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

Posts Tagged ‘cleanability testing’


Tuesday, February 24th, 2009

White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

AGAWAM, MASS. – February 24, 2009 – Biopharmaceutical manufacturers, responsible for an extensive repertoire of products – including recombinant proteins, monoclonal antibodies, and vaccines – are faced with many aspects of testing specific to the type of product being assessed. A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services.

The white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product” focuses on what many consider the most critical part of a biological drug product’s manufacturing life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”). It is available for download at: http://www.microtestlabs.com/control-environment.

Specifically, the white paper discusses establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

In the white paper, the authors:

  • Warn to test only when necessary to reduce interventions.
  • Explain to test using methods that give data as quick as fittingly possible to condense processing times.
  • Discuss how to utilize a client’s knowledge of the product, the contractor’s knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.

The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations, and Alex Mello, Director of Project Management, Manufacturing, both of Microtest Laboratories (http://www.microtestlabs.com/), a contract manufacturer and provider of contract manufacturing testing services.

To download the white paper, “Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product,” visit: http://www.microtestlabs.com/control-environment.

About Microtest
Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services 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 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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