Tag Archives: Clean Rooms

April 15, 2008 — /SARATOGA, CA/ — California Code Compliance, Inc. (CaCCi), a new inspection and compliance service firm, has been formed to help manufacturers and manufacturing operations manage risk and reduce liability with strategic programs that ensure their electronic and heavy machinery complies with global safety and manufacturing standards.

Carol Foster has been appointed president of CaCCi with corporate headquarters based in Saratoga, CA. Joining Foster is Howie Foster as operations director, Michael LaFrance as technical director, and Steven Simons as director of eastern operations. In addition to managing the east coast satellite office located in New Fairfield, CT, Simons serves as CaCCi’s RF and EMC testing specialist. The technical staff also includes an electrical P.E. with extensive electrical distribution design and facilities experience, and additional field inspectors.

“With product liability and safety lawsuits on the rise in the United State and the European Union (EU) that are capable of devastating the reputation and financial standing of a manufacturing corporation, we formed CaCCi to help companies with an economic and turnkey solution to prevent this from happening,” says Foster. “Our team has 175 years of combined manufacturing experience, and that enables CaCCi to deliver a depth and breadth of expertise on the most critical domestic and international standards.”

CaCCi services include consultation, development, training, and execution on compliance programs that address such standards as CE Marking (or CE Mark); SEMI S2; SEMI S2-93A; National Electrical Code (NEC); NFPA 70; Restriction of Hazardous Substances Directive or RoHS; Waste Electrical and Electronic Equipment Directive (WEEE); OSHA; and more. Additionally, CaCCi conducts third-party field inspection, labeling, and manual review for equipment used in automotive, semiconductor, flat panel, optical, and solar cell industries.

“We believe that companies using CaCCi’s services will benefit by producing the most compliant products and having the safest work facilities. This will reduce their potential liability and strengthen their public trust in responsible business practices. It will also result in increased safety, higher corporate profits through greater equipment and workforce up time, and lower insurance premiums,” adds Foster.

Visit www.cacci.us

April 15. 2008 — /PRIME NEWSWIRE/ — DANBURY, CT and GOETTINGEN, GERMANY — ATMI, Inc. (Nasdaq:ATMI) and Sartorius Stedim Biotech SA have agreed that Sartorius Stedim will distribute and market ATMI LifeSciences’ unique LevTechR levitated mixing system together with Sartorius Stedim’s own biopharmaceutical mixing bag technology.

“We are pleased with the continuation of the successful business relationship between Sartorius Stedim Biotech and LevTech through ATMI LifeSciences,” says Reinhard Vogt, executive vice president and a director of Sartorius Stedim Biotech. “As the leading company for disposable process solutions, we are happy to be able to offer as part of our product portfolio this unique mixing technology, which provides users with unparalleled advantages in process quality and operational efficiency.”

“We’re excited to continue the LevTech arrangement with Sartorius Stedim Biotech and to build momentum in this fast growing disposable mixing market segment,” says Mario Philips, general manager of ATMI LifeSciences. “This agreement is consistent with our focus on providing process efficiency solutions to our biopharma customers through enabling proprietary technologies and long-term continuity of supply.”

The agreement extends a May 2005 agreement between the two companies. That agreement made Sartorius Stedim the exclusive distributor of LevTech’s disposable bag mixing system, which uses patented technology to levitate and drive a single-use impeller inside sterile disposable bags. The extension of the agreement also includes a 10-year supply guarantee that provides customers with a high assurance of supply when validating this technology into their processes.

LevTech was acquired by ATMI in January 2008 and integrated into ATMI’s LifeSciences business, which is focused on single-use bioprocess containers and processes for the biopharmaceutical industry. Under the new agreement between LevTech, now a wholly-owned subsidiary of ATMI, and Sartorius Stedim, the LevTech disposable bag mixing system will be available through Sartorius Stedim as well as through ATMI LifeSciences, which offers its own bioprocess containers.

About ATMI, Inc. and ATMI LifeSciences

ATMI, Inc. provides innovative materials and high-purity materials handling and process optimization solutions designed to increase production yields, accelerate new product introductions, reduce capital expenditures, and mitigate risks for its global semiconductor, flat panel, and specialized process customers. ATMI LifeSciences is a leader in single-use mixing, storage, and bioreactor technology; fluoropolymer-based products; and custom engineered, flexible packaging solutions. Its fundamental knowledge of polymers, specially selected resins, as well as cleanroom manufacturing experience, coalesce to insure optimum performance in critical disposable process operations. ATMI LifeSciences has manufacturing facilities in Hoegaarden, Belgium, Minnesota, and Kentucky.

Visit www.atmi.com

About Sartorius Stedim Biotech S.A.

Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance, and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, filtration, purification, fluid management, and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely, and economically. For next-generation processes, the company focuses on single-use technologies and added-value services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “Turning science into solutions.”

Visit www.sartorius-stedim.com

April 15, 2008 — /PRNewswire/ — AMSTERDAM — SynCo Bio Partners B.V., a leading GMP biopharmaceutical manufacturer,has signed a master services agreement with OncoMed Pharmaceuticals, a company developing novel therapeutics that target cancer stem cells. Under the agreement, SynCo will fill and finish batches of OncoMed’s lead product, antibody OMP-21M18, for use in Phase I clinical trials.

Announcing the agreement, Pierre Warffemius, CEO, says, “We are delighted that a company at the forefront of cancer therapies has recognised our expertise in biopharmaceutical processing by choosing us to fill their lead antibody for early clinical trails.”

Paul J. Hastings, president and CEO of OncoMed says, “We selected SynCo Bio Partners because we needed a GMP-accredited contract manufacturing organisation that had a proven track record in filling biologics. With SynCo’s expertise in all aspects of biopharmaceutical manufacture, they were an ideal partner for us at this crucial stage in our development.”

OncoMed recently announced that it had signed a worldwide strategic alliance with GSK to develop cancer stem cell antibody therapeutics. One of the key projects in this alliance will be the development of OncoMed’s lead antibody product candidate, OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008.

SynCo will fill and finish antibody OMP-21M18 at its Amsterdam-based facility. This facility is able to fill a wide range of biopharmaceuticals into vials, including protein, polysaccharide, and live-microbial-based products using the latest filling and finishing equipment.

About SynCo Bio Partners B.V.

SynCo Bio Partners is a GMP-licensed bulk drug substance and final product CMO with in-depth clinical and commercial production experience with mammalian and microbial systems. This experience has been acquired by developing new production processes for a number of international clients and producing a wide variety of different vaccines, live bacterial products, and recombinant proteins in its state-of-the-art, GMP-licensed facilities in the last seven years.

Visit www.synco-biopartners.com

About OncoMed Pharmaceuticals Inc.

OncoMed Pharmaceuticals is discovering and developing novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence, and metastases. The company has established a library of antibodies for the treatment of solid tumors such as breast, colon, prostate, and lung cancers. OncoMed is a leader in cancer stem cell research and the identification of novel cancer stem cell targets. Privately held, the company’s investors include US Venture Partners, Latterell Venture Partners, Morgenthaler Ventures, The Vertical Group, Adams Street Partners, De Novo Ventures, and Bay Partners.

Visit www.oncomed.com

April 15, 2008 — /FDA/ — The Food and Drug Administration (FDA) announces that at least 21 people in 13 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella that was found in the recently recalled unsweetened puffed rice and unsweetened puffed wheat cereals produced by Malt-O-Meal.

The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private label brands including Acme, America’s Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw’s, ShopRite, Tops, and Weis Quality. The cereals have “Best if used by” dates from April 8, 2008 (coded as APR0808) through March 18, 2009 (coded as MAR1809).

Consumers should throw out any product in their homes from these recalled lots. Grocery stores and other retailers should promptly remove the cereals from their shelves.

Salmonella is a type of bacteria that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Symptoms of foodborne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. In persons with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.

Individuals who believe they may have experienced an illness consistent with the symptoms described above after consuming a puffed wheat or puffed rice cereal made by Malt-O-Meal should contact their health care practitioner immediately and report the illness to their state or local health authorities.

On April 5, 2008, Malt-O-Meal voluntarily recalled the cereals because the company’s routine testing found Salmonella in a product produced on March 24, 2008.

The FDA is working with Malt-O-Meal to determine the cause of the contamination and with the states and the Centers for Disease Control and Prevention to identify and prevent additional illnesses.

A full list of recalled products can be found at www.malt-o-meal.com/recallinfo.

Visit www.fda.gov

April 15, 2008 — /PRWEB/ — SAN JOSE, CA — Glove boxes are sealed enclosures in which all items are handled through long, relatively impermeable gloves secured to ports in the walls of the enclosure. Basic Glove boxes are engineered for general laboratory isolation applications. Though gloveboxes incur high capital expense initially, they are cost effective in long term.

Europe dominates the global glove box market with sales estimated at $37 million for 2006, as stated by Global Industry Analysts, Inc. France, Germany, Italy, and the United Kingdom account for over 70 percent of the European Glove box market. The United States market for glove boxes is projected to reach $30 million by 2009.

Major players profiled in the report include Cole-Parmer Instrument Company, Coy Laboratory Products, Inc., Glove Box Technology, Ltd., Innovative Technology, Inc., Labconco Corporation, Laminar Flow, Inc., M Braun GmbH, Sheldon Manufacturing, Inc., Terra Universal, and T-M Vacuum Products, Inc.

The report “Glove Boxes: A Global Strategic Business Report” was published by Global Industry Analysts, Inc. and enumerates recent developments, mergers, acquisitions, and other strategic industry activities. Analysis is presented for established and emerging markets including the United States, Japan, France, Germany, the United Kingdom, Italy, Asia-Pacific, and rest of world.

About Global Industry Analysts, Inc.

Global Industry Analysts, Inc. (GIA) is a reputed publisher of off-the-shelf market research. Founded in 1987, the company is globally recognized as one of the world’s largest market research publishers. The company employs over 700 people worldwide and publishes more than 880 full-scale research reports each year. Additionally, the company also offers a range of over 60,000 smaller research products including company reports, market trend reports, and industry reports encompassing all major industries worldwide.

Visit www.strategyr.com

April 14, 2008 — /Newton, MA/ — Microfluidics, a wholly owned subsidiary of MFIC Corporation, announces methods for processing bulk carbon nanotubes. Microfluidics has devised a methodology to process, deagglomerate, purify, and stabilize these processed nanotubes so they can be used in an optimal manner, thus achieving enhanced functionality and performance.

The company has identified and demonstrated numerous operational protocols utilizing its MicrofluidizerR processor systems to prepare these bulk nanotubes for their ultimate specific uses. These applications capitalize on the unique mechanical, electrical, and thermal properties of carbon nanotubes and require dispersion of the nanotubes in liquid media and independent length reduction of the carbon nanotubes.

Carbon nanotubes are noted for their tubular shape, extremely small diameter with respect to length, and exceptional physical, mechanical, and electrical properties. When prepared in diameters in the 10 to 50-nm range, the unique characteristics of strength, conductivity, and quantum behavior become highly desirable and are thus incorporated into a multitude of commercial products.

Microfluidizer processors are ideal for conditioning carbon nanotubes -and nanomaterials in general- for applications that include high tensile strength polymers, fabric treatments, lubricants, medical therapeutics, computer memory and chips, electronic devices, medical diagnostic biolabels, and photovoltaic cell components.

About Microfluidics

Microfluidics, a wholly owned subsidiary of MFIC Corporation, is a supplier of advanced fluid processing equipment and reaction technology for laboratory, pilot scale, and manufacturing applications. The equipment enables the manufacture and formulation of numerous nanomaterials and nanoscale products and produces the most uniform and smallest liquid and suspended solid particles available.

Microfluidics has been a worldwide supplier of Microfluidizer high shear fluid processing systems to the biotechnology, pharmaceutical, chemical, cosmetics/personal care, and food industries since 1984. As leader in the field, Microfluidics has enabled numerous companies and institutions to formulate, validate, and produce licensed drugs for the worldwide healthcare market.

Visit www.microfluidicscorp.com

April 14, 2008 — /PRWEB/ — Jupiter, FL — In October 2007, the Occupational Safety and Health Administration (OSHA) had issued a new directive CPL 03-00-006 to address fires and dust explosion hazards that may exist at facilities handling combustible dust.

Due to the recent increase in dust explosion losses and fatalities, OSHA has stepped up their auditing process to which this document focuses. This new directive describes enforceable policies and procedures regarding inspection of facilities that handle combustible dust. As a result, OSHA intends on conducting an extensive amount of complex process and safety management inspections at randomly select facilities.

Facilities will be randomly selected for inspection. These inspections will be similar to the OSHA inspection program for refineries, which began in June 2007.

Any company that handles powders and bulk solids is susceptible to inspection. Many, if not all, are scrambling to prepare for the pending investigations. Despite the fines that might be imposed for not passing an inspection, there are significant and very real risks involving dust explosions, which include the initial blast, secondary fires, loss of life, and significant loss of process revenue.

“You can’t completely eliminate the danger, but a risk analysis can certainly reduce probability and severity of an industrial dust explosion,” says David Cvetas, president of Cv Technology, a global leader in dust explosion protection and consulting. “What we’re seeing now is the bar being raised on the standards necessary for compliance to that risk.”

In addition to providing strategic consulting to examine and assess the risk of dust explosion, CV Technology manufactures products that are designed to prevent or mitigate dust explosions. Isolation valves; rupture discs and panels; and flameless vents are custom tailored to minimize, and in some cases prevent, any damage or other interruptions to the process if an explosion were to happen.

Regulations aside, a professionally-conducted risk analysis can identify many potential sources of dust explosions before they occur. Companies now are not only preventing potential loss of life, but also protecting their assets and valuable process revenue from dust explosions.

“Every top corporate officer or CEO needs to have a thorough business-impact analysis so that they understand just how and where their enterprise is vulnerable. If there are combustible dust vulnerabilities, they need to determine what strategies will mitigate or control those vulnerabilities,” says Cvetas. “Paramount to all this, human lives are at risk, and reducing that risk is what’s most important.”

Other areas of advanced preparation include emergency response to stabilize the situation following an incident; ongoing dust explosion protection awareness and training programs; public relations and crisis coordination; and plans for communicating with employees, customers, suppliers, and stockholders during a crisis.

Visit www.cvtechnology.com

April 14, 2008 — /ENDICOTT, NY/ — The Center for Advanced Microelectronics Manufacturing (CAMM) located at the Endicott Interconnect Technologies, Inc. facility was inaugurated on Monday, March 31 in a ceremony attended by business, political, and community leaders. Dr. Mark Poliks, director of research and development at EI and technical director of the CAMM, hosted the event. A collaborative effort by Binghamton University, Endicott Interconnect Technologies, and Cornell University, the CAMM will pioneer microelectronics manufacturing research and development in a roll-to-roll (R2R) format. These efforts will result in flexible, rugged, lightweight electronic components and innovative products that will be critical to next-generation applications in areas such as military and homeland security; lighting; energy and power generation; displays; and product identification and tracking.

Plans for the CAMM were initiated in 2005 when the United States Display Consortium (USDC) selected Binghamton University to manage this new initiative. The USDC provided $12 million in equipment to establish the CAMM, which is hosted by Endicott Interconnect Technologies and draws collaborative resources from Cornell University.

“Endicott Interconnect Technologies is proud to have a leadership role in the creation and development of this center that began with the first discussions with the USDC, the winning proposal written with Binghamton University, and continues each day as a unique working partnership,” states Poliks.

From this initial collaboration, the CAMM has grown into a facility that consists of a 10,000-square foot area and cleanroom. It includes an integrated roll-to-roll flexible electronics prototype manufacturing line and an associated microfabrication laboratory. CAMM facilities also include a precision lithography stepper, vacuum coaters, and an in-line defect inspection capability.

“Endicott Interconnect is very proud to serve as host to the CAMM. Our unique working partnerships with both Binghamton University and Cornell University have resulted in a truly impressive facility that offers the opportunity to develop new technology and manufacturing capability for low-cost, high function electronic systems on flexible substrates. This technology will be the backbone of tomorrow’s electronics, fueling job growth in the U.S. and in our industry,” comments Jay McNamara, president and CEO at Endicott Interconnect Technologies.

Currently, most advanced electronics components are produced on silicon or quartz wafers, or on plates of specialized glass in a “batch” process that has been the backbone of the integrated circuit and flat panel display industries. An R2R process, which integrates electronics on flexible plastic, means, in theory, that components can be produced more efficiently, at higher yields, and at a lower cost than is common practice today, and it opens up potential new application areas for flexible electronics.

Under professor Bahgat Sammakia, director of Binghamton University’s New York State Center of Excellence in Small Scale Systems Integration and Packaging Center, of which the CAMM is an integral component, and Poliks, the facility will evaluate equipment and materials developed under the auspices of USDC, industry, and its own research and development program that will be further developed into a fully-integrated prototype manufacturing line. The CAMM will also provide large-scale testing whereby academic and industrial research groups can test their work for manufacturing applicability without the high costs and risks typically associated with such activities.

Equipment is accessible to both the university community and private industry, which participates in the CAMM through paid membership fees and funded research programs. CAMM’s corporate members include Endicott Interconnect Technologies, General Electric, Kodak, Corning Incorporated, Texas Instruments, Plastic Knowledge, and Samsung Electronics Company. Additional partners and supporters include the National Aeronautics and Space Administration; the Army Research Laboratory; and New York State Foundation for Science, Technology, and Innovation.

Visit www.endicottinterconnect.com

April 14, 2008 — /PRNewswire/ — NEW YORK — Dover Corporation (NYSE:DOV) announced it completed the acquisition of Neptune Chemical Pump Company. Neptune will become part of Dover’s newly-formed Pump Solutions Group within the fluid management segment. Terms of the transaction were not released.

Neptune, based in Lansdale, PA, is a premier manufacturer of chemical metering pumps, chemical feed systems, and peripheral products. Neptune’s key product lines are well known for their use in metering, dosing, and injecting chemicals with emphasis on water and waste water treatment. Other major applications include agricultural, food and beverage, and laboratory use. Neptune’s fast and flexible business model features speed to market delivery and a reasonably priced alternative when compared to its competitive peer group.

Commenting on the acquisition, Soma Somasundaram, president of Dover’s Fluid Solutions platform says, “The Neptune acquisition is consistent with our Pump Solutions Group strategy. It complements and broadens our existing pump portfolio while offering strong synergy opportunities within the PSG. Neptune’s strong presence in water and waste water treatment further expands our presence in attractive end markets, giving us a low flow, accurate metering alternative to go along with Wilden’s high viscosity and corrosive fluids coverage and Blackmer’s major position in the fuel transportation market.”

John Allen, president of the Pump Solutions Group states, “We expect to grow Neptune by leveraging their product offering through PSG’s extensive network of distributors and suppliers world wide. Neptune’s diaphragm pumps join existing pump technologies within the Wilden, Blackmer, Almatec, and Griswold brands to give our customers and distributors an exciting and expanded product set.” Mike Dowse, Neptune’s president says, “We are excited to be part of the Pump Solutions Group. PSG’s global initiatives and synergistic activities will lead Neptune into new markets while introducing best practices and expanded opportunities.”

The Pump Solutions Group features a leading manufacturer of air-operated double diaphragm pumps (Wilden) and one of the major providers of sliding vane pumps (Blackmer). Other brands within PSG include Almatec, a provider of specialty premium air-operated double diaphragm pumps for biomedical, chemical, food grade, and electronics markets; Mouvex, a maker of eccentric disc pumps used in an array of applications around the globe; and Griswold, an ANSI centrifugal pump manufacturer. The Pump Solutions Group has plants in California, Michigan, and Georgia as well as international facilities in Germany, China, India, France, and the Czech Republic.

About Dover

Dover Corporation, with over $7 billion in annualized revenues, is a global portfolio of manufacturing companies providing innovative components and equipment, specialty systems, and support services for a variety of applications in the industrial products, engineered systems, fluid management, and electronic technologies markets.

Visit www.dovercorporation.com

April 11, 2008 — /ROCKVILLE, MD/ — According to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research web site, as of April 9, Genzyme Corp. (Cambridge, MA), Genzyme Europe B.V., and Genzyme Polyclonals, S.A.S. (Lyons, France) are initiating a voluntary recall of three finished product lots of Thymoglobulin (anti-thymocyte globulin (rabbit) 25 mg/vial): C7014C01, C7008C01, and TH175-05.

FDA’s site states that “[t]his recall was initiated when Thymoglobulin lot C7014C01 failed a periodic stability test based upon appearance of the reconstituted product. Reconstituted solution from lot C7014C01 initially passed this stability test prior to market release. The specification for the appearance of reconstituted Thymoglobulin solution is a clear, limpid to slightly opalescent liquid. Samples from lot C7014C01 have recently exceeded the slightly opalescent stability specification based upon visual examination of the reconstituted product. The two additional lots involved in this recall, lot numbers TH175-05 and C7008C01, are being recalled based on a predicted stability failure for appearance prior to the labeled expiration dates. Customers are asked to immediately discontinue all use of these lots and to return all Thymoglobulin vials to Genzyme Corp.”

Thymoglobulin is a sterile lyophilized drug manufactured from rabbit proteins given via injection to kidney transplant recipients in order to treat organ rejection.

On February 29, FDA also posted a voluntary recall notice regarding lot number CG024CAA of the drug with the same reasons for recall specified.

Source: FDA
Visit www.fda.gov