In the Spotlight - Pharmaceutical Technology

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In the Spotlight
New product reviews for September 2012, featuring products for manufacturing.

Pharmaceutical Technology
Volume 36, Issue 9, pp. 28

Tablet press expedites changeover times



Fette's FE35 Tablet Press offers one of the fastest changeover times in its class. Its single-rotary design allows the machine to be fitted with up to 51 stations, enabling the production of up to 367,000 tablets per hour. The machine is assembled with detachable, FDA-certified polymer panels and offers 360-degree access. The FE35's direct torque drive offers energy-efficient, zero-maintenance operation. To increase flexibility, a switch cabinet can be positioned internally or externally, and the machine's power cabinet features an innovative cooling design. A fast, easy turret changeover set-up includes cams and punches, and is segmented to permit expedient refitting. Other turret features include a coded tablet scraper and coded filling cam detection, as well as a central, multifunction connector for oil, air, and electricity.

Fette Compacting America
http://www.fette-compacting-america.com/
Product available throughout North America

Aseptic transfer valve



ChargePoint Technology has launched its new aseptic transfer valve, which enables the safe and clean transfer of sensitive product. The design of the valve ensures the integrity of the critical sealing area by achieving a Grade A area within the valve itself. This method eliminates the need for the construction of Grade A areas in new plants and enables aseptic transfers to take place in lower class rooms in existing production areas. The two stage operation firstly involves steam cleaning in place of the active half of the valve, including assurance that the 'ring of concern' is clean. Then, vaporized hydrogen peroxide is introduced into a sealed chamber formed between the discs of the two halves of the valve to ensure that critical sealing faces are decontaminated before the transfer.

ChargePoint Technology
http://www.chargepoint.com/
Product available throughout North America and Europe

Robot-controlled antiswash effect



As the use of robots in pharmaceutical processes increases, swashing of liquid is often an undesired side effect with quick start-and-stop motions. Liquid coating the wall of the vial could adversely affect the freeze drying process. Optima pharma's robot control system keeps the meniscus level, even during quick combinations of lateral and rotational movement. The new, robotic control also inhibits swashing of liquid in the vial.

OPTIMA Packaging Group
http://optima-packaging-group.de
Product available throughout Europe

Wet mill improves API milling capabilities



The Quadro Ytron HV combines inline emulsification and wet mill capabilities in one machine, and offers more than 55 times the high shear energy of conventional rotor–stator systems with precise process scaling from laboratory formulation, to pilot and production processing. Other pharmaceutical applications for the machine include the development of submicron emulsions (high shear homogenizing with a droplet size = 0.2–1 Ám), drug suspensions (high shear wet milling with a particle size = 1–10 Ám), and topical formulations and semisolids (droplet/particle size = 0.4–3 Ám). The HV-Series features three different models ranging from 7.5–60 horsepower with capacities ranging from 1–285 L/min.

Quadro Engineering
http://www.quadro.com/
Product available globally

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
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