In the Spotlight January 2006

January 1, 2006
Pharmaceutical Technology, Pharmaceutical Technology-01-02-2006, Volume 30, Issue 1

New tubing specifically designed for peristaltic pumps has been introduced by Maztech (Elkton, MD, www.smartshieldtubing.com).

Durable Tubing for Peristaltic Pumps

New tubing specifically designed for peristaltic pumps has been introduced by Maztech (Elkton, MD, www.smartshieldtubing.com). The company's "SmartShield" tubing is lined with PTFE, which has several advantages, explains Michael Zumbrum, PhD, president of Maztech. PTFE gives SmartShield tubing "universal chemical compatibility," Zumbrum says. Its chemical resistance and highly reinforced design make the tubing durable. In addition, SmartShield tubing does not absorb preservatives that are present in process fluids. And, because PTFE does not need a plasticizer, there is no risk that this material will leach into process fluids.

SmartShield tubing (Maztech)

SmartShield tubing also can simplify validation. Zumbrum notes that because the tubing's product-contact surface is entirely PTFE, "a lot of barriers come down" because PTFE is inert. Zumbrum says that SmartShield tubing withstands pressures as much as 500 psig and, therefore, can be steam sterilized.

Validation Life Cycle Tracking Software

"CuroFDA" software from IT&E (San Diego, CA, www.iteinternational.com) is the first focused application for the management of validation within the pharmaceutical and biopharmaceutical industries, according to Jim Murray, IT&E's director of computer and laboratory system validation. CuroFDA software is fully Part 11-compliant and provides a centralized method for tracking the validation status of equipment, cleaning, and manufacturing systems within a company, regardless of its size. The application tracks deviations and records change controls against each validation independently.

CuroFDA (IT&E)

The software's tracking application reminds users about upcoming tasks and triggers revalidation by e-mail notification. Because the CuroFDA system holds information about the validation status of all a company's equipment and systems, it can help eliminate reduplication. The application provides full audit trails, preconfigured reports, and allows for ad hoc reporting.

Efficient Powder Disperser Reduces Batch Time

Quadro Ytron (Waterloo, Canada, www.quadro.com) has introduced its "ZC5" powder disperser. The unit's rotor–stator design creates a vacuum in the reactor head. Richard Franzke, marketing manager at Quadro, says that the vacuum created by the rotor–stator enables the instrument to pull in powder faster than other dispersers. The vacuum also helps the unit produce homogenous dispersions that are free of lumps. Uniform dispersions, in turn, allow the unit to wet powders in a single pass. According to Franzke, this technique "reduces batch time by up to 90%."

ZC5 (Quadro Ytron)

The ZC5 disperser easily integrates into bulk-powder delivery systems and, Franzke maintains, is the "highest capacity in-line high-shear powder disperser" currently available.

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