Tag Archives: Clean Rooms

February 21, 2007 — /IEST/ — ROLLING MEADOWS, IL — The final draft International Standard (FDIS) version of International Organization for Standardization (ISO) Standard 14644-6 Cleanrooms and controlled environments, Part 6: Vocabulary is now available through the Institute of Environmental Sciences and Technology (IEST). This FDIS document is an indispensable resource for anyone operating a cleanroom or controlled environment.

ISO/FDIS 14644-6 is an up-to-date, international dictionary of all cleanroom terms and definitions used in the ISO 14644 Cleanrooms and controlled environments and the 14698 Biocontamination series. Each definition is followed by the Standard designation and section in which it is used. An index makes finding a particular definition easier.

ISO established Technical Committee (TC) 209 Cleanrooms and associated controlled environments in 1992 to address a need for global cleanroom standards rather than the collection of differing national standards in place at that time. ISO 14644-6 is the last document of the original list proposed by ISO/TC 209 in 1992. Since that time, two additional documents, ISO 14644-8 Classification of airborne molecular contamination and 14644-9 Classification of surface particle cleanliness, were added to the program. The cornerstones of the series are Part 1: Classification of air cleanliness and Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.

Working Group 6 of ISO/TC 209 was responsible for the harmonization and unification of the terms, definitions, and units within ISO Standard series 14644 and 14698, as well as for the harmonization with internationally used definitions. The task was difficult because of the multilingual and multidisciplinary character of the work.

The 34-page FDIS 14644-6 is available online at http://www.iest.org/iso/iso6.htm or by calling (847) 255-1561.

Founded in 1953, IEST is an international technical society of engineers, scientists, and educators that serves its members and the industries they represent (simulating, testing, controlling, and teaching the environments of earth and space) through education and the development of recommended practices and standards.

IEST is an ANSI-accredited standards-developing organization; Secretariat of ISO/TC 209 Cleanrooms and associated controlled environments; Administrator of the ANSI-accredited US TAG to ISO/TC 209; Administrator of the ANSI-accredited US TAG to ISO/TC 142 Cleaning equipment for air and other gases; and a founding member of the ANSI-accredited US TAG to ISO/TC 229 Nanotechnologies.

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

February 16, 2007 — /FDA News/ — On February 14, 2007, FDA advised consumers not to eat any Peter Pan peanut butter purchased since May 2006 and not to eat Great Value peanut butter with a product code beginning with “2111” purchased since May 2006 because of risk of contamination with Salmonella Tennessee. Salmonella is a bacterium that causes foodborne illness, and “Tennessee” is a type of Salmonella. All Peter Pan peanut butter purchased since May 2006 is affected; only those jars of Great Value peanut butter purchased since May 2006 with a product code beginning with “2111” are affected. Although Great Value peanut butter with the specified product code has not been linked by CDC to the cases of Salmonella Tennessee infection, the product is manufactured in the same plant as Peter Pan peanut butter and, thus, is believed to be at similar risk of contamination. Great Value peanut butter made by manufacturers other than ConAgra is not affected.

Number of Cases and State Locations:
The Centers for Disease Control and Prevention (CDC) has identified 290 people from 39 states who have gotten sick from Salmonella Tennessee, the Salmonella type associated with this outbreak. Forty six (46) patients are known to have been hospitalized and there have been no reported deaths.

The 39 states with reported illness are: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia.

Advice to Consumers:
FDA continues to advise consumers not to eat any Peter Pan peanut butter purchased since May 2006. FDA also continues to advise consumers not to eat any Great Value peanut butter purchased since May 2006 with product codes beginning with the numbers “2111” on the jar lid. All such products should be thrown out. If consumers cannot find a number on the jar lid or are unsure, the safest thing to do is to discard the product.

Individuals who have recently eaten the affected Peter Pan and Great Value peanut butter and who have experienced any symptoms of Salmonella infection should contact their health care provider immediately. Symptoms include fever, diarrhea and abdominal cramps. For persons in poor health or with weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.

Anyone who has a jar of the affected peanut butter and who has become ill also should report that they have a jar to state or local health authorities. Individuals who have eaten the affected peanut butter within the last week and who do not feel sick most likely will not get sick. However, persons who begin to have any of the symptoms outlined above should see a health care professional.

FDA Actions To-Date:
On February 13, 2007, FDA was notified by CDC and state health departments of data showing an outbreak of Salmonella Tennessee infection in people who reported having eaten certain jars of Peter Pan peanut butter. Since that time, FDA has been conducting an active investigation of Peter Pan and Great Value peanut butter made by ConAgra in the same facility.

On February 13, FDA contacted ConAgra officials. On February 14, ConAgra agreed to initiate a product recall.

On February 14, FDA took the following actions:
–Notified the public of the findings related to the Salmonella outbreak and advised consumers not to eat peanut butter from jars with a certain product code.
–Notified its counterpart agencies in Canada and Mexico, the World Health Organizations’ INFOSAN Food Safety reporting program and the food safety authority at the European Commission.
–Sent a team of microbiologists and experienced field investigators to begin its inspection of ConAgra’s manufacturing plant in Georgia. The inspection will include collecting environmental, raw ingredient and product samples, and reviewing manufacturing and quality assurance records.

Next Steps:
–FDA laboratory personnel will analyze samples collected from the manufacturing plant.
–FDA will conduct a thorough inspection and assess its own inspectors’ observations of the manufacturing plant for any necessary follow up actions. If international distribution is documented, FDA will inform and work with its counterpart agencies in those countries.
–FDA will continue to work closely with CDC and state health authorities to track any additional cases of Salmonella Tennessee illness.
–FDA will continue to work with ConAgra and inspect records to determine the distribution of the recalled product both within the United States and overseas.
–FDA will continue to provide regular updates to the public as this investigation unfolds.

Recall Status and For More Information:
ConAgra is recalling all Peter Pan peanut butter and all Great Value peanut butter beginning with product code 2111 that already was distributed. The company also is destroying all affected products in its possession. The company has stopped production and is working to identify the cause of the contamination. ConAgra has advised consumers to destroy all Peter Pan peanut butter and any Great Value peanut butter beginning with product code 2111.

For more information see: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01563.html (press releases) and http://www.cfsan.fda.gov/~dms/pnutbuqa.html (questions and answers).

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:_Marianne Duong_(818) 874-4647

February 16, 2007 — /FDA News/ — Westlake Village, CA — Dole Fresh Fruit Company announced the recall of cantaloupes in the Eastern U.S. and Quebec due to potential health concerns. Some cantaloupes packed on January 25, 26 and 27, 2007 by an independent, third-party grower in Costa Rica have tested positive for Salmonella. Although no illnesses have been reported, Dole voluntarily has decided to recall all cantaloupes imported from Costa Rica and packed by that grower.

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.

Approximately 6,104 cartons of cantaloupes were distributed to wholesalers in regions of the eastern United States and Quebec between February 5 and February 8, 2007. The cantaloupes have a light green color skin on the exterior, with orange flesh. The cantaloupes were distributed for sale in bulk in cardboard cartons, with 9, 12 or 15 cantaloupes to a carton. The recalled cartons are dark brown with “Dole Cantaloupes” in red lettering. They have a thirteen-digit number on a white tag pasted to the carton; the tenth digit is a 2.

The recall is a result of a random test by the company. Consumers who have uneaten cantaloupe purchased in the eastern United States or Quebec, on or after February 5, 2007, may contact their retail store to see if the product is the recalled brand. Consumers with additional questions should contact the Dole Consumer Center at (800) 232-8888.

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

February 16, 2007 — /FDA News/ — The Food and Drug Administration (FDA) is warning consumers not to use certain jars of Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast baby food because of the risk of contamination with Clostridium botulinum, a bacterium which can cause botulism, a life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

The affected product was sold in single individual jars and in variety packs (which contains 4 jars of the apple peach barley in the pack along with other varieties). The food is part of the firm’s “2nd Vegetables, Fruits and Blends” line intended for babies 6 months and older. The food was distributed through retail stores and sold through the Earth’s Best website. If consumers have any of the specified jars in their home, they should not use it and destroy it immediately. No illnesses have been reported to FDA or the manufacturer to date in connection with this problem.

The affected baby food is as follows: (see figure)

Botulism, a potentially fatal form of food poisoning, usually causes illness within 18-36 hours of exposure. Initial indication of illness in infants is decreased frequency or absence of stools. Other signs and symptoms noted are poor feeding, weak suck, lethargy, listlessness, weak cry, decreased body tone, and diminished overall movement. Difficulty with swallowing may be evident as secretions drooling from the mouth. This may be followed by decreased respiratory effort which may lead to respiratory arrest from airway occlusion from unswallowed secretions. Older populations who may be consuming the product as part of a pureed diet might experience symptoms such as blurred vision, dizziness, dry mouth, and progressive weakness from head to legs. Constipation and urinary retention are also common. Caregivers or people observing these problems should seek immediate medical attention for those affected.

Hain Celestial Group initiated a recall of the food on February 9th. The recall is ongoing. Production and distribution of the product has been suspended as FDA and the company work to determine the source of the problem. Hain Celestial Group distributed 4,072 cases of the specified individual jars consisting of 24 jars per case and 38,298 variety packs with the specified jars.

Consumers who have questions should contact Hain Celestial Group at 1-800-434-4246.

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: Georgia Duke (423) 238-7111, Ext. 22432

/FDA News/ — Collegedale, TN — McKee Foods of Collegedale, TN., is recalling certain Little Debbie(r) Nutty Bars in Georgia, Maryland, North Carolina and Virginia because an ingredient may contain small particles of metal. These products were distributed to retailers and in vending machines on Thursday, Feb. 1 and Friday, Feb. 2.

The Nutty Bars are in the following retail packages:

12 oz. cartons, (12 bars, twin wrapped) with these carton-end codes:
Guaranteed Fresh_MAR 31 2007_01302091
or
Guaranteed Fresh_APR 01 2996_01312091

25.2 oz. cartons, (24 bars, twin wrapped) with these carton-end codes:
Guaranteed Fresh_MAR 31 2007_01302101
or
Guaranteed Fresh_MAR 31 2007_01302102

3 oz. single-serve packages (2 bars, twin wrapped) with this code:
Sell By_APR 01 2007_01312101

The particles were detected through internal quality checks. No consumer complaints have been reported.

Consumers who have purchased products with these codes are asked to contact McKee Foods at 1-800-522-4499 for information and a full refund.

February 13, 2007 — /BUSINESS WIRE/ — CARLSBAD, Calif. — Asymtek, a Nordson company and leader in dispensing technology and pioneer in jetting technology, enables lab-on-a-chip applications with its hot wax jetting technology. Hot wax is used as a gate or valve, to contain fluids on a chip until the critical time when they are released to interact with other fluids or specimens deposited on a chip for diagnostic testing. A wax gate or valve, when used in place of a mechanical valve, provides a cost-effective solution that is easier to manufacture.

Asymtek’s DispenseJet(r) DJ-9000 jet precisely dispenses an exact amount of wax onto discrete locations on the chip. The wax keeps the fluids used in the biological test in place on the chip and contaminant-free. When the chip is heated to a specified temperature, the wax designed for that temperature melts, releasing each specific fluid into the flow path at the point it is needed in the testing process. Hot wax is a phase change material, changing from a solid to a liquid when it is melted, then reverting back to a solid when cooled. Waxes can be formulated to melt at a specific temperature for the application, and multiple formulations can be used on the same chip.

Jetting is an automated, non-contact process that dispenses fluids quickly, cleanly, accurately and reliably. With jetting, the wax is maintained in the jet at the precise temperature needed for optimal dispensing. Wax jetting technology can be used for lab-on-a-chip applications in all stages of development and manufacturing including prototyping, preproduction runs for clinical tests or FDA certification, as well as for mass production of lab-on-a-chip test kits.

“Jet dispensing technology creates new possibilities for lab-on-a-chip applications,” said Jim Klocke, senior business development manager of Asymtek. “Hot wax jetting is perfect for biomedical and laboratory applications because it is highly accurate and meets clean room conditions with no risk of contamination.”

Fluids can be jetted into spaces as tight as 175 micrometers. Fillet sizes as small as 300 micrometers, dot diameters of 0.20mm, shot volumes of 1.0 nanoliters, and a jet stream size as small as 50 microns can be achieved using Asymtek’s jet. Fluids with viscosities from 1 to 250,000 centipoise (cps) can be jetted for a variety of medical applications, including medical electronics device assembly.

About Asymtek
Asymtek(r), a world leader in automated fluid dispensing and pioneer of jetting technology, designs and manufactures a full line of dispensing and conformal coating systems for semiconductor package and printed circuit board assembly as well as automotive, medical, aerospace, disk drive, flat panel display, optoelectronic, appliance and other precision industrial manufacturing applications. Asymtek products deliver a wide variety of fluids, including glues, epoxies, solder pastes, coatings and gasketing materials. Founded in 1983 and acquired as a subsidiary of Nordson Corporation (Nasdaq:NDSN) in August 1996, Asymtek is an ISO 9001:2000 certified company. Asymtek has received numerous awards including Intel’s prestigious Supplier Continuous Quality Improvement award for three years in a row: 2003, 2004 and 2005. For more information, visit www.asymtek.com.
Photo available at: http://www.asymtek.com/images/hires/jetting_hotwax.jpg

Contacts
Asymtek, A Nordson Company_Roberta Foster-Smith, [email protected]_or_A R Marketing, Inc. (Agency Contact)_Andrea Roberts, [email protected]_or_International Offices:_U.S.A.: 760-431-1919_Europe: +31 (0) 43-352-4466_S.E. Asia: +65 6796 9500_Japan: +81 (0) 3-5762-2801_Taiwan: +886-2-2902-1860_Korea: +82-31-765-8337_China: +86-21-5854-2345_www.asymtek.com_www.asymtek.com.cn_www.asymtek.com/jp

VersiDoser(tm) and other novel drug delivery devices move toward distribution

February 14, 2007 — /BUSINESS WIRE/ — AUSTIN, Texas — Mystic Pharmaceuticals(tm), Inc. today announced expansion plans for its Cedar Park (Greater Austin), Texas R&D center to include clinical manufacturing operations for ophthalmic and intranasal drug delivery systems and pharmaceutical products under development by the company.

For Mystic Pharmaceuticals, a growing company specializing in novel drug delivery technology and pharmaceutical products, the expansion signals significant forward movement from research and development into the first stage of bringing its products into the commercial marketplace. Mystic’s unique technologies, which include groundbreaking new devices for administering drugs through the nose and eyes, have potential applications in diverse treatment sectors such as intranasal delivery for cancer and migraine pain, or vaccines, and front of eye delivery for those who suffer from ophthalmic diseases, or for vision correction and pre/post surgical procedures.

The Company’s expansion plans include the construction of two clean room manufacturing suites, expansion of research labs and the deployment of sophisticated pilot scale manufacturing lines to produce Mystic’s VersiDoser(tm) drug delivery systems. The VersiDoser(tm) platform is the company’s advanced, precision unit dose drug delivery technology which offers unparalleled capabilities for safe, convenient, preservative free, delivery of drugs by way of the eye, nose, ear or mouth.

“Texas is an emerging hub for leading-edge life science solutions,” said Timothy Sullivan, President & CEO. “We expect Mystic’s expanded Cedar Park, Texas pilot manufacturing facility to be fully operational by mid-2007, and are currently recruiting nationally to expand our team of experienced professionals.”

The company plans to use the expanded Cedar Park pilot scale facility to produce clinical supplies for upcoming clinical research required for FDA regulatory submissions for a pipeline of ophthalmic and intranasal drugs and biologics the company has under development internally and with strategic partners.

“This expansion of our facilities reflects an important next step for Mystic Pharmaceuticals to deliver on its mission to `protect the quality of human life through life science innovations’ by bringing pharmaceutical and biologic products to the market which are safer and easier to administer, reduce cost and waste, and enhance consumer compliance,” said Sullivan.

About Mystic Pharmaceuticals, Inc.
Mystic Pharmaceuticals(tm) is an integrated specialty pharmaceutical company based in Austin, Texas. Mystic develops precision unit dose drug delivery technology platforms for pharmaceuticals, biologic agents, vaccines and other compounds for ophthalmic and intranasal applications. Mystic combines its novel drug delivery systems with a pipeline of pharmaceuticals and biologics under development by Mystic or its partners, to meet the expanding global market demand for pharmaceutical products which are lower cost, simplified in administration and provide enhanced compliance for consumers.

For more information please visit the Mystic website: www.mysticpharmaceuticals.com
Contacts
Mystic Pharmaceuticals, Inc., Austin_Colleen Sullivan, +(1)512-918-2900, ext. [email protected]_or_Rhonda [email protected]

February 15, 2007 — /IEST/ — ROLLING MEADOWS, IL — This year, several new seminar topics will be offered to contamination control professionals at ESTECH 2007, the Institute of Environmental Sciences and Technology (IEST) 53rd annual technical meeting and exposition. The meeting will take place April 29

Features Class 100,000 molding and assembly cleanroom

February 16, 2007 — /PRNewswire/ — TIJUANA, BAJA CALIFORNIA NORTE, Mexico and OAK BROOK, Ill. — UPG, a full service contract manufacturer in the medical, consumer, automotive and electronics market segments announces the official opening of its newest custom manufacturing and assembly facility, UPG Tijuana.

“UPG Tijuana, our third plant in Mexico, brings advanced manufacturing capabilities to this region,” says Chuck Hoar, Vice President, Sales and Marketing. “It furthers our global strategy, which is to serve customers with high quality, cost-competitive components and product design and development expertise.” Included among the speakers at the ribbon-cutting ceremony are officials Sergio Tagliapietra Nassri, Secretary of Economic Development, Mexico, and Kurt Honold Morales, City Mayor, Tijuana.

The official plant opening is concurrent with the company’s name change from United Plastics Group, Inc. to UPG. “The name change reflects our success over the past few years at broadening our services and global reach,” says Richard Harris, CEO. “The new facility in Tijuana serves as an example of that — we want to be where our customers need us to be and we want to be able to incorporate a full spectrum of capabilities,” notes Harris.

UPG manufacturing solutions range from molding components to semi-finished subassemblies to multi-faceted fully-finished final products. Services include application design, tooling engineering, program and supply chain management. These services are offered collaboratively at both corporate and plant levels to ensure product quality, optimum deliverability and consistency across all UPG global facilities.

The 62,000 square foot plant features a white-room environment throughout and a Class 100,000 clean room. The plant is also ISO 9001/13485 certified and FDA registered. Equipment at the new facility includes 32 injection molding presses; 26 on the molding floor and 6 in the clean room. A full spectrum of plant offerings include 35 to 720 tons of clamping pressure, optimized material flow, flexible cell-based assembly, tooling repair and maintenance. In addition to the 13,000 square foot molding area, a 9,000 square foot assembly area allows for in-mold decorating (IMD) and other finishing processes.

“Our Tijuana plant, with its clean room and ISO 9001 and FDA certifications, provides custom contract manufacturing capabilities that were not previously available in the region,” says Thomas Cho, VP, Operations. “Our unique location, outside of the crowded industrial district, provides the added benefits of ready availability of labor and proximity to U.S. distribution channels.”

Cho adds that the nearly 100 employees at the plant also are working on a program to aid neighborhood schools, which include a middle school, Secundaria No. 53 Lic. Milton Castellanos Everardo and an elementary school, Escuela General Lazaro Cardenas. “Our plans include after-school activities, as well as providing some needed technology assistance and supplies.”

About UPG
Headquartered in Oak Brook, Ill, UPG ( http://www.upgintl.com/ ) is among the top global contract manufacturers. With more than 615,000 square feet of manufacturing capacity and 300 molding machines in 11 facilities in the United States, Mexico, Europe and China, UPG is dedicated to being the leading international provider of outsourced product development and manufacturing solutions.

Source: UPG
CONTACT: Aaron Katz of Incite Strategic LLC (Agency), +1-262-482-0825,[email protected] , or Chuck Hoar, Vice President, UPG, +1-508-328-0881,[email protected]
Web site: http://www.upgintl.com/

Gift of semiconductor wafer chamber and associated pumps to help further the research facility’s mission to move nanotechnology from laboratory to manufacturing

February 12, 2007 — /BOC EDWARDS/ — WILMINGTON, MASS — BOC Edwards, a leading supplier of vacuum, abatement, chemical management equipment and services to the world’s semiconductor OEMs and fabs, announced today that it has donated one DFP 200 Dense Fluid Processor High-precision Advanced Wafer Chamber System and associated pumps, valves and other components to the MassNanoTech Institute. The University of Massachusetts Amherst’s campus-wide initiative for nanoscale science and engineering.

The donation will be used by the MassNanoTech Institute in support of its educational and research programs under the auspices of the Center for Hierarchical Manufacturing.

“BOC Edwards is interested in supporting the local community and universities whenever possible,” said Phil Blakey, US semiconductor president, BOC Edwards. “This donation is meant to assist in furthering education and technological innovation.”

“We are pleased to accept this generous donation from BOC Edwards,” said James Watkins, director, MassNanoTech Institute. “One of the goals of the MassNanoTech Institute is to fabricate new nanoscale devices and collaborate with industry in the development of prototypes and new technology. This equipment will assist in our R&D programs that are focused on moving nanotechnology from the laboratory to manufacturing.”

About BOC Edwards
A member of The Linde Group, BOC Edwards employs around 4600 people and is a leading supplier of integrated solutions for the manufacture of microelectronic devices, including semiconductors and flat panel displays. Partnering with fabs, foundries and process tool manufacturers, BOC Edwards provides process-enabling subsystems that are supported by best-in-class operations and maintenance services for its global customer base.

The Linde Group is a world leading industrial gases and engineering company with more than 53,000 employees working in around 70 countries worldwide. Following the acquisition of The BOC Group the company has gases and engineering sales of approximately 12 billion euro. The strategy of The Linde Group is geared towards earnings-based growth and focuses on the expansion of its international business with forward-looking products and services. For more information, please see The Linde Group online at http://www.linde.com

Specific information on BOC Edwards can be found at www.bocedwards.com .
E-mail inquiries can be sent to [email protected] .

About MassNanoTech
The MassNanoTech Institute is the University of Massachusetts Amherst’s campus-wide initiative for nanoscale science and engineering. The campus has built a strong reputation for innovation in nanoscale research, with breadth across many departments. Over 50 faculty investigators from eight departments in three colleges are working in the field of nanotechnology, generating over $36 million in research funding since 1997 from a variety of federal and industry sources. Ongoing efforts include multiple prestigious NSF awards, licensing of key technology, acquisition of specialized characterization equipment, and the education and training of many talented graduate students working on innovative technologies in individual faculty labs. MassNanoTech provides a single point of contacts for academic and industrial collaborators.

For more information, please see http://www.umass.edu/massnanotech/index.htm