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Solvay Achieves ISO Certification for Solviva® Biomaterials
Solvay achieves ISO 13485:2003 certification for the quality system that governs the production of its Solviva® Biomaterials offered for use in implantable medical devices.
Solvay Advanced Polymers, LLC, announced today that it has achieved ISO 13485:2003 certification for the quality system that governs the production of its Solviva Biomaterials offered for use in implantable medical devices. The international quality standard facilitates harmonized medical device regulatory requirements for quality management systems applicable to medical devices and related services.
ISO 13485:2003 is a quality standard that specifies certain quality system requirements to ensure consistent manufacturing, according to Judy Melville, business manager, Solviva products. “This achievement demonstrates our commitment to the medical device industry,” said Melville. “It also reaffirms our position as a reliable supplier that is solidly focused on meeting the quality standards of our customers.” Melville noted that a key element of the ISO quality standard is the use of validation methods to ensure consistent high-quality manufacturing. Solvay Advanced Polymers produces its unique line of biomaterials – featuring exceptional strength, stiffness, and biocompatibility – at a dedicated manufacturing facility in Alpharetta, Ga.
The entire line of Solviva Biomaterials is manufactured in compliance with ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. The company’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in a lab accredited to the ISO 17025:2005 standard.
The Solviva Biomaterials line includes Zeniva® polyetheretherketone (PEEK), one of the most biostable plastics available with high strength and stiffness plus excellent toughness and fatigue resistance; Proniva® self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastics that offers exceptional biocompatibility and hardness; Veriva® polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva® polysulfone (PSU), which offers practical toughness in a strong, transparent polymer.
Solviva Biomaterials can be sterilized via all conventional methods including gamma radiation, ethylene oxide, and steam. These products are available in resin for injection molding or extrusion, as well as stock shapes for machined components. Solvay Advanced Polymers is currently in active product trials with several medical device manufacturers using the broad range of Solviva biomaterials.
Solvay’s experience as a key materials supplier in the healthcare field spans more than 20 years. The company has been a leading manufacturer of high-performance plastics, offering its traditional range of materials for medical devices. More recently, Solvay has successfully introduced its line of Solviva Biomaterials for a range of implantable devices. The company is a full-service supplier, providing design, technical service, and application development support for the global healthcare market.
Source: http://www.solvayplastics.com
BASF starts operations at expanded Ecoflex plant
BASF has started operations at its expanded plant for the production of the biodegradable plastic Ecoflex®. Expansion of the existing plant in Ludwigshafen will increase production capacity for Ecoflex from 14,000 to 74,000 metric tons per year. At the same time, BASF will ramp up compounding capacity for Ecovio®, a derivative of Ecoflex.
“We are already successful in the market with our biodegradable polyester Ecoflex and the related innovation, Ecovio. The larger production capacities will enhance our position significantly,” said Dr. Wolfgang Hapke, president of BASF’s Performance Polymers division. “The capacity expansion will also enable us to respond even more effectively to our customers’ wishes.”
Ecoflex is a plastic that has the properties of conventional polyethylene but is fully biodegradable under industrial composting conditions in accordance with DIN EN 13432. Ecovio is a derivative of Ecoflex that is also biodegradable and that contains up to 75 percent renewable raw materials. Typical applications are shopping bags, organic waste bags, mulch films for agricultural applications, and food packaging. One of the latest innovations is Ecovio FS Paper, which is used to provide a biodegradable waterproof coating on the interior surfaces of paper cups and cardboard containers.
With Ecovio and Ecoflex, BASF is already one of the world’s leading suppliers of biobased and biodegradable plastics. Both of these properties are increasingly in demand, and the market for biodegradable and biobased plastics is currently growing by more than 20 percent per year.
About BASF
BASF is the world’s leading chemical company: The Chemical Company. Its portfolio ranges from chemicals, plastics and performance products to agricultural products, fine chemicals as well as oil and gas. As a reliable partner BASF creates chemistry to help its customers in virtually all industries to be more successful. With its high-value products and intelligent solutions, BASF plays an important role in finding answers to global challenges such as climate protection, energy efficiency, nutrition and mobility. BASF posted sales of more than €50 billion in 2009 and had approximately 105,000 employees as of the end of the year. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (AN).
BASF Plant Science set to cultivate Amflora potatoes in Germany and Sweden in 2011
BASF Plant Science has concluded its Amflora cultivation plans for the 2011 season. Amflora, the genetically enhanced potato for use in the starch industry, will this year be cultivated on two hectares of land in Üplingen (Saxony-Anhalt, Germany).
" There are many good reasons for the use of Amflora in Germany, which after all is renowned for growing starch potatoes. Separating the starch components in conventional potatoes for industrial use is not cost-effective or environmentally sound. Amflora is an innovative new variety which produces pure amylopectin starch. It therefore helps to cut down on resources, energy and costs and offers farmers and the starch processing industry real added value," says Peter Eckes, Managing Director of BASF Plant Science.
In addition to Germany, BASF Plant Science will again be planting out Amflora in Sweden during the 2011 season. After receiving approval from the authorities for the majority of the Amflora seed stock, BASF Plant Science will this year be concentrating on propagating seed stock for cultivation in subsequent years. BASF is performing very strict internal quality checks for this purpose and is only using the best quality seed stock.
About Amflora
Amflora is a genetically modified potato variety which produces pure amylopectin starch. Conventional potatoes produce a mixture of amylopectin and amylose starch. In many potato starch applications, for example in the paper, adhesive and food industries, only amylopectin is needed, but separating the two starch components is uneconomical. Amflora produces pure amylopectin starch and thus helps to save resources, energy and costs. Moreover, paper manufactured with amylopectin starch has greater tear resistance, and the addition of amylopectin to concrete and adhesives gives them a longer pot life. In the case of Amflora, BASF Plant Science and its partners in the starch industry decided to focus on industrial applications.
About BASF Plant Science
BASF is the world’s leading chemical company: The Chemical Company. Its portfolio ranges from chemicals, plastics and performance products to agricultural products, fine chemicals as well as oil and gas. BASF Plant Science – a BASF group company – is one of the world’s leading companies providing innovative plant biotechnology solutions for agriculture. Today, about 700 employees are helping farmers meet the growing demand for improved agricultural productivity and healthier nutrition for humans and animals. BASF Plant Science has developed an unparalleled gene discovery platform focusing on yield and quality traits in crops such as corn, soybean and rice. Jointly with leading partners in the seed industry BASF Plant Science is commercializing its products. Current projects include higher yielding row crops, nutritionally-enhanced corn for animal feed or higher content of Omega-3’s in oil crops for preventing cardiovascular diseases. To find out more about BASF Plant Science, please visit www.basf.com/plantscience.
CARDIA SETS UP SUBSIDARY TO COMMERCIALISE NOVEL CO2 STARCH TECHNOLOGY
Cardia Bioplastics is pleased to announce that is has established a 100% subsidiary “CO2STARCH Pty Ltd”. This vehicle will be used to commercialise the company’s patented novel CO?polymer-starch blending technology.
CO2STARCH Pty Ltd will hold all the intellectual property and patents and will serve as the platform for the development and commercialization of a family of CO2based polymers.
Cardia launched the world's first CO2+Starch biodegradable carrier bag (made using CO2 emissions) in October 2010 and has since received interest in the technology from several major international organizations including petrochemical companies. The breakthrough technology allows PPC (polypropylene carbonate) to be blended
with starch.
In simple terms, CO2 emissions are captured and used as a substitute for oil and then further blended with starch as an additional substitute for oil to create a renewable and sustainable bioplastics that rely less on fossil fuels.