Tag Archives: Clean Rooms

February 28, 2008 — /BELLEVUE, WA/ — Pharmacy OneSource, creator of the Simplifi 797 quality assurance web application, is pleased to announce that industry expert Eric S. Kastango, MBA, RPh, FASHP, CEO of Clinical IQ, has updated the included policies and procedures reference section in Simplifi 797 to match USP’s revised chapteron pharmaceutical compounding, “Sterile Preparations.”

The revised chapter was finalized in December 2007 and tightened standards and conditions for sterile compounding over the previous version of Chapter 797. These revisions will become official on June 1, 2008.

“Policies and procedures are the foundation for a robust compounding quality system,” says Kastango. “I’m very excited that Simplifi 797 has these updated policies and procedures to complement the outstanding software that provides pharmacists and technicians the tools to be successful.”

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

About Pharmacy OneSource

Pharmacy OneSource is pharmacies’ number 1 software-as-a-service provider. Its 50 innovative team members provide best-in-class SaaS solutions to current and future challenges within health-system pharmacies worldwide. Its SaaS solutions contribute to high performance pharmacies through better outcomes, lower costs, and system-wide results. More than 1,000 healthcare organizations worldwide utilize the company’s HIPAA compliant web-based services, including Accupedia,Amplifi, Quantifi,ScheduleRx, Sentri7, Simplifi 797, and UnitStock.

Visit www.pharmacyonesource.com

About Clinical IQ

Clinical IQ, LLC is a privately held consulting company based in Florham Park, NJ. It is led by Eric Kastango, MBA, RPh, FASHP, President and CEO, who is seen as an expert in many areas of the pharmacy industry, but particularly in USP Chapter processes. Clinical IQ, LLC aims to serve as the trusted source for pharmacy information services and product solutions for all its customers who range from local start-up operations to established national companies in the hospital, home care, and specialty compounding industries. With this aim, Clinical IQ creates software, classroom training, web based training, audit tools, and many other informational products to make sterile compounding and related areas of pharmacy safer.

www.clinicaliq.com

February 28, 2008 — /ARLINGTON HEIGHTS, IL/ — The Institute of Environmental Sciences and Technology will hold its annual technical meeting and exposition, ESTECH 2008, May 4-7, 2008 at the Hilton Chicago/Indian Lakes Resort in Bloomingdale, IL. Several new tutorials, along with the popular certificate program on ISO Standards, will be offered for contamination control professionals.

Don’t miss the upcoming ISO 14644 tutorials. Discover strategies for applying the ISO technical committee 209, cleanrooms and associated controlled environments 14644, cleanroom standards to meet today’s requirements and tomorrow’s goals. Knowledge of the ISO 14644-1 and 14644-2 standards has become an operational and contractual necessity in today’s cleanroom environments. The tutorial certificate program will be comprised of three tutorials: Understanding the ISO Series; Testing to Determine the Classification of Air Cleanliness; and Testing Cleanroom Performance Using ISO 14644-3. These tutorials can be taken as part of the certificate program or as stand-alone courses. This tutorial certificate program includes copies of ISO 14644-1, ISO 14644-2, and ISO 14644-3.

In addition to the certificate program, several new stand-alone tutorials will be available: Advanced Topics in Contamination Control; Swabbing Protocols for Cleaning Validation; Pharmaceutical Perspectives on Detergents and Cleaning Validation: Regulation and Current Practices; and Using NFPA 70E: Electrical Safety in the Workplace in the Cleanroom Environment.

In Advanced Topics in Contamination Control, illustrative laboratory test results will be presented to validate two recently developed technologies for cleaning

February 26, 2008 — /PRNewswire/ — LEHIGH VALLEY, PA — Air Products (NYSE:APD), a pioneer of cryogenic food freezing and chilling technologies, announces the grand opening of its Asia Food Technology Center at the Thailand Science Park in Bangkok. The Center has been established to provide innovative solutions and technical expertise to support the ever-increasing demands from the growing Asian food market.

By strategically locating its technology center in Thailand, one of the world’s leading food processing markets, Air Products can now work even closer to its Asian customers to drive forward new food processing innovations. Air Products is also able to leverage cutting-edge microbiological and food science research capabilities within the Thailand Science Park and nearby universities.

“Our investment in the Asia Food Technology Center underscores the company’s commitment to Asia and to the food processing market. To put our focus on where the market is, the Center enables Air Products to respond more quickly to the changing needs of our food customers, in which time-to-market and innovations are critical for their success,” says Ivo Bols, vice president and general manager of Merchant Gases, Air Products Asia.

On showcase at the center is a broad selection of Air Products’ FreshlineTM food preservation solutions, which maintain the quality and freshness of foods. The Center also includes other facilities such as a laboratory kitchen and a cold storage room. The set up enables the company to work with customers to develop innovations and resolve issues which relate to maintaining high quality and freshness of a wide variety of food products. It also houses a state of the art training center, and is envisaged to be a center of excellence to serve food customers throughout the Asian region.

“Air Products has been serving the food industry globally for over 40 years. The food processing sector in Asia requires the support of unmatched industry experience, expertise, and technical excellence to keep pace with its dynamic growth. By establishing its new Food Technology Center in Asia, Air Products has significantly enhanced its position as the premier food solutions provider to the food industry,” says Dr. Terrence Yee, regional director of applications, Air Products Asia.

The center is integrated into the company’s global advanced technology network, complementing existing technical facilities in North America and Europe.

About Air Products

Air Products serves customers in industrial, energy, technology, and healthcare markets worldwide with a unique portfolio of atmospheric gases, process and specialty gases, performance materials, and equipment and services. Founded in 1940, Air Products has built leading positions in key growth markets such as semiconductor materials, refinery hydrogen, home healthcare services, natural gas liquefaction, and advanced coatings and adhesives. The company is recognized for its innovative culture, operational excellence and commitment to safety and the environment. Air Products has annual revenues of $10 billion, operations in over 40 countries, and 22,000 employees around the globe.

Visit www.airproducts.com

Dr


February 28, 2008

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February 26, 2008 — /WILMINGTON, MA/ — Watson-Marlow, the world’s leading peristaltic pump manufacturer for the biopharmaceutical industry, has acquired Flexicon A/S, a leading manufacturer of peristaltic-based aseptic filling systems, through its parent company Spirax-Sarco Engineering. The acquisition includes Flexicon America, the company’s U.S. based subsidiary.

Watson-Marlow, well known in the biopharmaceutical industry for its expansive range of production-duty peristaltic metering and transfer pumps, now greatly expands its capabilities in filling applications. Flexicon has been marketing peristaltic-based aseptic filling and capping equipment for the past 22 years, specializing in filling systems for clinical-trial production. The company’s product portfolio ranges from stand-alone units for hand filling to fully automatic filling, stoppering and capping machines. The fully automatic systems are customized to fit any container, be it a vial, bottle, test tube, or non-self-standing micro-tube. Utilizing peristaltic pump and tubing technology, Flexicon filling systems provide a completely disposable flow path, enhancing productivity and traceability while reducing maintenance as compared to piston type or time/pressure fillers.

About Watson-Marlow

Watson-Marlow is the world’s largest manufacturer of peristaltic tube pumps for biopharmaceutical, pharmaceutical, and process applications with the widest range of pumps, pumpheads, and tubing available for end-users and OEMs. As the pumped fluid does not come into contact with the pump itself – only with the tube

February 26, 2008 — /BLOOMSBURG, PA/ — Kleerdex, CO., LLC, manufacturer of KYDEXR thermoplastic sheets, announces it has attained the exclusive right to produce thermoplastic sheets with MicrobanR, an antimicrobial product protection for the production of healthcare equipment enclosures and airline interior components. Microban protection is built-in to continuously fight the growth of microbes such as odor and stain causing bacteria, mold and mildew, keeping products cleaner between cleanings. It doesn’t wash or wear off. Increased consumer awareness of microbes, coupled with the importance of maintaining a cleaner environment, makes KYDEX sheet an ideal option for thermoformers and fabricators in these and other industries.

Under this arrangement, Kleerdex will offer Microban protection as an option for the following thermoplastic sheets marketed under the KYDEX name: KYDEX T MB, KYDEX XD MB, KYDEX 150 MB, and KYDEX 5555 MB products.

“Microban protection is an important addition to support the KYDEX sheet portfolio. We are pleased that Microban International has chosen Kleerdex to be the exclusive provider of microbe-resistant thermoplastics for the airline industry and in selected healthcare product applications,” says Michael Karr, North American business manager. “The benefits to our clients and to consumers are substantial. The use of Microban protection in airline interior products is particularly advantageous to keep items made from thermoplastic sheets, including meal trays, arm rests, and monitor shrouds cleaner between cleanings.”

“In addition, the potential for KYDEX sheets to support microbe-resistant environments in other applications is enormous,” continues Karr. “Our manufacturing clients can now provide antimicrobial protection using KYDEX thermoplastics in a wide variety of applications including furniture in hospitals, nursing homes and medical offices, self-serve kiosks, food processing machines, serving counters, retail facilities, orthotics, and more.” While Microban protection is not a substitute for normal cleaning practices, it will keep these products cleaner for the useful life of the product.

Companies using KYDEX thermoplastics in exclusive applications can market their products with the Microban trademark.

About Kleerdex

Kleerdex Co. LLC is a U.S. based manufacturer of proprietary thermoplastic sheet products marketed worldwide under the trademark KYDEX. The company’s headquarters, major manufacturing operation, customer service, and R&D facilities in Bloomsburg, PA are certified to the ISO 9001:2000 quality management system and the ISO 14001 environmental management system. Additional administrative offices are in Mount Laurel, NJ, and Reno, NV. Technical service, customer service, and sales representatives provide technical advice on designing and manufacturing components with KYDEX sheet products.

Visit www.kydex.com

About Microban International, Ltd.

Microban International, Ltd. is a global technology and marketing company dedicated to enhancing high quality consumer, industrial and medical products with branded built-in protection from microbes. Microban International licenses the Microban global brand name, sells custom-engineered compounds, and provides a range of services, including regulatory and marketing support. The Microban brand promises continuous and durable antimicrobial product protection, built-in during manufacture to not wear out for the useful life of the product. Microban International is headquartered in North Carolina with operations in North America, Europe, and Asia.

Visit www.microban.com

February 26, 2008 — /PRNewswire/ — BURLINGTON, MA — Hyaluron Contract Manufacturing (HCM), a leading provider of pharmaceutical development services, continued to expand its business in 2007 with revenues increasing greater than 75 percent and staffing increasing greater than 60 percent to support past and anticipated future growth. Additionally, HCM acquired additional space at its Burlington, MA facility to expand its analytical chemistry, microbiology, and engineering laboratories, as well as to provide additional manufacturing capacity.

“We are very proud of our recent growth,” Shawn Kinney, president of HCM states. “It’s a reflection of our ongoing commitment to continuous improvements and to providing high quality products and services to our customers.”

HCM has continued to strengthen its management team with the appointment of Susan McNamara to the newly created position of director of quality, Christopher Paolillo to the position of director of contract administration and legal affairs, and other key hires.

Susan McNamara has over seventeen years of experience in the biotechnology industry, bringing novel recombinant proteins into clinical and commercial production. Before joining HCM, McNamara was associate director, QC microbiology at Wyeth Biotech. Prior to that, McNamara was employed by Fisons Pharmaceuticals and SmithKline.

Christopher Paolillo has over twenty-seven years of experience as corporate counsel and as an attorney in private practice and with the office of Air Force Judge Advocate. He brings to HCM substantial experience in contracts, licensing, intellectual property, and commercial transactions. Prior to HCM, Paolillo was employed by ACI Worldwide (formerly P&H Solutions) as vice president and corporate counsel.

Located in Burlington, MA, HCM has been offering aseptic formulation and filling services to biotechnology and pharmaceutical companies. At the core of HCM’s business is a commitment to quality, regulatory compliance, and on-time delivery.

Visit www.hyaluron.com

February 26, 2008 — /FDA/ — FDA’s Office of Criminal Investigations announced that two Chinese nationals and the businesses they operate, along with a U.S. company and its president and chief executive officer, were indicted by a federal grand jury on Feb. 6, 2008. The indictments are for their roles in a scheme to import into the United States products they claimed were wheat gluten. The products were contaminated with melamine and used to make pet food.

A federal grand jury in Kansas City, MO returned a 26-count indictment against:

  • Xuzhou Anying Biologic Technology Development Co., LTD. (XAC), a Chinese firm that processes and exports plant proteins to the United States
  • Mao Linzhun, a Chinese national who is the owner and manager of XAC
  • Suzhou Textiles, Silk, Light Industrial Products, Arts and Crafts I/E Co. LTD. (SSC), a Chinese export broker that exports products from China to the United States
  • Chen Zhen Hao, president of SSC and a Chinese national

Also charged in a separate, but related, 27-count indictment were:

  • ChemNutra, Inc., a Las Vegas corporation that buys food and food components from China to sell to U.S. companies in the food industry
  • ChemNutra owner Sally Qing Miller
  • Chem Nutra owner Stephen S. Miller, husband of Sally Qing Miller

ChemNutra contracted with SSC to purchase food-grade wheat gluten, according to the indictment. SSC then entered into a separate contract with XAC to supply the wheat gluten it needed to fulfill its contract with ChemNutra.

Among the charges against all seven defendants are: delivering adulterated food that contained melamine into interstate commerce, and introduction of a misbranded food into interstate commerce.

The indictments allege that more than 800 tons of purported wheat gluten, valued at nearly $850,000, were imported into the United States between November 6, 2006, and February 21, 2007.

Melamine can be used to create products such as plastics, cleaning products, glues, inks, and fertilizers. Melamine has no approved use as an ingredient in human or animal food in the United States.

Wheat gluten is a natural protein derived from wheat or wheat flour, which is extracted to yield a powder with high protein content. Pet food manufacturers often use wheat gluten as a thickener or binding agent in the manufacture of certain types of pet food.

On March 15, 2007, a pet food manufacturer alerted FDA to the deaths of 14 cats and dogs. The animals were reported to have developed kidney failure after eating pet food that had been manufactured with the purported wheat gluten.

Visit www.fda.gov

February 26, 2008 — /GLEN ALLEN, VA/ — Materials for use in thin-film and organic photovoltaics will reach $3.8 billion by 2015, according to a new study by industry analyst firm NanoMarkets. According to the firm’s analysis, the thin-film and organic photovoltaic market is becoming a source of opportunity for both traditional electronic chemicals suppliers and innovative materials firms. In addition, innovations at the material level will have a profound impact on the future of PV as a whole.

Some of the main points in the report include:

  • Thin-film PV is no longer a niche consumer of electronic materials. By 2015, amorphous silicon PV will use more than $900 million in silane gas and other silicon-based materials. A few years ago, producers of crystalline silicon found that conventional photovoltaics was a major new business opportunity. Thin-film PV is bringing the same kind of opportunity to the leading suppliers of electronic chemicals
  • CIGS promises all the advantages of thin-film PV, but with conversion efficiencies almost as high as conventional PV. However, whether or not CIGS can keep this promise will depend on innovative materials firms. For example, the CIGS industry is looking for better formulations of selenium that avoid the volatility problems experienced in high temperature manufacturing processes. CIGS cell construction also makes the choice of materials for the top contacts highly demanding. NanoMarkets believes that such problems will be overcome in the next few years and that by 2015, the CIGS PV sector will consume a total of $1.1 billion in materials.
  • New materials are the key to PV. In the near future, thin-film materials will provide entirely new directions for PV. Silicon inks will soon be available that will combine the manufacturability advantages of organic PV, but with much higher conversion efficiencies. Slivers of crystalline silicon have been developed that combine the high efficiency of crystalline silicon with the flexibility and ease of fabrication of thin film; this technology is already being used in a pilot plant. Further off lies the commercialization of inorganic nanocrystals designed to overcome the one electron per solar photon limitation in solar energy conversion. CdSe, CdS, and CdTe nanocrystals have all been employed in this way in the lab and hint at a thin-film PV of the future with energy conversion ratios well into the double digits.

    About the report

    NanoMarkets’ new report, “Materials Markets for Thin-Film and Organic Photovoltaics,” provides a complete analysis of the commercial opportunities in thin film and organic PV materials markets. The report includes detailed eight-year forecasts of thin-film and organic materials broken out by material functionality and chemistry, as well as reviews of the latest research and the corporate strategies of firms active in the sector. Photovoltaic technologies covered include amorphous silicon, cadmium telluride, CIGS, dye cells, and pure organic approaches. Key firms mentioned in the report are: Air Liquide, BASF, Dow Corning, Evonik, Indium, Konarka, Linde, Nanosolar, Mitsui Toatsu Chemicals, Nanoco, Plextronics, Praxair, REC, Redlen, Sanyo, Sputtering Materials, Sulfurcell, Umicore, and Voltaix.

    About NanoMarkets

    NanoMarkets analyzes emerging market opportunities in electronics created by developments in advanced materials. The firm has published numerous reports related to organic, thin film, and printable electronics materials and applications. The firm also publishes a blog found at www.nanotopblog.com. NanoMarkets research database is the industry’s most extensive source of information on top electronics.

    Visit www.nanomarkets.net