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Posts Tagged ‘Microtest’


Monday, December 3rd, 2007

Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers

AGAWAM, MASS. – December 3, 2007 – A new, free white paper, addressing the challenges of new U.S. Food and Drug Administration (FDA) regulations awaiting combination products manufacturers, is now available for download at www.microtestlabs.com/combinationpaper.

While combination products are experiencing dramatic growth, the convergence of drug/biologics and devices brings a host of regulatory challenges. Manufacturers must ensure their products meet cGMP practices as well as pass muster with the FDA, ISO, and USP.

Steven Richter, Ph.D., Microtest President & Chief Scientific Officer, addresses the critical issues associated with this complex process, including defining the FDA’s regulatory framework, reviewing developments in FDA thinking, and identifying future considerations in developing effective quality assurance systems.

“The combination products market – medical devices embedded with pharmaceutical or biologics components –is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Richter, who is author of the announced white paper, “Combination Products: Navigating Two FDA Quality Systems.”

Navigant consulting, estimating the combination products market at $5.9 billion in 2004, predicts a nearly $9.5 billion market in 2009. In 2005, the FDA received 275 combo product submissions, and an estimated 30% of new products under development today are combo products.

“For manufacturers, the convergence of devices and drugs or biologics also brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products,” he said.

The paper’s contents include: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

Download the free white paper at: www.microtestlabs.com/combinationpaper. For more information visit Microtest on the Web at www.microtestlabs.com, or call toll-free: 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 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

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Posted in Biosciences, Manufacturing |


Monday, October 15th, 2007

Microtest Labs of Agawam Wins Massachusetts Economic Impact Award

Agawam, Mass., October 15, 2007 – Microtest Laboratories (www.microtestlabs.com) of Agawam has been honored with a Massachusetts Economic Impact Award for its strong record of job creation and business expansion.

The company was named the Silver Level award recipient in the western Mass. region by the Massachusetts Alliance for Economic Development (MAED).

“To be recognized as an economic leader in western Mass. is a huge honor for us,“ said Steven Richter, Ph. D., President and Scientific Founder of Microtest. “The success of our region is very important to Microtest, our employees, business partners and education partners, especially as we strive to expand the state’s presence of life sciences and biotechnology companies throughout western Mass.”

Microtest, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, employs more than 100 in Agawam. The company recently completed a $7.5 million expansion to its headquarters, adding new state-of-the art pharmaceutical testing laboratories and new aseptic fill/finish manufacturing facilities – along with new professional staff.

The company has working partnerships with economic and business organizations throughout Western Mass. – and deep relationships with the region’s educational institutions.

MAED is a private, non-profit partnership of business, industry leaders, and government dedicated to the economic growth of Massachusetts. MAED will recognize its 2007 Team Massachusetts Economic Impact Award winners during a special luncheon on November 20, 2007. For more information, visit http://www.massecon.com.

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 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)

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Posted in Biosciences, Health/Medical |


Monday, September 17th, 2007

Microtest Labs of Agawam Is Finalist for Mass. Alliance For Economic Development’s Team Massachusetts Economic Impact Award

Agawam, Mass., Sept. 17, 2007 – Microtest Laboratories of Agawam has been named as a finalist for the 2007 Team Massachusetts Economic Impact Award by the Massachusetts Alliance For Economic Development (MAED).

The Awards honor the companies that have made the strongest contributions over the past year to the Massachusetts economy through job creation and business expansion. Microtest is being considered for its impact and contributions in Western Mass.

Microtest, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries, employs more than 100 in Agawam. The company recently completed a $7.5 million expansion to its headquarters, adding new state-of-the art pharmaceutical testing laboratories and new aseptic fill/finish manufacturing facilities – along with new professional staff.

The company has working partnerships with economic and business organizations throughout Western Mass. – and deep relationships with the region’s educational institutions.

“Everyone at Microtest is extremely proud” of being named a finalist by MAED, said Steven Richter, Ph. D., President and Scientific Founder of Microtest. “Our mission is to become a long term economic driver in the valley.”

“Being named as a Finalist is more than an honor. I’m always telling everyone – in and out of state – that the exciting growth and success we’re enjoying at Microtest today is directly due to the contributions of our employees, and the educational, state and local support and resources of Massachusetts,” Richter said.

MAED is a private, non-profit partnership of business, industry leaders, and government dedicated to the economic growth of Massachusetts. MAED will announce its 2007 Team Massachusetts Economic Impact Award winners during a special luncheon on November 20, 2007. For more information, visit http://www.massecon.com.

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. (www.tizinc.com)

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Posted in Biosciences, Health/Medical |


Wednesday, September 12th, 2007

Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers

AGAWAM, MASS. – September 12, 2007 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest (http://www.microtestlabs.com/).
The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies.

For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at: http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm.

Microtest Sterility White Paper Pharma For pharmaceutical manufacturers, sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue. Pharmaceutical manufacturers can download the white paper at: www.microtestlabs.com/sterilitypaper/pharma-paper.htm.

The author of the white papers is Steven Richter, Ph.D., President and Scientific Founder of Microtest, a leading provider of medical device and pharmaceutical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology, and with more than 15 years of experience, is a single-source manufacturing solution.

For information on Microtest’s unique single-source solutions that minimize schedule disruptions and accelerate time to revenue, visit Microtest on the Web: www.microtestlabs.com or toll-free: 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 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/)
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Posted in Manufacturing |


Monday, July 9th, 2007

New, Free White Paper Details Compliance Requirements for Pharmaceutical, Medical Device Manufacturers

AGAWAM, MASS. – July 9, 2007 – A new, free white paper, detailing critical industrial sterilization and contamination control programs and compliance challenges in the pharmaceutical and medical device manufacturing industries is now available for download at www.microtestlabs.com/environmentpaper.

One of the biggest challenges faced by medical device manufacturers is determining exactly what is required for compliance. For parenteral manufacturers, the environmental control parameters are highly stringent and pose significant compliance challenges.

In the white paper, titled “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” Microtest Project Manager Scott Mackin, reviews key elements of a best practice environmental testing program, including sterilization standards, FDA compliance requirements and vital factors in maintaining controlled environments.

At Microtest (http://www.microtestlabs.com/), Mackin has assisted a number of medical device manufacturers in designing, implementing, and maintaining both sterilization and environmental monitoring programs.

Microtest, a full service testing services and contract manufacturer, offers a complete range of onsite and remote monitoring programs for specialized environmental testing services. Microtest experts utilize cutting edge technology and processes to determine viable microbial and nonviable particulate levels of any area used for medical device and pharmaceutical cleanroom or manufacturing purposes.

Download the free white paper, “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” at: www.microtestlabs.com/environmentpaper. Or, for more information, visit Microtest on the Web at www.microtestlabs.com, or call toll-free: 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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Press release contact: Tiziani Whitmyre, http://www.tizinc.com

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Posted in Biosciences, Manufacturing |


Monday, June 25th, 2007

New Free White Paper Helps Pharmacy Directors Meet USP 797 Regulations

AGAWAM, MASS. – June 25, 2007 – A new, free white paper to help directors of compounding pharmacy with the problems meeting new USP 797 regulations is now available from Microtest Laboratories at www.usp797.com/whitepaper.

In the last several years, the U.S. government has issued a series of regulations, contained in General Chapter (USP 797), mandating tighter control of sterile preparations in compounding pharmacies. All covered pharmacies were warned to be prepared to demonstrate and document their compliance with all relevant USP 797 provisions as of January 1, 2008, and failure to comply may have catastrophic consequences.

Reaching full compliance poses a serious dilemma for pharmacy directors and USP 797 is a complex document with ever-changing implications. As a result, many facilities are struggling with the implementation of sterility best-practices programs as well as to provide adequately controlled compounding environments, in terms of personal, air, and surface contamination. Many also face the challenge of furnishing the documented procedure sets, environmental monitoring, end-product testing, and process validation necessary to provide critical controls on the sterile products they prepare.

The new, free white paper, “The Compliance Dilemma: Problems and Solutions in Meeting USP 797 Regulations for Compounding Pharmacies,” can help. The white paper discusses the areas in which compounding pharmacies face increasing compliance burdens, including risk levels, personnel training, environmental control, and procedural controls. It also outlines the host of solutions offered by a turnkey consulting/training/testing supplier.

The paper is authored by Douglas M. Jaciow, director of compliance services for Microtest Laboratories, a 30-year clinical laboratory veteran, an A.S.M., and an A.S.C.P. board-certified microbiologist/mycologist.

Download the free white paper at: www.usp797.com/whitepaper.

Microtest (http://www.usp797.com/) is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. Founded in 1984, the company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption. Mictrotest’s unique single-source capability to provide testing and manufacturing solutions allows the company to support a full pharmaceutical or medical device product release. Our facilities in Agawam, Massachusetts, include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological, and virological laboratories; Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus depyrogenation capabilities; purified water systems; and voice/data systems.

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Press release contact: Tiziani Whitmyre, http://www.tizinc.com

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Posted in Health/Medical |


Tuesday, June 19th, 2007

Microtest Labs, Texcel Medical Join Forces to Offer Pharma Companies “One Stop” Solution for Combo Product Testing & Development

AGAWAM, MASS. – June 19, 2007 – Microtest Laboratories and Texcel Medical today announced a strategic alliance to provide pharmaceutical manufacturers and biotechnology companies with a competitive advantage when developing the latest breed of “combination products.”

An estimated 30 percent of new products under development this year are combo products — consisting of medical devices embedded with pharmaceutical or biologics components. Growing at a 10 percent compound annual growth rate, the market is expected to reach approximately $9.5 billion in 2009.

“The combination products market is booming. Yet, many pharmaceutical companies are struggling to manage the convergence of devices and drugs or biologics and the host of unique FDA testing guidelines, practices and regulations that such products require,” according to Steven Richter, Ph.D., President, Microtest (www.microtestlabs.com).

“For such firms, outsourcing is the solution – provided that the arrangement is struck with the right partner. This is the strategy behind the Microtest/Texcel alliance,” Richter said.

Microtest, based in Agawam, Mass. is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The company brings both world-class testing facilities and deep regulatory experience to the alliance, as well as comprehensive combination product solutions that include GLP testing services, sterilization validation, package testing, stability testing, biocompatibility testing, and clinical trial material application.

Texcel, of East Longmeadow, Mass. (www.texcelaser.com), provides manufacturing infrastructure and engineering expertise for surgical, interventional, and implantable medical devices. The firm completes the alliance’s offering for pharma manufacturers with a host of solutions for active implantable devices – and an ISO 13485:2003, ISO 9001:2000 and FDR registered facility.

“Together, we offer a unique, seamless synergy of expertise in the design, prototyping, development, testing, approval, and manufacturing of combination products. For pharma companies, the result is an instant competitive advantage and acceleration in time-to-market in an increasingly fast-moving, competitive, and global economic market,” said Larry Derose, President, Texcel.

For more information on Microtest, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. For more information on Texcel, visit www.texcelaser.com or call 1-413-525-5700 or toll-free 1-800-754-1800.

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Press release contact: Tiziani Whitmyre, http://www.tizinc.com

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Posted in Manufacturing |


Monday, June 4th, 2007

Med-Conduit Turns to Microtest for Medical Device Testing Services

AGAWAM, MASS., June 4, 2007 – Med-Conduit, an innovative developer and marketer of central venus catheters (CVCs) has teamed with Microtest Laboratories of Agawam, Mass., a leading provider of testing services to the medical device industry.

CVCs are found in use at intensive care and long term units in hospitals. When inserted into a patient, it enables that patient’s skin to grow into the device and form a biological seal that has a significant impact on preventing infection at the site of insertion, explained Dr. Gerald Bousquet, M.D., President, Med-Conduit.

Microtest is conducting bacteria testing on a new cap that Med-Conduit is implementing for its CVCs, said Dr. Bousquet.

Dr. Bousquet turned to Microtest for its current testing needs after working with the company and its founder, Steve Richter, Ph.D., on a previous project.

Dr. Richter had assisted Dr. Bousquet to navigate the stringent US Food and Drug Administration (FDA) application process and successfully obtain the critical FDA approvals he required to manufacture and sell a product at his previous company, Microwave Medical Systems. The product, the Microwave Sanitizer, is a microwave designed to sanitize the catheter connection area to decrease the risk of infection for patients in peritoneal dialysis.

“Dr. Richter’s prior experience working at the FDA, combined with his deep expertise and background in medical device development, and his personal passion to succeed, made all the difference in securing the approvals we required,” Dr. Bousquet said. “Dr. Richter even traveled with our company principles to meet with the FDA in Washington, DC.”

Microtest offers a host of single-source solutions that assist medical device manufacturers facing a rising volume and complexity of challenges in product development and validation, including:

  • Medical device sterilization validations
  • Package validations
  • Microbiology and clean room services, and
  • Analytical services.

A new free white paper written for medical device manufacturers discusses sterility testing as well as reviews different testing methodologies Titled “Sterility Testing: Essential Things You Must Know,” it’s authored by Dr. Richter, and is available for download at: http://www.microtestlabs.com/sterilitypaper.

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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Press release contact: Tiziani Whitmyre, www.tizinc.com

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Posted in Manufacturing |


Wednesday, May 30th, 2007

Microtest to Highlight Medical Device, Analytical Capabilities at MD&M East

AGAWAM, MASS. – May 30, 2007 – Microtest Laboratories will highlight its expanded medical device, contract manufacturing and analytical testing capabilities at the Medical Device & Manufacturing (MD&M) East Conference, June 11-14 at the Jacob Javits Convention Center in New York City.

With the completion of a $7.5 million capital improvement program, the addition of new resources and skilled professionals, and the purchase of a MicroSeq® Microbial Identification System, Microtest has bolstered its services and emerged as a leader in the medical device manufacturing market.

Microtest’s enhanced medical device sterility validation and release testing services (www.microtestlabs.com/medical-device-testing) includes:

  • Gamma/EO Sterilization Validation: Bioburden; Bioburden Recovery; Bacteriostasis/Fungistasis; Sterility; Dose Calculation; Spore Strip Population; Ethylene Oxide Residuals
  • Reusables: High/Low Level Disinfection; Cleaning Studies; Steam / EO / Chemical SterilizationEndotoxin: FDA / USP Gel Clot; Chromogenic; Turbidimetric
  • Sterility: USP; ANSI/AAMI/ISO; Product Immersion; Product Flush; Biological Indicator; Membrane Filtration; Steritest(TM) / Sterisolutest(TM)

Microtest’s upgraded analytical services (www.microtestlabs.com/analytical-chemistry-testing), performed as needed in accordance with USP/ISO/BP/AOAC/AAMI/JP requirements, include:

  • Services: ETO, ECH, EGLY Residuals Analysis; ETO, Pilot Vessel Studies; Formaldehyde Residuals Analysis
  • Water Testing: TOC (Total Organic Carbon); pH and Conductivity; Total Chlorine; Total Nitrates and Heavy Metals
  • Wet Chemistry: Heavy Metals; Non-volatile Residues; Residues on Ignition; Direct Titration; Nitrates

For more information on Microtest capabilities and services, visit Steve Richter, PH.D., Microtest President, in the Microtest booth, number 1544, at MD&M East, June 11-14 in the Jacob Javits Convention Center in New York City. Or, visit the Microtest website at www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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.

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Press release contact: Tiziani Whitmyre, www.tizinc.com

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Posted in Manufacturing |


Tuesday, May 1st, 2007

Microtest to Highlight Virology and Pharmaceutical Testing, Contract Manufacturing Capabilities at Bio International Convention

AGAWAM, MASS. – May 1, 2007 – Microtest Laboratories (http://www.microtestlabs.com/) will highlight its expanded contract manufacturing, virology, and pharmaceutical testing capabilities at the BIO International Convention, May 6-9 at the Boston Convention & Exhibition Center.

With its completion of a $7.5 million capital improvement program, Microtest has added a new state-of-the-art pharmaceutical testing laboratory, a series of segregated virology testing laboratories, new aseptic fill/finish manufacturing facilities, and purchased a MicroSeq® Microbial Identification System – along with the hiring of additional professional staff.

With this addition, Microtest has bolstered its services and emerged as a leader in the contract manufacturing market.

“As a customer-focused provider of both contract laboratory testing and contract manufacturing services, we offer unique cross-over benefits for our customers,” said Steve Richter, PH. D., Microtest President. “These include a complete range of pharmaceutical and virology test services that can support full in-process and product release testing as well as product stability testing, raw material qualification, and assay development/validation,” added Richter.

“Moreover, since we manufacture the pharmaceutical product – as a growing provider of fill/finish operations –we have 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,” Richter noted.

For more information on Microtest capabilities and services, visit Richter in the Microtest booth, number 533/A20, at the BIO International Convention, May 6-9 in the Boston Convention & Exhibition Center in Boston.

Or, visit the Microtest website at www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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.

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Press release contact: Tizinani Whitmyre, www.tizinc.com

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Posted in Biosciences, Manufacturing |

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