In the Spotlight September 2011

Editors' Picks of Pharmaceutical Science & Technology Innovations

As science advances and regulations evolve, new classes of products become available. Recent years, for example, have witnessed increased emphasis on highly potent products and biopharmaceuticals. As patients' demands change, drugmakers must have the proper equipment to produce needed medicines. This month's products help manufacturers respond to public demand and regulatory requirements. A tablet press from Manesty produces scalable results. Biocontainers from Meissner provide thermal stability for sensitive products. Emerson's pinch valve helps provide precise flow control.

Tablet press enables adjust-ments to precompression force

Bosch–Manesty's Xpress 100 R&D rotary tablet press incorporates a hybrid turret that uses four stations of B- or D-format punches and dies. The turret's four unused stations are blanked off. Users can exchange cams rapidly, rather than exchanging turrets. The machine's cams are double-sided, and the upper cam track includes a cut-out that lets users access and remove punches. Lower punches can be removed when they are at the level of the ejection cam, which is open. Users can adjust the precompression force from 0 to 4 kN independently of the main compression.

Xpress 100 rotary tablet press Bosch–Manesty www.boschpackaging.com

The tablet press includes load cells that analyze precompression, main compression, ejection, scrape-off, and punch-tightness forces. A servo motor and encoder for the turret calculate theoretical punch displacement, which tells personnel the exact position of the punch at all times. One paddle feeder fills the necessary amount of powder into the dies and replicates powder feed behavior at production scale.

Biocontainers provide chemical resistance

The FluoroFlex biocontainers are the most recent addition to Meissner's One-Touch series of single-use systems. Based in polyvinylidene fluoride, the biocotainers are made of a recently developed, multilayer coextruded film that was designed to meet the demanding requirements of the pharmaceutical industry. The FluoroFlex products can be used for all applications for which traditional polyolefin-based biocontainers are appropriate. The film was designed to provide thermal stability, chemical resistance, and robustness that exceed those of traditional polyethylene-based biocontainers.

FluoroFlex biocontainer Meissner Filtration Products www.meissner.com

Pinch valve automates control of sterile liquids

The Baumann 85000 sanitary pinch valve from Emerson Process Management offers an automated solution for control applications within single-use manufacturing. The valve is designed to enable consistent quality, better record keeping, and improved batch control. Its Fisher Fieldvue digital valve controller provides an installed equal-percent flow characteristic for precision control. Combining the valve with a PlantWeb system facilitates technology transfer for process scale-up.

Baumann 85000 pinch valve Emerson Process Management www.emersonprocess.com

The Baumann 85000 can clamp around existing disposable tubing, which enables the user to bypass extractables and leachables testing on the liner, thus ensuring compatibility with the liquid-control process and compliance with FDA requirements. Its tube–shell design eliminates the need to replace the liner with each batch, which simplifies changeout of disposable tubing between batches and reduces users' inventory. Its epoxy-coated actuator features stainless-steel fasteners that enhance corrosion resistance. Also, the valve plunger does not contact the process fluid and operates with a shutoff rating equal to ASME/FCI 70-2, Class VI.