Particles

02/01/2006

Compiled by Angela Godwin

M+W Zander lands major contract

Engineering, construc-tion and manage-ment firm M+W Zander (Stuttgart, Germany; www.mw-zander.com) has received a major contract-valued at about 700 million euros-to engineer and construct a new semiconductor facility in the Middle East. In addition to general construction, the project includes setup of the technical facility equipment and approximately 200,000 square feet of cleanroom space. The company plans to complete the construction phase of the project in Q3 2007.

New strategy expected to improve efficiency

Sartorius (www.sartorius.com), an international laboratory and process technology provider, has recently merged each of its Sartorius Biotechnology business areas into one group. The transformation is expected to allow the company to utilize its resources in the most effective and efficient manner. According to the company, Sartorius can now supply and support the entire process chain, from upstream through downstream, including final form and fill.

FDA warns manufacturers of fraudulent flu products

Last month, the FDA warned nine companies to stop marketing their flu products, which claim to be effective for preventing avian flu or other flu strains. These claims, the FDA says, are unproven and deceptive, with no supporting scientific evidence to demonstrate the effectiveness or safety of the products. Acting FDA Commissioner Andrew von Eschenbach expressed concern regarding the use of unsubstantiated flu therapies, stating that it “increases the risk of catching and spreading the flu...because people assume they are protected and safe, and they aren’t.”

FFU performance testing

With support from the California Energy Commission’s Public Interest Energy Research (PIER) Program, Lawrence Berkeley National Laboratory (LBNL) is performing standardized testing of the energy performance of fan-filter units (FFUs) at no cost to participants. LBNL is seeking loan or donation of 2’ x 4’ fan-filter units for testing. Those supplying units will receive the test results for their units: energy performance at various airflows and pressure conditions. All participants will be kept anonymous in LBNL testing and in subsequent publications. The new performance information obtained will support the design and application of energy efficiency units. Relevant activities were previously reported in a special report “FFUs: Setting a course for energy efficiency” (CleanRooms, September 2004). Those wishing to participate should contact: Tengfang (Tim) Xu, Ph.D., PE, (510) 486-7810, e-mail: [email protected].

Reprocessed devices spark debate

A Washington Post (www.washingtonpost.com) article questioning the safety and reliability of reprocessed medical devices has generated a flurry of discussion. The December 11 article cited several examples where, it alleges, reprocessed medical devices had failed and caused patient injury. The article also points out the lack of FDA oversight in the reprocessing industry. On December 12, The Association of Medical Device Reprocessors (AMDR; www.amdr.org) issued a press release refuting the allegations, stating the article was “deliberately misleading.” AMDR maintains that there is no evidence to support increased patient risk when reprocessed medical devices are used. Original equipment, it says, can occasionally fail as well. The organization insists that reprocessing results in a safe, sterile, functional product and says that the FDA has stringent reprocessing-related regulations to ensure patient safety. Reprocessing of medical devices, says AMDR, saves healthcare dollars.