Compiled by Steve Smith
News snippets from the world of contamination control
Conference considers cleanroom cleaning
ROLLING MEADOWS, Ill. – Contamination-control working group sessions as well as a variety of tutorial classes covering issues related to cleanrooms and controlled environments will highlight the Institute of Environmental Sciences and Technology’s (IEST; www.iest.org) fall conference, to be held November 13-16 at the Hyatt Regency Woodfield, Schaumburg, Ill. Three new working groups-nanotechnology; recommended actions following disruptions in cleanroom operations; and methods of cleaning cleanrooms and equipment-will be meeting for the first time. The latest recommended practices will be discussed and developed. Registration information can be found at the IEST Web site.
Overseas operations opportunity
BETHESDA, Md. – James Lyda has been named the Parenteral Drug Association’s (PDA; www.pda.org) acting director of European operations. Based in Basel, Switzerland, Lyda formerly served as the PDA’s vice president for external and regulatory affairs. He has served with the Food and Drug Administration (www.fda.gov) for more than 20 years as an investigator and supervisory investigator, and has held responsibility for import operations and international affairs. His most recent FDA assignment was as deputy director of the international affairs staff in the Office of the FDA Commissioner.
BRAUNSCHWEIG, Germany – QSA GmbH, a manufacturing partner of biomedical nanotechnology developer pSivida Limited (www.psivida.com), has completed construction and validation of a state-of-the-art cleanroom facility at QSA’s Auriga Medical facility to supply the cancer therapy BrachySil. The cGMP facility is designed to fulfill the final process in the manufacture of the cancer treatment for future clinical and commercial use, and represents the final stage in establishing a marketing and supply infrastructure.
Laser lab launched
PORTLAND, Oreg. – Electro Scientific Industries (ESI; www.esi.com), a provider of production laser systems for microengineering applications, has opened a 20,000-square-foot research and development cleanroom facility. The company says its new cleanroom is designed to shorten the qualification period for tools and processes, helping to quickly transition projects from the lab to production. The facility includes separate labs for samples process, structural dynamics, controls and research. In addition to encouraging increased cross-sharing of ideas among company professionals, the facility is also designed to provide improved materials handling-considered critical to the further development of ESI’s next-generation laser programs.
Infected injectables identified
LANHAM, Md. – Bacterial contamination of three different types of an injectable cardioplegia solution, manufactured by Central Admixture Pharmacy Services Inc. (www.capspharmacy.com), has prompted a voluntary product recall pending further investigation and FDA notification. The injectables, found to be contaminated with Gram-negative rods, were manufactured only at the Lanham, Md., facility and affect products distributed to hospitals in Maryland, Delaware, Washington, D.C., and Virginia.
DuPont donates disinfectants
NEW ORLEANS, La. – In an effort to assist with clean-up in the Gulf region, DuPont Personal Protection has made a donation of disinfectants and antiseptics to the city of New Orleans. Valued at $75,000, the donation includes antiseptic hand wipes and products for both large and small-scale disinfection from DuPont’s RelyOn line of products, designed to disinfect hands and hard, nonporous surfaces to reduce the spread of germs. RelyOn products have been proven effective against such pathogens as Hepatitis A, B and C, influenza, and HIV. This donation is in addition to the $1 million contribution DuPont made to the Red Cross and Salvation Army in August.
Rx for reducing risk
GENEVA, Switzerland – STMicroelectronics (www.st.com) has teamed with Finnish biochip assay developer Mobidiag (www.mobidiag.com) to introduce a lab-on-a-chip for DNA-based detection of sepsis-causing bacteria. The technology features a diagnostic panel from Mobidiag that runs on ST’s In-Check lab-on-a-chip platform, and enables early detection of disease that’s designed to result in better treatment choices for patients and lower overall costs to healthcare systems. The platform identifies ten sepsis-causing bacterial species as well as methicillin-resistant strains of Staphylococcus aureus from positive blood culture samples. The diagnostic panel has been designed to optimize the choice of antibiotic therapy in combination with results from Gram-straining-an empirical comparative method of differentiating bacterial species. The companies claim that highly accurate and rapid results can help reduce the risks of antibiotic misuse and help physicians select the right treatment as early as possible.
Back in business
MISSISSAUGA, Ontario – Following an extension of the normal summer shutdown at its Draxis Pharma manufacturing facility in Montreal, Draxis Health Inc. (www.draxis.com) has resumed production of sterile and lyophilized (freeze-dried) products. The regular summer shutdown for maintenance at the pharmaceutical contract manufacturing plant was scheduled to run for up to three weeks, but according to an official statement, the company deemed it necessary to replace additional major pieces of equipment in the affected areas and to conduct further cleaning and validation of the facility’s sterile core. Specific reasons were not cited. Production in the sterile core gradually ramped up over a period of several weeks, with production of sterile topical products and products filled into vials coming on line in mid-September and the balance resuming production shortly thereafter.
Beating beverage bacteria
SAN DIEGO, Calif. – Mexico’s largest bottled-beverage supplier, Kimpen, has completed a two-month beta test of JMAR Technologies’ (www.jmar.com) BioSentry technology, validating its capabilities to detect and classify E. coli and Pseudomonas should they occur in beverage production water. The laser-based contamination warning system is designed to provide continuous, automated water-quality monitoring, detecting and classifying waterborne microorganisms in real time. Kimpen plans to install a BioSentry system in each of its two commercial factories in the Yucatan Peninsula for two months of additional testing, and then install an additional fifteen systems to ensure that at least one BioSystem is in continuous operation in each of Kimpen’s fifteen factories.
New recommended practice for filter testing
ROLLING MEADOWS, Ill. – A newly revised recommended practice for testing HEPA and ULPA filter properties has been released by the Institute of Environmental Sciences and Technology (www.iest.org). Contamination Control Recommended Practice IEST-RP-CC021.2, Testing HEPA and ULPA Filter Media, discusses test methods for determining physical and filtration properties. The document covers equipment, procedures, and data reporting for various test methods. Applications include acceptance criteria for test methods, test aerosol and particle size, and test face velocity. Tests described in the revised document include airflow, resistance, filter media penetration using photometric and particle count techniques, basis weight, thickness, tensile strength, elongation, stiffness, weight loss at elevated temperature, and water repellency. More information can be found by visiting the IEST Web site.