Tag Archives: Clean Rooms

March 12, 2007 — /BOC Edwards/ — LONDON — CCMP Capital, through affiliates of CCMP Capital Advisors LLC and CCMP Capital Asia, Ltd., premier international private equity firms, have reached agreement with The Linde Group, the global gases company, to acquire BOC Edwards, a leading manufacturer of vacuum equipment. The deal is valued at £460m, with an additional payment of £45m if CCMP Capital is successful in developing the business and subsequently exiting its investment.

BOC Edwards is a leading global supplier of equipment and services to the world’s most advanced industries, including semiconductor, flat panel display, chemical, metallurgical, analytical instrumentation and R&D. It supplies major manufacturers in Asia, Europe and the Americas through a worldwide manufacturing and sales network.

The acquisition follows last year’s acquisition of The BOC Group by Linde and Linde’s announcement last September that it intended to focus on its global gases operations and would review strategic options for the divestment of BOCEdwards.

CCMP Capital Advisors and CCMP Capital Asia are acquiring the main vacuum and semiconductor equipment business of BOC Edwards. The pharmaceutical division will remain a subsidiary of The Linde Group.

Commenting on the announcement, Nigel Hunton, Chief Executive of BOC Edwards, said: “We are delighted to welcome CCMP as our new partners. We feel they have a real understanding for our business and its potential and that their financial strength and scale will support the company as we develop our operations worldwide and capitalise on our strong market position. This is the start of a new independent era for BOC Edwards in which we can focus on delivering world class products and services to our customers.”

Stephen Welton from CCMP Capital Advisors added: “We are very pleased to have reached agreement to acquire BOC Edwards. Our Diligence has confirmed the leading position of BOC Edwards, its management and staff, its extensive product range and its strong customer relationships. We believe that under CCMP’s ownership BOC Edwards can move to a new level as an independent company and develop its technology in new markets whilst retaining leadership in its core areas.”

John Lewis from CCMP Capital Asia, commented: “BOC Edwards is an outstanding business with a rapidly growing Asian customer base, including leading semiconductor companies and equipment manufacturers in Greater China, Korea, Japan and Singapore. We will support management, using CCMP’s presence and experience in these markets to help BOC Edwards get closer to their fast growing Asian customer base.”

The companies expect to close the transaction between the beginning of May and the end of June subject to regulatory review and customary closing conditions.

About BOC Edwards
BOC Edwards is a leading supplier of integrated solutions for the manufacture of microelectronics devices, including semiconductors and flat panel displays. It is also a world leader in vacuum technology for industrial, scientific, process, and R&D applications. BOC Edwards employs around 4,000 people globally, in the design, manufacture and support of high technology vacuum equipment. BOC Edwards invented the concept of the commercial oil-free ‘dry’ vacuum pump and now supplements this with a wide range of other pumping technologies as well as related products and services.

About CCMP Capital
CCMP Capital Advisors, LLC investment team has invested over $10 billion in over 375 buyout and growth equity transactions since 1984. The foundation of CCMP Capital’s investment approach is to leverage the combined strengths of its deep industry expertise and proprietary global network of relationships by focusing on five targeted industries: Consumer, Retail and Services; Energy; Healthcare Infrastructure; Industrials; and Media and Telecom. Through active management and its powerful value creation model, CCMP Capital’s team has established a reputation as a world-class investment partner.

Selected investments include: AMC Entertainment, Aramark Corporation, Generac Power Systems, Grupo Corporativo ONO, Hanley Wood, Harbor Point Re, PQ Corporation, Quiznos Sub, SafetyKleen Europe and Warner Chilcott. Prior to forming CCMP Capital, the firm’s principals led the buyout and growth equity investment business of J.P. Morgan Partners, LLC, a private equity division of JPMorgan Chase & Co. CCMP Capital follows the successful investment strategy its principals developed and implemented as members of J.P. Morgan Partners.

CCMP Capital is a registered investment adviser with the Securities and Exchange Commission.

About CCMP Capital Asia
CCMP Capital Asia is one of the largest and most experienced buyout firms in Asia, with US$2.7 billion in capital commitments under management. Since its launch in May 1999, CCMP Capital Asia has advised on total investment commitments of over US$1.6 billion in 24 companies with total transaction value of over US$10 billion. The commitments are spread across Asia in CCMP Capital Asia’s focus markets of Australia, Greater China, Japan, Korea and Singapore. CCMP Capital Asia’s core strategy is to target control investments in market leading companies with strong cash generative business models, high barriers to entry and differentiating capabilities or products. In particular, the Firm focuses on companies where it is able to utilize its operationally driven business model to create value and drive returns.

Representative investments include: Air International Thermal, ASAT, Buy The Way, Godfrey’s, Haitai Confectionary, Mando Corporation, Metalform, Rhythm Corporation, Sanda Kan Industrial, Waco and Yellow Pages Singapore.

Media Inquiries: Michael Herndon, 301-827-6242
Consumer Inquiries: 888-INFO-FDA

March 12, 2007 — /FDA News/ — The Food and Drug Administration (FDA) today published a draft final guidance advising processors of fresh-cut produce how to minimize microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables, which are often sold to consumers in a ready-to-eat form.

The document — “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” — suggests that fresh-cut processors consider a state-of-the-art food safety program such as the Hazard Analysis and Critical Control Points (HACCP) system, which is designed to prevent, eliminate, or reduce to acceptable levels the microbial, chemical, and physical hazards associated with food production.

The guidance complements FDA’s regulations of manufacturing practices and incorporates comments received in response to its draft issued in March 2006. The current version will not be final until the White House Office of Management and Budget completes an authorization step required by the Paperwork Reduction Act, and the agency announces that the guidance is final.

“Ensuring the safety of the American food supply is one of this Agency’s top priorities,” said Andrew C. von Eschenbach, MD, Commissioner of Food and Drugs. ” Americans are eating more fresh-cut produce, which we encourage as part of a healthy diet. But fresh cut-produce is one area in which we see foodborne illness occur. Offering clearer guidance to industry should aid in the reduction of health hazards that may be introduced or increased during the fresh-cut produce production process.”

Dr. von Eschenbach will testify before a hearing by the Agriculture, Rural Development, and Related Agencies Subcommittee of the Senate Committee on Appropriations, which will address the processes in place and improvements being made regarding food safety, specifically the safety of fresh produce and vegetables. The hearing will take place in Madison, Wisconsin, on March 12, 2007.

Processing produce into fresh-cut product increases the risk of bacterial contamination and growth by breaking the natural exterior barrier of the produce by peeling, slicing, coring, or trimming the produce with or without washing or other treatment before the produce is packaged for consumers. Examples of fresh-cut products are shredded lettuce, sliced tomatoes, salad mixes (raw vegetable salads), peeled baby carrots, broccoli florets, cauliflower florets, cut celery stalks, shredded cabbage, cut melons, sliced pineapple, and sectioned grapefruit.

Consumers can reduce their risk of illness from fresh-cut produce by following safe handling practices such as refrigerating the product after purchase; using only clean hands, utensils or dishes in preparing the product; and discarding the product when the “use by” date has expired.

The Guide complements FDA’s Current Good Manufacturing Practice regulations for food (21 CFR 110) and provides a framework for identifying and implementing appropriate measures to minimize the risk of microbial contamination during the processing of fresh-cut produce. Specifically, it discusses the production and harvesting of fresh produce and provides recommendations for fresh-cut processing in the following areas: (1) personnel health and hygiene, (2) training, (3) building and equipment, (4) sanitation operations, and (5) fresh-cut produce production and processing controls from product specification to packaging, storage and transport. The Guide also provides recommendations on recordkeeping and on recalls and tracebacks.

The Guide also recommends that processors encourage the adoption of safe practices by their partners throughout the supply chain, including produce growers, packers, distributors, transporters, importers, exporters, retailers, food service operators, and consumers. These practices include:
*Establishing a company policy that employees report any active case of illness to supervisors before beginning work and training;
*Training supervisors to recognize typical signs/symptoms of infectious disease; maintain the proper first aid to protect and cover any wound; and not allow an employee to work with any aspect of fresh or fresh-cut produce, processing equipment or tools until the wound has healed and/or the infectious disease has been treated.

FDA believes awareness of the common risk factors discussed in this guidance and implementation of preventive controls determined by a firm to be appropriate to its individual operations will enhance the safety of fresh-cut fruits and vegetables. More information on safe handling practices of produce can be found at http://www.fightbac.org/.

Written comments on the Guide are acceptable at any time and should be sent to FDA’s Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments on the Guide-specific to issues involving the Paperwork Reduction Act should be faxed within 30 days of the publishing date of the Federal Register notice to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

The Guide is accessible on the FDA Website at: http://www.cfsan.fda.gov/guidance.html

March 1, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are reminding consumers of the dangers of drinking milk that has not been pasteurized, known as raw milk. Raw milk potentially contains a wide variety of harmful bacteria — including Salmonella, E. coli O157:H7, Listeria, Campylobacter and Brucella — that may cause illness and possibly death.

Consuming raw milk may be harmful to health. From 1998 to May 2005 CDC identified 45 outbreaks of foodborne illness that implicated unpasteurized milk, or cheese made from unpasteurized milk. These outbreaks accounted for 1,007 illnesses, 104 hospitalizations, and two deaths. This is based on information in CDC’s Morbidity and Mortality Weekly Report for the week of March 2, 2007. The actual number of illnesses was almost certainly higher because not all cases of illness are recognized and reported.

Consumers who become ill after consuming raw milk, and pregnant women who believe they consumed contaminated raw milk or cheese made from raw milk, should see a doctor or other health care provider immediately.

Symptoms of illness caused by raw milk vary depending on which harmful bacteria are present. Symptoms may include but are not limited to: vomiting, diarrhea, abdominal pain, fever, headache and body ache.

Most healthy people will recover from illness caused by harmful bacteria in raw milk or in foods made with raw milk within a short period of time. But some individuals can develop symptoms that are chronic, severe, or even life-threatening. Illnesses caused by pathogens found in raw milk can be especially severe for pregnant women, the elderly, infants, young children and people with weakened immune systems.

Since 1987, in order to better protect consumers from such risks, FDA has required all milk packaged for human consumption be pasteurized before being delivered for introduction into interstate commerce. Pasteurization, a process that heats milk to a specific temperature for a set period of time, kills bacteria responsible for diseases such as listeriosis, salmonellosis, campylobacteriosis, typhoid fever, tuberculosis, diphtheria and brucellosis. FDA’s pasteurization requirement also applies to other milk products, with the exception of a few aged cheeses.

Proponents of drinking raw milk often claim that raw milk is more nutritious than pasteurized milk and that raw milk is inherently antimicrobial, thus making pasteurization unnecessary. Research has shown that these claims are myths. There is no meaningful nutritional difference between pasteurized and raw milk, and raw milk does not contain compounds that will kill harmful bacteria.

In fact, raw milk, no matter how carefully produced, may be unsafe. The CDC, the American Medical Association, the American Academy of Pediatrics, the National Conference on Interstate Milk Shipments, the National Association of State Departments of Agriculture, the Association of Food and Drug Officials and other organizations have endorsed the pasteurization of milk and restriction of the sale of products containing raw milk. Because even pasteurized milk contains low levels of nonpathogenic bacteria that can cause food to spoil, it is important to keep pasteurized milk refrigerated.

Raw Milk Q&A [FDA] http://www.cfsan.fda.gov/~dms/rawm-toc.html

Food Facts: The Dangers of Raw Milk [FDA] http://www.cfsan.fda.gov/~dms/rawmilk.html

MMWR: Escherichia coli O157:H7 Infection Associated with Drinking Unpasteurized Milk [CDC] http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5608a3.htm

21 CFR, Sec. 1240.61 Mandatory pasteurization for all milk and milk products in final package form intended for direct human consumption [U.S. Government Printing Office] http://a257.g.akamaitech.net/7/257/2422/10apr20061500/edocket.access.gpo.gov/cfr_2006/aprqtr/21cfr1240.61.htm

Raw Milk Position Statements
FDA Raw Milk Position Statement [FDA] http://www.cfsan.fda.gov/~ear/mi-03-4.html

AMA Position on Milk and Human Health [American Medical Association] http://www.ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/H-150.980.HTM&&s_t=&st_p=&nth=1&prev_pol=policyfiles/HnE/H-145.999.HTM&nxt_pol=policyfiles/HnE/H-150.946.HTM&

AAP Position on Unpasteurized Milk and Cheese [American Academy of Pediatrics] http://aapredbook.aappublications.org/cgi/content/full/2006/1/A.VII

Additional Raw Milk Information
On the Safety of Raw Milk [FDA] http://www.cfsan.fda.gov/~ear/milksafe.html

FDA Testimony on Raw Milk [Ohio Department of Agriculture] http://www.ohioagriculture.gov/dairy/documents/FDATestimonyRawMilk.pdf

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Contact:_Simply Fresh Fruit _323-586-0000

March 1, 2007 — /FDA News/ — Los Angeles, CA — Simply Fresh Fruit Inc. is recalling Simply Fresh Fruit Fresh Cut Fruit trays dated with sell by date 022607 due to possible salmonella contamination. On February 23, Simply Fresh Fruit Inc. was notified by Castle Produce that cantaloupe shipped by Castle to Simply Fresh Fruit Inc. on February 16 was subject to a recall due to possible Salmonella contamination.

Persons infected with Salmonella may experience a variety of symptoms and illnesses. According to the U.S. Food and Drug Administration healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in more severe illnesses and potentially can be fatal.

The cantaloupe was processed into 2,250 trays of five-pound fresh cut fruit and distributed by Costco throughout Los Angeles metropolitan areas. Costco was notified on February 23 and the product was removed immediately from sale; there have been no reported illness from consumption of this product and the product is now out of code. The recall is for trays labeled “Simply Fresh Fruit Fresh Cut Fruit Tray” with a sell by date of 2-26-07. Customers who may have uneaten trays with the 2-26-07 code date may arrange for the return of the product for a full refund by calling Simply Fresh Fruit at 323-586-0000.

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Contact: Gebauer Company 800-321-9348

March 1, 2007 — /FDA News/ — Cleveland, OH — Gebauer Company, a 107-year-old medical device manufacturer and marketer, today announced a nationwide, voluntary firm initiated recall of certain lots of its Salivart Oral Moisturizer, product number 0386-0009-75. These lots may contain some units that do not meet the Company’s internal specification for aerobic microorganisms and mold.

The problem was discovered during routine stability testing. The problem is not uniform throughout the lots. Use of the affected units of these lots of Salivart Oral Moisturizer may cause temporary and reversible health problems such as nausea, vomiting, and diarrhea.

Lot numbers and expiration dates are located on the bottom of the product can. The recalled product lots are: (see figure)

Customers who believe they are in possession of the recalled product should stop using the product and dispose of it immediately in their regular trash.

“We are committed to the quality of our products and we are taking all necessary measures to remedy this production issue,” said John Giltinan, President of Gebauer Company. “Salivart Oral Moisturizer has been used safely since 1990 and is supported by our history of meeting high safety and efficacy standards.”

Should customers require additional information, they are to contact Gebauer Company Customer Service at (800) 321-9348.

Consumers advised to avoid raw oysters harvested from San Antonio Bay

Media Inquiries: Michael Herndon, 301-827-6242
Consumer Inquiries: 1-888-SAFEFOOD

March 2, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) is investigating an outbreak of norovirus-associated illness linked to eating raw oysters harvested from San Antonio Bay, TX. FDA advises consumers to avoid eating raw oysters harvested from this area after February 1, 2007, as a result of reports of illnesses in people who attended a Maryland event where these oysters were served. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus. The illness typically lasts one to two days.

Consumers who ate oyster products served in restaurants after February 1 and experienced symptoms of norovirus are encouraged to contact their healthcare provider and local health department. Consumers concerned about oysters purchased during this period should contact their place of purchase to determine if the oysters are from the affected lot of oysters.

To date, illnesses have been reported by 25 individuals who ate raw oysters over the weekend of February 9, 2007 – February 11, 2007 at a Bull & Oyster Event in Maryland. The Maryland Department of Health & Mental Hygiene’s test results from ill patients are positive for norovirus.

The implicated oyster beds in the San Antonio Bay were closed by the Texas Department of Health Services on February 24, 2007 and remain closed. Bayview Seafood, a distributor in Seadrift, TX, issued a voluntary recall on February 26, 2007. Another distributor, Rose Bay Oyster Company of Swanquarter, NC, issued a voluntary recall on February 28, 2007. Oysters subject to the recall were mislabeled by the Rose Bay Oyster Company, indicating Galveston Bay as the harvest area; the implicated oysters were actually harvested from San Antonio Bay. Oysters with tags that read: “Gal 1, 2/2/07” are subject to the recall.

FDA will continue working with health officials in Maryland to track any additional cases of norovirus illness. FDA will continue to provide regular updates to the public as this investigation unfolds.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

Cooking destroys the virus, eliminating the risk of illness for both healthy and immunocompromised individuals. FDA advises that it’s always best to cook seafood thoroughly to minimize the risk of foodborne illness. Consumers can continue to enjoy oysters in many cooked preparations by following this advice:

At Restaurants and other Foodservice Establishments:
*Order oysters fully cooked.

In the Shell:
*Purchase oysters with the shells closed.
*Throw away any oysters with shells already opened.

To prepare oysters for eating, choose one of the following methods:
*Boil oysters until the shells open. Once open, boil for an additional 3-5 minutes.
*Steamer – add oysters to water that is already steaming and cook live oysters until the shells open; once open steam for another 4-9 minutes.
*Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time, may cause uneven heat distribution, which may cause the oysters in the middle to not get fully cooked.
*Discard any oysters that do not open during cooking.

Shucked Oysters:
To prepare oysters for eating, choose one of the following methods:
*Boil or simmer shucked oysters for at least 3 minutes or until the edges curl.
*Fry at 375 degrees for at least 3 minutes.
*Broil 3 inches from heat for 3 minutes.
*Bake at 450 degrees for 10 minutes.

For further information contact:

FDA Food Safety Hotline: 1-888-SAFEFOOD
FDA website: www.cfsan.fda.gov

Viability kit and bacteriophage solutions announced at Food Safety Summit

March 06, 2007 — ROANOKE, Va.–(BUSINESS WIRE)–Luna Innovations Incorporated announced today at the 2007 Food Safety & Security Summit in Washington, DC, two products that are under development to provide an integrated approach to the management of bacterial contamination in food: a rapid bacterial viability kit to assess decontamination efficiency and to evaluate the cleanliness of surfaces, and what is anticipated to be the first in a family of bacteriophage products.

Luna’s rapid bacterial viability kit is specifically designed to assess the presence of bacteria to determine the effectiveness of a decontamination routine used to clean surfaces in the food processing and manufacturing industry. The kit is intended to be a faster solution than standard culture methods, giving food manufacturers more timely information about their decontamination processes.

Luna’s initial bacteriophage product candidate is targeted to destroy Listeria monocytogenes, a common foodborne pathogen responsible for the disease Listeriosis. According to the Center for Disease Control, about 20% of the people in the United States who become seriously ill with Listeriosis each year die. Luna’s approach is to use a variety of phage types, creating a broad killing agent, to improve the safety of food. The mixture is being designed to be added in line with current food production and manufacturing processes or sprayed on food surfaces to reduce L. monocytogenes contamination. Luna’s phage product candidate is all natural and does not contain preservatives or potentially-allergenic substances. The phage also does not alter the taste, odor, or color of foods.

“The products currently under development at Luna are aimed at providing a safe solution for the control of deadly microorganisms in meat, fruits and vegetables,” said Dr. Richard Obiso, Director of Life Sciences at Luna Innovations.

About Luna Innovations:
Luna Innovations Incorporated researches, develops and commercializes innovative technologies in molecular technology and sensing solutions. Luna accelerates the process of bringing new and innovative products to market by focusing on technologies that can fulfill identified market needs and then takes these technologies from the applied research stage through commercialization. Since its inception, Luna has successfully developed products for the energy, telecommunications, life sciences and defense industries. Headquartered in Roanoke, Virginia, the company has research, development and manufacturing facilities in Blacksburg, Charlottesville, Hampton, and Danville, Virginia and a sales office in McLean, Virginia.

Forward Looking Statements
This release includes information that constitutes “forward-looking statements” made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995, including statements regarding the relative speed of the company’s rapid bacterial viability kit relative to standard culture methods, the ability of the company’s bacteriophage product candidates to destroy L. monocytogenes on equipment and food surfaces, and the safety of products currently under development. Actual results may differ materially from the expectations expressed in such forward-looking statements as a result of various factors, including risks and uncertainties set forth in the company’s periodic reports and other filings with the Securities and Exchange Commission. Such filings are available at the SEC’s website at http://www.sec.gov, and at the company’s website at http://www.lunainnovations.com. The statements made in this release are based on information available to the company as of the date of this release and Luna Innovations undertakes no obligation to update any of the forward-looking statements after the date of this release.

Contacts
Luna Innovations Incorporated
Karin Clark, Director of Marketing & Communications
1-540-769-8400; fax: 1-540-769-8401
[email protected]

February 28, 2007 — /BUSINESS WIRE/ — SAN JOSE, Calif. — SEMATECH’s program in developing solutions for extreme ultraviolet lithography (EUVL) infrastructure has brought the technology out of proof-of-feasibility and into the realm of identifying manufacturing challenges, participants at the annual SPIE Advanced Lithography conferences learned here yesterday.

During a review of the SEMATECH EUV program and accomplishments, SEMATECH lithographers recounted achievements in multiple areas of EUV, bringing it from a potential future lithography technique to the leading contender for commercial production of microchips at the 32 nm half-pitch technology generation and beyond.

However, they cautioned that significant challenges – including contamination issues, source reliability, and the demand for improved resists – must be solved to enable the successful introduction of reliable EUV beta tools by 2009.

“With the recent introduction of alpha tools, EUV lithography has reached an historic milestone,” said Stefan Wurm, EUV program manager for SEMATECH. “The challenge before us is to develop the critical infrastructure for beta tools, so that EUV can be evaluated in manufacturing pilot lines.”

Wurm and other SEMATECH leaders spoke to more than 300 attendees at SPIE’s Emerging Lithographic Technologies XI conferences, one of several multi-day meetings of SPIE – the International Society for Optical Engineering. They described a series of SEMATECH-led achievements that has helped make EUV a high-volume manufacturing (HVM) lithography candidate with the potential of being available for the 32 nm half-pitch generation.

In brief, SEMATECH, working with its industry partners, has demonstrated new results to build on many earlier reported success stories:
*Achievement of nearly defect-free reticle handling for shipping, long-term storage, and vacuum transfer through demonstration of a dual pod reticle container. EUVL reticles, which do not use pellicles, require such a novel handling solution.

*Cleaning of 30 nm defects from EUVL mask blanks at good removal efficiency, which is essential to developing and demonstrating defect-free EUVL mask blanks

*Demonstration of capability for optical and actinic inspection tools to find EUV phase defects. New advancements in defect detection technology are required to meet production targets, and SEMATECH has a unique combination of optical and actinic inspection capability.

*SEMATECH, through multiple sites, provided most of the exposure capability to member companies and resist suppliers developing imaging materials for EUVL that have recently demonstrated <30 nm half-pitch imaging. Rapid cycles of learning are required to ensure that resist materials are ready for 32 nm half-pitch HVM. In addition to exposure capability, SEMATECH has formulated a best-known-method for measuring EUV resist outgassing, based on a methodology established in conjunction with the College of Nanoscale Science and Engineering of the University at Albany. *SEMATECH has shown that it can detect <40 nm mask blank defects, which was enabled by a joint development program of the Lasertec M7360. This will enable further progress in defect-free mask blank production and reticle handling.

Encouraging as these results are for SEMATECH members and the litho industry, SEMATECH identified further challenges for making EUVL manufacturing ready. Among them are:
*Solving reliability issues and improving cost of ownership (COO) for EUV sources. Within a year or two, sources exceeding 60 watts must be made to operate continuously for several months, with uptime and COO comparable to those of optical litho sources.

*Design, build and commercialize a third-generation mask blank defect inspection tool to meet the emerging requirements of 32 nm half-pitch manufacturing.

*Continuing to develop ever-more efficient mask cleaning technologies, including commercialization of localized cleaning techniques currently being developed.

*Producing an affordable, stand-alone EUV interference lithography (IL) tool that suppliers can use to develop advanced resists at their own facilities. This would enable screening within one or two years of the most promising resist platforms for 22 nm half-pitch lithography.

“These are big challenges but the industry has climbed taller mountains before,” said Michael Lercel, SEMATECH lithography director. “The SEMATECH EUV Program, based on strong partnerships with the industry, continues to be the single most important industry resource for enabling advanced lithography infrastructure. For EUV lithography to be successful, the infrastructure is the key enabling element. That is what will make or break it as a manufacturable technology.”

For 20 years, SEMATECH(r) (www.sematech.org) has set global direction, enabled flexible collaboration, and bridged strategic R&D to manufacturing. Today, we continue accelerating the next technology revolution with our nanoelectronics and emerging technology partners.

Contacts
SEMATECH Dan McGowan, 512-426-8194 [email protected]

FFU market expected to grow through 2010

By Robert McIlvaine and Karen Vacura, The McIlvaine Company

A fan filter unit (FFU) consists of a small blower with a matched fan, an optional digital or solid-state speed controller, and a HEPA/ULPA filter, all enclosed in an aluminum or stainless-steel box. The unit maintains specific airflow and is commonly installed directly into cleanroom ceiling grids. Smaller and more portable than traditional airflow systems, with typical sizes of 2 feet x 2 feet or 2 feet x 4 feet, FFUs can be focused in targeted areas. They can be added to existing cleanrooms without major refitting, enabling updates as needs and standards change.

FFUs, favored in semiconductor cleanrooms, are also utilized in flat-panel display (FPD), nanotechnology, high-tech automotive, life sciences, and food industries, as well as in new technologies such as photovoltaic and fuel cell cleanrooms, according to M&W Zander (Stuttgart, Germany), a leading total facility solutions provider. FFUs are also in use in hospitals and laboratories.

Because performance is improved while installed costs are driven lower, the use of FFUs continues to gain market share over centralized systems, says Howard Abramowitz, president of AirCare Automation, Inc. (Austin, TX), a manufacturer of control cards used in the units. The expansion of smaller clean-air spaces, the creation of special areas within ballroom clean spaces, and minienvironments have created more opportunities for FFUs.

Michael O’Halloran, director of technology at CH2MHill, states that FFUs offer many advantages and are designed for a specific situation and low power consumption. Dominant in the semiconductor industrial lithography tool environment, they are commonly installed with a separate fan unit to control temperature.

FFUs are equipped with either standard AC induction motors or electronically commutated (EC) motors, which are special brushless direct current motors that operate from the AC line. EC motors incorporate specialty drive and control electronics that make the FFUs in a cleanroom easier to adjust, monitor and tie together in a network. This allows the units to operate only when needed, thus saving energy.

EC FFU units require a smart-motor fan system, an interface to the fan, network consolidation, and PC software customization for each individual installation. These systems systems have been the gold standard since the Envirco MAC 10 IQ was introduced in 2001, says Abramowitz. At that time, AC systems were unable to match the performance and system integrity of the EC systems and a clear, two-tier system evolved. With the introduction of AC control systems that operate out-of-the-box, “smarts” could be added to AC systems at a nominal cost and thus began the process of closing the gap between the AC and DC solutions.

Click here to enlarge image

Abramowitz points out that smart FFUs provide monitoring feedback so facility managers can quickly address any failings. Without such controls, failures can go undetected for days or longer.

Click here to enlarge image

Nejat Babür, mechanical department manager at CH2MHill, states that DC motors are frequently used due to energy efficiency benefits. A DC motor can use less power, generating less heat than a standard AC motor. Costs vary depending on how complicated the control systems are and whether a separate cooling unit is required.

DC motors maintain proper airflow by modulating speed internally using a control algorithm that checks the motor torque, an important concern in cleanrooms, Babür explains. For instance, in pharmaceuticals, a constant airflow of 90 ft./min. in ISO 5 (or EU Grade A) areas is required. Currently, about 15 percent of pharmaceutical cleanrooms use FFUs. Fan companies are developing specialized fans as they learn specific pharmaceutical requirements for cGMP compliance.

Les Goldsmith, national specialty filtration sales manager for Envirco, explains that the dominating factors in choosing a fan filter unit are energy efficiency and controllability. Envirco, a division of Fedders Engineered Products, offers the MAC 10® Original, a low-energy, low-sound, low-profile FFU; the MAC 10 IQ, a combination of the GE ECM™ motor, a patented baffling system and a forward-curved fan; and the MAC 10 Rx, featuring a stainless-steel housing, for pharmaceutical processing environments.

The cost of Envirco’s Standard AC 2-foot x 4-foot unit is about $600 USD, and about $800 USD for a DC 2-foot x 4-foot unit with an EC motor. Installation cost is the same.

M&W Zander products include the Ultra Filter Fan Unit for applications that do not require individual speed control and central monitoring. The units can be controlled in groups of up to eight units and, for monitoring purposes, a control panel or a beeper is optional. M&W Zander’s Hightec Ultra Filter Fan Unit is equipped with a DC motor and a control and monitoring system linked to a network through an easy-to-install system, allowing individual settings and monitoring. M&W Zander also offers a compact unit, suitable for applications with limited clearance.

Identifying and selecting energy-efficient units in cleanroom applications can bring about savings in energy costs over the lifetimes of the units while maintaining and improving the effectiveness of contamination control. To characterize performance of FFU products, a series of standard laboratory tests has been developed by Lawrence Berkeley National Laboratory to quantify total pressure efficiency and power consumption across a range of operating conditions (CleanRooms, November 2006).

Current and future FFU sales

The growth in sales of FFUs is first and foremost impacted by the growth of the cleanroom industry. Since much of this growth is taking place in Asia, it is not surprising that there will be more purchases of FFUs in Asia in the coming decade than there will be in the rest of the world combined.

Another factor is the increasing popularity of FFUs as opposed to separate fans and filters. Over the years, the percentage of projects incorporating this design will continue to grow. The trend toward minienvironments instead of big cleanrooms also impacts growth.

Forecasts for FFUs have been compiled for each industry in each country. The following charts show the usage for 2000 and 2006 and forecasts for 2010. FFU sales of 80,000 units are forecast for the U.S. in 2010, while world sales will be 500,000 units (see Table 1). The U.S. market dropped between 2000 and 2002 and only recovered partially by 2006. By 2010, it will only have returned to the 2000 level.

Sales for the same period are displayed in constant dollars with the year 2000 as the base price (see Table 2). They are also in standard unit prices and not adjusted for the lower pricing in Asia. Since prices in Asia are less than half those in Europe and the U.S., a tabulation based on actual selling price would reflect a smaller world market.

M&W Zander, Envirco and Huntair are worldwide suppliers of FFU systems. There are a number of regional suppliers in Europe and Asia, resulting in a high world total of FFU suppliers

Robert McIlvaine is president and founder of The McIlvaine Company in Northfield, IL. The company first published Cleanrooms: World Markets in 1984 and has since continued to publish market and technical information for the cleanroom industry. He can be reached at [email protected]. Karen Vacura is the air filtration market editor for The McIlvaine Company. She can be reached at [email protected].

Karen Vacura is the air filtration market editor for The McIlvaine Company. She can be reached at [email protected]

Attendee questions from the CleanRooms Webcast are answered

On January 30, 2007, CleanRooms hosted its second Webcast focused on USP <797>. With participation from members of the USP <797> Expert Committee, now evaluating proposed revisions to the Chapter, the presentation put to rest some of the “urban legends” surrounding the standard and provided attendees with practical information and answers to the immediate and real-world challenges and questions they have today. Remaining questions that could not be answered during the one-hour Webcast are presented and answered here.

When will the final version of USP be published?

The final version will be published after the USP Sterile Compounding Committee has had time to adequately review all of the comments received.

What is the difference between validation and certification of cleanrooms?

Validation of a cleanroom or a primary engineering control is based on the specific needs of a particular facility as determined by that facility. Validation performed at one facility is often very dissimilar to that done at a different facility. Certification is the application of industry-based protocols to specific applications in an attempt to assure repeatable tests are performed using the same methods and instrumentation on every piece of equipment. Certification of primary and secondary engineering controls is often a component of an overall facility validation. Primary engineering controls should be certified to industry-based protocols such as the Controlled Environment Testing Association’s (CETA) application guides and National Sanitation Foundation (NSF) International Standard 49. The secondary engineering controls, such as cleanrooms, are often validated to the owner’s specific criteria that will include certification.

Where can we find a list of companies that are certified to validate or certify cleanrooms?

A list of qualified certifiers for validation of sterile compounding facilities currently does not exist. CETA is in the process of developing an accreditation program for this.

Where can we find a list of laboratories that measure surface contamination from hazardous drugs?

To our knowledge no such list exists. Environmental sampling is a relatively new approach used to determine the level of workplace contamination by antineoplastic agents. The procedure has been used extensively in other situations, especially for monitoring contamination from radioactive materials. Typically, work surfaces are sampled with a moistened wipe and the material is extracted and analyzed for specific antineoplastic agents. Currently, it is possible to identify and quantitate six to eight agents with this technique. Often, analytical labs will work with potential clients to incorporate new analytical methods if one can be identified, so don’t hesitate to inquire even if a particular lab doesn’t advertise this capability. There are a few labs and methods mentioned in the research literature; these might be a good place to start. Some references to aid in this search can be found at: http://www.cdc.gov/niosh/topics/antineoplastic/sampling.html#a. You might also check similar trade literature reports by certifiers, pharmacists and equipment manufacturers.

When do you think these proposed changes will become effective?

The Sterile Compounding Expert Committee is carefully reviewing and considering all comments received on or before the August 15, 2006, public commentary deadline. There are approximately 2,500 pages of comments from over 300 participants including hospitals, professional associations, vendors, stakeholders, and individual practitioners (pharmacists, nurses, physicians, etc.).

Due to the volume and criticality of these comments, it is not known when the review will be completed and the proposed revisions finalized. The committee is working hard to get a revised chapter out later this year.

How will these guidelines be enforced?

The USP has no enforcement authority. The primary responsibility of enforcement falls to the state boards of pharmacy. Many states are in the process of rewriting their laws and regulations to enhance existing sterile and nonsterile compounding regulations to harmonize with USP <797>. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) still requires a gap analysis and action plan during survey but has neither the authority nor the trained surveyors to survey to USP chapter requirements.

Can you have an open concept in a negative room?

A negative pressure cleanroom must be maintained at a minimum pressure of 0.01 in./WC. It seems unlikely that this can be maintained in an open-concept cleanroom.

Do you need a dedicated air-handling unit (AHU) for the cleanroom or can you share one from another area? If so, must you still meet the air-changes-per-hour (ACPH) requirements?

You do not need a dedicated AHU if the existing HVAC system can handle the additional load. You still need to meet the ACPH requirements regardless of which HVAC system you employ.

Should you design the function and equipment of the room first, trying to predict the particle generation, and then design the HVAC system?

Ideally, the ACPH requirements are based on particle generators, heat load considerations, personnel traffic and other considerations and should be taken into account when determining HVAC requirements. The USP ACPH recommendations are minimum requirements and should not be looked at as specific numbers. USP states: “More air changes may be required based on the number of personnel and processes.”

Can you store supplies in the cleanroom?

Ideally, supplies in the cleanroom should be limited. The cleanroom should be as spartan as possible, containing only the supplies and inventory needed for that compounding day. Excessive amounts of supplies and inventory in the cleanroom are a hassle when performing daily, weekly and monthly cleaning procedures.

Can you compound IVs and chemo in the same room?

As stated in USP <797>: “The ISO Class 5 BSC [biosafety cabinet] or CAI [compounding aseptic isolator] shall be placed in an ISO Class 7 room that is physically separated, i.e., in a different room, from other preparation areas…”

Do you need pressure-locked doors into the anteroom and/or buffer room?

No.

How do the standards relate to oncology offices?

The standards in USP Chapter 797 are intended to apply to all persons who prepare compounded sterile preparations (CSP) and all places where CSPs are prepared, e.g., hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians’ practice facilities, and other locations and facilities in which CSPs are prepared, stored, and transported. Persons who perform sterile compounding include pharmacists, nurses, pharmacy technicians, and physicians. These terms recognize both that most sterile compounding is performed by or under the supervision of pharmacists in pharmacies and that this chapter applies to all healthcare personnel who prepare, store, and transport CSPs. In Virginia, the Board of Medicine adopted emergency regulations requiring all physician offices that engage in compounding (which is broadly defined) to meet USP Chapter 797-Sterile Compounding Rule emergency regulations. Oncology offices that don’t have a licensed pharmacy area are regulated by the state board of medicine and may be required to comply with other local, state and federal (e.g., OSHA, NIOSH) requirements.

Will JCAHO, FDA or state boards of pharmacy survey my facility for compliance?

Possibly any or all of those organizations will survey your facility, depending on your state. You should contact your state board of pharmacy directly for more information.

Can two people work and compound under the same laminar bench and still maintain ISO 5?

If that device has been designed for that operation and particle count testing confirms that ISO Class 5 is maintained, two people can work at the same time.

How many of the changes in the proposed revisions will be accepted and become a requirement?

That will be determined by the committee based on the review of the comments received.

In chemo rooms, how can you maintain ISO 5 on the bench if you are pulling dirty air (ISO 7 or 8) across the bench, based on airflow? Shouldn’t the chemo bench be in an ISO buffer room as well?

Work in a chemo room should only be done in a BSC or compounding aseptic containment isolator (CACI) specifically designed to provide ISO Class 5 and to contain at the same time. Work should never be performed on a bench in a chemo application.

How often do you need to do particle and bioburden counts?

Particle counting or nonviable sampling occurs every six months. Depending on your risk level, you are required to sample either monthly (low- and medium-risk level) or weekly (high-risk level). If you haven’t already, download a copy of the proposed changes to USP Chapter 797. Visit http://www.usp.org/USPNF/pf/generalChapter797.html to obtain a copy. The specifics can be found in this document.

State boards of pharmacy have full legal compliance such that fines can be imposed. Should we not have to follow their laws, regardless of USP <797>?

There are some state laws that are not harmonized with USP Chapter 797. The principle of preemptive law applies and pharmacists have to follow the stricter of the two laws (state vs. federal). It is best to contact your state board of pharmacy for more complete guidance. USP standards have been used in lawsuits as national standards of practice.

Can you elaborate on viable sample requirements?

Viable sampling is the collection of air, surface or personnel samples with the express purpose of detecting microbial contamination.

How are HEPA filters tested after installation (in situ)?

For cleanrooms, every application is slightly different. Ideally, the cleanroom contractor has made accommodations for field-testing. An aerosol challenge (typically polyalphaolefin [PAO]) is introduced upstream of the HEPA filters and the filters are scanned downstream with an aerosol photometer. Ceiling-mounted HEPA filters are usually easier to test than remotely located banks of filters.

What are the deadlines for facility implementation?

Technically, USP Chapter 797 has been in effect since January 1, 2004. JCAHO initially published 2008 deadlines but has since backed down on those dates, unless mandated by state boards of pharmacy.

Is there any historical data to justify 30 ACPH vs. the normal 60 ACPH for ISO 7 areas?

The rate of 30 ACPH is based on the minimum suggestions in the ISO 14644-4 document. Remember, USP specifically states: “More air changes may be required based on the number of personnel and processes.” It is interesting to note that, when discussing this document with people familiar with cleanrooms, they invariably comment on the concern that 30 ACPH might not be adequate to maintain ISO Class 7. When you discuss this with people less familiar with cleanrooms, they wonder why we require so much air. The final number of air changes will need to be determined on an individual basis but, with the amount of HEPA-filtered air added to the room from the primary engineering controls (except for an exhausted chemo hood), 30 ACPH will be a good starting point.

Is it true that all work surfaces and storage surfaces must be stainless steel in the cleanroom?

No, as long as they are smooth, impervious, free from cracks and crevices, nonshedding, cleanable, and will stand up to the disinfectants.

What is a reasonable date to expect the completed revision of USP <797>?

All USP chapters are dynamic and subject to change. The goal of the USP Sterile Compounding Committee is to get through the comments from the proposed changes and issue a revised chapter as soon as feasible.

Is coving necessary in a cleanroom?

Coving is ideal, but as long as cleaning can be accommodated and seams are sealed and caulked, it should be sufficient.

Please comment on the ability of an operator to shut off a laminar flow bench (LFB) and therefore change the effective ACPH. Wouldn’t it be better to have the primary airflow be at a minimum of 30 ACPH or, even better, 60 ACPH?

The primary engineering controls should never be turned off in a cleanroom. They are designed for continuous operation. I understand your concern that an operator can make a mistake and therefore affect the operation of the cleanroom. If you feel that concern is real for your institution, I recommend you bypass the on/off switch on the hood. That will be a much cheaper solution than ignoring the value of the HEPA-filtered air delivered to the cleanroom. This allowance by USP was intended as a cost-saving consideration.

Are open-concept cleanrooms a better alternative to traditional design? Where can I find more information on open-architecture designs?

Open architecture cleanrooms are not a better design, nor are they cheaper. Factoring in the air needed to achieve 40 FPM across the interface between two spaces, this becomes an expensive option. The open architecture design is acknowledged in ISO 14644-4, thus it is acknowledged by USP. There is not a lot of precedent in the U.S. for this type of design outside the pharmacy industry. You will also find that most of the early discussions regarding open architecture cleanrooms were conducted without consideration for engineering criteria: Just place a line on the floor, and the room magically works. Once criteria become part of the discussion, the costs seem to make this design impractical.

Which particle counter flow rates are applicable for environmental monitoring?

Most particle counters are available in 0.1 CFM, 1.0 CFM, and sometimes even larger sample volumes are available. Any sample volume will work depending on how much time can be allocated to particle counting. I assume most professional certifiers will use at least a 1.0 CFM counter, simply based on the amount of time needed when using a 0.1 CFM counter. A pharmacy looking for a particle counter might value the lower cost of a 0.1 CFM counter more than the implications of sample time. In this case, the particle counter can be set up for longer sample times while pharmacists go about their day.

What media requirements do you recommend for viable sampling?

Proposed revisions in USP recommend tryptic soy agar (TSA) and malt extract agar (MEA).

When it states that a cleanroom must meet the specification for 0.5 micron or greater, does that mean that more than one particle size should be monitored, or is monitoring only 0.5 micron sufficient?

Setting the counter for the cumulative mode will count all particles that size and larger. Reading in the differential mode will count that specific size range.

Are there any studies indicating the impact of venting hazardous drugs to the outside air?

I assume the questioner is concerned about negative impact to the outdoor environment or positive impact (in terms of disease reductions) to the indoor environment. In either case, I am unaware of any studies that enacted this change and then evaluated the results upon the respective environments.

I understand that cleanroom certification for nonviable particles is recommended every 6 months at a minimum: How do I know I’m in compliance between certifications?

Technically, you only “know” for a fact that you are in compliance when you perform the counts. However, with a properly designed unidirectional-airflow primary engineering control, you know what control points (proper velocity, unidirectional airflow, leak-free HEPA filter, good return locations) provided the ISO Class 5 conditions that were observed while you took the counts in dynamic operating conditions. If you know your control points and you prove that you will maintain class when those control points are maintained, you should have confidence that you will maintain class reliably between tests. The same is true for the room itself: If you know that your control points (adequate ACPH of HEPA-filtered air) provided ISO Class 7 when the test was performed, you will likely maintain ISO Class 7 between tests. Continuous monitoring is the best solution but it is often outside the realm of possibility for most compounding operations.

How can isolators be advocated for use with hazardous drugs when little third-party validation of this equipment has been performed? At least BSCs have third-party review through NSF.

The adoption of containment isolators as an acceptable primary control for protection against hazardous drug exposures was based upon a number of factors, including their similarity of design with respect to Class III BSCs, the use of similar protective concepts within the pharmaceutical manufacturing industry, a small number of research studies favorably reporting their use for hospital pharmaceutical compounding, and the announced intention to reference the use of isolators in USP <797> as an alternative primary engineering control for CSP compounding. Admittedly, the big risk with this reference is a lack of industrywide performance and testing standards for pharmacy compounding isolators. Unlike Class II BSCs, isolators do not have the advantage of an independent industry organization setting the standards, testing the designs, and setting criteria for field certification. There are many different isolator designs and not all of them perform the same. This lack of testing standards can result in a potentially dangerous situation in which consumers are limited in their ability to compare and select such equipment, thus becoming potentially vulnerable to selective performance claims unverified by independent testing organizations. Until performance and testing standards are adopted, consumers are encouraged to insist that their new isolator, as a procurement requirement, meet the test and performance criteria in CETA’s application guide CAG-002-2006. Hopefully, manufacturers will begin to voluntarily and uniformly adopt this or a similarly rigorous and comprehensive test and performance protocol.

Should we wait to renovate our pharmacy until the new regulations are finalized?

That is a decision each facility must make based on the needs of their operation.

CleanRooms would like to thank the experts who served on the Webcast panel: Jim Wagner, president of Controlled Environment Consulting; Eric Kastango, president and CEO of Clinical IQ; and Kenneth R. Mead, MS, PE, research mechanical engineer at the Centers for Disease Control and Prevention. Please visit www.cleanrooms.com for information on the next CleanRooms Webcast, as well as access to The plain truth about USP <797> in its entirety.