pressure. Attributes include a backlit LCD, selectable engineering units and min/max recall. The commercial Type D1005PS is a...

Oxygen permeation analyzer offers easy operation.(WHAT'S HOT)
December 1, 2008... [ILLUSTRATION OMITTED] The OX-TRAN[R] Model 1/50 oxygen transmission rate (OTR) analyzer is designed for simple out-of-the box user installation and includes an absolute coulometric method, built in software to minimize user error and...

Injection-molded polysulfone flow meters provide good chemical resistance.(FLUID HANDLING)
December 1, 2008... Manufactured from polysulfone, a heat-resistant thermoplastic material, these flow meters provide good chemical resistance. Inherently stable flow indications provide accuracy, repeatability of readings and allow for virtually maintenance-free...

Programmable dispensing system uses precision stepper motors to control piston pumps.(FLUID HANDLING)
December 1, 2008... The PDS-100 is a programmable dispensing system which uses precision stepper motors to control a variety of the company's patented valveless piston pumps. The PDS-100 has a range from 500. nanoliters per dispense to 2 liters per minute...

Sanitary pump offers clean-in-place capabilities.(FLUID HANDLING)
December 1, 2008... Sanitary pump is available in a convenient clean-in-place design for quick and easy cleaning. The suction housing is equipped with an additional sanitary connection to accept flow bypass piping and valves. During CIP operation, cleaning...

All-plastic butterfly valves designed to replace metal valves in larger size piping systems.(FLUID HANDLING)
December 1, 2008... [ILLUSTRATION OMITTED] Desigfied for long-term performance and flexibility, BYB Series industrial butterfly valves feature a rugged, one-piece plastic body that can stand up to high flow rates and elevated stress conditions. Lever operated...

Lab glass-and plastic-ware designed for all life science labs.(BIOPHARM MANUFACTURING)
December 1, 2008... [ILLUSTRATION OMITTED] Product line addresses the broad spectrum of life science applications including cell preparation, cell growth and cell disruption. The BioPortfolio line consists of two categories, BioSciWare[TM] and BioWise[TM[...

Smoothbore hose promotes increased drainability in biopharm applications.(BIOPHARM MANUFACTURING)
December 1, 2008... [ILLUSTRATION OMITTED] Coreflex[TM] Series U-COR hose features a Teflon[R] PFA core tube for cleanliness, compatibility, and temperature capabilities in sanitary applications. The smooth bore hose is designed to maximize hoop strength,...

Bioprocessing bags available sterilized and ready-to-use.(BIOPHARM MANUFACTURING)
December 1, 2008... [ILLUSTRATION OMITTED] Standard Flexboy[R] Bioprocessing bags are designed for the preparation, storage and transport of biopharmaceutical solutions, intermediates and final bulk products. Flexboys are available as sterilized and ready to...

Magnetic agitators meets the highest hygienic requirements.(BIOPHARM MANUFACTURING)
December 1, 2008... [ILLUSTRATION OMITTED] The BMR Series features absolute sealing, low maintenance requirements and more space on the tank cover for all types of connectors. The open design of the magnetic impeller permits cleaning in place operations. A...

Cell culture program brings products and services together for researchers.(BIOPHARM MANUFACTURING)
December 1, 2008... Company's Cell Culture Excellence[TM] program recognizes the importance of cell culture and its role in key research areas such as functional biology, disease studies, and cell-based drug discovery, and brings together a full array of...

Steam sterilizable sensor reduces costs for sanitary pH measurement.(BIOPHARM MANUFACTURING)
December 1, 2008... The SE Series pH electrodes are 12 mm diameter, gel filled, sealed combination pH electrodes that are designed for use with the company's SF Series fittings. These exceptionally smooth-surface fittings are able to be cleaned/sterilized in...

Simple to operate chromatography columns are available in a range of diameters.(BIOPHARM MANUFACTURING)
December 1, 2008... AxiChrom columns, a new concept in low-pressure chromatography, have been designed to support the lean-enabling approach to column operation and maintenance. Through Intelligent Packing, intuitive handling and predictable scale-up, AxiChrom...

Light scattering system requires just 2 microliters for biomolecular characterization.(BIOPHARM MANUFACTURING)
December 1, 2008... [ILLUSTRATION OMITTED] The Zetasizer [micro]V is an advanced light scattering system specifically intended for the characterization of proteins and other biomolecules. Unit is designed and optimized for maximum sensitivity and minimum...

Forklift attachment provides extra safety during drum lifting.(NEW PRODUCTS)
December 1, 2008... [ILLUSTRATION OMITTED] The L4F-QC forklift attachment includes an automatic cam device which locks the attachment to the forklift eliminating safety chains and the need for a driver to dismount the truck to secure the attachment to the...

Frequency control for blowers reduces energy costs.(NEW PRODUCTS)
December 1, 2008... [ILLUSTRATION OMITTED] The Omega Frequency Control (OFC) for positive-displacement blower packages continuously adjusts the blower speed--precisely matching blower delivery to the actual process flow demand. Unit can be used with...

Agitators designed for wide range of service.(NEW PRODUCTS)
December 1, 2008... The Model 20 HT/GT agitators are designed for a wide range of service in the pharmaceutical, chemical, and other general process industries. The agitators feature a high-efficiency gearbox designed specifically for agitator service. Models are...

To serve and protect: protect sensitive electrical controls while maximizing sanitary conditions.(ENCLOSURES)
December 1, 2008... Stainless steel electrical enclosures and cable management systems such as cable tray are used to protect vital processing controls, electrical systems, and data and power cabling in pharmaceutical applications. Yet while these enclosures and...

Today's tug-of-war--balancing speed with risk: reduce your recall risks and boost supply chain efficiencies with rapid screenings for microbial contamination.(TESTING)
December 1, 2008... [ILLUSTRATION OMITTED] Contamination in pharmaceutical products makes headlines, creates potential nightmares for drug manufacturers, and shakes the confidence of patients, physicians and regulatory authorities. Contamination causes a...

The lowly gasket: a materials science evolution: from humble beginnings the gasket has evolved into a technological tour de force.(PROCESSING)
December 1, 2008... The earliest sanitary process systems and lines used by the dairy, food, beverage and fine chemical or pharmaceutical processors were glass. Glass was an obvious choice, because it was an established technology, and glass was inert and...

Rotational viscometer provides both steady shear and yield stress testing in compact size.(NEW PRODUCTS)
December 1, 2008... The MERLIN Viscometer is a high performance rotational viscometer capable of both steady shear and yield stress testing in a rugged, compact size footprint. Designed for performing both routine rheological tests such as single point viscosity...

Custom manufactured batch tanks available with product specific agitation.(NEW PRODUCTS)
December 1, 2008... Company custom designs batch processors from pilot plant scale-up size to 6,000 gallon production units, each with tested and proven mixing options to meet those processing parameters. For liquids with low viscosities, below 10,000 CPS, various...

Pharmaceutical design horizontal peeler centrifuge designed for frequent product changeover.(NEW PRODUCTS)
December 1, 2008... This unit is not a modified chemical style peeler centrifuge, but a truly new design taking in all of the key requirements of pharmaceutical production. This unit's key design specifications include automated, certifiable cleaning in a closed...

FDA avoids shortage and strengthens safety of Sucraid.(FDA UPDATE: a monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration)
December 1, 2008... The FDA has issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution. The approval will prevent a product shortage by allowing the sole manufacturer of the...

FDA teams with WebMD for new online consumer health information.(FDA UPDATE: a monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration)
December 1, 2008... The U.S. Food and Drug Administration and WebMD have announced a collaboration that expands consumers' access to the agency's timely and reliable important health information. This joint effort reflects the FDA's emphasis on using innovative,...

FDA approves new drug to alleviate moderate to severe pain.(RECENT APPROVALS)
December 1, 2008... The FDA has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. * Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg. *...