Tag Archives: Clean Rooms

FEBRUARY 24, 2009–LOVELAND, CO–Hach Company has added OPS Systems, Inc. to its family of products. OPS Systems has been in business for over 30 years and has provided water-related reporting and analysis, preventive maintenance and laboratory information management (LIMS) software solutions specifically for water, wastewater, and industrial plant operations. OPS’ commitment to customer service and innovative customer solutions has made them a trusted vendor in the industry.

By combining OPS’ robust information management solutions with Hach instrumentation and water analysis expertise, Hach says it will be able to tie together instrumentation and software into more unique and complete solutions. The expanded product portfolio provides a focus on protecting public health and the environment, aiding with regulatory compliance and reducing costs, and will include a Hach Water Information Management Solution™ (HACH WIMS™), a computer maintenance management system (Hach JobCal®), and a LIMS system (Hach Aspen).

For additional information, contact Hach Company, P.O. Box 389, Loveland, Colorado, 80539, USA or call 1- 800-677-0067.

Visit www.hach.com

FEBRUARY 24, 2009–BASINGSTOKE, UK–Basan UK Ltd is expanding its storage facilities and investing in two new cleanrooms to improve its services to customers, says owner and Managing Director, Russ Bird. Begun in 2003, the company is affiliated with the European Basan group but is independently owned.

Unable to find suitably-sized facilities at its current location in Macclesfield, England, the Company is moving its logistics center to new and larger facilities in Basingstoke. The new headquarters building will take up two warehouse units and will double the storage capacity. The addition of two new cleanrooms will help support the company’s fast-growing cleanroom packing and irradiation services.

“Our new ISO Class 5 and ISO Class 7 cleanrooms will mean we can offer additional services as well as significantly increase capacity,” says Bird. “Cleanroom packing and irradiation of products for customers has become a significant growth area for us.”

Packing and irradiation of cleanroom products for both medical device and pharmaceutical companies has helped create some interesting partnerships for the company, says Bird. “We are more than just a supplier to these customers. We have become an integral part of their own production.”

Gina Abethell, operations director at Basan, says moving the Macclesfield Logistics center to new and larger premises, together with building additional cleanroom packing capacity and consolidating the Bathgate office into one location in Basingstoke, will help improve efficiency as well increase cost effectiveness. “We will be very sorry to lose our office in Scotland but the improvements in communications and cost reductions will enable us to service customer requirements even better than before.”

The company expects to complete the changes in the organization by the end of April 2009 and is forecasting continued growth.

Further information can be obtained from: Russ Bird, Managing Director, Basan UK Ltd, Unit 3 Newton Court, Rankine Road, Basingstoke, Hampshire, RG24 8GF, Tel; (44) 01256 364711

Visit www.cleanroomproducts.co.uk

FEBRUARY 2, 2009–HOLLAND, MI–Hudsonville Ice Cream today voluntarily recalled the 64-oz. containers of its Candy Bar Whirl Ice Cream (UPC# 70438 10250 8), which is available in Michigan grocers such as Meijer, Family Fare, D&W, Harding’s Market, L&L Food centers, and others.

This product contains pieces of candy bars that contain nuts that were processed in the Blakeley, GA plant of Peanut Corp. of America, which has just announced an expansion of a voluntary recall covering all peanut products processed in its plant since Jan. 1, 2007. Peanut Corp. of America is currently the focus of an ongoing investigation by the U.S. Food and Drug Administration (FDA) concerning recent Salmonella outbreaks initially associated with its peanut paste.

Hudsonville Ice Cream has not received any cases of reported illnesses related to this product. The recall did not affect any other flavors of Hudsonville Ice cream.

Hudsonville Ice Cream became aware of this issue today. As the FDA investigation of Peanut Corp. has progressed, additional products have been added to the recall. After Hudsonville Ice Cream received notification from its supplier, the company took immediately action, contacting customers and asking that they remove the product from their shelves. It is also putting a notification on its web site.

Consumers who have purchased Candy Bar Whirl are being instructed to return the product to the store where they purchased it for a full refund.

Consumers with questions or concern should contact Hudsonville Ice Cream at (616) 546-4005.

Source: Hudsonville Ice Cream

FEBRUARY 4, 2009–BELLEVUE, WA–Pharmacy OneSource, Inc., software as a service provider, announced today that Cancer Treatment Centers of America at Western Regional Medical Center has adopted Simplifi 797 to simplify meeting all of the requirements of USP Chapter 797 for compounding sites throughout the hospital.

“At Cancer Treatment Centers of America, we are committed to providing the highest quality cancer care to the patients we serve,” says Krystal Hicks, director of pharmacy, Cancer Treatment Centers of America at Western Regional Medical Center. “We’re excited to have this new software as it increases the safety of our patients and protects our health-care employees by providing quality assurance with back-up systems, which reduce errors and limit the toxicity of chemotherapy.”

Simplifi 797 is a web-based application that automates, integrates, and streamlines the quality activities and documentation required to meet USP-797. The software manages task scheduling for environmental monitoring and automates the reporting of exceptions and compliance.

Source: Pharmacy OneSource

Visit www.simplifi797.com

Visit www.pharmacyonesource.com

FEBRUARY 20, 2009–Decrease staff training travel costs by attending the next IEST Online Education Series, Cleanroom Operations and Procedures, taught by industry expert Anne Marie Dixon. The IEST online education program enables trainees to access modular learning from the convenience of their desks, conference rooms, or auditoriums. The per-location fee has no limit on the number of participants at each location.* The courses can be taken together as a series or as individual classes.

The deadline to receive the early-bird discounted rate ends March 12 for the entire six-part series and for the first part.

Part 1: Overview of Design, Certification, and Flows
Thursday, March 19, 2009 at 11 am-1 pm CST
Following a review of terms and definitions related to cleanrooms, this course will cover air pressure, HEPA filters, and testing and certification based on ISO 14644-1, 14644-3, and IEST-RP-CC006. Other topics include operational flows such as personnel, waste, material, equipment, and products, and the design of gown rooms and airlocks.

Part 2: Personnel — Rules, Regulations, and Gowning
Friday, March 20, 2009 at 11 am-1 pm CST
This class will explain the rules, regulations, and disciplines pertaining to cleanroom personnel. The role of hygiene and use of scrubs and building suits will be covered. This segment also will begin a discussion of gowning materials and procedures.

Part 3: Gowning Materials and Procedures Continued
Thursday, March 26, 2009 at 11 am-1 pm CST
This segment will cover gowning change requirements, cleanroom laundry operations, gowning qualifications, and gowning auditing.

Part 4: Cleaning — Equipment, Procedures, Testing
Friday, March 27, 2009 at 11 am-1 pm CST
This class will explain how to clean and sanitize cleanroom surfaces using the housekeeping procedures in IEST-RP-CC018. Topics include tools and equipment selection, methods, techniques, frequency, and the testing of surfaces.

Part 5: Monitoring
Thursday, April 2, 2009 at 11 am-1 pm CST
Part 5 will cover particle monitoring, including sampling for viable airborne and surface particles. Monitoring methods and equipment selection criteria will be presented with references to ISO 14644-2, 14698-1, and 14698-2. Analysis of data and reasons for excursions will be covered.

Part 6: Operational Training Issues
Friday, April 3, 2009 at 11 am-1 pm CST
This class on how to set up a training program will address what information to include in the curriculum, who should conduct the training, who should be trained, and culture changes.

The instructor of the course, Anne Marie Dixon, is owner and president of Cleanroom Management Associates, Inc., a consulting firm based in Carson City, NV, that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management. Dixon has been actively engaged in the field of contamination control for more than 30 years, with extensive experience in the areas of cleanroom operations, training, technical writing, strategic consulting, facility start-up, construction protocols, and process optimization. Dixon is a Fellow and past president of IEST; chair and head of Delegation of the United States Technical Advisory Group (US TAG) to ISO Technical Committee (TC) 209; and co-convener of ISO/TC 209, Cleanrooms and associated environments, WG 10: Nanotechnology.

More information is available at www.iest.org/training/online. To contact IEST, e-mail [email protected] or call (847) 981-0100.

*Access will be granted to one computer per location.

Source: IEST

Visit www.iest.org

JANUARY 26, 2009–AUSTIN, TX– DiFUSION Technologies, Inc., a medical device company targeting the orthopedic market, has successfully completed a series of laboratory tests of its silver ion-based antimicrobial technology designed to mitigate surgical site infections (SSIs) in spinal surgery. The technology will be incorporated into DiFUSION’s first spinal implant CleanFUZE(TM). Laboratory tests validate the controlled antimicrobial release of ionic silver and antimicrobial efficacy, achieving a 5-log reduction in microbial counts which is 99.999 percent effective. Currently, the company says, no antibiotic can achieve this efficacy.

In response to the rising incidence of SSIs within spinal surgery, which have been reported in large studies to range from 2.5 to 13 percent, DiFUSION has developed CleanFUZE(TM), an antimicrobial PEEK spinal interbody cage capable of stopping biofilm formation in the bone graft site and eliminating 650 types of bacteria including antibiotic-resistant bacteria such as MRSA for up to four weeks postoperatively. DiFUSION expects its technology will not only improve infection ratios, it will also save patient from additional surgery, weeks of IV antibiotics, and, in some cases, life-long exposure to oral suppressive antibiotics, amputation, and even death.

“DiFUSION is targeting a problem that costs hospitals and insurance carriers over $100,000 per SSI incidence, and CleanFUZE(TM) has the potential to not only obviate spinal surgical site infections but also save hospitals millions of dollars a year in associated costs to treat these infections,” says Dr. Peter Whang, a member of DiFUSION’s scientific advisory board and an assistant professor in the Department of Orthopaedics and Rehabilitation at the Yale University School of Medicine in New Haven, CT. “Moreover, as of October 2008, the Centers for Medicare and Medicaid (CMS) are no longer paying for hospital-acquired infections; therefore, health-care facilities are going to have to absorb these staggering costs.”

“DiFUSION’s solution addresses the U.S. Department of Health and Human Services’ (HHS) action plan released January 2009 to reduce and eliminate health-care associated infections (HAIs), one of the key areas being surgical site infections,” says orthopedic surgeon Dr. Matthew Geck, founder and board member of DiFUSION. “Our technology can have a profound impact on lowering the devastating infection rates recently reported by the HHS’ Centers for Disease Control and Prevention (CDC). HAIS are among the top ten leading causes of death in the United States, accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002.”

The infection-fighting material used in DiFUSION’s CleanFUZE(TM) is a “super silicate” molecule composed of antimicrobial silver ions that is compounded into the plastic spinal interbody cage. Once the interbody cage is implanted into the spinal disc space during spinal surgery, silver ions exchange with naturally occurring sodium ions in the bloodstream and diffuse antimicrobial silver ions for a period of four weeks.

Unlike other devices on the market, DiFUSION says, CleanFUZE(TM) will be capable of releasing its dosage amount over time and the rate of diffusion can be controlled by parts-per-billion. Additionally, rather than antimicrobial coatings currently used in devices, antimicrobial properties are embedded in the device to enhance the effectiveness.

Orthopedic surgeons will not need to alter currently accepted surgical techniques and/or utilize new implantation instruments, while hospital and insurance carriers will not be required to implement new procedure codes.

DiFUSION intends to conduct the appropriate filings to facilitate full FDA clearance by the end of 2009. Agreements are also in place with 15 distributors and discussions have been initiated with an additional 20.

Source: DiFUSION Technologies

Visit www.difusiontech.com

JANUARY 26, 2009–SAN JOSE, CA–SEMI PV Group has announced the addition of the Photovoltaic (PV) Equipment Data Collection Program to its market research portfolio for members. The program, a partnership between SEMI PV Group and Yole Developpement, will generate a quarterly PV equipment book-to-bill (B:B) report to provide subscribers with global information on the rapidly expanding PV equipment market.

Currently, the PV Group and Yole are recruiting PV equipment manufacturers to take part in the program, and the program will focus on an initial list of suggested categories. In addition to equipment used in the manufacturing of cells and modules, the categories also include equipment used in the manufacturing of ingots, wafers, and polysilicon. Each category will consist of data aggregated from a minimum of three companies. The final category list will be determined by participant interest.

Stanley T. Myers, president and CEO of SEMI, says, “Because such a large percentage of our members also serve the PV industry, this new data collection program is a logical fit within our existing offerings, ensuring a complete global snapshot of the PV equipment segment.”

“We have long enjoyed a strong relationship with SEMI, and have worked together in the past to provide market information on the MEMS and Nanotechnology programs, so we are pleased to be collaborating on the PV program,” says Jean-Christophe Eloy, founder of Yole Developpement. “I believe this collaboration fills in an obvious gap by providing up to date and accurate information on the PV equipment industry.”

The inaugural report will be issued in May, and will contain bookings and billing data from Q109. Subsequent reports will be issued quarterly in August, November, and February, and will be available for a subscription fee, with a discount for SEMI/PV Group members.

Companies interested in participating in the Worldwide PV Equipment Data Collection Program should contact Dan Tracy at [email protected] or Gaetan Rull at [email protected].

Source: SEMI PV Group

Visit www.pvgroup.org

JANUARY 27, 2009–CARLSBAD, CA–Jenny Craig, Inc. has announced a voluntary recall of its Jenny’s Cuisine(R) Anytime Peanut Butter Flavor Nutritional Bars (UPC Code 655447009347) for U.S and P.R. distribution with the following BEST BEFORE DATES: MAY1209ALO, MAY1209BLO, MAY2409BLO, MAY2509BLO, MAY2509ALO, MAY2609ALO, & MAY2609BLO, because the product contains peanut butter which was manufactured by Peanut Corp. of America (PCA), which is the focus of an ongoing Salmonella investigation by the U.S. Food & Drug Administration (FDA). PCA is one of the suppliers of peanut ingredients to the company’s contracted manufacturer.

There have been no cases of illness or adverse effects reported by any Jenny Craig customers, and no other products within the Jenny Craig food portfolio, including those made with peanut butter or other peanut ingredients are affected by this recall. No Salmonella contamination has been detected in the Jenny Craig Anytime Peanut Butter Flavor Bars. This voluntary recall is in line with FDA recommendations, and Jenny Craig has removed all products within existing inventory.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 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 the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis. For more information on Salmonella, visit the Centers for Disease Control and Prevention’s web site at www.cdc.gov (or call 1-800-232-4636).

“The health and safety of our clients are our number one concern,” says Amy Armish, director of food technology and quality assurance, Jenny Craig, Inc. “We are communicating directly with our clients and consultants and are urging all clients who have purchased or are in possession of this product to immediately destroy them. Clients seeking a replacement bar are being asked to visit their Jenny Craig centre or call their Jenny Craig consultant and a replacement bar will be issued in its place or an adjustment made to their next order.”

The Anytime Peanut Butter Flavor Nutritional Bars were distributed directly to clients through Jenny Craig centers or the at-home Jenny Craig Direct program. The Anytime Peanut Butter Flavor Nutritional Bar is not available in other retail stores and not sold under any other name. Clients having further questions or concerns may contact their local Jenny Craig center or call 1-800-JennyCare.

Source: Jenny Craig, Inc.

JANUARY 27, 2009–DURHAM, NC–bioMerieux, a developer of in vitro diagnostics, entered into an exclusive referral agreement on January 15 with ICNet Systems, Inc., an international provider of health-care associated infection (HAI) case management and surveillance software.

“Microbiology and serology data drive the activity around infection control surveillance,” says Herb Steward, executive vice president and general manager, bioMerieux North America. “ICNet Systems, Inc. offers our customers an important tool in the fight against HAIs, a strategic focus at bioMerieux.”

Through electronic interfacing with third-party database management systems, laboratory information systems (LIS), patient administration/hospital information systems, and surgical systems, ICNet automates the collection of data required by the infection control teams (ICTs), providing real-time alerts, reports, and analytical tools that save considerable infection control time and help target action more effectively.

ICNet is a web-enabled application that reportedly helps hospitals reduce medication costs through the more expeditious and appropriate use of real-time microbiology diagnostic data management, surveillance, and reporting. The use of the software can assist in decreasing the risk of spreading preventable infections through timelier root-cause analysis once a problem has been identified.

Source: bioMerieux

Visit www.biomerieux.com

Visit www.icnetplc.com

JANUARY 31, 2009–CINCINNATI,OH–The Kroger Co. is recalling peanut butter store-baked and store-packaged cookies and select cakes sold in its family of stores because the products have the potential to be contaminated with Salmonella.

Stores under the following names in the 31 states where Kroger operates are included in this recall: Kroger, Ralphs, Fred Meyer, Food 4 Less, Fry’s, King Soopers, Smith’s, Dillons, QFC, City Market, Foods Co., Jay C, Scott’s, Owen’s, Baker’s, Gerbes, Hilander, and Pay Less.

No illnesses have been reported in connection with the cookies and cakes.

Kroger is recalling all packages of the following Kroger, Store-Brand, and Private Selection store-baked and store-packaged cookies:
-Peanut Butter Cookies – Regular, Jumbo, Decorated, Iced, Gourmet, Mini and Sandwich cookies
-Assorted and Variety Bakery Cookies – Regular and Jumbo
-Private Selection Peanut Chocolate Chunk Cookies
-Private Selection Gourmet Variety Cookie Trays

Kroger is recalling all sizes of the following Private Selection Cakes, including whole, half and packaged slices:
-Private Selection Chocolate Trio Single-Layer and Double-Layer Iced Cakes

Customers who have purchased any of the cookies or cakes listed above should not consume these products and should return them to a store for a full refund or replacement.

The products Kroger is recalling may be associated with the peanut product recall by Peanut Corp.of America (PCA). FDA has indicated that PCA is the focus of its investigation into Salmonella-related illnesses that may be linked to contaminated peanut products. For more information, please visit FDA’s web site at www.fda.gov.

Kroger continues to follow FDA guidelines and, for the safety of customers, has withdrawn other products from sale that contain peanut ingredients implicated in this outbreak, as directed by the FDA and suppliers involved.

Salmonella is an organism that can cause serious and sometimes fatal infections, particularly in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s web site at www.cdc.gov.

According to FDA, peanut butter sold in jars, including Kroger brand peanut butter sold in the retailer’s family of stores, is not involved in the ongoing investigation.

Customers who have questions about the cookie and cake recall may contact Kroger toll-free at (800) 632-6900. For more information, please visit Kroger’s web site at www.kroger.com/recalls.

Kroger is notifying customers about this recall by placing signs in stores in bakery departments. Kroger is also activating its register receipt and phone call notification systems to alert customers about recalls of products they may have purchased.

Source: The Kroger Co.