By Bruce Flickinger

End users need to juggle product and worker protection, comfort, utility, and cost-effectiveness in making the right choices about specialist laundries and cleanroom garmenting programs.

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Any tailor will tell you that the signs of quality clothing can be found in the details, and the same can be said of cleanroom garments. In this analogy, companies such as Nitritex Ltd. (Newmarket, UK) are the high-tech haberdasheries, manufacturing cleanroom garments and apparel items to very high technical standards for customers operating a variety of demanding research and manufacturing environments.

“The construction of the garment is extremely important to ensure its effectiveness when worn in the cleanroom,” says Richard Bryant, Nitritex group sales director. “The fabric needs to be chosen carefully and be thoroughly technically specified to ensure it does not cause contamination in the finished garment. Each component–studs, thread, fabric, zippers–should be non-linting and made of non-plated stainless steel. Seams should be enclosed using continuous polyester thread at no less than 12 stitches per inch.” Garment edges usually are serged; that is, chain-stitched using two or more threads that form an overcast edge on a fabric.

Despite many advances in construction and fabric technology, the primary objective for cleanroom garment systems remains unchanged: to capture and entrain particles to prevent them from being dispersed externally and making contact with equipment or product. These contaminants largely are generated by the human body, including bacteria and yeasts, hair, dead skin cells, dandruff, and even elements such as sodium, potassium, chloride, and magnesium. It bears repeating here that people are the most significant source of contamination in cleanrooms and ancillary facilities.

But people also need to be protected, and a second but equally important function of cleanroom apparel is protecting workers from hazardous materials.

Risk assessments are used to ascertain the types and degree of worker protection required in a particular environment. Chemical splash protection is often needed, and difficult-to-control chemical flow or vapor eruption might warrant additional protection in some environments. Additionally, fire resistance is a concern for some applications, and awareness is heightened about OSHA/NFPA 70E requirements for protecting workers against potential arc flash events.

“The correct garment type is determined by the applicable technical standard, the type of cleanroom being operated, and the kind of work being carried out,” Bryant says. “We often provide on-site surveys to establish the correct garment type, along with training to assist wearers with the correct donning procedures to ensure that they adhere strictly to GMPs [Good Manufacturing Practices].”

Fabric options and tradeoffs

Garment considerations vary somewhat between industrial and life science cleanrooms. The former generally do not have a defined standard to work toward when choosing garments and must make the selection based upon the grade of cleanroom required or level of air cleanliness as defined by international standard. The life science or biopharmaceutical cleanroom, however, will have a more rigidly defined requirement for cleanroom clothing and its use as stipulated by GMP.

“Garments used in controlled environments share many common characteristics, such as compatibility with industrial laundering processes and low-particulation fabrics,” says Greg Winn, general manager, Controlled Environments Division, at White Knight Engineered Products (Charlotte, NC). “Carbon-grid fabrics are more commonly used in microelectronics applications because these customers will go to great lengths to control static buildup and/or discharge events. Pharma/life science customers must often maintain aseptic manufacturing conditions, so garments and materials undergo additional gamma sterilization or autoclaving procedures, which can significantly reduce material lifetime.”

Across all applications, key garment performance properties include air permeability, particle barrier efficiency, antistatic behavior, and moisture vapor transmission rate (MVTR). These speak broadly to a garment’s ability to both contain particles and keep the wearer comfortable. While all cleanroom garments need to meet technical specifications with regard to these properties, performance levels will vary and users need to assess carefully what criteria need to be emphasized while potentially compromising others.

An example is giving proper attention to worker comfort and mobility, which not only allows workers to carry out their duties throughout the day but also encourages compliance to the garment program. Cleanroom garments must permit the body to breathe, but the fabric’s breathability walks a fine line between comfort and contamination prevention: The body’s normal cooling process must be accommodated, but the airflow generated contains contaminants that can be transferred to the process or product. Lower MVTR and air permeability measurements mean lower potential for contamination but also reduced comfort for the wearer.

The fabrics used in making cleanroom apparel are largely polyester-based or 100 percent polyester weaves. Carbon matrices are used in some fabrics, and nylon and non-woven polyethylene materials are used in some special-purpose garment systems. The polyester weaves used in cleanroom garments are both hydrophobic and oligophilic and are constructed of very fine, tightly woven fibers. This creates small pore sizes for entraining skin flakes and other particles.

Sterilization, particularly gamma processing, will break down any fabric fiber to some extent. Polyester fabrics also are easily abraded by rough surfaces and are sensitive to extreme levels of acid or alkali and temperatures above 160

An exposure control plan is only as effective as the understanding and compliance of the personnel who implement it, so biosafety reviews are crucial

By Ted A. Myatt, Sc.D., Environmental Health & Engineering

In the past year, there have been a number of high-profile incidents at high-containment biological laboratories (biolabs). At Texas A&M University, a laboratory worker was exposed and infected with Brucella during an aerosolization experiment. This incident was not reported to the Centers for Disease Control and Prevention (CDC) as required by federal regulations. Research with “select agents” at the university was terminated and the university was levied a $1 million fine as result of not properly reporting the incident. At the CDC, a power outage in the Biosafety Level 4 (BSL-4) laboratories made headlines. In the United Kingdom, a faulty wastewater drain at a laboratory facility resulted in an outbreak of foot-and-mouth disease. Ongoing controversy surrounding the planned construction of a new, federally funded BSL-4 laboratory in Boston, MA, has increased the media coverage of these (and other) events. This increased media focus has fueled concern among the public about the potential for a release of infectious microorganisms from biolabs regardless of their containment level.

Primarily due to these publicized events, the U.S. Government Accountability Office (GAO) was asked to investigate oversight at BSL-3 and -4 laboratories in the U.S.¹ The GAO investigators identified six lessons from the incidents that are relevant not only for work in high-containment laboratories but all biolabs:

1. Identifying and overcoming barriers to reporting in order to enhance biosafety through shared learning from mistakes and to assure the public that accidents are examined and contained.
2. Training lab staff in general biosafety, as well as in specific agents being used in the labs to ensure maximum protection.
3. Developing mechanisms for informing medical providers about all the agents that lab staff work with to ensure quick diagnosis and effective treatment.
4. Addressing confusion over the definition of exposure to aid in the consistency of reporting.
5. Ensuring that laboratory safety and security measures are commensurate with the level of risk these labs present.
6. Maintenance of laboratories to ensure integrity of physical infrastructure over time.

Figure 1. When working in a biosafety cabinet in a Biosafety Level 2+ (BSL-3 practices in BSL-2 containment) area, the proper personal protective equipment includes a front closing gown, double gloves, and safety glasses. Photo courtesy of Environmental Health & Engineering (EH&E).Click here to enlarge image

All of these lessons can be applied to any biolab, including biotechnology and pharmaceutical laboratories. Development of new products from cells and tissues for therapeutic use, isolation and identification of genes, and introduction of genes into microorganisms, plants, animals, and human cells are all current and expanding biotechnologies. However, these procedures can present health risks for infections in laboratory workers during the handling of bacteria, fungi, viruses, viral vectors, recombinant DNA (rDNA), and organisms containing rDNA. Careful consideration of safety guidelines and regulations is warranted.

Relevant guidelines

The CDC and the National Institutes of Health (NIH) have developed guidelines for the four levels of biosafety. These guidelines, which are designed to protect not only laboratory personnel but also individuals in the surrounding community, are described in two publications: Biosafety in Microbiological and Biomedical Laboratories (BMBL) and the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). In addition, the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (Title 29 Code of Federal Regulations Part 1910.1030) applies to laboratory workers who come in contact with the human blood, bodily fluids, and tissues frequently used in research laboratories.

Companies and institutions with biolabs understand that complying with biosafety guidelines and regulations is critical to maintaining the safety of their workforce and to sustaining a solid relationship with the community in which they conduct business. Yet remaining in compliance can be demanding and complex as research and development efforts continue to expand into new areas. As a proactive approach, these companies and institutions are recognizing the value of investing in a laboratory review to ensure compliance with the existing guidelines and standards.

Review process is key to control plan

For many years, we have seen how a laboratory review process can be successful in mitigating potential gaps in biosafety, whether in biotechnology, pharmaceutical, or research laboratory environments. The review process typically begins with a meeting with lab representatives to understand overall activities in the laboratory. This is followed by a walkthrough to evaluate compliance with applicable biosafety guidelines and the OSHA standard, as well as a review of laboratory equipment and relevant documents, such as a biosafety manual.

A fundamental element of the laboratory review process is recognition that working safely in laboratories requires integration of safe laboratory practices and the design and operation of laboratory buildings. This integration of approaches, termed containment in the BMBL, includes primary containment provided by the use of good microbiological techniques and safety equipment as well as secondary containment provided by the design and operational procedures used by the laboratory facility.

Fgure 2. The pipetting work seen here requires a worker to be garbed with a lab coat, protective gloves, and safety glasses. Photo courtesy of EH&E.Click here to enlarge image

The biosafety guidelines summarized in the BMBL can be simply defined as a group of practices and procedures designed to provide safe environments for individuals who work in laboratories with potentially hazardous biological agents. Work with biological agents is classified into four distinct biosafety levels, BSL-1 to BSL-4, based on the potential health risks for both individuals who work in the laboratory environment and for members of the surrounding community. Each of these biosafety levels is matched with increasingly restrictive practices and facilities that are designed to reduce the risk of exposures to potentially hazardous biological agents.

Figure 3. Centrifuge work requires careful attention to load balance, proper cleaning of the equipment, and consistent use of personal protective equipment. Photo courtesy of EH&E.Click here to enlarge image

BSL-1 and BSL-2 practices and containment are applicable for the majority of work conducted in today’s biotechnology and pharmaceutical laboratories. BSL-1 is suitable for work with well-characterized biological agents that are not known to consistently cause disease in healthy adults; they pose minimal potential health hazards for laboratory personnel and the environment. BSL-2 is applicable for work with biological agents that present moderate potential health hazards to laboratory personnel and the environment. BSL-2 indicates that individuals working directly with the biological materials are at moderate risk for infection through skin and eye exposure, skin puncture, and ingestion.

Human cells, tissues, and body fluids may contain bloodborne pathogens (BBPs); therefore, work with any of these materials should be conducted at BSL-2. Although no specific federal regulations apply to the majority of cell and tissue culture activities in laboratories, the Bloodborne Pathogens Standard does apply to laboratory workers who come in contact with human blood, bodily fluids, or tissues. This standard was issued in 1991 based on health concerns related to increased risks for exposures to certain BBPs, such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and other infectious agents that may be present in human materials. In addition to HIV and the hepatitis viruses, the standard covers a wide variety of bloodborne diseases. Sources of potential exposures to BBPs include a variety of potentially infectious materials, including all human blood, blood products, certain body fluids, any body fluids in which visible blood is present, and any unfixed tissue or organ from a human (living or dead).

Figure 4. When working with liquid nitrogen, the personal protective equipment includes a full face shield over goggles; cryogenic gloves; full-length trousers/pants, apron, or laboratory coat; and footwear that covers the entire foot. Photo courtesy of EH&E.Click here to enlarge image

The Bloodborne Pathogens Standard requires that an exposure control plan be written and implemented. The exposure control plan includes several required elements and policies and procedures to eliminate or minimize BBP exposures. These elements include identifying all individuals in a laboratory group who may be at risk for BBP exposures, annual training, and providing appropriate personal protective equipment. Unlike the biosafety guidelines, the OSHA BBP Standard has the force of law and non-compliance can result in serious financial penalties.

To minimize potential exposures to aerosols or splashes of infectious biological agents, designated procedures are conducted in biological safety cabinets (BSCs) or other physical containment equipment. As recognized by the GAO, workers should be trained to recognize potential exposure events and the proper procedures for conveying information regarding the agents they work with to medical staff in the event of an exposure. BSCs provide the primary means of containment for working safely with potentially hazardous biological materials. However, training on how BSCs operate, which should be included in general biosafety training, and good microbiological practices are necessary to protect laboratory personnel, the environment, and the sterility of the product.

While the risks of releasing infectious agents out of a BSL-1 or BSL-2 facility are not as great as a release from a high-containment laboratory, the GAO recommendation for proper maintenance of a biolab is important. For example, filtration mechanisms are an essential laboratory design feature for reducing levels of infectious agents in the air entering a laboratory and for removal of these agents from air exiting the laboratory. Filtration is critical for biotechnology and pharmaceutical companies to ensure product sterility. High-efficiency particulate air (HEPA) filters are also integral components for optimal operation of BSCs. To ensure optimal operation, it is very important that BSCs are tested and certified annually, preferably by someone accredited by the National Sanitary Foundation (NSF). BSCs should also be certified when they are first installed and whenever they are moved, even to a nearby laboratory.

In addition to complying with OSHA regulations and CDC-NIH guidelines, another challenge for companies using biological agents is the transfer or shipping of biological agents. To lawfully send samples, specimens, or other research-related materials via aircraft or by ground transportation, companies must comply with standards from the U.S. Department of Transportation (DOT), the International Civil Air Association (ICAO), or the International Air Transport Association (IATA). Before any “dangerous goods” packages are offered for transport, specific training must occur, and training is required for all employees involved in the shipping process. The phrase “dangerous goods” refers to a diverse list of materials that can include dry ice, cell lines, fixed tissue specimens, and pathogenic microorganisms.

Conclusion

In summary, compliance with the biosafety guidelines recommended by the CDC and NIH and with the BBP Standard requirements mandated by OSHA provides clear advantages for biotechnology and pharmaceutical companies. The laboratory review process can ensure compliance and address a company’s ethical responsibilities to its employees as well as reduce potential liability concerns related to exposures to infectious agents. This approach can support companies in meeting the CDC-NIH goal of providing safe environments for both laboratory personnel and the surrounding community.

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Ted A. Myatt, Sc.D., is a senior scientist for Environmental Health & Engineering, Inc. (www.eheinc.com), a consulting and engineering services company based in Needham, MA. He also serves as the biological safety officer at Brigham and Women’s Hospital in Boston, MA, as well as a biosafety officer at several other high profile institutions. Myatt can be reached at [email protected] or 800-825-5343.

Reference

1. U.S. Governmental Accountability Office (GAO), Testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives, “High-Containment Biosafety Laboratories
   

Consider these recommendations for evaluating, validating, and implementing a USP <797>-compliant garment program

By Jan Eudy, Cintas

The latest revision to United States Pharmacopoeia (USP) General Chapter <797> Pharmaceutical Compounding–Sterile Preparations, was released in June 2008. The implementation of USP <797> in compounding pharmacies in the United States has been erratic at best. The information provided in this article is based on a case study of a company that operates compounding pharmacies in 23 metropolitan areas of the United States and its evaluation, validation, and implementation of a cleanroom garment program compliant to USP <797>.

The pharmaceutical cleanroom industry is acutely aware of the many possible sources of contamination that threaten production operations. The most significant threat is also the threat that is easiest to control–the people working in the cleanroom. These concepts of contamination control are the focus of USP <797> for compounding pharmacies.

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One of the most significant methods for reducing human contamination in the cleanroom is through a complete cleanroom uniform program. Cleanroom apparel is designed to capture and entrap particles and not allow contaminants to be dispersed into the critical environment. Apparel protects from numerous contaminants that are generated from the human body, including:

• Viable particles such as bacteria and yeasts
• Non-viable particles such as hair, dead skin cells, and dandruff
• Elements such as sodium, potassium, chloride, and magnesium

It is important to note that because the human body produces these contaminants in such large quantities the cleanroom apparel may be overwhelmed. Therefore, change frequencies and garment system configurations must be evaluated for the room cleanliness that each operation is expected to achieve.

USP <797> mandates that all compounding must be performed in an ISO Class 5 cleanroom environment or better. When the classification of the compounding pharmacy cleanroom has been determined and the decision made whether to use gloveboxes, unidirectional flow hoods, and barrier isolator systems to meet the cleanroom classification requirements of USP <797>, then cleanroom apparel can be selected. The compounding pharmacies in this case study chose to wear “tech suits” (also known as cleanroom undergarments) under the sterile coverall, hood, and boots as recommended in IEST-RP-CC003.3 for ISO Class 5 cleanroom applications.

The Institute of Environmental Sciences and Technology (IEST) published the recommended practice for garments, IEST-RP-CC003.3, “Garment Considerations for Cleanrooms and Other Controlled Environments,” in 2003. This document is a useful resource, providing guidance for the selection of fabric, garment construction, cleaning, and maintenance of cleanroom garments, and testing of cleanroom apparel and components for use in aseptic and non-aseptic clean-room environments.

Using ASTM and AATCC test methods

The contamination control industry has developed innovative fabrics and apparel to encapsulate workers in the cleanroom, thereby protecting the product and processes from possible deleterious contamination. There are several ASTM (American Society for Testing and Materials) and AATCC (American Association of Textile Colorists and Chemists) test methods used to evaluate new fabrics.

The weight of the fabric determines its strength and durability; however, a lighter fabric contributes to operator comfort. The grab tensile and tongue tear tests give an indication of the strength and durability of the fabric.

The pore size is an indicator of barrier efficiency. More particles will be entrained with a fabric that has a smaller pore size. Therefore, consideration of this characteristic is important to the evaluation of the fabric used in the cleanroom garment construction.

The moisture vapor transmission rate (MVTR) evaluates the ability to move moisture through the fabric and translates to more comfort for the operator. Moisture buildup causes the operator to feel hot due to the increase in humidity between the fabric and the body.

Air permeability is the ability of a fabric to allow air to pass through it, which is quantified by the volume-to-time ratio per area. Airflow in heating and cooling processes, such as the cooling process of the body, contains contaminants that can be transferred to the product. The lower the permeability or transfer of air from within the garment to the outside, the lower the contamination to the product.

There are several tests to determine the fabric’s splash resistance or ability for the fabric to resist absorption of liquids. These characteristics allow the operator to be better protected from spills in the cleanroom environment.

Static decay and surface resistivity testing is performed to document that the fabric is static dissipative. Fabrics outside of the static dissipative range of 105 to 1,011 Ω/square may cause an electrical discharge and subsequent product failure.

All testing of fabrics should be performed over time and exposure to gamma radiation. The results over time should not be significantly different from the original results, therefore demonstrating durability of the fabric characteristics over time.

These same tests may be used in the evaluation of the garment system (fabric and components of garments) to withstand chemicals used in the cleaning of the cleanrooms, the cleaning of the garments, the application of gamma radiation, and, in some cases, autoclaving.

Evaluation of seams and components via RP-CC003.3

Currently all reusable cleanroom garments are constructed of 99 percent polyester and 1 percent durable carbon yarns with cleanroom-compatible, gamma-compatible snaps, zippers, and binding. These garment systems are lightweight, non-linting, economical, and control both non-viable and viable particle contamination. The IEST document details recommended seam construction and components for cleanroom garments.

Using body box testing

All cleanroom garment systems will deteriorate over time due to multiple wash/dry/wear and sterilization cycles. The ability of the garment system to act as a barrier to contamination and its filtration efficacy is evaluated in a “body box” test. The body box is a mini-cleanroom. The particle cleanliness of the area is determined by typical room particle measurement with a particle counter and probe. Wearing the garment system, the operator inside the body box performs a series of prescribed movements to the prescribed cadence of a metronome. The particle measurement during the prescribed movements determines the garment system’s efficacy.

A compilation of the test results and information including the validation of the selected fabrics and garments was evaluated by the quality department of the compounding pharmacies during this case study.

Evaluation of the cleaning of the garment system

The latest revision of IEST-RP-CC003.3 details recommended parameters for the cleaning of cleanroom garments and revised the performance of the Helmke Tumble test for particle cleanliness. This revised version has established test parameters that, when followed precisely, produce results that are more robust, repeatable, and reproducible over various test laboratory settings. The Helmke Tumble test is specifically designed to test the particle shedding of a garment over time. This test evaluates the integrity of the garment as well as the cleanroom garment laundry’s overall ability to render the garment item “particulately clean.” The Helmke Tumble test evaluates particle shed at 0.3 μm and larger. The ASTM F51 test evaluates the same characteristics but at a larger micrometer particle (>5 μm) and fibers. This test is less reproducible due to technician variability over various laboratory settings.

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Additionally, extraction testing can be performed to determine if residual elements and/or compounds are present in the cleanroom garments after cleanroom laundering.

Validating a cleanroom garment system supplier

There are numerous steps involved in validating a cleanroom garment system supplier:

• Complete an installation qualification that audits the garment system supplier and evaluates their qualifying tests and testing results.
• Perform an operation qualification that includes a trial at the customer site and evaluation of the customer-qualifying tests and results.
• Conduct a performance qualification that includes evaluation of the performance of the fabric and garment system over time within the customer’s cleanroom.

All of these steps are necessary to ensuring that a garment system meets the expectations and apparel needs of the individual operation. This information, reviewed during an on-site audit, comprised the validation of the regularly scheduled cleaning of the garments and the cleanroom garment system supplier for the compounding pharmacies in the case study.

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Jan Eudy is corporate quality assurance manager at Cintas (www.cintas.com) and President Emeritus of the Institute for Environmental Science and Technology (IEST). She is also a member of the editorial advisory board for CleanRooms magazine.

Reference

For more information on the revised USP Chapter <797>, visit http://www.usp.org.

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 3, 2008 — /PRNewswire/ AGAWAM, MA — Microtest Laboratories has doubled its microbial identification and analytical services with the purchase of an additional MicroSeq(R) microbial identification system from Applera Corp.

The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified.

“With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients,” states Dr. Steven Richter, Microtest president and CSO. “As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage.”

Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. Traditional bacteria and mold identification lab tests are often less accurate and require up to a one-week turnaround time.

“In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” says Richter. “Our ability to provide rapid identification helps our customers minimize downtime, which directly affects their bottom line. When manufacturing is halted or a cleanroom is shut down and awaiting test results, there is no product going out the door and that translates to an interruption in sales.”

The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in:

• Contract manufacturing
• Pharmaceutical testing and validation
• Medical device testing and validation
• Environmental control and testing
• Water validation
• Mold identification
• Biologics/virology

The MicroSeq system is 99 percent reliable with repeatable results and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, MA, the company’s expertise and flexible processes enhance product safety and security, accelerate time-to-market, and minimize supply chain disruption.

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