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Press release news from the public relations clients of Tiziani Whitmyre, Inc.

Posts Tagged ‘pharmaceutical’


Tuesday, March 11th, 2014

Webinar Exploring “What’s the Risk? Fearing the Failure in Environmental Monitoring Systems” is Offered for Life Science Companies

AGAWAM, MASS. — March 11, 2014 — A webinar to help life science companies explore the importance of a well-implemented and understood environmental monitoring program, and its ability to generate valuable data, will be offered on Wednesday, March 26, from 1:30 p.m. to 3:30 p.m. EST. The online event will identify the common mistakes and misconceptions regularly encountered when managers “fear the failure” of environmental excursions.

Environmental monitoring systems demonstrate that a company’s various contamination control strategies are operating properly. Such systems can illustrate whether operations are in a state of control. Variations in the data can indicate a drift which could potentially impact product and patient safety.

But the data generated by environmental monitoring system may become skewed when a culture is created which fears environmental failures or excursions. The webinar, What’s the Risk? Fearing the Failure in Environmental Monitoring Systems,” will detail how key life science company management can work to avoid such cultures.

Webinar topics — tailored for quality assurance and control, manufacturing, microbiology, and facilities management in pharmaceutical, biotech, and medical device organizations — will include:

  • The big picture: what systems need to be monitored and why the data is valuable
  • Risk-based environmental monitoring program implementation
  • Culture and “buy-in:” how to create a culture of employee acceptance for contamination control programs
  • Responding to data: how to identify trends in the data and respond with appropriate actions

The webinar will be offered Wednesday, March 26, 1:30 p.m. to 3:30 p.m. EST. Featured speakers include Valerie Montgomery, environmental services manager, and Alison Zulick, environmental services leader, both of Microtest Laboratories, a leading provider of testing services and contract manufacturing for the life science industries.

To register or for more information about the webinar, What’s the Risk? Fearing the Failure in Environmental Monitoring Systems,” visit http://www.microrite.com/training/environmental-monitoring-systems-fearing-the-failure.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and compounding pharmacy industries. Based in Agawam, Massachusetts, USA, Microtest leverages its 30 years industry experience to help its clients meet their regulatory requirements.  For more information, visit http://www.microtestlabs.com or toll-free 1-800-631-1680.

 

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Press contact: Don Goncalves, 1-781-793-9380, dgoncalves@tizinc.com


Tuesday, September 10th, 2013

New FDA Regulations Streamlining the Governance of Combination Products are Detailed in New White Paper

AGAWAM, MASS. — September 10, 2013 — New Federal Food & Drug Administration (FDA) regulations have streamlined the governance of combination products — medical devices embedded with pharmaceutical or biologic components. A new white paper titled “Combination Products 3.0: Applying the New FDA Regulations in 2013” discusses the implications for manufacturers. The whitepaper is available to download at http://microtestlabs.com/combination-products-30.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new FDA product submissions.

“Over the last 10 years, FDA regulatory centers have struggled with the changes and challenges that these new technologies present. For manufacturers, the convergence of drugs, biologics, and devices has created both a host of regulatory issues — and many exciting opportunities,” according to Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., and author of the new white paper.

The new FDA publication, “21 CFR Part 4 — Current Good Manufacturing Practice Requirements for Combination Products,” revises regulations by establishing different categories of products. These included single-entity products (such as a drug-eluting stent) and co-packaged products (such as a packaged syringe and pharmaceutical). The rules also distinguished between a drug with a device, a biologic with a device, and a device with an HCT/P.

 

The new white paper discusses, in detail and example, how the new FDA rules guide a manufacturer into one of two approaches, depending upon the characteristics of their product.

 

According to Dr. Richter, “the FDA’s new streamlined approach for regulating combination products is a big step forward for the practitioner. It applies parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part 4 closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety.”

Download the new white paper, “Combination Products 3.0: Applying the New FDA Regulations in 2013,” from http://microtestlabs.com/combination-products-30. The white paper is presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Based in Agawam, Mass., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information about Microtest Laboratories, visit microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.


Wednesday, May 30th, 2012

Clean Room Environmental Best Practices for Medical Device & Pharmaceutical Manufacturers are Focus of Boston Seminar on June 6

AGAWAM, MASS. – May 30, 2012 – Sterile manufacturing environments at medical device and pharmaceutical companies require effective cleaning and disinfection programs to maintain aseptic conditions and prevent microbial contamination. To help, laboratory testing experts will present “Clean Room Environmental Best Practices,” a special seminar in Boston on Wednesday, June 6, 2012.

The seminar is designed for all professionals responsible for building, validating, and maintaining controlled environments in the medical device and pharmaceutical industries. The program will include technical presentations on:

• Best practices for qualifying and maintaining clean room facilities

• “The people factor” in terms of containment control

• Qualifying and evaluating clean room disinfectants

• Difficult challenges: Practical advice and solutions

Opportunities for questions and continuing interaction will be encouraged.

Clean Room Environmental Best Practices” is scheduled for 10 a.m. to 2 p.m. on Wednesday, June 6, 2012, at the MIT Endicott House, 80 Haven Street, Dedham, Massachusetts — located just minutes from Boston. The cost is $149. Breakfast, lunch, and networking opportunities are included.

The seminar is sponsored by Microtest Laboratories, a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest’s environmental sciences group helps its clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

For more information, contact Julie Adamski, toll-free, at 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.


Wednesday, May 11th, 2011

“Five Critical Factors for Selecting Fieldbus Valve Manifolds” — New White Paper from Numatics, Inc.

FLORHAM PARK, N.J. — May 10, 2011 — Fieldbus valve manifolds are replacing conventional hardwired solutions on a variety of highly automated machines in a wide variety of applications and industries. A new white paper, “Five Critical Factors For Selecting Fieldbus Valve Manifolds,” from Numatics, Inc., guides original equipment manufacturers (OEMs) and end users in the selection of the best solutions for their given applications.
The paper is available for download from http://www.numatics.com.
“Fieldbus valve manifolds find wide utility in packaging, automotive/tire, and material handling applications, as well as in the pharmaceutical, chemical, water, and wastewater industries,” said white paper author Enrico De Carolis, director of technology development at Numatics, Inc.
In the white paper, De Carolis presents the five crucial factors that controls engineers, specifiers, and buyers must consider before selecting pneumatic fieldbus valve manifolds — commissioning, distribution, modularity, diagnostics, and recovery — while outlining the shortcomings of conventional approaches.
In addition, De Carolis also discusses new designs that offer substantial improvements in the application, performance, and maintenance of these valve manifolds from the end users’ and OEMs’ points of view.
“Fieldbus valve manifolds more easily perform vital functions by integrating communication interfaces to pneumatic valve manifolds with input/output (I/O) capabilities. This allows programmable logic controllers (PLCs) to more efficiently turn valves on and off and to channel I/O data from sensors, lights, relays, individual valves, or other I/O devices via various industrial networks. The resulting integrated control packages can also be optimized to allow diagnostic benefits not previously available,” he said.
Follow Numatics, Inc. on Twitter at http://twitter.com/asconumatics and on Facebook at http://ht.ly/4jGNg.
Emerson Industrial Automation
Emerson Industrial Automation, a business of Emerson, delivers manufacturing solutions designed with leading technologies — including mechanical, electrical and ultrasonic — to provide the most advanced industrial automation possible for numerous and diverse industries worldwide. The company’s wide range of products and systems used in manufacturing processes and other equipment includes motion control systems, plastics joining, precision cleaning, materials-testing equipment, fluid control valves, alternators, motors, and mechanical power transmission drives and bearings. For information, visit www.emersonindustrialautomation.com.

About Emerson
Emerson (NYSE: EMR), based in St. Louis, Missouri (USA), is a global leader in bringing technology and engineering together to provide innovative solutions for customers in industrial, commercial, and consumer markets through its network power, process management, industrial automation, climate technologies, and tools and storage businesses. Sales in fiscal 2010 were $21 billion. For more information, visit www.Emerson.com.

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Press Contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com

Tuesday, July 13th, 2010

New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products

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AGAWAM, MASS. – July 13, 2010 – A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/).wpcover1

Combination products are a large and growing segment of the medical device market, with some analysts estimating they represent over 30% of all new product submissions to the FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of new challenges for testing, sterilization, and contamination avoidance.

Over the past 12 months, the FDA has addressed the dichotomy of dual quality systems by developing streamlined regulations for Good Manufacturing Compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010.

Once promulgated, manufacturers will be held accountable for compliance and the FDA will use it as a legal document for enforcement. In the new white paper titled, “Combination Products 2.0: Applying the New FDA Regulations,” Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., addresses the implications for manufacturers. (Download from: http://www.microtestlabs.com/combination-products-20/). In the white paper, Dr. Richter discusses:

  • The New Regulations
  • Determining Principal Mode of Action — Device or Drug?
  • Stem Cells & Human Tissue in Combination Products
  • The Implications for Testing and Validation
  • An Example: Drug-Eluting Stents

“The new FDA regulations governing combination products are a major step forward for the industry. They apply to parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part IV closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety. The ability of manufacturers to understand, establish, implement reliable testing procedures will be critical in complying with these new requirements,” Dr. Richter said.

Download a free copy of “Combination Products 2.0: Applying the New FDA Regulations” from http://www.microtestlabs.com/combination-products-20/.

Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact, Boston:  Don Goncalves, dgoncalves@tizinc.com, 781-793-9380, for Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations


Thursday, March 18th, 2010

New ASCO Low-Power Solenoid Valves Feature .55 watt Power Consumption, High Reliability

asco-num-01

FLORHAM PARK, NEW JERSEY, USA, March 18, 2010ASCO Numatics, the world’s leading manufacturer of comprehensive fluid automation, flow control, and pneumatics solutions, has introduced an ASCO low-power solenoid valve series that offers .55 watt power consumption while providing highly reliable operating performance.

The new valve is ideal for process applications in the refining, upstream oil and gas, chemical, pharmaceutical, food and beverage, and power generation industries.

“ASCO’s new low-power valve is an attractive choice for project and application engineers designing processing systems in remote locations or who want to install more devices on their bus networks,” said Robert W. Kemple, Jr., Executive Vice President, Sales and Marketing – Americas, ASCO Numatics. “No other solenoid valve on the market delivers higher performance per watt.”

The new solenoid valve is an optimal solution for applications powered by renewable energy sources such as solar panels. Its low-power consumption permits the use of smaller battery packs and enables extended operation on the existing back-up energy source.

The low-power valve is designed to be wired directly into a plant’s bus network I/O interface without the need for auxiliary power source. This means more discrete devices can be installed on a network segment. In addition, on PLC or DCS installation using traditional wiring the need for an additional relay is eliminated, plus a smaller power supply can be used – reducing the installation and operating costs.

The highly flexible valve comes in multiple options for flow efficiency and maximum and minimum temperature and pressure ratings. It has ATEX, FM, CSA, and UL approvals and is SIL-3 certified.

“Our new valve combines ASCO’s renowned reliability and availability with the industry’s lowest power consumption levels to offer an exceptional flow control solution that can accommodate virtually any low-power application,” said Kemple.

ASCO low-power solenoid valves can be purchased from ASCO distributors or directly from the company. Many of the valve’s configurations are available through the ASCO Today or ASCO 5-day shipping programs.

For more information, contact ASCO at 800-972-ASCO, by e-mail at info-valve@asco.com, or visit www.ascovalve.com/lowpower.

About ASCO Numatics
ASCO Numatics, a division of Emerson, offers comprehensive fluid automation solutions, including flow control and pneumatics products, for a wide range of industry-focused applications. The ASCO Numatics product line in North America consists of more than 50,000 valves, an extensive selection of air preparation equipment, and a full line of actuation products. ASCO products include solenoid pilot valves, angle body piston valves, linear indicators, redundant control systems, and pressure sensors. The Numatics line covers valve manifolds, cylinders, grippers, filters, regulators, and lubricators. For more information about ASCO Numatics products, visit www.asconumatics.com.

About Emerson
Emerson (NYSE:EMR), based in St. Louis, Missouri (USA), is a global leader in bringing technology and engineering together to provide innovative solutions to customers through its network power, process management, industrial automation, climate technologies, and appliance and tools businesses. Emerson’s sales in fiscal 2009 were $20.9 billion. The company is ranked 94th on the Fortune 500 list of America’s largest companies. For more information, visit www.Emerson.com.

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Public Relations contact, Boston, Don Goncalves, dgoncalves@tizinc.com, 781-793-9380, for Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations 


Tuesday, March 2nd, 2010

ASCO Light Weight Miniature Solenoid Valve Introduced with Extended Life and Higher Flow

asco-num-01

FLORHAM PARK, NEW JERSEY, USA, March 2, 2010ASCO Numatics, the world’s leading manufacturer of comprehensive fluid automation, flow control, and pneumatics solutions, has introduced the ASCO 411 Series miniature solenoid valve that offers up to twice the life of competing products plus higher flow rate performance. The new valve is ideal for applications in pharmaceutical, medical, analytical, and instrumentation products.

“Now, original equipment manufacturers (OEM) can receive the benefits of longer life, smaller size, lighter weight, higher flow, and lower power consumption — all in one miniature solenoid valve,” said Robert W. Kemple, Jr., Executive Vice President, Sales and Marketing – Americas, ASCO Numatics. “The 411 Series dramatically reduces the design tradeoffs and compromises engineers must make in applying valves to their products.”

The 411 Series’ unique plunger design significantly reduces wear on the poppet and is resistant to internal elastomer swelling that can disrupt performance. The new valve has been tested to exceed 500 million cycles in normal operating conditions, making it the longest-lived, most reliable product of its kind on the market.

ASCO has increased the valve’s flow rate by 12% to 15% over previous models, and the maximum operating pressure differential has been improved. “These factors will enable engineers to design products with greater operating speeds, higher pressures, and smaller volumes,” said Kemple.411

The new valve family incorporates a smaller, lighter weight plastic body that achieves a 12% to 15% overall weight reduction when compared to stainless steel and brass-bodied valves. This makes the 411 Series a good choice for miniaturized and portable medical devices and pharmaceutical products. Lower power consumption means the valve also is attractive for use in battery-powered applications. In addition, it is the only miniature solenoid valve that is fully compliant with RoHS regulations.

“The 411 Series is assembled and tested in a specially built Class 100 cleanroom that is dedicated to miniature solenoid valve production,” Kemple said. “Our valve’s exceptional reliability and its flexibility to address a wide range of specifications and operating characteristics provide the OEM with the widest variety of design options.”

The 411 Series can be purchased from ASCO distributors or directly from the company. Many of the valve’s configurations are available through the ASCO Today 24-hour or ASCO 5-day shipping programs.

For more information, contact ASCO at 800-972-ASCO, by e-mail at info-valve@asco.com, or visit www.ascovalve.com.

About ASCO Numatics
ASCO Numatics, formed by the merger of ASCO and Numatics, is a business unit of Emerson Industrial Automation. ASCO Numatics offers comprehensive fluid automation solutions, flow control and pneumatics for a wide range of industry-focused applications.  The ASCO Numatics product line in North America consists of more than 50,000 valves, an extensive selection of air preparation equipment, and a full line of actuation products.  ASCO products include solenoid pilot valves, angle body piston valves, linear indicators, redundant control systems, and pressure sensors. The Numatics line covers valve manifolds, cylinders, grippers, filters, regulators, and lubricators.  For more information about ASCO Numatics products, visit www.asconumatics.com.

About Emerson
Emerson (NYSE:EMR), based in St. Louis, Missouri (USA), is a global leader in bringing technology and engineering together to provide innovative solutions to customers through its network power, process management, industrial automation, climate technologies, and appliance and tools businesses.  Emerson’s sales in fiscal 2009 were $20.9 billion.  The company is ranked 94th on the Fortune 500 list of America’s largest companies. For more information, visit www.Emerson.com.

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Download high resolution image for publication: http://bit.ly/9WHMwT

Public Relations contact, Boston, Don Goncalves, dgoncalves@tizinc.com, 781-793-9380, for Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations 


Tuesday, June 3rd, 2008

Microtest Labs Doubles Microbial Identification, Analytical Services

AGAWAM, MASS. – June 3, 2008 – Microtest Laboratories (http://www.microtestlabs.com/) has doubled their microbial identification and analytical services with the purchase of an additional MicroSeq® Microbial Identification System.

The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified.

“With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients,” stated Dr. Steven Richter, Microtest President and Chief Scientific Officer. “As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage.”

Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time.

“In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Richter. “Our ability to provide rapid identification helps our customers minimize down-time, which directly affects their bottom-line. When manufacturing is halted or a cleanroom is shut-down and awaiting test results, there is no product going out the door and that translates to an interruption in sales.”

The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in:

  • Contract Manufacturing
  • Pharmaceutical Testing & Validation
  • Medical Device Testing & Validation
  • Environmental Control and Testing
  • Water Validation
  • Mold Identification
  • Biologics/Virology

The MicroSeq systems are 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today.

For more information about Microtest’s analytical testing and related services, visit contact the Microtest on the Web at: www.microtestlabs.com/medical-device-testing or by phone 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc.


Wednesday, October 10th, 2007

Free White Paper: “Virus Testing for Biological Products: Partnering With a Contract Lab”

AGAWAM, MASSACHUSETTS – October 10, 2007 – Microtest has announced the availability of a free white paper titled: “Virus Testing for Biological Products: Partnering With a Contract Lab.”

In manufacturing biological products, there is risk of virus contamination at many levels, from raw materials to processing. This contamination risk means virus testing is required. A proper testing program is essential to ensure the biological product achieves the fastest time to market. By working with a qualified contract laboratory, the best testing strategy can be executed to assure product safety.

In this white paper, Merribeth Morin, Ph.D, Director of Virology at Microtest, reviews the potential sources of contamination, cell bank characterization (virus safety), virus concerns during manufacturing, and ways to effectively partner with a contract testing laboratory.

Microtest offers a complete range of pharmaceutical and virology test services. These services can support full in-process and product release testing as well as product stability testing, raw material qualification and assay development/validation.

As a growing provider of fill/finish operations, Microtest has all the systems and procedures in place to fully support all the requirements of the FDA, EMEA and any drug-regulating body in the world. With a problem-solving approach, customer service focus, and technical expertise, Microtest has the ability to help pharmaceutical companies reduce costs and risk, support rapid regulatory approvals, and enjoy reliable, fast, turn-arounds.

For more information, contact Microtest on the Web at www.microtestlabs.com, or toll-free at: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com)


Wednesday, March 28th, 2007

Symmetry Medical Enhances Total Solutions® Offering Through Partnerships With Independent Test Laboratories

WARSAW, Ind. – March 26 , 2007 – Symmetry Medical Inc. (NYSE: SMA), an independent provider of products to the global orthopedic device industry, announced today it has partnered with two independent testing laboratories to further enhance Symmetry Medical’s Total Solutions® offering. Symmetry has partnered with Sherry Laboratories, which is located at Symmetry’s Design & Development Center (DDC) in Warsaw, Indiana, and with MicroTest Laboratories, Inc., which is located at Symmetry’s DDC facility in Manchester, New Hampshire.

Sherry Laboratories’ specialization in instrument durability, impact load cell testing and torque testing will enable Symmetry’s Warsaw DDC to identify necessary product modifications and quickly address the changes during the development cycle. Implementing the testing process into the overall manufacturing timeline is expected to reduce the time it takes to move product to market.

“Sherry Laboratories has been serving the medical device industry for nearly twenty years and is delighted to establish this unique partnership with Symmetry Medical,” said Christopher LaMothe, Chairman and CEO of Sherry Laboratories. “This industry leading concept allows Symmetry Medical’s customers to enjoy the confidence of independent third party testing as an integrated part of product design, development and quality assurance.”

“As the world’s leading independent provider of implants, related instruments and cases to orthopedic device manufacturers, as well as an established product design and development provider to several other segments of the medical device market, Symmetry recognizes the value that independent, on-site testing will bring to our design and development cycle. Partnering with Sherry Laboratories provides a natural extension of our value added services, which enable our customers to achieve greater speed to market,” said Barry Parker, Senior Vice President, Symmetry Medical Design & Development Center.

In partnering with MicroTest Laboratories, Inc., a leader in third-party independent testing services and contract manufacturing for the medical device, pharmaceutical and biotechnology industries, Symmetry Medical’s DDC in Manchester, New Hampshire becomes the first surgical instruments case manufacturer in the U.S. to offer services ranging from sterilization validation to cleanability testing.

“Symmetry Medical’s ability to consolidate third-party validation into the case design and manufacturing process provides a significant time-to-market advantage to medical device manufacturers. By instituting these measures, Symmetry ensures its customers the highest levels of quality and efficiency and positions itself ahead of what may soon to be a requirement throughout the industry,” said Dr. Steven Richter, President and Founder of MicroTest Laboratories, Inc.

“Our ongoing partnership with MicroTest Laboratories, a world class test organization, provides Symmetry Medical with the ability to enhance its Total Solutions offerings to its multitude of medical product customers,” said Michael Curtis, Senior Vice President and General Manager, Medical Products, Symmetry Medical. “The opportunity to provide total design, manufacturing sterilization and cleanability testing for all our medical products maintains our position as a supplier of choice in the medical device market.”

About Symmetry Medical Inc.
Symmetry Medical Inc. is a leading independent provider of implants and related instruments and cases to the orthopedic device industry. The Company also designs, develops and produces these products for companies in other segments of the medical device market, including dental, osteobiologic and endoscopy sectors and provides limited specialized products and services to non-healthcare markets, such as the aerospace market.

Forward-Looking Statements
Statements in the press release regarding Symmetry Medical Inc.’s business, which are not historical facts, may be “forward-looking statements” that involve risks and uncertainties, within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are predictive in nature and are frequently identified by the use of terms such as “may,” “will,” “should,” “expect,” “believe,” “estimate,” “intend,” and similar words indicating possible future expectations, events or actions. Such predictive statements are not guarantees of future performance, and actual results could differ materially from our current expectations. Certain factors that could cause actual results to differ include: the loss of one or more customers; the development of new products or product innovations by our competitors; product liability; changes in management; changes in conditions effecting the economy, orthopedic device manufacturers or the medical device industry generally; and changes in government regulation of medical devices and third-party reimbursement practices. We refer you to the “Risk Factors” and “Forward Looking Statements” sections in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission as well as the Company’s other filings with the SEC, which are available on the SEC’s Web site at www.sec.gov.

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Posted by Tiziani Whitmyre, www.tizinc.com


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