DECEMBER 24, 2008–SILVER SPRING, MD–The U.S. Food and Drug Administration (FDA) continues to caution consumers about a potential association between the development of illness in dogs and the consumption of chicken jerky products. The products–also called chicken tenders, strips, or treats–are imported from China. FDA continues to receive complaints of sick dogs that their owners or veterinarians associate with eating chicken jerky products. FDA issued a cautionary warning to consumers in September 2007.

Australian news organizations report that the University of Sydney is also investigating an association between illness in dogs and the consumption of chicken jerky in Australia. At least one firm in Australia has recalled its chicken jerky product and the recall notification stated the product was manufactured in China.

FDA, in addition to several veterinary diagnostic laboratories in the United States, is working to find out why these products are associated with illness in dogs. To date, scientists have not been able to determine a precise cause for the reported illnesses. The agency has conducted extensive chemical and microbial testing but has not identified any contaminant.

FDA continues to actively investigate the problem. Many of the illnesses reported may be the result of causes other than eating chicken jerky.

Tips for consumers:

• Do not substitute chicken jerky products for a balanced diet. The products are intended to be used occasionally and in small quantities. Owners of small dogs must be especially careful to limit the amount of these products.
• If you choose to feed your dog chicken jerky products, watch the dog closely. Stop feeding the product if your dog shows any of the following signs, which may occur within hours to days after feeding the product: decreased appetite, although some dogs may continue to eat the treats instead of other foods; decreased activity; vomiting; diarrhea, sometimes with blood; increased water drinking or increased urination.

Call your veterinarian if signs are severe or last for more than 24 hours. Blood tests may indicate kidney failure (increased urea nitrogen and creatinine). Urine tests may indicate Fanconi syndrome (increased glucose).

Although most dogs appear to recover, some reports to FDA have involved dogs that have died. Consumers and veterinarians should report cases of animal illness associated with pet foods or treats to the FDA Consumer Complaint Coordinator listed for their area at www.fda.gov/opacom/backgrounders/complain.html.

Source: FDA

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JANUARY 6, 2009–ARLINGTON HEIGHTS, IL–Companies can save travel budget dollars by training their entire staff online during the new two-part IEST online education course, “Environmental Monitoring for Microorganisms.” The IEST online education program enables registrants to learn at a desk, conference room, or auditorium. For greater cost savings, the per-location fee has no limit on the number of students who may participate at each location.* The series will take place Wednesday, Feb. 18, 2009 and Wednesday, Feb. 25, 2009 from 11:00 a.m.-12:00 p.m., Central Standard Time. The courses can be taken together as a series or as individual classes.

The live, online presentation is designed to provide the tools to implement and maintain a compliant and practical environmental monitoring program for microorganisms in the non-sterile and aseptic cleanroom. The presentation will cover the principles of monitoring for microorganisms as described in IEST-RP-CC023.2, Microorganisms in Cleanrooms, guidance on implementation and maintenance of an environmental monitoring program for microorganisms, and case studies of microorganisms in non-sterile and aseptic cleanroom operations. Part One of the series will focus on non-sterile cleanroom operations, and Part Two will focus on aseptic cleanroom operations.

Instructor Jan Eudy is the corporate quality assurance manager for Cintas Corp. At Cintas, Eudy oversees research and development, directs the quality system and ISO registration at all cleanroom locations, and supports validation and sterile services, and established and implemented the company’s HACCP program. She is a Fellow and a past president of IEST and represents Cintas on the FPA Advisory sub-committee to the FDA for the revision of the Food Processing cGMPs. Eudy has a degree in medical technology from the University of Wisconsin with graduate studies in medical microbiology at Creighton University. She is a registered medical technologist and specialist in microbiology with ASCP, registered microbiologist with NRM in consumer product testing and quality assurance, ISO 9000 provisional auditor RAB (QSA), and certified quality auditor with ASQ.

More information is available online at www.iest.org or by calling IEST at (847) 981-0100.

* Access will be granted to one computer per location.

Source: IEST

DECEMBER 16, 2008–SOUTHAMPTON, PA–High-purity tubing and hose manufacturer AdvantaPure recently tripled the size of its cleanroom facility to allow for the increased production of molded silicone components. Manifolds and other process components for the pharmaceutical and clean application industries are produced in a newly created area. The original cleanroom is now used primarily for the manufacture of silicone stoppers and sealing systems for containers of glass, metal, or plastic.

“The number of orders coming in for molded products was quickly rising,” says Michael Needling, AdvantaPure’s director of manufacturing operations. “Seeing this, we planned and built the new space before we reached capacity in the existing room. We now have several team members producing manifolds and stoppers full time. And the new area has room for additional expansion.”

The new space houses several liquid injection molding (LIM) stations used in the production of silicone manifolds, along with work tables, storage areas, and an R&D section. A separate cleanroom, which was also part of the facility expansion, is used for manufacturing and packaging hose assemblies and for pressure testing. Access is restricted to essential team members in both HEPA-filtered rooms to maintain product purity. The company’s plant engineer and maintenance personnel handled construction.

AdvantaPure uses its expanded space to manufacture custom single-use silicone manifolds consisting of tubing; fittings in T, Y, cross, and reducer styles; and other specified components. Sealing systems and stoppers, with or without ports for tubing inserts or vents, are produced for flexible container systems, carboys, laboratory apparatus and bottles, and sampling and storage receptacles.

Source: AdvantaPure

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DECEMBER 18, 2008–SAN JOSE, CA–North America-based manufacturers of semiconductor equipment posted $805 million in orders in November 2008 (three-month average basis) and a book-to-bill (B:B) ratio of 1.00, according to the November 2008 Book-to-Bill Report published by SEMI. A book-to-bill of 1.00 means that $100 worth of orders were received for every $100 of product billed for the month.

The three-month average of worldwide bookings in November 2008 was $805.4 million. The bookings figure is about 4 percent less than the final October 2008 level of $839.7 million and about 29 percent less than the $1.13 billion in orders posted in November 2007.

The three-month average of worldwide billings in November 2008 was $807.3 million. The billings figure is about 7 percent less than the final October 2008 level of $871.4 million and about 42 percent less than the November 2007 billings level of $1.38 billion.

“The book-to-bill ratio reached parity as billings have declined sharper than bookings over the past six months,” says Stanley T. Myers, president and CEO of SEMI. “2008 is closing with expected declines on the year, which have been further exacerbated by the deepening seismic global economic situation over the past quarter.”

The SEMI book-to-bill is a ratio of three-month moving averages of worldwide bookings and billings for North American-based semiconductor equipment manufacturers. Billings and bookings figures are in millions of U.S. dollars.

The data contained in this release were compiled by David Powell, Inc., an independent financial services firm, without audit, from data submitted directly by the participants. SEMI and David Powell, Inc. assume no responsibility for the accuracy of the underlying data.

Source: SEMI December 2008

Visit www.semi.org

Company simultaneously withdrawing all Peanot Butter product as precaution

DECEMBER 12, 2008–FRAMINGHAM, MA–Cambrooke Foods, LLC is announcing a voluntary recall of all batches of its Low Protein Imitation Cream Cheese (“Cheddar Wizard,” “Herb & Garlic,” and “Plain” flavors).

Cambrooke Foods is undertaking this voluntary recall as a precaution because some of these products may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

During routine batch testing before shipment, Listeria was detected in batches of Imitation Cream Cheese at the company’s Randolph, MA facility. These batches of Imitation Cream Cheese products were destroyed and never shipped to customers.

No illnesses have been reported for any batch of Imitation Cream Cheese.

To be cautious and proactive, Cambrooke Foods is also conducting a market withdrawal of all batches of its Low Protein Peanot Butter because it is produced using the same machinery used to produce the Imitation Cream Cheese products. Testing has not confirmed Listeria contamination in any batch of Low Protein Peanot Butter nor have any adverse events been reported as a result of its consumption. No other Cambrooke Foods product is produced using the machinery in question.

These products are sold directly to consumers with special dietary needs, as well as a limited number of distributors in the United States and Canada. The company has ceased the production and distribution of these products.

Cambrooke Foods is working directly with the U.S. Food and Drug Administration (FDA) to investigate the cause of the contamination.

Customers should discard all units in their possession and contact the company to have their account credited. Customers should register their notice of this recall with the company by visiting www.cambrookefoods.com/information/product_recall.php. If there are questions, contact Cambrooke Foods at 866-456-9776, ext. 1015, or via e-mail at [email protected].

Source: Cambrooke Foods/FDA

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DECEMBER 12, 2008–SILVER SPRING, MD–The U.S. Food and Drug Administration (FDA) is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel & Charles LeBlanc Fisheries Ltd., Cap-Pelè, NB, Canada, because the fish may contain the Clostridium botulinum (C. Botulinum) toxin. Consumers should not consume the product.

C. botulinum toxin can cause botulism, a serious and sometimes life-threatening condition. The toxin cannot be removed by cooking or freezing. The fish were imported into the United States and sent to the following Florida distributors:
Quirch Foods Inc.
Den-Mar Exports LLC
Dolphin Fisheries Inc.
Labrador & Son Food Products Inc.

The fish were packed in 30-lb, white plastic pails with green plastic lids. The brand name “Michel & Charles LeBlanc Fisheries Ltd.” appears on the side of the pails, as does the phrase “Product of Canada.” One hundred seventy-three (173) 30-lb. pails of fish were distributed. The fish may have been repacked or sold loose by retailers in Florida.

The FDA considers any ungutted fish over 5 in. in length that is salt-cured, dried, or smoked, such as the ungutted, salt-cured alewives/gaspereaux fish, to be adulterated because it could contain the C. botulinum toxin. The Florida Department of Agriculture and Consumer Services discovered the ungutted alewives/gaspereaux fish from Michel & Charles LeBlanc Fisheries Ltd. being sold in stores and alerted the FDA. The FDA prohibits the sale of this adulterated product in the United States.

To date, there have been no reported illnesses associated with this product. However, consumers who have purchased ungutted, salt-cured alewives/gaspereaux fish in Florida should contact the place of purchase to determine if the fish they bought originated from Michel & Charles LeBlanc Fisheries Ltd. If the fish were from this company or if the source of the fish cannot be determined, consumers should immediately discard the fish and any foods made with these fish.

Symptoms of botulism poisoning can begin from six hours to 10 days after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness that affects first the shoulders and then moves progressively down the rest of the body. Botulism poisoning can also cause paralysis of the breathing muscles, which can result in death unless assistance with breathing (mechanical ventilation) is provided.

Individuals who show these symptoms and who may have recently eaten alewives/gaspereaux fish should seek immediate medical attention.

Source: FDA

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DECEMBER 16, 2008–SAN JOSE, CA–SEMI today reported that worldwide semiconductor manufacturing equipment billings reached $6.56 billion in 3Q08. The billings figure is 16 percent lower than 2Q08 and 41 percent less than the same quarter a year ago. The data is gathered in cooperation with the Semiconductor Equipment Association of Japan (SEAJ) from more than 150 global equipment companies that provide data on a monthly basis.

SEMI also reported worldwide semiconductor equipment bookings of US$5.60 billion in 3Q08, 37 percent less than the same quarter a year ago and 20 percent less than the bookings figure for 2Q08.

See quarterly billings data by region in millions of U.S. dollars, year-over-year and quarter-over-quarter growth rates by region, below.

Note: Figures may not add due to rounding.

Source: SEMI/SEAJ December 2008

Visit www.semi.org

Since human-generated contamination plays a large role in critical environments, special care must be taken to provide appropriate garments to minimize the human impact on the cleanroom. Other important factors include specialty fabrics to safeguard technicians, as well as proper laundering and care of reusable attire.

Compiled by Carrie Meadows

Coat aprons for splash protection

Ansell coat aprons offer medium- to heavy-duty splash protection specific to the food processing, laboratory, electronics, medical, pharmaceutical, and chemical processing industries. The series includes four versions that are made of the highest quality virgin vinyl in 6- and 8-mil thickness. Coat aprons are offered with dielectrically welded seams, which eliminate contaminant traps and permit cleaning to Fed. Std. 209E Class 100 standards. There are no exposed elastic or metal parts to create static or corrosion. Each garment has 40-mil PVC grommets permanently welded to the apron for greater strength and longer life.

Ansell
Red Bank, NJ
www.ansellpro.com

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Compiled by Carrie Meadows

Static-dissipative binders for critical environments

Desco now offers its line of ESD three-ring binders with static-dissipative clear overlay pockets. Insert covers or documents in pockets on the front, back, and spine. Interior pockets allow additional storage for quick and easy access. Interior and exterior vinyl surfaces are static dissipative and are suitable for handling documents in ESD-protected areas; any charge will be removed when the binder is grounded. The format is 8 1/2

By George Miller

Construction subcontractors’ lack of awareness of their surroundings is perhaps one of the most frustrating issues, from a contamination control point of view, faced by health-care facility managers.

One example: “Information technology subcontractors will come in to string cable,” says Dennis Tremblay, senior scientist specializing in building and life safety issues at the environmental and engineering consultancy Environmental Health & Engineering (EH&E; Needham, MA). “They start lifting ceiling tiles without regard for containment of the site.”

Tremblay, who is also fire safety manager at Brigham & Women’s Hospital in Boston and a certified fire protection specialist, has penned the second release of the 2006 document Infection Control in the Healthcare Environment During Construction. In the document, he finds that it is possible to provide a “standardized and effective” infection control risk assessment (ICRA) program that causes a minimum of disruption in hospitals, which somehow always seem to be under construction. The key is a database that aids in program management by allowing all key personnel access to ICRA documents, and providing infection control training before contractors are allowed on site.

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