Tag Archives: Clean Rooms

June 29, 2007 — LEIPZIG, GERMANY — A conference stream dedicated to the subject of Laboratory Safety and Biosafety will take place at L.A.B. 2007. The World Health Organization published its first edition of the Laboratory Biosafety Manual in 1983, making the issue of biosafety essential to laboratories worldwide. Since then, many countries have used guidance provided in the manual to develop codes of practice. The day-long conference at L.A.B. will debate many of the issues raised in the Laboratory Safety Manual.

The conference, which will examine areas such as safety techniques, incident response and the role of management in laboratory safety, is organized by Leipziger Messe and chaired by John Day, head of quality and safety at the Laboratory of the Government Chemist (LGC). LGC is the U.K.’s leading independent provider of analytical and diagnostic services.

L.A.B. — the European trade fair and conference devoted to analysis, bio and laboratory equipment — occurs from October 2-4, 2007, at ExCeL London International Conference and Exhibition Centre. The Laboratory Safety and Biosafety conference, which will be held on October 3, 2007, concentrates on the following areas:

  • Designing safety into your laboratory and equipment, including implementing the life-cycle approach to safety management.
  • Developing and maintaining a culture of safety.
  • Biosafety and biocontainment techniques, including information for Biosafety Level 2 (BSL-2), BSL-3, and BSL-4 laboratories and Control of Substances Hazardous to Health (COSHH) legislation.
  • Assessment and management of laboratory risks.
  • Laboratory incident response and investigation, from the principles of crisis management to managing the investigation process.
  • Safety, efficiency and the budget — the role of management in laboratory safety.
  • A Health & Safety Executive (HSE) presentation.
  • Planning and implementing occupational health management in a laboratory environment.

    Chairman John Day, Head of Quality and Safety at LGC, comments, “This subject area is both relevant and interesting to professionals from all industry sectors attending L.A.B. The issue of biosafety is currently high on the agenda of laboratories worldwide and more traditional safety issues are constant concerns in all laboratories. The WHO guidance notes encouraged countries to accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of materials in laboratories within their geographical borders. However, we still have a long way to go to develop and reinforce these procedures. I look forward to discussing these issues with an international audience from countries across Europe, USA and beyond, to develop and maintain a culture of safety.”

    The L.A.B. conference, which takes place October 2-3, consists of six streams focusing on relevant industry issues. Delegates will also have the opportunity to visit the L.A.B. exhibition itself, thus making direct contact with leading international exhibitors working in the laboratory safety and biosafety fields.

    To guarantee a place on the “Laboratory Safety and Biosafety” conference stream, or for more information, visit www.lab-uk.co.uk/conference. Participants who register before August 15 will pay just 75 GBP for the full day’s program. To enquire about presenting a paper in this stream, contact Oxford International, [email protected]. For more information about L.A.B., please go online to www.lab-uk.co.uk, contact Leipziger Messe at +49-341-678-1211, or E-mail [email protected]

    About Leipziger Messe
    Leipziger Messe is an experienced trade fair partner, offering custom trade fair concepts to satisfy the needs of exhibitors and visitors alike. Leipziger Messe has 30 offices worldwide, which ensures local representation, assistance and information throughout the world’s important international markets. Its all-round services range from developing trade fair concepts to stand construction, travel services and realizing the event. The company’s portfolio is constantly expanding, offering exhibitors and visitors the international platform they require to network and successfully cultivate business relations.

    About John Day
    John Day is currently group quality manager and safety advisor at LGC. With a background in chemistry and food science, John has over 30 years’ experience working in foods, forensics, environment, customs, alcohol and research. He is currently a member of the EA Permanent Liaison Group and Eurolab Technical Committee on Quality Assurance.

    The World Health Organization
    For more information about The World Health Organization’s Laboratory biosafety manual, please visit:
    www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf

    • June 26, 2007 — /PRNewswire/ — HAYWARD, CA — Today, Delphon Industries announced its acquisition of UltraTape Industries of Salem, OR. UltraTape is a manufacturer of adhesive tapes used in cleanroom environments. The acquisition supports Delphon’s mission to merge innovative technologies in order to provide unique materials and services to the high technology market.

    “UltraTape is known as an innovator in the area of adhesive tapes used in advanced technology industries and is a perfect complement to the suite of products and services Delphon’s portfolio companies provide to these same markets. The purchase of UltraTape is part of our strategy to support our semiconductor, electronics, and medical customers with high quality products and to achieve strong corporate growth,” says Jeanne Beacham, president of Delphon Industries.

    UltraTape, founded in 1992, manufactures custom cleanroom and construction process tapes in addition to antistatic and medical/pharmaceutical tapes for use in critical environments.

    About Delphon
    Delphon Industries, LLC was started in 2004 in order to provide a platform for merging innovative technologies. The company specializes in bringing together unique high technology products and services in order to meet the specific needs of its customers. Under its corporate umbrella, the company operates Gel-Pak of Hayward, CA, Quik-Pak of San Diego, CA and TouchMark of Hayward, CA. For more information, visit www.delphon.com.

    Source: Delphon Industries, LLC

    Contact:
    Jeanne Beacham, [email protected], or Darby Davis, [email protected], both of Delphon Industries, LLC, 510-576-2220
    Web site: http://www.delphon.com/

    June 26, 2007 — /PRNewswire-FirstCall/ — WILMINGTON, MA — MKS Instruments, Inc., a leading provider of process control technologies for improving productivity in semiconductor and other advanced manufacturing processes, has announced that SEZ AG, the world leader in single-wafer technology, has selected MKS’ LIQUOZON(R) LoopO3 dissolved ozone systems for its next-generation single wafer processors. The MKS generators were chosen because of their compact size, modular design, and unique ability to precisely deliver ultra-pure ozonated water for cleaning processes.

    “By using ozonated water as the cleaning agent, the LIQUOZON LoopO3 offers an environmentally friendly alternative to existing semiconductor cleaning technologies,” says Dr. Christiane Gottschalk, senior manager of sales and customer service for ozone products with the MKS Power and Reactive Gas Products Group. “It’s cost effective, too. Its point-of-use generation of ultra-pure ozonated water and the ease of conversion of ozone back to oxygen greatly reduce costs for buying, storing, and disposal of cleaning chemicals.”

    The ultra-compact, stand-alone LIQUOZON LoopO3 system is the most compact source for wet wafer processing with ozone including a pump for the recirculation loop. It features fast cycle times and up to 10 L/min of DIO3 at ozone concentrations up to 62 ppm, ideal specifications for low flow, single-wafer applications such as organic clean, water mark removal, and oxide growth. It also features closed-loop concentration control and DI water recirculation for fast response to changing flow requirements and significant water savings. These features maintain constant ozone concentration and operating pressure, assuring process repeatability at varying flow rates. The system’s unique recirculation system that results in zero UPW consumption during idle, its MTBF of >20,000 hours, and its ability to serve multiple process chambers combine to significantly reduce the cost of ownership.

    Other DIO3 delivery systems in the MKS LIQUOZON product family include the LIQUOZON Single, LIQUOZON Smart, LIQUOZON 100, and the LIQUOZON XF.

    About MKS
    MKS Instruments is a leading worldwide provider of process control solutions for advanced manufacturing processes such as semiconductor device manufacturing and thin-film manufacturing for flat-panel displays, optical storage media, architectural glass, and electro-optical products. We also provide technology for biopharmaceutical and medical imaging equipment. Our instruments, components, and subsystems incorporate sophisticated technologies to power, measure, control, and monitor increasingly complex gas-related semiconductor manufacturing processes, thereby enhancing our customers’ uptime, yield, and throughput, and improving their productivity and return on invested capital.

    Source: MKS Instruments, Inc.

    Contact:
    Lisa Condon of MKS Instruments, Inc.
    Tel.: 978-284-4050
    E-mail: [email protected]
    Web site: http://www.mksinst.com/

    June 26, 2007 — /PRNewswire-FirstCall/ — MARLBOROUGH, MA — Rohm and Haas Electronic Materials will invest $60 million in leading-edge lithography equipment to support its extensive research and development of advanced 193 nm photoresist and anti-reflective coatings used in the manufacture of semiconductor devices.

    “As a leading material supplier to the semiconductor industry, our ability to deliver advanced lithography materials is critical, especially as the industry moves down below the 45 nm node,” says Dr. Dominic Yang, business unit director, microelectronic technologies. “This investment will not only enable deep technical partnerships with the front runners in the memory, foundry, and logic segments, but will bring to these customers high-quality products manufactured and tested using the best tools in the industry.”

    As part of its investment, Rohm and Haas Electronic Materials will purchase ASML’s TWINSCAN(TM) XT: 1900Gi 193nm Step and Scan system. This tool, along with a new 300 mm coat/develop track and state-of-the-art defect and metrology equipment, will be installed in first quarter of 2008.

    Dr. Peter Trefonas, research and development director for microelectronic technologies, says the addition of an immersion tool is an important investment for Rohm and Haas. “Many of the world’s leading semiconductor manufacturers — our customers — are installing advanced immersion equipment on their commercial lines. This immersion tool investment is the right step at the right time for us,” says Trefonas.

    “Our 193 nm materials are increasingly being selected as the process of record in the industry,” Trefonas adds. “As adoption of immersion technology widens, Rohm and Haas Electronic Materials will continue to push the edge of materials innovation.”

    About Rohm and Haas Company
    Leading the way since 1909, Rohm and Haas is a global pioneer in the creation and development of innovative technologies and solutions for the specialty materials industry. The company’s technologies are found in a wide range of markets including: building and construction, electronics, food and retail, household and personal care, industrial process, packaging, paper, transportation, and water. Our innovative technologies and solutions help to improve life everyday, around the world. Based in Philadelphia, PA, the company generated annual sales of approximately $8.2 billion in 2006. Visit http://www.rohmhaas.com/ for more information.

    About Rohm and Haas Electronic Materials
    Rohm and Haas Electronic Materials develops and delivers innovative material solutions and processes to the electronic and optoelectronic industries. Focused on the circuit board, semiconductor manufacturing, advanced packaging, and flat-panel display industries, its products and technologies are integral elements in electronic devices around the world. Additional information about Rohm and Haas Electronic Materials can be found at http://www.rohmhaas.com/.

    Source: Rohm and Haas Company

    Contact:
    Jeremy Cole
    Tel: 508-229-7047
    E-mail: [email protected]

    Dr. Rick Hemond
    Tel.: 508-229-7299
    E-mail: [email protected]

    June 20, 2007 — /PRNewswire-FirstCall/ — REDWOOD SHORES, CA — Oracle today announced that Sacramento, CA.-based Ampac Fine Chemicals (AFC), a wholly owned subsidiary of American Pacific Corporation that manufactures active pharmaceutical ingredients and registered intermediates, has deployed Oracle(R) E-Business Suite financial, procurement, and manufacturing capabilities to help facilitate regulatory compliance, improve operational efficiency, and ensure scalability to support company growth. AFC selected Business & Decision, a Certified Advantage Partner in the Oracle PartnerNetwork, to implement and host the solution.

    As a supplier to the pharmaceutical industry, AFC must operate in full compliance with the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP). The company is automating many aspects of its quality system with Oracle Process Manufacturing, which allows it to standardize and control its end-to-end manufacturing processes. As important, AFC uses Oracle Process Manufacturing and Oracle E-Records to help ensure an audit trail of materials, as well as manufacturing and distribution processes, by providing a framework for securely capturing, storing, and printing 21 CFR Part 11-compliant electronic records and signatures.

    “Oracle E Business Suite is a critical element of our strategy to maintain operational excellence in all aspects of our business,” states Dr. Aslam Malik, president of AFC.

    “We looked at several enterprise application vendors, including SAP and Ross,” says Paul Kane, AFC’s chief financial officer. “Only Oracle offered a solution that could meet our unique needs as a process manufacturer in the life sciences industry. In fact, Oracle Process Manufacturing is so well suited to our industry and business that we completed implementation and validation of our new system in just six months — enabling faster return on our technology investment.”

    Beyond automating its quality system, AFC is using Oracle Process Manufacturing to drive greater operational efficiency and productivity in its manufacturing operations. With Oracle, the company is automating core manufacturing management processes and building a single source of information that enables visibility across the entire manufacturing lifecycle — from scheduling and work-in-progress through distribution, release to customer and invoice payment. The Oracle Applications have also been integrated with the company’s materials requirements planning (MRP) process to improve scheduling and help ensure that the correct raw materials are at the appropriate manufacturing facility when needed — enabling the company to reduce the risk and expense involved with storing excess inventory of raw materials.

    AFC selected Business & Decision, an international consulting company, to guide it through its implementation and host its Oracle E-Business Suite solution. Business & Decision was involved with the initiative at every stage of the process — from identifying the best solution for AFC’s needs to completing documentation and managing the training process.

    Mapping and analyzing key business processes were important components of Business & Decision’s work with AFC as the company wanted to minimize customization to reduce implementation costs and accelerate deployment. The process design component, therefore, was critical because the company had committed to adapting its business processes to fit the best-practices supported by the software.

    “We are delighted to contribute to the success of the implementation of Oracle E-Business Suite for AFC. We are genuinely proud to have helped select, design, deploy and now host these critical applications for a regulated environment,” said Robin Kearon, chief executive officer of Business & Decision, North America.

    Oracle is a registered trademark of Oracle Corporation and/or its affiliates. Other names may be trademarks of their respective owners.

    June 20, 2007 — /PRNewswire/ — HEERLEN, THE NETHERLANDS, and AACHEN, GERMANY — Solland Solar is planning its second expansion within one year. The shareholders of the solar cell producer have agreed to increase production capacity almost threefold. From mid-2008, Solland Solar will be able to produce solar power with a total capacity of 170 MWp per year, instead of the current 60 MWp/a.

    With a view to the expansion, Solland Solar is constructing an extra production hall on the German part of the Avantis industrial park, located midway between Heerlen and Aachen, where the company is based. According to the current plans, the new production capacity will be put into full service in the spring of 2008. Space has already been reserved on the current location for another two production halls in anticipation of further expansion.

    Solland Solar’s expansion is being undertaken in anticipation of the growing demand for solar energy. Research by the German Photon Consulting confirmed at the beginning of April that there is an increasing demand in the market, stimulated by the global concern about climate change due to the burning of fossil fuels (coal, oil, gas). Because of this, CO2-free alternatives such as solar energy are becoming increasingly popular. Photon estimated for example that the current production capacity of solar cells, 2.7 GW, will have increased fourfold in 2010.

    Solar energy is also becoming increasingly appealing to consumers due to its significantly lower cost. According to calculations by the EPIA, the industry association devoted to the European solar market, cost price will amount to EUR 0.20 per kWh within the next 10 years.

    Solland Solar
    Solland Solar is a Dutch-German manufacturer of solar cells (photovoltaic cells). Solland Solar’s capacity came to 20 MWp/a at the start of production towards the end of 2005. After a recent expansion, the capacity was increased to 60 MWp/a, with a view to reaching the level of 170 MWp/a from mid-2008.

    Constant growth is a key objective of Solland Solar, which strives for a production capacity of 500 MWp/a in 2010 (2007: 60 MWp/a), with relevant turnover of EUR 1 billion (2006: EUR 40 million). The number of employees will also increase, from 160 in 2007 to 400 in 2008 and 1,000 in 2010.

    Delta Solar and Sunergy acquired a controlling interest in Solland in February 2007.

    The achievements of Solland Solar have not gone by unnoticed. It won “The Rising Star Award” of Deloitte/FEM Business in 2006 and the “Euregion Meuse-Rhine Investment Award” earlier this year.

    Web site: www.sollandsolar.com

    Source: Solland Solar

    Contact:
    Wendy Kleijnen, Public Relations Dept.
    Tel.: +31(0)45-8800-600
    E-mail: [email protected]

    Nano Risk Framework to aid in responsible development of nanotechnology

    June 21, 2007 — /PRNewswire-FirstCall/ — WASHINGTON, DC — DuPont and Environmental Defense today released a comprehensive framework to assist with the responsible development and use of nanotechnology and to help inform global dialogue on its potential risks. The Nano Risk Framework is intended for use around the world by small and large companies, regulatory agencies, universities, and others with an interest in commercializing nanoscale materials.

    DuPont and Environmental Defense began a partnership on nanotechnology in September 2005, creating a multi-disciplinary team with expertise in science, engineering, law, and business. The goal was to develop a systematic and disciplined process for evaluating and addressing the environmental, health, and safety risks of nanomaterials across all stages of a product’s lifecycle — from initial sourcing through manufacture, use, and recycling or disposal.

    The resulting framework offers a thorough and usable six-step process for organizations to identify, assess and manage potential risks. The six steps within the framework include:

    • Describing the material and the intended application.
    • Profiling the material’s lifecycle in this application.
    • Evaluating the associated risks.
    • Assessing risk management options.
    • Deciding and documenting actions.
    • Regularly reviewing new information and adapting actions accordingly.

    “Nanotechnology has the potential to unleash innovations in materials, energy, and other fields that could lead to powerful environmental and health benefits,” says director of corporate partnerships at Environmental Defense Gwen Ruta. “Our intent is to help reap the full promise of this technology without creating unintended consequences. We want to get this right the first time around.”

    “This framework outlines a disciplined process for the responsible development of nanomaterials,” says DuPont vice president and chief sustainability officer Linda Fisher. “At DuPont, we have adopted this approach as a part of our mandatory product stewardship process, and we encourage others to do the same. While we do not see this framework as a substitute for regulation, we hope that it assists governments in drafting appropriate regulations.”

    In developing the framework, DuPont and Environmental Defense solicited and received significant feedback from a broad range of interested parties, including other companies and NGOs, government officials, and academics. The framework uses proven risk-management techniques in order to fully integrate with any current environmental, health, and safety practices in place within companies. It also provides several new elements that can be instrumental in understanding the unique potential risks of nanomaterials, including: the recommendation to develop informational profiles (or “base sets”) regarding the properties, hazards, and exposures associated with a given nanomaterial; and guidance on developing more detailed information on physical-chemical properties, ecotoxicity and environmental fate than has typically been used in existing risk management profiles.

    In order to evaluate the effectiveness, flexibility, and practicality of the framework, DuPont conducted three demonstration projects on three different classes of nanoscale materials: a new titanium dioxide-based product, carbon nanotubes, and zero valent iron.

    “These projects were selected not only because they are of interest to DuPont, but also because they represent a good test of the framework,” says DuPont global regulatory affairs director Terry Medley. “Each represents a different position for DuPont in the value chain and is at a different stage of development. The projects required different resources, produced varying outcomes, and each demonstrated different aspects of the Framework.” The three projects were:

    • A new titanium dioxide-based product, called DuPont(TM) Light Stabilizer 210, which is designed as sun protection for plastics. An announcement about this product and its commercial availability will be made in the near future. Not all of the particles in this product fit the specific definition of nanomaterials, since a significant fraction is larger than the threshold 100 nm size. However, this material proved to be a good test of the framework’s methodology. The framework helped DuPont develop a comprehensive exposure and hazard profile for this material prior to commercialization.
    • Carbon nanotubes incorporated into polymer nanocomposites to improve mechanical and electrical properties of engineering thermoplastics. DuPont currently conducts basic research and development using carbon nanotubes for potential future product applications. The company used the framework to refine internal management procedures and to identify questions to be answered for such applications before they move from R&D toward commercialization.
    • Nano zero valent iron, which DuPont was evaluating for potential use in groundwater remediation. Use of the framework identified a number of questions regarding the physical safety, fate, and transport of the material for this environmental application. DuPont chose not to pursue use of this material until these questions could be addressed.

    Environmental Defense, a leading national non-profit organization, represents more than 500,000 members. Since 1967, Environmental Defense has linked science, economics, law, and innovative private-sector partnerships to create breakthrough solutions to the most serious environmental problems.

    DuPont is a science-based products and services company. Founded in 1802, DuPont puts science to work by creating sustainable solutions essential to a better, safer, healthier life for people everywhere. Operating in more than 70 countries, DuPont offers a wide range of innovative products and services for markets including agriculture and food; building and construction; communications; and transportation.

    Source: DuPont

    Contact:
    Michelle Reardon of DuPont, 302-774-7447, [email protected]

    Melanie Janin of Environmental Defense, 202-572-3240, [email protected]

    Web site: http://www.dupont.com/

    June 22, 2007 — /FDA News/ — The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

    “This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” says Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

    The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

    “The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” says Robert E. Brackett, PhD, director of FDA’s Center for Food Safety and Applied Nutrition.

    Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

    The aim of the final rule is to prevent inclusion of the wrong ingredients; too much or too little of a dietary ingredient; contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals; and improper packaging and labeling.

    The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

    As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements.

    Under the interim final rule the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.

    The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

    June 25, 2007 — ST. PAUL, MN — Ecolab Inc. announced today a new Hand Hygiene Monitoring Compliance Program for hospitals and healthcare facilities. The Ecolab Hand Hygiene Compliance Monitoring Program provides a multi-intervention approach that combines effective hand hygiene products, a step-by-step implementation process, patient empowerment education and training materials, ongoing measurement, and benchmarking to increase and sustain hand hygiene compliance. According to the Centers for Disease Control, proper hand hygiene is the single most effective method for preventing healthcare-associated infections (HAIs) in hospitals.

    “Simply put, proper hand hygiene enables hospitals to provide better patient care and to reduce costs,” says Tim Mulhere, vice president and general manager of healthcare at Ecolab. “The Ecolab Hand Hygiene Compliance Monitoring Program provides all the tools and resources hospitals need to drive hand hygiene compliance and reduce healthcare-associated infections.”

    Elements of the Ecolab Hand Hygiene Compliance Monitoring Program include:

    • Patient empowerment — Patient empowerment programs increase awareness of the importance of hand hygiene and encourage patients and their families to ask their healthcare provider to wash or sanitize their hands prior to any direct contact. Ecolab has developed a comprehensive set of materials, including brochures, posters, buttons, and a video, under a program entitled “It’s OK To Ask,” that encourage patients to actively participate in their care. According to recent studies (1999-2006) in the American Journal of Infection Control and Journal of Hospital Infection Control, patient empowerment and measurement have been shown to increase and sustain compliance on average 56 percent.
    • Measurement — Measurement of compliance data establishes an accurate, current baseline compliance rate against which progress can be tracked. Ongoing measurement and reporting further supports compliance by enabling hospitals to objectively measure the progress of programs and promote improvements.
    • Benchmarking — Confidential reporting of data and analysis helps hospitals to validate their hand hygiene program as it grows. In addition, ongoing compliance can be compared against data from similar sized hospitals and units including in

    A no-fault settlement provides a clear path to resumption of operations at Shelhigh, including product shipment

    June 25, 2007 — /PRNewswire/ — UNION, NJ — Shelhigh announced today that it has reached a no-fault settlement agreement with the U.S. Food and Drug Administration (FDA) that provides a clear path to the resumption of operations at Shelhigh, including product shipment.

    “I am extremely pleased that the FDA and Shelhigh were able to reach a settlement that will permit us to resume shipments of our life-saving products to patients around the world,” says Dr. Shlomo Gabbay, chief scientific officer for Shelhigh.

    The FDA acknowledges that it did not mandate a product recall, Shelhigh did not conduct a recall, and no product recall is required by the settlement just announced.

    The agreement calls for independent experts to inspect and certify that Shelhigh’s manufacturing processes are in substantial compliance with Federal regulations. These independent inspectors have already begun their review and the firm anticipates that any required changes will be easily implemented. Upon completion of the experts’ certification, the FDA will conduct normal inspections to confirm that the requested changes were made. Importantly, this approach will provide the fastest means for Shelhigh to resume product shipment.

    This was not an agreement ordered by the court, but rather a mutual no-fault settlement that the court agreed to sign so that FDA and Shelhigh can resume good relations, and Shelhigh can resume delivering its life-saving products. Shelhigh is pleased to announce that FDA declared, “FDA did not invoke the Federal Food, Drug, and Cosmetic Act to mandate that Shelhigh recall its devices, and Shelhigh did not conduct a recall of its devices.”

    “Shelhigh has always been committed to maintaining a good working relationship with the FDA, while providing its life-saving products to patients in need,” says Gabbay. “As is well-documented, Shelhigh’s track record of providing effective and revolutionary products is extraordinary, and we are pleased to demonstrate that our manufacturing process is exact and complete, and in full compliance.”

    About Shelhigh
    Shelhigh is known for its proprietary No-React(R) tissue products that utilize the widely accepted glutaraldehyde fixation process while avoiding the acknowledged problems that accompany glutaraldehyde. No-React tissue products have over 10 years proven performance of resisting infection and calcification, even in cases of active infective endocarditis. Today Shelhigh offers a wide variety of cardiothoracic surgical solutions, all incorporating No-React tissue for superior performance. To learn more about Shelhigh and its products please visit http://www.shelhigh.com/. Visitors may also sign up for the Shelhigh newsletter for automatic updates.

    Source: Shelhigh, Inc.

    Contact:
    Douglas Goldman of Shelhigh, Inc.
    Tel.: 908-206-8706
    E-mail: [email protected]