compiled by Angela Godwin
New space for growing engineering firm
Evergreen Engineering (Eugene, OR; www.evergreenengineering.com), an engineering consulting firm serving industries such as bioscience, clean manufacturing, and semiconductor, has leased 8,133 square feet of office space in Hillsboro, OR, in order to accommodate its growing staff. The new space will also provide an in-house venue for client-oriented training sessions and seminars.
FDA issues guidance for cGTP
Following serious allegations of safety violations against two cell manufacturers, the FDA last month issued a guidance to industry aimed at reminding manufacturers of human cells, tissues, and cellular- and tissue-based products (HCT/Ps) of their regulatory responsibilities. The guidance, “Compliance with 21 CFR Part 1271.150(c)(1) - Manufacturing Arrangements,” reminds HCT/P manufacturers that they are responsible for ensuring that current good tissue practices (cGTP) are observed-within their own establishments as well as by contract manufacturers. According to the FDA, cGTP “require manufacturers to recover, process, store, label, package and distribute human cells or tissues in a way that prevents the introduction, transmission, or spread of communicable diseases and prevents contamination during manufacturing.” “Patient safety is our primary concern,” said Jesse Goodman, MD, MPH, director of FDA’s Center for Biologics Evaluation and Research (CBER). “This guidance serves to emphasize the important role that manufacturers play in enhancing tissue safety by helping to ensure that those that perform work for them also comply with the regulations.” To access the guidance, visit http://www.fda.gov/cber/gdlns/cgtpmanuf.htm.
Microcontamination control company announces organizational changes
Particle Measuring Systems (PMS; www.pmeasuring.com), an industry leader in particle monitoring and microcontamination control, recently announced organizational changes to the company. Kristi Urquidi, a PMS employee for eight years, has transitioned from vice president of manufacturing to vice president of engineering. Paul Kelly, president of PMS, said, “Ms. Urquidi has done an outstanding job of developing our operations capabilities and will bring that perspective, along with her exceptional project management skills, to the engineering department.” In addition, Brad Schindler, who has extensive experience in the semiconductor industry, was named the company’s new director of manufacturing. Of the recent changes, Kelly said, “Particle Measuring Systems has experienced tremendous growth over the last several years. These changes position us to continue to lead the way in microcontamination monitoring as we develop new products and expand into new markets.”
New hybrid membrane technology
DuPont has introduced its Hybrid Membrane Technology (HMT), a new offering for air and liquid filtration that is designed to fill the performance gap between traditional nonwovens and microporous films. The material comprises continuous submicron fibers and is available on a commercial scale in the form of “membrane-like” sheet structures. HMT will be the leading technology provided in a portfolio of DuPont Nonwoven technologies that will be offered through DuPont Separations Solutions (DSS), a new growth initiative dedicated to developing and implementing technologies for filtration. According to Matt Trerotola, vice president and general manager of DuPont Nonwovens, “Trends ranging from stricter regulatory requirements to rising energy costs are requiring organizations in industries such as automotive, food and beverage, HVAC and life sciences to seek new separation and filtration technologies that deliver increased levels of safety and efficiency. The launch of the DuPont Separations Solutions initiative and the introduction of HMT demonstrate our commitment to providing these and other industries with the technologies required to fill their diverse needs-both today and into the future.”