Tag Archives: Clean Rooms

March 27, 2008 — /PRWEB/ — Orangeburg, SC — As one of the world’s leading suppliers to a medical device industry whose products are integral components in life-saving technology, Zeus, Inc. understands how important collaboration is to developing the next medical breakthrough.

With a focus on prototype development, assembly solutions, consultation, research, analysis, and characterization, Zeus’ newly-formed contract research and development division represents a concerted effort to take its extensive experience in collaborative medical device development to the next level.

“Zeus can now help companies condense the R&D phase by supplementing their efforts with our contract research services,” says vice president of research and strategic business development Bob Ballard. “We have a team to develop the concept, the lab that tests it, and the capabilities to make it.”

Staffed by a multidisciplinary team of scientists and engineers, Zeus’ analytical lab is equipped with cutting-edge technology and custom machinery, enabling advanced manufacturing and process development.

Integrity and confidentiality have been Zeus cornerstones for over 40 years. During that time, it has collaborated with physician researchers and medical device companies from initial ideas through the manufacture of commercial products. This unique creative consortium of science and technology leads to the acceleration and streamlining of product development. Along with its longstanding commitment to quality and customer support, Zeus is well-positioned to help device makers accelerate their own pathways to success.

Source: Zeus, Inc.

About Zeus, Inc.

Headquartered in Orangeburg, SC, Zeus, Inc. is a world leader in the design and production of high-performance polymer tubing used in demanding applications. It operates 10 facilities on seven campuses in North America, Europe, and Asia. Zeus products and services are preferred by companies in medical, automotive, electrical, fluid handling and mechanical markets.

Source: Zeus, Inc.

Visit www.zeusinc.com

March 27, 2008 — /PRNewswire/ — PHILADELPHIA, PA — Honeywell (NYSE:HON) announcesthat it will expand production of AclarR film to meet growing demand for the clear, moisture-barrier material, which is used extensively in pharmaceutical packaging.

An upgrade of existing production capability, combined with overall productivity improvements, is expected to boost Aclar production by up to 23 percent by the end of 2008 at the business’ Pottsville, PA facility.

“This is another step in our continued strategy to invest to meet the packaging needs of the pharmaceutical industry now and in the future,” says Jeff Czarnecki, global segment leader for the specialty films segment of Honeywell Performance Products. Czarnecki notes that the business implemented productivity improvements at the Pottsville site in 2007, which also boosted capacity.

Rick Knight, global business manager for healthcare, says pharmaceutical companies worldwide continue to demand thermoformed packaging material with superior barrier capabilities. “Honeywell is committed to supporting pharmaceutical companies globally as they introduce new products to the marketplace,” he says.

The announcement was made at INTERPHEX, the world’s largest and most comprehensive pharmaceutical conference and exhibition. The event focuses on leading-edge technology, education, and sourcing of products and services that drive scientific innovation for life sciences manufacturing.

As part of its commitment to the pharmaceutical industry, Honeywell is continuing its technical training and educational series to address critical aspects of thermoform packaging. The program consists of half- and one-day workshops.

Aclar is a polychlorotrifluoroethylene (PCTFE) fluoropolymer film that has excellent moisture barrier and chemical stability. Aclar film is crystal clear, biochemically inert, chemical-resistant, nonflammable, and plasticizer- and stabilizer-free.

In addition to Aclar, Honeywell Specialty Films manufactures CapranR biaxially oriented nylon film, also known as biaxially oriented polyamide (BOPA) film; Capran heat stabilized nylon film; AclonTM fluoropolymer resins, which provide the highest moisture barrier of any clear thermoplastic resins; and Honeywell PCTFE, ECTFE, and PMP barrier films for high performance industrial applications.

About Honeywell

Honeywell Specialty Materials, based in Morristown, NJ, is a $4.9 billion, global leader in providing customers with high-performance specialty materials, including fluorine products; specialty films and additives; advanced fibers and composites; intermediates; specialty chemicals; electronic materials and chemicals; and technologies and materials for petroleum refining.

Honeywell International is a $36 billion diversified technology and manufacturing leader, serving customers worldwide with aerospace products and services; control technologies for buildings, homes and industry; automotive products; turbochargers; and specialty materials. Based in Morris Township, NJ, Honeywell’s shares are traded on the New York, London, and Chicago Stock Exchanges.

Visit www.honeywell.com

March 25, 2008 — /PRNewswire/ — HARLEYSVILLE, PA — Raymond J. De Hont, chairman and CEO of Met-Pro Corporation (NYSE:MPR), announced today that a $1.2 million order originally reported on October 30, 2007 to supply Strobic Air Tri-StackTM fans for use in a research facility located in the Middle East has been increased to $2.3 million, making it one of the largest projects of its kind ever awarded in the region. The equipment is expected to ship in the second quarter of the company’s fiscal year, ending January 31, 2009.

As a result of the amended contract, the company’s international division, in cooperation with its Strobic Air subsidiary, will now supply a total of 40 Strobic Air Tri-Stack fans, utilizing 18 heat recovery plenums, to exhaust fumes from multiple research laboratories. Each of the fans will be equipped with Strobic Air’s patented acoustical silencer nozzle, which minimizes sound output levels at the fan discharge. Strobic Air was awarded this project based on their reputation for innovative, best-in-class products to solve complex laboratory exhaust challenges.

“Strobic Air’s superior quality and outstanding performance continues to enhance its reputation as the worldwide supplier of choice for critical laboratory ventilation requirements,” states De Hont. “This order, our first with this leading international contractor, arose from the growing worldwide recognition of our ability to help solve the rising demand for more environmentally sensitive development. We remain optimistic that our innovative products and solutions will increasingly appeal to not only markets in the Middle East, but to markets around the world that need to meet the proliferation of environmental regulations.”

About Met-Pro

Met-Pro Corporation, with headquarters in Harleysville, PA, was recently recognized, for the second consecutive year, as one of America’s “200 Best Small Companies” by Forbes magazine. The company was also recently named as one of America’s “Top Publicly-Held Manufacturers” by Start-It magazine. Through its business units in the United States, Canada, Europe, and The People’s Republic of China, a wide range of products and services are offered for industrial, commercial, municipal, and residential markets worldwide. These include product recovery and pollution control technologies for purification of air and liquids; fluid handling technologies for corrosive, abrasive and high temperature liquids; and filtration and purification technologies including proprietary water treatment chemicals and filter products.

Visit www.met-pro.com

March 25, 2008 — /FDA/ — The U.S. Food and Drug Administration has issued an import alert regarding entry of cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer. Based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada. The import alert advises FDA field offices that all cantaloupes shipped to the United States by this company are to be detained.

In addition, the FDA has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove from their stock any cantaloupes from this company. FDA also advises consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from this specific grower and packer. If so, consumers should throw away the cantaloupes.

To date, FDA has received reports of 50 illnesses in 16 states and nine illnesses in Canada linked to the consumption of cantaloupes. No deaths have been reported; however, 14 people have been hospitalized. The states are Arizona, California, Colorado, Georgia, Illinois, Missouri, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Tennessee, Utah, Washington, and Wisconsin.

The FDA is taking this preventive measure while the agency continues to investigate this outbreak in cooperation with the Centers for Disease Control and Prevention and state partners. Such intervention is a key component of FDA’s Food Protection Plan.

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 have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.

FDA recommends that consumers take the following steps to reduce the risk of contracting Salmonella or other foodborne illnesses from cantaloupes:

  • Purchase cantaloupes that are not bruised or damaged. If buying fresh-cut cantaloupe, be sure it is refrigerated or surrounded by ice.
  • After purchase, refrigerate cantaloupes promptly.
  • Wash hands with hot, soapy water before and after handling fresh cantaloupes.
  • Scrub whole cantaloupes by using a clean produce brush and cool tap water immediately before eating. Don’t use soap or detergents.
  • Use clean cutting surfaces and utensils when cutting cantaloupes. Wash cutting boards, countertops, dishes, and utensils with hot water and soap between the preparation of raw meat, poultry, or seafood and the preparation of cantaloupe.
  • If there happens to be a bruised or damaged area on a cantaloupe, cut away those parts before eating it.
  • Leftover cut cantaloupe should be discarded if left at room temperature for more than two hours.
  • Use a cooler with ice or use ice gel packs when transporting or storing cantaloupes outdoors.

Visit www.fda.gov

March 25, 2008 — /SAN JOSE, CA/ — SEMI, the global industry association for companies that supply manufacturing technology and materials to the world’s chip makers, reports that worldwide sales of semiconductor manufacturing equipment totaled $42.77 billion in 2007, representing a year-over-year increase of six percent. The data is available in the Worldwide Semiconductor Equipment Market Statistics (SEMS) Report, now available from SEMI.

Compiled from data submitted by members of SEMI and the Semiconductor Equipment Association of Japan (SEAJ), the Worldwide SEMS Report is a summary of the monthly billings and bookings figures for the global semiconductor equipment industry. The report, which includes data for seven major semiconductor producing regions and 23 product categories, shows worldwide billings totaled $42.77 billion in 2007, compared to $40.47 billion in sales posted in 2006.

“Supported by the momentum of the 300-mm ramp and intensive memory investments, the global semiconductor equipment industry experienced its second best year ever,” says Stanley T. Myers, president and CEO of SEMI. “Of note are the Taiwan and China regions where Taiwan has surpassed Japan and the China new equipment market is approaching the size of Europe’s new equipment market.”

For the first time, the Taiwan market region sold more semiconductor equipment than any other region, growing 46 percent over 2006 to reach $10.65 billion. Japan claimed the number two spot with $9.31 billion in equipment sales. South Korea ascended to third place reaching $7.35 billion, passing North America at $6.55 billion. China continued with its expansion by growing 26 percent over 2006, reaching $2.92 billion. The Rest of World region, which aggregates Singapore, Malaysia, the Philippines, other areas of Southeast Asia, and smaller global markets, decreased 18 percent. The equipment market in Europe decreased eight percent in 2006.

The global wafer processing equipment market segment increased 11 percent, the assembly and packaging segment grew 15 percent, and the total test equipment sales decreased 21 percent. Other front end, which includes mask/reticle equipment, fabrication facilities, and wafer manufacturing equipment, increased two percent.

About SEMI

SEMI is the global industry association serving the manufacturing supply chains for the microelectronic, display, and photovoltaic industries. SEMI member companies are the engine of the future, enabling smarter, faster, and more economical products that improve lives. Since 1970, SEMI has been committed to helping members grow more profitably, create new markets, and meet common industry challenges. SEMI maintains offices in Austin, Beijing, Brussels, Hsinchu, Moscow, San Jose, Seoul, Shanghai, Singapore, Tokyo, and
Washington, D.C.

Visit www.semi.org

Mar 24, 2008 — /Marketwire/ — OTTAWA, ONTARIO — Health Canada testing of heparin products marketed in Canada has identified a contaminant in products from manufacturer B. Braun Medical Inc. The Department is working with the company on its recall of the affected Canadian products from the market.

The contaminant, over-sulphated condroitin sulphate, has also been found in heparin products in the United States and Australia.

On March 11, 2008, Health Canada requested that all suppliers of heparin for sale in Canada test their heparin products using the same methodology that uncovered the contamination in the United States. Health Canada is continuing its testing of heparin products from all Canadian companies and will continue to update Canadians as needed.

Heparin acts as a blood thinner, preventing the formation of clots, and is used after surgery and in dialysis, among other uses. Health professionals should only use heparin where it is medically essential after careful weighing of the risks and benefits for each individual patient. Patients should be monitored during and immediately following heparin administration for signs of allergy or anaphylactic reaction.

Adverse reaction reports to Health Canada do not show an increase in adverse reactions, including allergic reactions, related to heparin. There was one report of an allergic adverse reaction related to heparin from January 1, 2007 to March 6, 2008.

Patients should consult their physician or pharmacist if they are using B. Braun heparin products or if they experience allergic symptoms with any heparin products. Patients should not stop use of heparin without consulting a health care practitioner.

Visit www.hc-sc.gc.ca

Mar 24, 2008 — /Marketwire/ — OTTAWA, ONTARIO — Health Canada is warning parents and caregivers not to use a certain lot of PediaCol drops, a product for infants taken orally to relieve symptoms of excess gas associated with colic. The product, labelled with the lot number PDC701, was found to be contaminated with yeast and may pose serious health risks. Due to their immature immune systems, infants and young children may be at risk of adverse health effects. Children with weakened immune systems are particularly vulnerable to the potential health risks.

In general, symptoms of exposure to products contaminated with yeast may include, but are not limited to, nausea, vomiting, diarrhea, fever, weight loss, lethargy, coughing, or decreased appetite. For children with weakened immune systems the effects may be more serious.

Euro-Pharm International Canada Inc. has initiated a recall of the product. The drug identification number is 02245510 and the affected lot number of the product is PDC701, both of which can be found on the product label. PediaCol is available at pharmacies across Canada, and over the Internet. Health Canada will monitor the effectiveness of this recall.

Health Canada advises retailers to remove the affected lot of PediaCol from their shelves, and consumers should return the product to the place of purchase. As a precautionary measure, consumers should also discard any bottles that may have been used to store or administer the product. Parents and caregivers who have administered the product to an infant and have health concerns should consult with a health care professional.

Visit www.hc-sc.gc.ca

March 19, 2008 — /FDA/ — In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government.

This is an important step forward in FDA’s plans to hire and place FDA staff in China over the next 18 months. In addition, FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

“In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters,” says Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. “Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market.”

Building the FDA’s capacity outside of the United States supports the agency’s “Beyond our Borders” initiative. The initiative facilitates the building of stronger cooperative relationships with FDA’s counterpart agencies around the world and enhanced technical cooperation with foreign regulators. The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality.

Visit: www.fda.gov/oia/overview.html

March 20, 2008 — /ARLINGTON HEIGHTS, IL/ — Several new seminar topics will be offered to contamination control professionals at ESTECH 2008, the Institute of Environmental Sciences and Technology (IEST) 54th annual technical meeting and exposition. The meeting will take place May 4-7, 2008, at the Hilton Chicago/Indian Lakes Resort in Bloomingdale (Northwest Suburban Chicago), IL. The goal of ESTECH 2008 is to provide a base of understanding that will allow participants to enhance their skills while at the same time allowing for exposure to real-world experience and expertise.

Cleaning and analysis topics ranging from a study of the effectiveness of surface vacuum cleaning on a large range of particle sizes to the possible dissolving of filters by liquid CO2 in an automated CO2 cleaning system will be discussed in the seminar “Surface Cleaning and Contamination Analysis.” Additional topics include wiper performance and plasma surface preparation for cleaning prior to a bonding process.

The Microbiology seminar will cover microbial monitoring methods for testing and qualifying controlled environments for medical product manufacturing. Recommendations for types, frequency, and levels of testing will be reviewed. In addition, the methods for microbial identification commonly employed will be discussed and compared with recommendations as to which methods are more appropriate in different situations.

Another new seminar offered to attendees this year is “Cleanroom Flame Resistant Garment Testing and Validation.” This seminar will discuss the development of flame resistant fiber and fabric for cleanroom FR garments and the manufacture and testing of cleanroom FR garments.

Successful design and operation of cleanrooms can sometimes be impaired or improved by simple, but overlooked, issues or concepts. The seminar “Cleanroom Design Secrets Revealed” will feature industry-leading speakers discussing basic to advanced techniques, case studies, and practical solutions being used in successful, high-performance cleanrooms. Their experience covers a number of industries including healthcare, pharmaceutical, biotech, aerospace, academic and research, nanotechnology, and semiconductor manufacturing. Attendees at all levels will gain exceptional exposure to practical concepts, techniques, and know-how from these cleanroom professionals.

A number of other contamination topics will be discussed by industry experts. Additional seminar topics include filters, electrostatic discharge, USP <797>, time dependent haze, and nanotechnology.

Visit: www.iest.org

March 24 — /WASHINGTON/ — Investigators have moved closer to understanding how a widely used blood thinner killed as many as 19 Americans, identifying the chemical that tainted the heparin products. Meanwhile, the American companies that made heparin and its main ingredient blamed suppliers from China for the contamination.

The Food and Drug Administration states that the chemical was a kind of souped-up version of a compound commonly used to treat arthritic joints. The chemical — over-sulfated chondroitin sulfate — is not approved for use in prescription drugs sold in the United States, and it doesn’t normally figure in the production of heparin, FDA officials say.

“It should not be in heparin and, obviously, it should not be in the form that it is in,” Dr. Janet Woodcock, director of FDA’s drug division said in a conference call with reporters.

Now that they’ve identified the substance, investigators are trying to determine whether it caused the more than 700 reports of serious side effects in heparin users, and whether it was introduced deliberately into heparin products.

As much as half of the main ingredient in suspect heparin supplies was found to be the contaminant. That chemical looks like the main ingredient in heparin and acts like it during routine quality testing. It was made by chemically treating the compound normally used to treat joint pain, FDA officials say.

That compound — chondroitin sulfate — is structurally similar to heparin and shares some of the same blood-thinning properties, but is not used for that purpose, says Stuart T. Haines, a professor at the University of Maryland School of Pharmacy who specializes in the proper use of drugs. The chemical is often made from shark, squid, and other fish, Haines says.

Heparin’s main ingredient usually comes from pig intestines that are crushed and then purified. China is the world’s leading supplier. The ingredient is shipped to the United States for processing into finished heparin products.

Although they won’t go so far as to place blame on heparin suppliers in China, FDA officials say they’re working with Chinese authorities on determining how the contaminant got into shipments. They said additional supplies from the Changzhou, China, plant that supplied the main ingredient to the recalled heparin products were found to have the contaminant.

Scientific Protein Laboratories, which partly owns the Changzhou plant and sold the main ingredient used in the recalled heparin products, says contamination occurred somewhere along its chain of Chinese suppliers. The Waunakee, WI, company issued a press release saying its testing showed that the raw materials it received were tainted.

The company is recalling all of its heparin ingredients made from materials provided by Chinese suppliers whose goods tested positive for the contaminant.

Baxter International Inc. of Deerfield, IL, recalled most of its heparin products last month after some were linked to hundreds of reports of serious side effects, including quickening heartbeats, nausea, and dizziness. Baxter issued its own statement that also attributed the contamination to Chinese suppliers.

The recall has triggered a worldwide investigation and deepened concerns about the safety and quality of imports from China. Senator Edward M. Kennedy of Massachusetts called on FDA to get from drug companies the names of their suppliers now that the contaminant has been identified.