Particles

12/01/2002

FDA clears Pall's bacteria detection system

EAST HILLS, NY—The U.S. Food and Drug Administration (FDA) has granted clearance to Pall Corp. to market a system that detects bacterial contamination in platelets.

The launch of the Pall BDS (bacteria detection system) comes at a time when the nation's blood safety experts have called for immediate action from the blood banking community to initiate a program to detect the presence of bacteria in platelets.

The risk of receiving contaminated platelets is 50 to 250 times higher than the combined risk of transfusion-related infections from HIV, hepatitis and human T cell leukemia.

Bacteria are the most common infectious agents transmitted by blood and are a far greater threat to patient health than viruses such as HIV and hepatitis," says Roslyn Yomtovian, director of blood bank transfusion medicine services and associate professor of pathology at University Hospitals of Cleveland.

"The Pall BDS gives us a novel approach to address the long-standing problem of bacterial contamination of platelets, a problem that has been eluding us for years," she adds.

Platelet contamination is the leading cause of death and spread of disease from transfusion-transmitted infection.—MAD

Air Energy Systems expands acquired MSS facility

MONTGOMERYVILLE, PA—Air Energy Systems has expanded the MSS Clean Technology manufacturing facility in Atlanta, a business it recently acquired.

The additional manufacturing area enables the company to increase production capacity for the MSS Pharma Wall System. According to officials, the expansion is necessary to meet the demand for modular wall and ceiling systems that are compliant with federal current good manufacturing practices (cGMPs) and meet recommended standards from the International Society for Pharmaceutical Engineering (ISPE; Tampa, FL) for cleanroom manufacturing.—MAD

Cleanroom supplier shuts down

BRIARCLIFF, NY—Sales erosion has forced Hong Kong Batteries Ltd. (Hkbil), a distributor of cleanroom supplies and tools, to cease operations.

Along with supplies for controlled environments, Hkbil, a wholly owned subsidiary of SETO Holdings Inc., distributed rechargeable battery packs for power tools, notebook computers and camcorders.

Hkbil, which teamed with an unnamed China company, also manufactured small precision disposable diamond and other base material tools that are used to separate electronic components and devices.

Revenues of $2,039,543 from Hkbil comprised 30 percent of the company's revenues for the fiscal year ended January 31, 2002, and Hkbil revenues of $64,404 at July 31, 2002 represented only 3 percent of the company's overall revenues at that date.

"Management felt that Hkbil's drastic reduction in revenue and its inability to post profits necessitated this action," according to a company statement. "Management estimates that the company will realize a loss from discontinued operations of approximately $660,000 from the write down of the goodwill associated with the original acquisition of Hkbil."—MAD

E. coli contamination sparks 111,000-pound meat recall

OMAHA, NE—Skylark Meats Inc. has recalled more than 111,000 pounds of ground beef after a 3-pound package tested positive for E. coli O157:H7, according to the U.S. Department of Agriculture (USDA) and the Florida Department of Agriculture and Consumer Services (FDACS).

Tests conducted by FDACS on a 3-pound package of frozen ground beef, which was produced at the plant on Sept. 10, revealed that the hamburger was contaminated with a deadly E. coli strand.

According to Skylark, there have been no illnesses associated with or reported on the product, while additional tests of the product turned up negative.

Siding with caution, Skylark conducted a voluntary recall, involving 66,600 pounds of frozen ground beef, sold through a grocery chain and packaged individually in 3-pound, packages car-rying the "Skylark 100% Pure Ground Beef" label, with "sell by" dates of "9/10/03" and 44,440 pounds of frozen ground beef that was deemed for institutional use.

Jim Leonard, Skylark's president, says food safety assurance systems include documented process control systems, pre-operative sanitation, sanitary cleaning between production shifts, temperature audits, employee training, packaging system audits, temperature verification on shipping trailers and lab testing of products used.—MAD

Kronos, HoMedics propel consumer contamination control market

BELMONT, MA—Kronos Air Technologies Inc. and HoMedics USA Inc. have entered into a multi-year, multi-million-dollar agreement that will bring proprietary technology to the consumer.

The agreement provides for exclusive North American, Australian and New Zealand retail distribution rights for next-generation consumer air movement and purification products based on the Kronos air movement system, a silent, non-turbulent, and energy-efficient system designed for air circulation, cleaning and odor removal in family rooms, bedrooms, bathrooms and kitchens.

The initial term of the agreement is three and one half years with the option to extend the agreement for six additional years. Kronos will be compensated through an initial royalty payment and ongoing quarterly royalty payments based on a percentage of sales. HoMedics will pay minimum royalty payments of at least $2 million during the initial term and on-going royalty payments to extend the agreement. Kronos will retain full rights to all of its intellectual property.

HoMedics's commitment includes a multi-million-dollar marketing and advertising campaign to promote the Kronos-based product line. The products will be manufactured and distributed by HoMedics, which distributes to Wal-Mart, Home Depot, Sears, Bed Bath & Beyond, and Linens 'N Things.—MAD

FDA says Urgent Care injectable products not sterile

SPARTANBURG, SC—A nationwide alert instituted by the U.S. Food and Drug Administration (FDA) indicates that all injectable drugs prepared by Urgent Care Pharmacy lack assurance of sterility.

An inspection of Urgent Care's facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution. According to the FDA, non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death.

On September 16, Urgent Care recalled all lots of its injectable methylprednisolone acetate after four patients, who were administered the drug, developed a wangiella, a rare, life-threat-ening fungal meningitis that effects the lining of the brain and spinal cord.

These patients were treated at three different North Carolina hospitals and clinics. Spinal fluid from all of these patients tested positive for a fungus consistent with that found in the Urgent Care product analyzed by both the FDA and Centers for Disease Control and Prevention (CDC). One patient later died despite anti-fungal therapy.

Urgent Care, the FDA reports, has refused to voluntarily recall any other injectable products they prepared and refused to provide the agency with a complete list of products they distributed.

The FDA is working to identify recipients of these products so that it can directly alert them to the serious risks involved. FDA is continuing to work with the CDC, along with officials from both North Carolina and South Carolina, and will take whatever additional action is needed. —MAD

Daw sells Intelligent Enclosures

SALT LAKE CITY, UT—Daw Technologies Inc., a cleanroom component designer, manufacturer and installer, has sold all of the assets of its Intelligent Enclosures business unit, which specializes in minienvironments, to a group consisting of former managers of that business unit.

Daw will continue to provide manufacturing services for Intelligent Enclosures. Terms of the sale were not disclosed.

Don McCauley, chief financial officer of Daw, says while the minienvironment business remains a viable market, company officials felt the company needed to put more resources behind its core cleanroom products and construction and ultra-high purity piping services.

Daw, he adds, was not able to provide the focus and resources necessary to make the minienvironment portion of the business as successful as anticipated when it was acquired in 1998.

"The sale will allow Daw to focus more on its core competencies," says Jim Collings, Daw's chief executive officer. "Intelligent Enclosures has excellent people and technology, and we believe that the concentrated focus the new owners can provide will allow Intelligent Enclosures to achieve success. We see this as a win-win situation for both parties."—MAD