09.05.12
Saint-Gobain to Phase Out Use of DEHP
Saint-Gobain Performance Plastics (SGPPL) Healthcare Markets has announced it will discontinue manufacturing of medical grade tubing containing DEHP in June 2013. While the company’s current products comply with global regulatory standards when used as directed, it is taking a proactive approach by offering replacement products that are non-DEHP.
The abbreviation DEHP is a simpler nomenclature for the organic compound bis(2-thylhexyl)phthalate, commonly used as a plasticizer for manufacturing items made out of polyvinyl chloride (PVC) plastics. In medical device manufacturing, it often is used as a plasticizer for products such as intravenous tubing and bags, catheters, nasogastric tubes, dialysis bags and tubing, blood bags and transfusion tubing, and air tubes.
The U.S. Food and Drug Administration released data in 2002 warning that elevated exposure to DEHP could cause a variety of health concerns, the most egregious of which are “effects on the development of the male reproductive system and production of normal sperm in young animals.” In 2008, the director of the Center for Reproductive Epidemiology at the University of Rochester in New York, Shanna H. Swan, published a study that suggested the same: Prenatal exposure to phthalates such as DEHP potentially could lead to smaller penis size and incomplete descent of testicles in baby boys.
“We are committed to staying one step ahead of evolving regulations in the healthcare industry,” said Aaron Updegrove, marketing manager at SGPPL’s Healthcare Markets business. “This is an integral part of our medical strategy that aligns with a corporate wide initiative to remove DEHP from all of our products. Over the next 12 months, we’ll be working closely with our customers to coordinate a smooth transition to a non-DEHP plasticized solution, ensuring compliance well in advance of a REACh deadline.”
More than 18 months ago, SGPPL introduced its Tygon ND product family, which provides a variety of tubing solutions that utilize a non-DEHP plasticizer. Suited for applications that require contact with bodily fluids such as minimally invasive devices and drug-delivery technologies, Tygon ND solutions are formulated to meet REACh standards (European Union guidelines on hazardous chemicals) and are available in a range of durometers and plasticizers to meet customer and application requirements.
SGPPL also manufactures Tygon S-22-216 and S-97-E—clear, non-DEHP polymer tubing solutions that, according to the company, offer superior peristaltic pump life, exceptional flexibility, and extremely low levels of extractables. Both products are designed for critical applications where fluid administration is of primary importance, such as in dialysis equipment and catheters. Tygon S-97-E also can be used for extracorporeal membrane oxygenation pumps.
Following the discontinuation of DEHP manufacture next year, Saint-Gobain will continue the sale of its remaining inventory of medical grade tubing containing DEHP until December 2013. Once inventory is exhausted, no other products containing DEHP will be sold.
Baxter Breaks Ground on Manufacturing Facility
Baxter International Inc. has broken ground in Stanton Springs, Ga., (a new community about 40 miles from Atlanta) for its new manufacturing facility. Georgia Gov. Nathan Deal deemed Aug. 1 “a glorious day for the state of Georgia.”
“Georgia supports Baxter’s mission to save lives, and this occasion is one of many milestones we look forward to celebrating with the company as it establishes a presence in Georgia,” said Deal. “Baxter’s decision to build a facility here is a watershed event for the state, not only in our goal to establish Georgia as a hub for global health, but in our mission to provide high-quality jobs for our citizens.”
In April, Baxter announced its plans to build a facility in Georgia that will manufacture plasma-based therapies that treat chronic and life-threatening illnesses. The Stanton Springs site also will house warehouse and plasma testing laboratory facilities. Construction is expected to begin in the first quarter of 2013, and completion of construction of the first manufacturing buildings is planned for 2015.
Additional construction will continue into 2016 and the plant is anticipated to begin commercial production in 2018. In addition to the manufacturing facility, Baxter will locate plasma collection centers in a number of communities around the state.
In addition, Stanton Springs also will be home to a biotech training center that will provide a workforce pipeline for Baxter and other members of the state’s biosciences industry. The training center will be owned by the state and operated by Georgia Quick Start, a customized workforce training program.
“In a few years,” said Baxter CEO Robert L. Parkinson, Jr., “Baxter team members working in facilities located on the ground where we are standing today to produce lifesaving biologic treatments for patients around the world.”
Georgia’s life-sciences industry and university research, plus the U.S. Centers for Disease Control and Prevention (located in Atlanta), have a $23 billion annual economic impact on the state and employ more than 105,000 people, according to statistics from the 2011 “Shaping Infinity” report, released by Georgia BIO. The bioscience industry in Georgia created $19.5 billion in output and contributed $7.5 billion to the state’s gross domestic product as well as $496 million in tax revenues for state and local governments.
Baxter International develops, manufactures and markets products for patients with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. The company is headquartered in Deerfield, Ill.
Helix Medical to Invest in Cambus Medical
Helix Medical LLC is acquiring a 50 percent share in Cambus Medical as of January 2013. Helix also will provide expansion financing this year to the manufacturer of high precision hypotubes and micro-component solutions.
Hypotubes (hypodermic tubes) are a critical component of catheter systems for diagnostic and therapeutic interventions. Cambus operates a manufacturing site in Spiddal, near Galway, Ireland. The company’s manufacturing capabilities include injection molding, electrical discharge machining and electrochemical machining, laser precision cutting, laser welding and marking, assembly and packaging.
Helix Medical also holds a 50 percent share in VistaMed Ltd., a Carrick-on-Shannon, Ireland-based designer and manufacturer of specialty catheter systems and extruded medical tubing. VistaMed’s Chairman, John O’Shaughnessy, also serves as chairman of Cambus Medical. The partnership with Cambus expands Helix’s offering to include a full range of components and design and manufacturing services for minimally invasive surgery devices.
“Cambus adds another key technology component to our portfolio and represents an important milestone in our long-term strategy to build a comprehensive global organization that serves as a strategic partner to medical device manufacturers,” said Jorg Schneewind, Ph.D., president and CEO of Helix Medical.
“Cambus Medical is positioned to serve the market for high precision catheter components and complements the catheter business of our partner VistaMed,” said Max Kley, Ph.D., president of Helix Medical Europe.
“Helix Medical’s global presence combined with our complementary engineering and manufacturing capabilities,” added Barry Comerford, managing director of Cambus Medical, “offers an ideal platform for the expansion of Cambus Medical’s service and product portfolio to customers worldwide.”
Founded in 2006, Cambus Medical is an ISO 13485 registered medical technology company.
Helix Medical’s medical manufacturing capabilities include design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services. The company operates U.S. Food and Drug Administration-registered medical device facilities, certified ISO 13485 with Class 7 and 8 clean rooms. Helix was founded in 1984 and is based in Baldwin Park, Calif.
Sirtex Medical to Expand in the United States
Sirtex Medical Inc., a subsidiary of Sirtex Medical Ltd., is expanding operations in the United States in response to an increased demand for SIR-Spheres Microspheres, the only microsphere radiation therapy for the treatment of colorectal liver metastases approved by the U.S. Food and Drug Administration. The company will place additional sales, marketing and functional support staff in Massachusetts and across the country. The microspheres currently are produced at the company’s facility in Wilmington, Mass.
Sirtex’s expansion is part of the company’s global growth plan that began in the United States in July 2010, with additions in July 2011, and the latest occurring this year.
“Sirtex continues to reach new milestones related to the number of U.S. dose sales, and we look forward to continuing to expand the business and build awareness for SIR-Spheres microspheres so more patients have access to this cancer treatment,” said Michael Mangano, president of Sirtex Medical Inc. “This latest expansion will allow us to accommodate current and future growth by addressing the increased demand for SIR-Spheres microspheres in treatment centers across the country and effectively reaching more patients diagnosed with colorectal liver tumors.”
Selective internal radiation therapy (SIRT), also known as radioembolization, is a proven technology for inoperable liver cancer that delivers doses of radiation directly to the site of tumors. In a minimally invasive treatment, millions of radioactive SIR-Spheres microspheres are infused through a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.
Clinical studies have confirmed that patients with metastatic colorectal cancer treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.
Sirtex Medical Inc. is a manufacturer of targeted, innovative liver cancer therapies, and is headquartered in Woburn, Mass.
Joining Technologies Commits to Achieving Medical Device ISO This Year
Joining Technologies Inc. is on schedule to be certified to the ISO 13485 standard for the manufacture of medical devices this year. The welding services firm already is certified to quality management standards under the National Aerospace and Defense Contractors Accreditation program and AS9100, Joining Technologies hopes the decision to obtain the ISO 13485 demonstrates its commitment to processing parts to the same rigorous standards as its major medical device customers, officials noted.
Achieving the new standard is expected to strengthen Joining Technologies’ relationship with current customers, expand its growing medical customer base, and further enhance its capabilities with Tier 1 suppliers.
To guide the certification process, Joining Technologies has contracted with Connstep, a non-profit business consulting organization that specializes in assisting manufacturing firms implementing ISO quality management systems. Connstep will help with the internal quality auditing, prepare the company for the registration audit, and train internal quality auditors. The formal audit with the ISO registrar is expected to occur this fall.
Headquartered in East Granby, Conn., Joining Technologies provides precision fusion processes, including laser and electron beam welding, laser additive manufacturing, and weld system design and integration.
Saint-Gobain Performance Plastics (SGPPL) Healthcare Markets has announced it will discontinue manufacturing of medical grade tubing containing DEHP in June 2013. While the company’s current products comply with global regulatory standards when used as directed, it is taking a proactive approach by offering replacement products that are non-DEHP.
The abbreviation DEHP is a simpler nomenclature for the organic compound bis(2-thylhexyl)phthalate, commonly used as a plasticizer for manufacturing items made out of polyvinyl chloride (PVC) plastics. In medical device manufacturing, it often is used as a plasticizer for products such as intravenous tubing and bags, catheters, nasogastric tubes, dialysis bags and tubing, blood bags and transfusion tubing, and air tubes.
The U.S. Food and Drug Administration released data in 2002 warning that elevated exposure to DEHP could cause a variety of health concerns, the most egregious of which are “effects on the development of the male reproductive system and production of normal sperm in young animals.” In 2008, the director of the Center for Reproductive Epidemiology at the University of Rochester in New York, Shanna H. Swan, published a study that suggested the same: Prenatal exposure to phthalates such as DEHP potentially could lead to smaller penis size and incomplete descent of testicles in baby boys.
“We are committed to staying one step ahead of evolving regulations in the healthcare industry,” said Aaron Updegrove, marketing manager at SGPPL’s Healthcare Markets business. “This is an integral part of our medical strategy that aligns with a corporate wide initiative to remove DEHP from all of our products. Over the next 12 months, we’ll be working closely with our customers to coordinate a smooth transition to a non-DEHP plasticized solution, ensuring compliance well in advance of a REACh deadline.”
More than 18 months ago, SGPPL introduced its Tygon ND product family, which provides a variety of tubing solutions that utilize a non-DEHP plasticizer. Suited for applications that require contact with bodily fluids such as minimally invasive devices and drug-delivery technologies, Tygon ND solutions are formulated to meet REACh standards (European Union guidelines on hazardous chemicals) and are available in a range of durometers and plasticizers to meet customer and application requirements.
SGPPL also manufactures Tygon S-22-216 and S-97-E—clear, non-DEHP polymer tubing solutions that, according to the company, offer superior peristaltic pump life, exceptional flexibility, and extremely low levels of extractables. Both products are designed for critical applications where fluid administration is of primary importance, such as in dialysis equipment and catheters. Tygon S-97-E also can be used for extracorporeal membrane oxygenation pumps.
Following the discontinuation of DEHP manufacture next year, Saint-Gobain will continue the sale of its remaining inventory of medical grade tubing containing DEHP until December 2013. Once inventory is exhausted, no other products containing DEHP will be sold.
Baxter Breaks Ground on Manufacturing Facility
Baxter International Inc. has broken ground in Stanton Springs, Ga., (a new community about 40 miles from Atlanta) for its new manufacturing facility. Georgia Gov. Nathan Deal deemed Aug. 1 “a glorious day for the state of Georgia.”
“Georgia supports Baxter’s mission to save lives, and this occasion is one of many milestones we look forward to celebrating with the company as it establishes a presence in Georgia,” said Deal. “Baxter’s decision to build a facility here is a watershed event for the state, not only in our goal to establish Georgia as a hub for global health, but in our mission to provide high-quality jobs for our citizens.”
In April, Baxter announced its plans to build a facility in Georgia that will manufacture plasma-based therapies that treat chronic and life-threatening illnesses. The Stanton Springs site also will house warehouse and plasma testing laboratory facilities. Construction is expected to begin in the first quarter of 2013, and completion of construction of the first manufacturing buildings is planned for 2015.
Additional construction will continue into 2016 and the plant is anticipated to begin commercial production in 2018. In addition to the manufacturing facility, Baxter will locate plasma collection centers in a number of communities around the state.
In addition, Stanton Springs also will be home to a biotech training center that will provide a workforce pipeline for Baxter and other members of the state’s biosciences industry. The training center will be owned by the state and operated by Georgia Quick Start, a customized workforce training program.
“In a few years,” said Baxter CEO Robert L. Parkinson, Jr., “Baxter team members working in facilities located on the ground where we are standing today to produce lifesaving biologic treatments for patients around the world.”
Georgia’s life-sciences industry and university research, plus the U.S. Centers for Disease Control and Prevention (located in Atlanta), have a $23 billion annual economic impact on the state and employ more than 105,000 people, according to statistics from the 2011 “Shaping Infinity” report, released by Georgia BIO. The bioscience industry in Georgia created $19.5 billion in output and contributed $7.5 billion to the state’s gross domestic product as well as $496 million in tax revenues for state and local governments.
Baxter International develops, manufactures and markets products for patients with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. The company is headquartered in Deerfield, Ill.
Helix Medical to Invest in Cambus Medical
Helix Medical LLC is acquiring a 50 percent share in Cambus Medical as of January 2013. Helix also will provide expansion financing this year to the manufacturer of high precision hypotubes and micro-component solutions.
Hypotubes (hypodermic tubes) are a critical component of catheter systems for diagnostic and therapeutic interventions. Cambus operates a manufacturing site in Spiddal, near Galway, Ireland. The company’s manufacturing capabilities include injection molding, electrical discharge machining and electrochemical machining, laser precision cutting, laser welding and marking, assembly and packaging.
Helix Medical also holds a 50 percent share in VistaMed Ltd., a Carrick-on-Shannon, Ireland-based designer and manufacturer of specialty catheter systems and extruded medical tubing. VistaMed’s Chairman, John O’Shaughnessy, also serves as chairman of Cambus Medical. The partnership with Cambus expands Helix’s offering to include a full range of components and design and manufacturing services for minimally invasive surgery devices.
“Cambus adds another key technology component to our portfolio and represents an important milestone in our long-term strategy to build a comprehensive global organization that serves as a strategic partner to medical device manufacturers,” said Jorg Schneewind, Ph.D., president and CEO of Helix Medical.
“Cambus Medical is positioned to serve the market for high precision catheter components and complements the catheter business of our partner VistaMed,” said Max Kley, Ph.D., president of Helix Medical Europe.
“Helix Medical’s global presence combined with our complementary engineering and manufacturing capabilities,” added Barry Comerford, managing director of Cambus Medical, “offers an ideal platform for the expansion of Cambus Medical’s service and product portfolio to customers worldwide.”
Founded in 2006, Cambus Medical is an ISO 13485 registered medical technology company.
Helix Medical’s medical manufacturing capabilities include design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services. The company operates U.S. Food and Drug Administration-registered medical device facilities, certified ISO 13485 with Class 7 and 8 clean rooms. Helix was founded in 1984 and is based in Baldwin Park, Calif.
Sirtex Medical to Expand in the United States
Sirtex Medical Inc., a subsidiary of Sirtex Medical Ltd., is expanding operations in the United States in response to an increased demand for SIR-Spheres Microspheres, the only microsphere radiation therapy for the treatment of colorectal liver metastases approved by the U.S. Food and Drug Administration. The company will place additional sales, marketing and functional support staff in Massachusetts and across the country. The microspheres currently are produced at the company’s facility in Wilmington, Mass.
Sirtex’s expansion is part of the company’s global growth plan that began in the United States in July 2010, with additions in July 2011, and the latest occurring this year.
“Sirtex continues to reach new milestones related to the number of U.S. dose sales, and we look forward to continuing to expand the business and build awareness for SIR-Spheres microspheres so more patients have access to this cancer treatment,” said Michael Mangano, president of Sirtex Medical Inc. “This latest expansion will allow us to accommodate current and future growth by addressing the increased demand for SIR-Spheres microspheres in treatment centers across the country and effectively reaching more patients diagnosed with colorectal liver tumors.”
Selective internal radiation therapy (SIRT), also known as radioembolization, is a proven technology for inoperable liver cancer that delivers doses of radiation directly to the site of tumors. In a minimally invasive treatment, millions of radioactive SIR-Spheres microspheres are infused through a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.
Clinical studies have confirmed that patients with metastatic colorectal cancer treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.
Sirtex Medical Inc. is a manufacturer of targeted, innovative liver cancer therapies, and is headquartered in Woburn, Mass.
Joining Technologies Commits to Achieving Medical Device ISO This Year
Joining Technologies Inc. is on schedule to be certified to the ISO 13485 standard for the manufacture of medical devices this year. The welding services firm already is certified to quality management standards under the National Aerospace and Defense Contractors Accreditation program and AS9100, Joining Technologies hopes the decision to obtain the ISO 13485 demonstrates its commitment to processing parts to the same rigorous standards as its major medical device customers, officials noted.
Achieving the new standard is expected to strengthen Joining Technologies’ relationship with current customers, expand its growing medical customer base, and further enhance its capabilities with Tier 1 suppliers.
To guide the certification process, Joining Technologies has contracted with Connstep, a non-profit business consulting organization that specializes in assisting manufacturing firms implementing ISO quality management systems. Connstep will help with the internal quality auditing, prepare the company for the registration audit, and train internal quality auditors. The formal audit with the ISO registrar is expected to occur this fall.
Headquartered in East Granby, Conn., Joining Technologies provides precision fusion processes, including laser and electron beam welding, laser additive manufacturing, and weld system design and integration.