Tag Archives: Clean Rooms

January 25, 2008 — /PRNewswire/ — DEERFIELD, IL — Baxter Healthcare Corporation has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/ml 10 and 30-ml multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter is conducting a thorough investigation of these reports to identify the cause of the increase in allergic-type reactions.

Adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, feeling your heart beat strong or fast, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, and difficulty opening the mouth. Some of these reactions may be severe or life threatening.

Heparin is a prescription, injectable blood anticoagulant (also called a blood thinner). The 1,000 units/ml multi-dose vials are primarily used for hemodialysis and cardiac invasive procedures. To date, the company has not observed a significant increase in adverse event reports occurring with any other of its heparin presentations.

Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact Baxter at 800-667-0959. Representatives are available Monday through Friday from 7 a.m. to 6 p.m. CT.

Baxter International Inc. (NYSE:BAX), through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease, and trauma. The company applies its expertise in medical devices, pharmaceuticals, and biotechnology to make a meaningful difference in patients’ lives.

Visit www.baxter.com

January 28, 2008 — /AMBERG, GERMANY/ — Herding Filtertechnik GmbH and Herding Filtration LLC are pleased to announce their second USA office opening. Effective March 1, 2008, Herding will open an office in Houston, TX. The Houston office will join the current Herding office in Detroit, MI. John M. Kelly will assume responsibilities as general manager of the Houston office.

According to Dr. Urs Herding (president, Herding Filtertechnik GmbH) & Christophe Vanoplinus (operations manager, Herding Filtration LLC), “The new location will allow us to better meet the growing, nationwide demands of our clients.” Headquartered in Amberg, Germany where the company was founded in 1977, Herding opened its Herding Filtration LLC Detroit office in 1999 to better accommodate North American client requests. The new Houston location is expected to emulate the success of the busy Detroit office and support continuing business growth in the southern and western states.

About Herding

Herding is the global leader in permanent filter media for process industries. The HERDINGR Sinter-Plate filters have proven their value for more than 25 years in a variety of application in several industries such as: powder painting, chemicals, pharmaceutical, metal processing, glass/ceramics, laser industry, cement, foodstuffs,and more. For more information call 248-673-4514 or e-mail [email protected].

Visit www.herding.com

January 22, 2008 — /SAN DIEGO, CA/ — RASIRCR, the steam purification company, releases research indicating that a new steam delivery method results in significant improvement in uniformity throughout the furnace from oxides as thin as 25 Angstroms to as thick as 150,000 Angstroms, eliminating the need for pyrolytic steam. The paper, Improved Uniformity through New Steam Delivery Method, was written by Jeffrey Spiegelman.

Semiconductor, flat-panel, solar, and optical devices all use oxide films as an essential feature. Uniformity of that oxide film is an important factor determining device yield. When oxygen is part of the process recipe, the partial pressure within the furnace tube will not be uniform. In the study, RASIRC found that by eliminating the oxygen gas, water vapor pressure stays relatively constant and film uniformity improves across the furnace.

Four facilities with horizontal furnaces and one with a vertical furnace participated in the study. Process recipe temperatures and run times were kept constant. Existing water vapor generating technologies were replaced with a RASIRC steamer and hydrogen and oxygen gases were eliminated. The total steam supplied was initially the same as the replaced technology and then adjusted to maximize performance.

Different facilities using different methods

January 22, 2008 — / FDA / — B. Braun Medical, Inc. was recently notified by its contract manufacturer, AM2PAT, Inc., of a nationwide recall of all lots and sizes of pre-filled heparin and saline flush syringes. Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted.

Based on ongoing FDA inspection of AM2PAT, Inc.’s facility and CDC investigation, it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra pre-filled heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries or death.

Customers may contact the B. Braun Medical, Inc. Customer Support Department at 800-227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for a replacement product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Visit www.fda.gov/medwatch/report.htm

IMEC sets foot in Taiwan


January 22, 2008

January 22, 2008 — /HSINCHU, TAIWAN/ — IMEC today officially established IMEC Taiwan in the Hsinchu Science Park. IMEC Taiwan initially starts as a representative office, but is expected to grow into an R&D center within the coming six months.

IMEC Taiwan aims to set up a win-win situation by facilitating the access for Taiwanese semiconductor companies to IMEC’s R&D programs and tap into the local high technology skills. The establishment of IMEC Taiwan follows several memoranda of understanding and collaborations between IMEC and leading Taiwanese companies, R&D institutes, and universities, with the strong support of the National Science Council Taiwan.

IMEC intends to reinforce its collaborations in Taiwan by focusing on semiconductor process technology research with foundries, on IC and system design with companies and academia, on dedicated training, on facilitating the interaction between Europractice IC service and the Taiwanese foundries for low-cost IC prototyping and small volume production, and on developing heterogeneous process technologies for fablite and fabless companies.

“Taiwan is worldwide recognized as the core of semiconductor foundry manufacturing. Combined with its innovative power, the Taiwanese industry will also become a leading player in the development of new applications. We are convinced that an institute like IMEC Taiwan can add value in this evolution,” says Professor Gilbert Declerck, president and CEO of IMEC. “By bridging the cultural, language, and geographical gap, we can facilitate the access to our programs and easily interact with local companies. We intend also to tap into the local pool of highly schooled labor to strengthen our system and IC
design team.”

About IMEC

IMEC is a world-leading independent research center in nanoelectronics and nanotechnology. Its research focuses on the next generations of chips and systems, and on the enabling technologies for ambient intelligence. IMEC’s research bridges the gap between fundamental research at universities and technology development in industry. Its unique balance of processing and system know-how, intellectual property portfolio, state-of-the-art infrastructure, and its strong network of companies, universities, and research institutes worldwide position IMEC as a key partner for shaping technologies for future systems.

Visit www.imec.be

January 21, 2008 — /LIVERPOOL, NY/ — R. Vijayakumar, PhD, has announced the formation of AERFIL, LLC, a new consulting services company offering services in aerosol science, filtration, and contamination control. According to “Vijay,” AERFIL’s client focus will be small and medium-sized companies that need technical and industry expertise to compete effectively in the marketplace, but cannot afford full time resources. “Knowledge grows by sharing, and AERFIL will also offer our clients opportunities to mentor young professionals, both in and out of house, on a non profit basis.” Vijay is a globally recognized expert in aerosol science and filtration with over 25 years experience in the industry. He is also a member of the Cleanrooms magazine editorial advisory board. Vijay can be reached at [email protected]

Visist www.aerfil.com