Tag Archives: Clean Rooms

September 21, 2007 — /PR Newswire/ — ENGLEWOOD, CO — Baxa Corporation, a leading provider of systems for safe fluid handling and delivery in hospital pharmacies, announces the addition of two new international product distributors. These agreements — with Magallan Pharma Trading Corporation in Colombia and Pentafarma & Co. in The Dominican Republic — will enable Baxa to extend its global reach and expand product promotion in South America and the Caribbean.

“Global markets offer significant potential for growth in Baxa Corporation’s key product lines,” says Steve Welch, vice president of new business development. “These new partnerships expand the visibility of the Baxa brand and give us opportunities for sales growth and market expansion. With their focus on pharmacy efficiency and patient safety, Baxa products offer a unique value in healthcare worldwide.”

Baxa Corporation provides distributor training and technical support at its headquarters in Englewood, CO. Privately held, Baxa Corporation has subsidiaries and sales offices in Canada and the United Kingdom; direct representation in Austria, Belgium, Finland, France, Germany, Luxembourg, the Netherlands, and Switzerland; and distribution partners in 35 other countries worldwide.

About Baxa Corporation
Baxa, a customer-focused medical device company, provides innovative, solution-based technologies for fluid handling and delivery. Its systems and devices promote the safe and efficient preparation, handling, packaging, and administration of fluid medications. Key products include Rapid-Fill(TM) Automated Syringe Fillers, Exacta-Med(R) Oral Dispensers, MicroFuse(R) Syringe Infusers, Repeater(TM) Pharmacy Pumps, and Exacta-Mix(TM) and MicroMacro(TM) Multi-Source Automated Compounders; used worldwide in hospitals and healthcare facilities — www.baxa.com.

About Magallan Pharma Trading
Magallan is a newly formed company within a group of companies serving the healthcare industry in Colombia. “Salud Total,” overseeing Magallan, is the third largest health services company in Colombia. Magallan is responsible for location of needed products, Colombian registration with the health authorities, and product distribution.

About Pentafarma CxA
Pentafarma is a pharmaceutical and medical device distributor in the Dominican Republic selling supplies to hospitals in that country. Clients include oncology and gynecological hospitals and surgery centers.

Source: Baxa Corporation

September 21, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) is warning consumers not to drink or consume raw (unpasteurized) cream labeled as “ORGANIC PASTURES Grade A RAW CREAM” in one-pint plastic bottles coded “SEP 14” through “SEP 21.”

This product, marketed by Organic Pastures Dairy Company (“Organic Pastures”), Fresno, CA, may be contaminated with Listeria monocytogenes, an organism which can cause a serious and sometimes fatal disease called Listeriosis 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, Listeriosis can cause miscarriages and stillbirths among pregnant women.

The product was sold in retail stores throughout California and was also available worldwide via phone orders, and is not pasteurized. 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 brucellosisis.

The California Department of Food and Agriculture issued an order to Organic Pastures on September 7 to withdraw the raw cream from retail distribution after routine product sampling at the facility detected the bacteria. As of Sept. 20, 2007, the California Department of Agriculture has now permitted Organic Pastures to sell and distribute raw cream within the state of California. FDA advises consumers to throw away product labeled as “ORGANIC PASTURES Grade A
RAW CREAM” with code dates “SEP 14” through “SEP 21”.

Individuals who have consumed Organic Pastures raw cream and who have experienced any of the symptoms described above should contact a doctor or other health care provider immediately.

No illnesses have been reported to date.

Consumers with questions may contact Mark McAfee, chief executive officer/founder of Organic Pastures, at 1-877-RAW-MILK (1-877-729-6455).

Web site: www.fda.gov

September 24, 2007 — /PR Newswire/ — BUDAPEST, HUNGARY — ThalesNano Inc., a leading developer and manufacturer of flow chemistry, flow reactor technology, and hydrogenation technology solutions, announced today that it had continued to expand globally by opening a subsidiary in the United Kingdom and by signing distributor agreements in Scandinavia, Italy, and India.

Building its own subsidiary reflects ThalesNano’s commitment to bridging closer ties with its customers and expanding operations globally; it is intended to enhance activities in particular towards the chemical and pharmaceutical sectors, and to reinforce visibility. The U.K. representatives will bring both added value in operational terms and flexibility for customers.

Alex Drijver, CFO, comments, “Chemists will have a local point of contact for advice on the most up-to-date chemistry technologies and solutions. ThalesNano Inc. was already operating successfully through a distributor company in the UK and can now strengthen and consolidate its position with help of its local team of professionals. The U.K. is a strategic market for the company’s growth, as the country’s R&D spending is the largest within Europe and has the most developed and innovative pharmaceutical and chemical industry. In this way, ThalesNano Inc. can effectively support U.K. customers at all times with the necessary technology knowledge.”

The new U.K. ThalesNano team replaces former distributor Asynt Inc., with whom the company’s contract expired in September. The Danish distributor company Biolab A/S is taking over customers from Asynt Inc. in the Scandinavian region; in Italy, Stepbio S.R.L. is the new distributor of ThalesNano products.

As a result of ThalesNano’s global expansion, and as a response to the demand for its products and technologies from India, the company has started its operation through cooperation with Inkarp Instruments Pvt. Ltd.

Ferenc Darvas, PhD, president and chairman, comments, “The development and growth of both ThalesNano’s sales team and the distributor network comes two years after the initial launch of the award winning H-Cube(R), which is rapidly becoming the standard for performing hydrogenation reactions in research laboratories.”

About ThalesNano Inc.
ThalesNano Inc. is a technology-intensive company that provides solutions for leading pharmaceutical and biotechnology companies from all over the world. It is specialized in developing and providing microscale flow instruments for chemistry, by exploiting the benefits of combining microfluidics, mezofluidics or nanotechnology with flow chemistry. The award winning development, H-Cube(R), has been recognized as one of the 100 most technologically significant and innovative new products of 2005 by R&D Magazine and is the first in a new wave of continuous-flow hydrogenation reactors.

Web site: www.thalesnano.com

Source: Thalesnano Nanotechnology Inc.

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.

September 18, 2007 — /FDA News/ — MONTEREY, CA — Dole Fresh Vegetables, a division of Dole Food Company, Inc., has announced that it is voluntarily recalling all salad bearing the label “Dole Hearts Delight” sold in the U.S. and Canada with a “best if used by (BIUB)” date of Sept. 19, 2007, and a production code of “A24924A” or “A24924B” stamped on the package. The “best if use by (BIUB)” code date can be located in the upper right hand corner of the front of the bag. The salad was sold in plastic bags of 227 grams in Canada and one-half pound in the U.S., with UPC code 071430-01038.

Symptoms of E. coli O157:H7 exposure could include stomach cramps and diarrhea. Bloody diarrhea may develop. E. coli disease sometimes leads to a complication called hemolytic uremic syndrome (HUS). If you exhibited any of these symptoms within 3 to 5 days of consuming any of the products specified above, seek medical attention.

To date, Dole has received no reports that anyone has become sick from eating these products. The recall is occurring because a sample in a grocery store in Canada was found through random screening to contain E. coli O157:H7. No other Dole salad products are involved.

Eric Schwartz, president, Dole Fresh Vegetables, states, “Our overriding concern is for consumer safety. We are working closely with the U.S. Food and Drug Administration, the Canadian Food Inspection Agency, and several U.S. state health departments.”

Consumers who may still have any of the “Dole Hearts Delight” salads with a “best if used by date” of September 19 and a production code of “A24924A” or “A24924B” should dispose of the product. This product was sold in Ontario, Quebec, and the Maritime Provinces in Canada and in Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania, Tennessee, and neighboring states in the U.S. Consumers can call the Dole Consumer Center toll-free at 800-356-3111. Consumers are reminded that products should not be consumed after the “best if used by” date.

Web site: www.fda.gov

September 19, 2007 — /IEST News/ — ARLINGTON HEIGHTS, IL — The Institute of Environmental Sciences and Technology (IEST) Working Groups develop the standards and Recommended Practices that capture the best practices across industries and distill the experiences of leaders in these fields. Approximately twenty-two working group sessions will be held at the IEST Fall Conference, November 11-14, 2007 at the Hilton Garden Inn in Hoffman Estates (Northwest Suburban Chicago), IL. Learn about the latest research in the controlled environments and cleanroom industries from leading industry experts in your field. Registration is now open at www.iest.org/fallconference/fallconference.htm.

Working groups meeting this year include:

  • Combined meeting of filtration WG-CC001, WG-CC007, WG-CC021, and WG-CC034
  • WG-CC002: Unidirectional Flow Clean-Air Devices
  • WG-CC003: Garment System Considerations for Cleanrooms and Other Controlled Environments
  • WG-CC006: Testing Cleanrooms
  • WG-CC013: Calibration Procedures and Guidelines for Select Equipment Used in Testing Cleanrooms and Other Controlled Environments
  • WG-CC016: The Rate of Deposition of Nonvolatile Residue in Cleanrooms
  • WG-CC020: Substrates and Forms for Documentation in Cleanrooms
  • WG-CC022: Electrostatic Charge in Cleanrooms and Other Controlled Environments
  • WG-CC024: Measuring and Reporting Vibration in Microelectronics Facilities
  • WG-CC025: Evaluation of Swabs Used in Cleanrooms
  • WG-CC031: Outgassing Performance Criteria for Cleanroom Materials
  • WG-CC036: Testing Fan Filter Units
  • WG-CC040: Cleaning of Equipment Surfaces in Cleanroom and Other Controlled Environments
  • WG-CC041: Recovery from Disruption to Cleanrooms and Other Controlled Environments
  • WG-CC042: Liquid-borne Particle Counting
  • WG-CC101: Forum on Air Cleanliness Technology
  • WG-CC200: Overview: Planning, Design, Construction, and Operational Considerations for Facilities Engaged in Research or Production at the Nanometer Scale
  • WG-CC205: Nanotechnology Safety: Applying Prevention through Design Principles to Nanotechnology Facilities
  • WG-CC901: IEST-STD-1246D: Product Cleanliness Levels and Contamination Control Program

To advertise at the Fall Conference through a sponsorship or the program book, contact Heather Dvorak at (847) 981-0100 or [email protected].

For further information regarding IEST and its publications, visit the IEST website at www.iest.org.

About IEST
Founded in 1953, IEST is an international not-for-profit 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.

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.

September 19, 2007 — /FDA News/ — SAN FRANCISCO, CA — Quong Hop & Co. of South San Francisco, CA, is recalling all SOY DELI brand tofu with code date DEC 17 2007 and certain varieties of SOY DELI and QUONG HOP brand tofu with code date SEP 23 2007.

The recall includes the following products in the following sizes and code dates:

  • All varieties and sizes of SOY DELI TOFU coded DEC 17 2007
  • 30 OZ SOY DELI NIGARI TOFU coded SEP 23 2007
  • 12 OZ SOY DELI WATER PACK TOFU coded SEP 23 2007
  • 16 OZ QUONG HOP WATER PACK TOFU coded SEP 23 2007

These products are being recalled because they have the potential to 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, abdominal pain, and diarrhea, Listeria infection in severe cases can cause miscarriages and still births among pregnant women. Consumers experiencing any of these symptoms should seek immediate medical attention.

The recalled “SOY DELI” and “QUONG HOP” brand products are distributed in the Midwest and West coast throughout supermarkets and natural food stores. The date code can be found on the front panel of all the aforementioned products printed in blue ink.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after a routine test by Washington State Department of Agriculture’s Food Safety Program revealed the presence of Listeria monocytogenes in a 12 oz vacuum pack package of “SOY DELI FIRM ORGANIC
NIGARI TOFU.” The company is voluntarily recalling all products produced during the same time period as the sampled product to ensure customer safety.

Consumers who have purchased the recalled products are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 650-553-9900.

Web site: www.fda.gov

September 20, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) is warning consumers not to consume Baby’s Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (shown as “10/08” on the label), distributed by MOM Enterprises, Inc., of San Rafael, CA. FDA confirmed through laboratory analysis the presence of cryptosporidium after investigating the illness of a 6-week-old infant in Minnesota who consumed the product. Cryptosporidium is a parasite that can cause intestinal infections.

The most common symptom of infection is watery diarrhea. Other symptoms can include dehydration, weight loss, stomach cramps or pain, fever, nausea, and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. While most people with healthy immune systems will recover without treatment, the infection could be serious or life-threatening for certain individuals. Infants, children, and pregnant women are susceptible to dehydration resulting from diarrhea, which can be life-threatening. Individuals with weakened immune systems are also at risk for a more serious and life-threatening form of illness.

Parents of children who have recently consumed Baby’s Bliss Gripe Water, apple flavor, and have these symptoms should seek immediate medical attention. Parents and caregivers who have given this product to their infants and children should be alert for diarrhea and other signs of Cryptosporidium infection.

Approximately 17,600 bottles of the product were distributed nationwide in retail stores and sold over the Internet between November 2006 and September 2007. A code of 26952V with an expiration date of 10/08 appears on the bottle’s carton. The product is sold in a four-ounce plastic bottle packaged inside of a cardboard carton which is labeled with the following: “Baby’s Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups, and teething. Dietary Supplement. 4 fl. ozs. (120 ml). Ginger Extract. Fennel Extract. Other ingredients: Deionized Water, Vegetable Glycerin, Fructose, Natural apple flavor, Citric acid, Bioflavonoid Extract, and Grapefruit Seed Extract. Distributed by: MOM Enterprises, Inc., San Rafael, CA 94903 USA.” FDA advises consumers to throw away bottles of the product described above that they have in their possession.

MOM Enterprises, Inc. is fully cooperating with FDA’s investigation into the cause of the contamination and is recalling all potentially contaminated products. FDA continues to investigate and will provide updates as more information becomes available. Consumers can call the FDA at 1-888-723-3366.

Web site: www.fda.gov

September 17, 2007 — BILLERICA, MA — Millipore Corporation, a life science leader providing technologies, tools, and services for the bioscience research and biopharmaceutical manufacturing industry, today unveiled its new brand initiative and visual identity. The re-branding affirms Millipore’s transformation from high-performance filtration systems provider to leading life science corporation, focused on delivering the pioneering technologies and deep expertise necessary for customers to reach their research and scientific goals. Millipore will communicate this perspective in a new corporate tagline that also serves as the cornerstone of the company’s new brand promise: “Advancing Life Science Together(TM). Research. Development. Production.”

“Millipore is passionate about collaborating with our customers to solve the world’s most challenging human health issues,” says Martin Madaus, chairman, president, and CEO of Millipore. “We intimately understand the needs and ambitions of scientists and engineers, an understanding honed after proudly working with them, side by side, for more than 50 years. As we aim to accelerate the entire development process for our customers — from research to discovery all the way to drug production — we are confident that the new Millipore brand look and message will generate greater global awareness of our expanded capabilities and expertise,” he adds.

The new visual representation of the brand will appear in the company’s advertising and documentation, and on its products and packaging. A newly re-branded Millipore web site will also be launched later this fall, featuring improved functionality, a robust search engine, and additional tools that will make it even easier to do business with Millipore.

With leadership comes a responsibility to give back to the community, which is why the company established the Millipore Foundation more than 20 years ago. Today, to further promote innovation and research in the life science industry, Millipore also announced a $500,000 research gift made through the Millipore Foundation to the Harvard Stem Cell Institute (HSCI). HSCI is a scientific collaborative within Harvard University and its affiliated hospitals seeking to fulfill the promise of stem cell biology as a basis for cures and treatments for a wide range of chronic and medical conditions. Millipore’s gift will support the HSCI Seed Grant Program, which provides early funding for innovative projects in any field of stem cell research.

“We are pleased to welcome Massachusetts-based life science industry leader Millipore as the first corporate donor to the Harvard Stem Cell Institute Seed Grant Program,” says Brock Reeve, executive director of the Harvard Stem Cell Institute. “HSCI and Millipore share a commitment to collaboration, with both entities working tirelessly to shorten the distance between theory and discovery — between the present and future — in continuing to move the life science industry forward.”

Millipore’s 6,100 employees around the globe are dedicated to serving as innovative life science partners with their customers, while tapping the industry’s enormous potential to transform scientific understanding and ultimately improve the quality of human life.

About Millipore — Advancing Life Science Together(TM)
Millipore is a life science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world’s challenging human health issues. From research to development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. Millipore Corporation is an S&P 500 company with more than 6,100 employees in 47 countries worldwide.
Web site: www.millipore.com

About The Harvard Stem Cell Institute (HSCI)
The Harvard Stem Cell Institute (HSCI) is a scientific collaborative established in 2004 to fulfill the promise of stem cell biology as the basis for cures and treatments for a wide range of chronic, life-threatening medical conditions. In addition to its scientific work, the Harvard Stem Cell Institute has programs focused on the ethical and legal implications of stem cell research, produces a series of lectures and presentations to help inform the public, has a summer research program for college students, and helps educate high school teachers about stem cell science. Because of the current restrictions on federal funding of embryonic stem cell research, the Harvard Stem Cell Institute depends upon the foresight and generosity of private individuals, foundations, and corporate donors to carry on its work. For more information about the Harvard Stem Cell Institute, please go to http://hsci.harvard.edu. For a slide show, please visit http://hsci.harvard.edu/introduction-video.

Source: Millipore Corporation

September 17, 2007 — LEHIGH VALLEY, PA — Effective October 1, Air Products will increase the price of certain high-purity process chemicals in North America. The increases for drums will range between 5 to 10 percent, and bottles will range from 13 to 18 percent. The company attributes the increase primarily to the continued escalation in raw material prices, especially those which are influenced by volatile energy prices along with other market factors.

Likewise, the cost of many packaging materials has also been on the rise on account of higher basic chemical feedstock materials. Air Products continuously strives to minimize the impact of these changes via sourcing, manufacturing, and distribution initiatives. To date, however, the pace of these increases has exceeded the company’s ability to mitigate them.

Source: Air Products
Web site: www.airproducts.com

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.

September 17, 2007 — /FDA News/ — B. Braun Medical Inc., Bethlehem, PA, announced on July 30, 2007 a voluntary nationwide recall of Normal Saline Flush syringes with lot numbers ending in “SFR” due to an increase in customer complaints for particulate matter in the saline. The FDA has been apprised of this action.

The introduction of particulate matter into the blood stream may result in phlebitis and/or damage to vital organs such as the brain, kidneys, heart, and lungs. To a less likely extent, there is a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause severe injury and/or death. Symptoms would generally be expected to develop quickly and are unlikely to develop more than 24-48 hours after the administration of the product. However, the risk associated with use of this product is cumulative and increases with each additional exposure. A patient may not develop any
symptoms until they have received multiple doses of the product. To date, B. Braun has received no reports of any patient injury associated with this issue.

Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to usage of this product. Customers that have the affected product in their possession may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.

This voluntary recall affects normal saline 3mL in 12mL syringes, designated by product code 513584, and normal saline 10mL in 12mL syringes, designated by product code 513587. Between June 11 and July 18 of this year, B. Braun Medical Inc. distributed approximately 33,000 units of product code 513584 and 1.2 million units of product code 513587 of lot numbers ending in “SFR” to hospitals and distributors. The product code, identified as REF, and lot number, identified as LOT, can be found on the syringe label just below the product description.

These flush syringes have been found to contain particulate matter, which has been identified as a medical grade silicone. While this silicone is biocompatible, routinely used in the medical device industry and is an expected component of these syringes, the visible particulate matter caused by the silicone in these “SFR” lots may pose a health risk.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Web site: www.fda.gov