Compiled by Carrie Meadows

The transfer of product or equipment from one area to another presents a prime opportunity for a contamination event to occur. Doors and pass-throughs specifically designed for clean processing environments can help maintain necessary cleanliness levels.

Standard and custom pass-through configurations

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AES pass-throughs help maintain a high-level of cleanliness for critical manufacturing processes. AES Clean Technology offers wall- or floor-mounted pass-throughs in standard or custom sizes and configurations built to fit the needs of each project. Featuring double-wall construction, gasketed doors, and a vision panel, the pass-throughs can be constructed of laminate, epoxy-painted steel, or stainless steel. Sales coordinator Mary Waters is available to speak with customers about the materials of construction, features, and options needed to create an innovative, efficient pass-through that will minimize contamination and protect operations. For more information, call (888) 237-2532, ext. 103.

AES Clean Technology, Inc.
Philadelphia, PA
www.aesclean.com

Pass-through airlocks

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Clean Air Products introduces Series 18 pass-through airlocks. Designed to transfer parts and equipment into and out of cleanrooms, they significantly reduce potential contamination by decreasing the number of people entering and exiting the cleanroom. The new units are available in white polypropylene or optional stainless steel. Standard models are constructed of half-inch sheets of solid polypropylene welded together, providing a solid plastic airlock entry system that prevents deterioration common to other airlocks made of laminated Formica over particle board. The airlock doors are made with a heavy-duty stainless-steel frame, stainless-steel continuous hinges, a Plexiglas viewing window, closed-cell PVC door gasket, and a 90

JUNE 12, 2008 — CROWN POINT, IN — MicroWorks Inc., a microbiology consulting and training firm, has announced it will expand its laboratory, manufacturing, and distribution center in Crown Point, IN, creating up to 19 new jobs by 2011.

The firm, which provides its training and consulting services to pharmaceutical manufacturers and suppliers across the country, will invest $1.6 million to purchase an existing 10,000 sq. ft. facility at 2200 W. 97th Place to house its expanded operations.

“MicroWorks is a home-grown Indiana company and a prime example of an entrepreneurial life sciences business that is investing in Indiana and creating jobs for hard-working Hoosiers,” says Governor Mitch Daniels.

MicroWorks, which currently employs six associates, plans to begin hiring lab technicians and clerical staff immediately to coincide with the new facility’s opening later this summer. The company also plans to hire microbiologists and warehouse positions by the end of 2009.

The expansion comes less than three months after the company launched its MicroWorks Swab Sampling System, a system that replaces traditional swab methods and contact plates typically used in recovering microorganisms from environmentally controlled cleanrooms.

“Northwest Indiana was the right place for our growing business due to the close proximity to major markets such as Indianapolis and Chicago and our central location in the country,” says Dawn McIver, founder and chief executive of MicroWorks. “The timing for this expansion was coordinated with the launch of our new product and the current regulatory atmosphere towards upcoming rapid microbiological methods, which we plan to offer to our clients.”

Founded in 1996, the company has built its business around providing training and performing projects for companies across the pharmaceutical industry, including environmental monitoring programs, disinfectant qualification, and contamination control.

The Indiana Economic Development Corp. offered MicroWorks Inc. up to $32,500 in training grants based on the company’s job creation plans. The City of Crown Point will consider property tax abatement.

“This development is reducing blight and creating quality career opportunities for our local workforce,” says Crown Point Mayor David Uran. “We celebrate this as a community and are proud that MicroWorks is calling Crown Point home.”

About MicroWorks
MicroWorks, Inc. is a microbiological consulting and training firm that was established to assist pharmaceutical manufacturers in the completion of their studies. The company, which operates out of 10,000 sq. ft. of laboratory and office space in Crown Point, IN, provides a full range of microbiological services including, consulting, training, monitoring, and equipment validation.

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JUNE 10, 2008 — /PRNewswire/ — PASADENA, CA — Jacobs Engineering Group Inc. has received a contract from Estelux to provide engineering, procurement, and construction management (EPCM) services for a new polysilicon manufacturing facility at the existing petrochemical site in Ferrara, Italy.

Estelux is an Italian startup company with a mission to provide first-class polysilicon, strategic to the entire photovoltaic supply chain. SOLON Group, one of the largest European solar module and photovoltaic systems manufacturers, owns shares in Estelux.

Officials did not disclose contract details.

Polysilicon is purified silicon, which is the base of all crystalline silicon photovoltaic cell panels. Estelux’s plant production will cover a fundamental step in an integrated complete photovoltaic supply chain that starts with solar-grade polysilicon production and ends with the installation of photovoltaic systems.

Jacobs will execute the work from its Milan, Italy, office with support from specialist offices in Greenville, SC, and Mumbai, India. Jacobs’ Milan office previously completed the preliminary design of the plant.

The new plant will consist of two production buildings, where the polysilicon production process starts with trichlorosilane decomposition to form silicon rods, with a special closed process system, and a finishing building, with laboratories and control rooms, where the rods are crushed, transformed, and packed in a contamination controlled environment. The facility will have top-class off-gas treatment plants; a high-voltage electrical substation (with transformation and distribution stations for medium and low voltage); a wastewater treatment plant; distillation and fractionation columns; associated utilities; and other infrastructure.

The original and traditional production process called “Siemens process” has been optimized by Estelux Team to achieve a top-class product quality. The plant will reach its full operating capacity in 2010, with a polysilicon production of 4,000 tons per year. The total investment will amount to approximately 360 million euros.

The facility will be built on an area inside the Ferrara petrochemical site. Environmental impacts will be minimized during the demolition and enabling works prior to construction. Design and construction will maximize energy saving through solar panel utilities usage and recycling technologies, as well as sustainable water and rail transportation solutions and logistics issues. The plant’s proximity to the raw material for production limits hazardous materials handling to directly controlled adjacent areas inside the petrochemical site.

Estelux’s CEO Domenico Sartore notes, “Estelux is a pioneer in the photovoltaic and sustainability industry and we are glad to have Jacobs as a partner in this investment because we share the same vision and approach of developing innovative solutions.”

In making the announcement, Jacobs group vice president Robert Matha says, “We are proud to be selected by Estelux for this strategic project. Jacobs is committed to deliver the highest value of service to help them establish a strong market-leader position and satisfy the growing demand for polysilicon-based renewable energy sources.”

About Jacobs Engineering Group
Jacobs, with more than 55,000 employees and revenues exceeding $9.0 billion, provides technical, professional, and construction services globally.

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JUNE 9, 2008 — /FDA Digest/ — U.S. Department of Health and Human Services (HHS) Secretary Mike Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

Today’s action supports the fundamental change in strategy currently underway at FDA to adapt to the demands of the rapidly growing and changing global economy. These funds will expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007.

“Last year we outlined important changes in how this nation deals with imports. We are moving from an intervention strategy — where we stand at the border and try to catch things that are unsafe — to an integrated strategy of prevention with verification. We are rolling the borders back and seeking to build safety and quality into products at every step of the way before they reach American consumers,” Secretary Leavitt says.

The Secretary continues, “Combined with crucial legislative proposals, this increase will allow FDA to continue to transform its regulatory strategies to meet the challenges of the evolving global marketplace. I urge Congress to act quickly to give FDA the authority and funding it needs to enhance the safety of our food and medical products.”

Under the budget amendment, FDA will be able to expedite steps to improve import safety, including:

• FDA will significantly expand its reach beyond American borders by establishing a presence in five countries or regions and by implementing other measures that will help ensure greater foreign compliance with FDA standards.
• Another initiative will offer expedited entry for goods bearing certification by trusted parties.
• FDA will modernize its information technology
  infrastructure.
• Finally, FDA will conduct at least 1,000 more foreign inspections of food and medical product facilities and an additional 1,000 domestic inspections with funds in the budget amendment.

The increase brings the Administration’s total proposed increase in the FDA’s budget for FY 2009 to $404.7 million — a 17.8 percent boost in funding from FY 2008.

Some new authorities requested for federal agencies in the Action Plan for Import Safety that Congress has not yet granted include:

• Authorizing FDA to accredit highly qualified third parties to evaluate compliance with FDA requirements.
• Authorizing FDA to require certification of designated high-risk products as an additional condition of importation.
• Authority to refuse admission of imports from a firm who delayed, limited, or denied FDA access to its facilities.
• Empowering FDA to issue a mandatory recall of food products when voluntary recalls are not effective.

“FDA’s mission to protect and promote the health of the America public will be greatly aided by these additional funds to implement our strategic plan,” says Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. “FDA has already embarked on an ambitious program to transform the agency. This added funding will ensure that FDA can move ahead with these proposals more rapidly.”

Consistent with the Administration’s emphasis on fiscal discipline, the budget amendment is fully paid for within budgetary totals.

The budget amendment proposes the following increases for core FDA programs:

• Protecting America’s Food Supply (+$125 million) — The increase allows FDA to intensify actions to implement FDA’s Food Protection Plan. Announced on Nov. 6, 2007, the Food Protection Plan is an integrated, risk-based strategy to help ensure the safety of domestic and imported food and feed. The $125 million increase adds to the $42.2 million increase proposed for food protection in the budget announced in February 2008.

The increase in food protection activities will allow FDA to reduce threats to the food supply, expand FDA’s international presence, and increase technical assistance to help ensure that foreign and domestic food facilities comply with food safety standards. FDA will also be able to improve the risk-based approach it uses to conduct more targeted import exams and foreign and domestic inspections of food manufacturing, processing, and packaging facilities. FDA will pursue additional research on ways to prevent intentional and unintentional contamination, deploy screening technologies to identify microbial and chemical contamination, and respond more quickly to contain outbreaks of food-borne illness.

• Safer Drugs, Devices, and Biologics (+$100 million) — The increase of $100 million for the FDA’s medical product programs will strengthen FDA’s ability to ensure the safety and effectiveness of medical products, from product development and pre-approval testing through approval and post-approval safety surveillance. FDA faces growing challenges from the globalization of medical product development and manufacturing. The increase for medical product programs will allow the FDA to respond to this trend.

FDA will more aggressively conduct active safety surveillance to identify early signs of adverse events linked to medical products. FDA will also implement new requirements under the FDA Amendments Act of 2007 related to clinical trials, pediatric drugs and devices, postmarket study commitments, and the labeling and safe use of drugs. FDA will also establish unique device identifiers to track devices, facilitate device recalls, and support inventory management during disasters and the response to terrorism events. Finally, FDA will conduct more import exams and foreign and domestic inspections of medical product manufacturers.

• Modernizing FDA Science and Workforce (+$50 million) — The budget amendment also proposes increases to strengthen FDA’s capacity to support product safety and development in areas of emerging science such as nanotechnology, cell and gene therapies, robotics, genomics, advanced manufacturing, and the critical path initiative. FDA will also improve laboratories and other facilities that are essential to carrying out FDA’s mission and invest in science training, professional development, and fellowship programs to strengthen and modernize the FDA workforce.

The program increases listed above include $65 million to modernize FDA’s information technology infrastructure. Additional information is available online at www.importsafety.gov; www.fda.gov; and www.fda.gov/oc/initiatives/advance/food.html.

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JUNE 7, 2008 — /FDA Digest/ — The U.S. Food and Drug Administration (FDA) is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.

FDA recommends that consumers not eat raw red Roma, raw red plum, raw red round tomatoes, or products that contain these types of raw red tomatoes unless the tomatoes are from the sources listed below. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made. Consumers should continue to eat cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, or tomatoes grown at home.

On June 5, using traceback and other distribution pattern information, FDA published a list of states, territories, and countries where tomatoes are grown and harvested which have not been associated with this outbreak. This updated list includes: Arkansas, California, Georgia, Hawaii, North Carolina, South Carolina, Tennessee, Texas, Belgium, Canada, Dominican Republic, Guatemala, Israel, Netherlands, and Puerto Rico. The list is available at www.fda.gov. This list will be updated as more information becomes available.

FDA’s recommendation does not apply to the following tomatoes from any source: cherry, grape, and tomatoes sold with the vine still attached. FDA recommends that retailers, restaurateurs, and food service operators not offer for sale and service raw red Roma, raw red plum, and raw red round tomatoes unless they are from the sources listed above. Cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, may continue to be offered from any source.

Since mid-April, there have been 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin. Salmonella Saintpaul is an uncommon type of Salmonella.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that will be ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source of the tomatoes associated with the outbreak.

FDA is taking these actions while the agency continues to investigate this outbreak with state and federal partners. Such actions are a key component of FDA’s Food Protection Plan (see “Food safety plan emphasizes ‘effective action’ to prevent food supply contamination”), a scientific and risk-based approach to strengthen and protect the nation’s food supply. FDA will continue to issue updates as more specific information becomes available.

Information on safe handling of produce can be found at www.cfsan.fda.gov. Tomato consumer page can be found at www.fda.gov. Updates from the Centers for Disease Control and Prevention can be found at www.cdc.gov.

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