In the Spotlight June 2009

Editors' Picks of Pharmaceutical Science & Technology Innovations

Drugmakers never stop looking for components and equipment that will create therapies more quickly, more reliably, and more efficiently. The industry's need pushes pharmaceutical and biopharmaceutical manufacturing technology to evolve continually. This month's featured products are designed to improve the speed and flexibility of the pharmaceutical production line. Continental Disc's rupture discs can withstand harsh conditions. Thomas Engineering has unveiled a tablet coater designed to facilitate cleaning validation and reduce contamination. And Millipore's membrane adsorber can remove impurities at high salt concentrations.

Tablet coater provides flexibility

The Accela-Cota Flex 500 production-class tablet coater from Thomas Engineering (Hoffman Estates, IL) incorporates drums that can be removed and exchanged in 30 min without tools. This feature lets operators dedicate a drum to a particular product, thus facilitating cleaning validation and reducing risk of cross contamination. The tablet coater accepts drums of various sizes, allowing users to choose the right drum for the process they must perform. Removing the drums enables operators to clean the inside of the coater thoroughly. The machine's mixing baffles are also interchangeable.

Accela-Cota Flex 500 tablet coater Thomas Engineering www.thomaseng.com

Rupture disc withstands severe conditions

Continental Disc (Liberty, MO) has added the MP unit to its SanitRX series of rupture discs. The product was designed for applications during which conditions frequently change between positive pressure and vacuum. The company moved the disc's score line from the contact side to the downstream side so that it is subject to less stress when pressure changes. The new position also improves the disc's cleanability. The disc can be cleaned or steamed in place.

SanitRX MP rupture disc Continental Disc www.contdisc.com

The disc complies with the American Society for Mechanical Engineers's bioprocessing equipment criteria for process-side surface finish and fully traceable metal and elastomer materials. The component also is free of polishing compounds, release agents, and animal derivatives. The disc is appropriate for pressure-vessel applications such as autoclaves, fermenters, and heat exchangers.

Membrane adsorber uses nontraditional chemistry

The ChromaSorb solution is a single-use anion-exchange membrane adsorber from Millipore (Billerica, MA) designed to remove negatively charged impurities. The product has greater binding strength at high salt concentrations than traditional resins and current membranes, according to the company. This strength results from a primary-amine gel with a high charge density that coats the adsorber's base membrane. The gel provides many areas of contact for negatively charged impurities such as host-cell proteins and viruses to bind.

ChromaSorb membrane adsorber Millipore www.millipore.com

Because ChromaSorb devices can continue to bind at high salt concentrations, no product dilution is required. The ChromaSorb product is designed for flow-through applications at the polishing step of the purification of monoclonal antibodies and recombinant proteins.