industry pr

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

Health/Medical Newsfeed


Monday, January 23rd, 2012

Disinfectant Qualifications in Pharmaceutical Manufacturing Environments is Focus of New White Paper

AGAWAM, Mass. — Jan. 23, 2012 — A new white paper outlining the six steps that pharmaceutical and medical device manufacturers must employ to qualify disinfectants used in their environmental cleaning processes is now available from Microtest Laboratories athttp://www.microtestlabs.com/6stepspaper-disinfectant-qualification.

“Sterile pharmaceutical and medical device manufacturing environments require an effective cleaning and disinfection program to maintain aseptic conditions and prevent the microbial contamination of the product. The qualification of the chemical disinfectants used in these environments is extremely important, yet it is often overlooked,” stated Deborah Ensign, supervisor, R&D of Microtest Laboratories, in the new white paper, “Six Steps to Qualifying Disinfectants.”

In fact, “disinfectant qualifications require more planning, time, and resources than many companies realize,” she said.

“Any time a new disinfectant is introduced into the cleaning process within the facility, a qualification should be performed. From start to finish, a disinfectant qualification can require from 2 to 12 months.

“The timeline for a disinfectant qualification will depend on a number of variables, including the number of disinfectants and challenge organisms being tested as well as the number of surfaces (for the coupon method) being evaluated,” Ensign noted.

“The bottom line is that no matter whether the disinfectant qualification is performed internally — or by an outside testing laboratory — these six steps must be addressed,” she warned.

Download a free copy of the white paper, “Six Steps to Qualifying Disinfectants” for pharmaceutical manufacturing companies from Microtest Laboratories website athttp://www.microtestlabs.com/6stepspaper-disinfectant-qualification.

Deborah Ensign is supervisor, R&D Lab, at Microtest Laboratories Inc. She has over 20 years of experience in regulatory microbiology and contract laboratory operations. Ms. Ensign supervises Microtest’s Specialized Microbiology department. She holds a bachelor of arts degree in microbiology and is a nationally registered microbiologist. Ms. Ensign oversees all reusable testing (cleaning, disinfecting, and sterilization) and serves as a resource for USP testing, specifically <51>, <61>, and <62>.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical manufacturing, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., 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, visithttp://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.

Bookmark and Share

Tags: , , ,
Posted in Health/Medical, Life Sciences, Manufacturing |


Tuesday, November 1st, 2011

New Howard Leight MAX Small Earplugs Maximize Hearing Protection and Comfort for People with Smaller Ear Canals

SMITHFIELD, RHODE ISLAND, USA – November 1, 2011 — Honeywell Safety Products today introduced MAX® Small earplugs — an extension to the flagship Howard Leight® MAX single-use earplug family. MAX Small’s reduced size offers people with smaller ear canals a more comfortable fit and high attenuation (NRR 30).

MAX Small has the same bell shape and patented varied-cell polyurethane foam as the standard MAX earplug, though is 20% smaller in geometry.

Through customer feedback and evaluations with Howard Leight’s VeriPRO® ear plug fit testing system, employees with smaller ear canals have reported trouble obtaining a good fit – and adequate protection – from other high attenuating roll-down foam earplugs on the market.

“The right ear plug should feel comfortable in the ear canal without compromising protection. MAX Small meets that need by ensuring a high level of attenuation and a more comfortable fit as in a single-use foam earplug,” said Renee S. Bessette, COHC, Global Brand Manager, Howard Leight / Honeywell Safety Products.

In end-user trials involving automobile manufacturing workers and safety inspectors, individuals with smaller ear canals have reported achieving a better in-ear fit — and attained higher attention — with MAX Small earplugs than with the use of larger single-use earplugs.

MAX Small is available in both corded and uncorded models, and is available immediately from industrial safety distributors in the US and Canada.

For more information, visit http://www.howardleight.com/earplugs/max-small.

About Howard Leight®

Under the Howard Leight brand, Honeywell Safety Products is a leading global provider of passive and intelligent hearing protection solutions, and is the founder of the HearForever™ initiative. For over 30 years, the company and its predecessors have pursued the prevention of occupational noise-induced hearing loss through innovation in hearing protection design, technology, performance and comfort, and the promotion of progressive Hearing Conservation Programs.  Leading solutions include the highest attenuating Max® single-use earplug; patented Air Flow Control™ technology for optimal earmuff attenuation; QuietDose™ personal in-ear dosimetry; and the industry-changing VeriPRO® earplug fit testing system. Visit the Howard Leight website at http://www.howardleight.com and follow us on Twitter at http://twitter.com/HowardLeight.

About Honeywell

Honeywell International (http://www.honeywell.com) is a Fortune 100 diversified technology and manufacturing leader, serving customers worldwide with aerospace products and services; control technologies for buildings, homes and industry; automotive products; turbochargers; and specialty materials. Based in Morris Township, N.J., Honeywell’s shares are traded on the New York, London, and Chicago Stock Exchanges. For more news and information on Honeywell, please visit http://www.honeywellnow.com.

This release contains certain statements that may be deemed “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, that address activities, events or developments that we or our management intends, expects, projects, believes or anticipates will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this release are also subject to a number of material risks and uncertainties, including but not limited to economic, competitive, governmental, and technological factors affecting our operations, markets, products, services and prices. Such forward-looking statements are not guarantees of future performance, and actual results, developments and business decisions may differ from those envisaged by such forward-looking statements.

 # # #

Note to Editors:

  • Press contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com

 

 

Bookmark and Share

Tags: , , , , ,
Posted in Business, Health/Medical, Hearing Protection |


Monday, October 31st, 2011

White Paper Helps Schools Address Risks and Costs Associated with PCBs

Needham, Mass. – October 31, 2011 – A new, free white paper assists schools and municipalities with management of the challenges and costs that can result from the discovery of polychlorinated biphenyls (PCBs) in their buildings.

The paper titled “What You Need to Know About Managing PCBs in Schools” details the nature of PCBs in buildings, required compliance issues, potential liabilities, and current risk management strategies for dealing with PCBs in school buildings.

“The current broad based regulatory focus on PCB-contaminated building products represents a  significant liability for schools, municipalities, building owners, real estate developers, REITS, financing institutions, and contractors, “says John McCarthy, President and co-founder of EH&E, a Needham, Massachusetts-based environmental services firm.

“The scientific, engineering, and regulatory aspects of building-related PCBs are complex and development of safe, cost effective solutions requires a detailed understanding of their often subtle interrelationships. Attempting to address this issue with incomplete information can dramatically impact the cost of operations, renovation or demolition of a building. Costs can quickly rise to millions of dollars for a single school building. Administrators of schools and other municipal real estate must be aware of the regulatory requirements, implications for building operations, and strategies to effectively minimize their risk and remediation costs,” he said.

This white paper describes a strategy to effectively identify potential risks avoid regulatory mishaps, address PCB-containing materials in a systematic manner and maintain a healthy school environment. It also provides guidance on how to assess the need for, and effectively estimate the costs of any remediation efforts, so that these costs can be appropriately managed and minimized in the project budget.

Download the white paper “What You Need to Know About Managing PCBs in Schools” at http://www.eheinc.com/pcb_mgmt_schools.htm.

Or, for more information contact EH&E directly on the web at: www.eheinc.com or by phone at 800-825-5343. 

About EH&E

EH&E (www.eheinc.com) has provided an extensive range of environmental and engineering consulting services for over 20 years. The EH&E team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry.  The firm’s wealth of readily-accessible information is a powerful resource for its clients.

Bookmark and Share

Tags: , , , , , ,
Posted in Buildings & Facilities, Health/Medical |


Tuesday, October 18th, 2011

Immunetics, Inc. to Present Novel, Rapid Test for Bacterial Contamination of Platelets at American Association of Blood Banks (AABB) Annual Meeting

Boston, Mass. — October 18, 2011 — Immunetics, Inc. announced plans to present a novel, rapid test for bacterial contamination of platelets at the American Association of Blood Banks (AABB) Annual Meeting, Oct. 21st-25th, in San Diego.

Bacterial contamination of platelets has been identified as the #1 infectious risk of transfusion, with approximately 1 out of 2,000 platelet units contaminated. Transfusion of bacterially contaminated platelets poses a significant health risk, potentially resulting in serious to fatal illness in the recipient. Traditional methods for detecting bacteria are based on inoculation of platelet samples into culture bottles followed by a 24-72 hour waiting period. In addition to the lengthy incubation period, recent studies have shown these methods to be prone to both false positive and false negative results. Culture testing has been routine for single donor platelets but is not practical for pooled whole blood-derived platelets, which must be used within 4 hours of pooling. About five million platelet units are collected annually in the United States along with an equal number in other countries.

Immunetics’ BacTx® rapid test can detect bacterial contamination by clinically relevant species in less than one hour, at levels below those shown to be harmful to transfusion recipients.

Multi-center clinical trials have been concluded in which the performance of the BacTx test was evaluated on whole blood-derived random-donor platelet units.

The results of these studies, and implications for other studies, will be presented and discussed by two clinical investigators at the AABB Meeting in a breakfast workshop entitled “BacTx – A Novel Method for the Detection of Bacteria in Platelets,” on Monday, Oct. 24, 2011, at 7:00-8:15 a.m., in Room 29 C/D in the San Diego Convention Center. The presenters are: W. Andrew Heaton, M.D., Sr. Director of Transfusion Medicine, NSLIJ Health System and Michael R. Jacobs, M.D., Ph.D., Director, Clinical Microbiology, University Hospitals, Case Medical Center. The BacTx test is currently under pre-market review by the FDA.

For more information, contact Immunetics (http://www.immunetics.com) at 617-896-9100 or 800-227-4765, or visit Immunetics at booth # 643 at the AABB Annual Meeting.

About Immunetics

Immunetics Inc. (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is to deliver better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston. Follow Immunetics on Twitter at http://twitter.com/immunetics.

# # #

Press contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com

Bookmark and Share

Tags: , , , , , , , , , ,
Posted in Biosciences, Health/Medical |


Tuesday, September 27th, 2011

New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm

Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is detailed in a free white paper available at http://www.microtestlabs.com/dietarypaper.

The white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008.

Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111.

“Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims.  And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories.

“In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said.

For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on:

  • Developing the Necessary Quality System
  • Management “Buy In”
  • Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
  • Chemistry and Manufacturing Controls (CMC)

The white paper is available at: http://www.microtestlabs.com/dietarypaper.

“The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer.

“Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.”

For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper.

For more information, visit http://www.microtestlabs.com. 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, visithttp://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Bookmark and Share

Tags: , , , , ,
Posted in Biosciences, Health/Medical, Life Sciences |


Wednesday, September 21st, 2011

Building, Validating & Maintaining Controlled Environment Facilities is Focus of Oct. 18th Seminar in Boston Hosted by Microtest Laboratories

AGAWAM, Mass. — Building, validating, and maintaining a controlled environment facility is the subject of a daylong seminar on Oct. 18, 2011, hosted by Microtest Laboratories at the MIT Endicott House in Dedham, Massachusetts.

Titled “Keeping It Clean? The Building Blocks of Facility Control,” the seminar will focus on the clean room testing, disinfection validation, and related contamination testing issues that arise from manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

In each seminar program, industry experts will present practice advice and sound solutions in an interactive format that will encourage a high level of engagement by participants for questions, answers and discussion. The topics will include:

  • Killing The Bugs Without Killing Yourself: Disinfectant Qualifications
  • Feeling Like A Fish Out of WFI?: Water System Validation and Maintenance
  • Got A Lot On Your Plate: Clean-room Validations and Maintenance
  • The Old In & Out: Considerations On Insourcing vs. Outsourcing

“Keeping It Clean? The Building Blocks of Facility Control” will be presented 8:30 a.m. to 3:30 p.m. on Tuesday, Oct. 18, 2011, at the MIT Endicott House, 80 Haven Street in Dedham, Mass., just outside of Boston. Registration and a complimentary continental breakfast is at 8 a.m. Lunch will be served at Noon. The cost is $149 per person and includes meals, refreshments, and workshop handouts.

To register or for more information, visit the Microtest Laboratories website at http://www.microtestlabs.com/seminar/index.asp. Or, contact Julie Adamski at 413-786-1680, toll-free at 1-800-631-1680, or at jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in controlled environment facility testing, laboratory testing, and contract manufacturing services 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.

# # #

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

 

Bookmark and Share

Tags: , , , , , ,
Posted in Biosciences, Health/Medical, Uncategorized |


Wednesday, September 14th, 2011

Robert F. Higgins Joins Advanced Practice Strategies Board of Directors

— Healthcare Investor Joins Leading Continuing Medical Education Provider —

Boston, Mass., September 14, 2011 — Advanced Practice Strategies (APS), the leading provider of continuing medical education solutions for risk management and patient safety, today announced that Robert F. Higgins, founding partner of Highland Capital Partners and Senior Lecturer at Harvard Business School, has been elected to APS’ Board of Directors.

“Bob has a remarkable track record working with early-stage healthcare companies,” said Dennis Ferrill, chief executive officer of APS. “His expertise in the healthcare industry will enable him to make significant contributions to the APS board. I look forward to working with him as APS undergoes a period of rapid growth and expansion as we advance outdated continuing medical education practices and dramatically improve patient safety.”

“APS represents an outstanding opportunity to expand the knowledge base of our nation’s medical professionals,” said Higgins. “Medical error is a massive and growing problem. APS is building the next generation of learning tools for physicians, nurses, and other medical professionals. I look forward to working with Dennis and the team to improve the performance of clinical professionals and enhance patient outcomes.”

At Highland Capital Partners, Higgins has helped build many successful companies in the healthcare service, IT, medical device, and biotechnology sectors. He has served as a director for numerous public and private firms. Higgins is a former director of the National Venture Capital Association and president of the New England Venture Capital Association. In addition, he has been recognized by the prestigious Forbes Midas List and AlwaysOn Venture Capital 100 as one of the top venture capitalists in the industry.

At Harvard Business School, Higgins co-created and currently teaches a course titled, “Entrepreneurship and Venture Capital in Healthcare.” He is a member of the Healthcare Initiative, the Social Enterprise Initiative, and the Harvard Faculty Committee for the MD/MBA program. In addition, he received the 2008 HBS Healthcare Alumni Achievement Award.

Prior to founding Highland, Higgins was the chief executive of the John A. Hartford Foundation, the Clark Foundation, and the Burden Foundation. He was also the assistant to the U.S. Secretary of Commerce and assistant to the head of the international division of the U.S. Treasury. He is a graduate of Harvard College and Harvard Business School.

About APS

Advanced Practice Strategies (APS) is building the next generation of continuing medical education for physicians, nurses, and other medical professionals. APS is dedicated to improving the lives of both patients and their caregivers through effective, innovative education solutions. APS’ flexible, state-of-the-art eLearning program has helped hospitals and clinicians reduce risk and enhance patient safety across the country. APS’ Demonstrative Evidence Group is the nation’s leading provider of visual strategies and materials for courtroom defense against medical malpractice claims. Strategic partners include the Risk Management Foundation of the Harvard Medical Institutions and the Hospital Corporation of America. APS is headquartered in Boston, Massachusetts. For more information, visit http://www.aps-web.com.

# # #

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

Bookmark and Share

Tags: , , , , , ,
Posted in Health/Medical |


Monday, July 25th, 2011

Advanced Instruments Introduces A2O Advanced Automated Osmometer Featuring Breakthrough Automation and Performance Levels

a2o-150NORWOOD, MASSACHUSETTS, USA, July 25, 2011 - Advanced Instruments, Inc., today introduced the A2OTM Advanced Automated Osmometer, a multi-sample instrument that sets new benchmarks for analytical performance, ease of use, and true walk away operation capabilities in osmolality testing. The announcement was made at the American Association for Clinical Chemistry’s 2011 Clinical Lab Expo.

“The A2O represents a major step forward in osmometry technology and offers clinical laboratory customers an exceptional opportunity to enhance their productivity and workflow,” said Kelly Peterson, product manager, Advanced Instruments. “It combines a highly functional design, exceptional performance, and an intuitive software control package that is both powerful and elegantly simple to operate.”

A2O Eliminates Time-Consuming Manual Pipetting

With its intelligent liquid handling, the A2O is the first osmometer to eliminate time-consuming and labor-intensive manual pipetting – the leading cause of sampling errors and inaccurate test results. The instrument fully automates sample processing to achieve dramatic gains in laboratory productivity and efficiency.

The instrument’s flexible software brings exciting new features and benefits to clinical laboratories:

  • Intuitive touchscreen interface provides easy-to-use functionality and operation
  • Integrated quality control features include automated system calibration, statistical monitoring and reporting, method control limits for controls and patient samples, and built-in system linearity checks
  • Selectable system operation and access levels provides operator login and password protection
  • Positive sample identification eliminates transcription errors
  • Sample testing protocols can be customized specifically for each laboratory’s unique test requirements

“Advanced Instruments has leveraged its 50 years of freezing-point technology experience to revolutionize osmolality testing,” said Peterson. “The A2O’s technology will allow clinical laboratory users to achieve more results, faster – and more efficiently.”

For more information on the A2O Advanced Automated Osmometer, visit http://www.aicompanies.com/A2O or call +1 781.320.9000.

About Advanced Instruments, Inc.

Advanced Instruments, Inc., and our subsidiaries, Delta Instruments and Mart® Microbiology, design and manufacture instrumentation for clinical, pharmaceutical, biotechnology, microbiology, and food laboratories. Our quality brands include Spiral Biotech, Fiske Associates, and D & F Control Systems. The products we make help healthcare providers improve their quality of care, and industrial companies enhance their quality and productivity.

Advanced Instruments products are available from a worldwide distributor network. For more information on our products and services or to find your nearest distributor, visit us at http://www.aicompanies.com or e-mail us at info@aicompanies.com.

# # #

Note to Editors:

Bookmark and Share

Tags: , , , , ,
Posted in Health/Medical, Life Sciences |


Wednesday, July 6th, 2011

Microtest Laboratories Announces New Fast-Track Toxicity Testing for Medical Devices Using Zebrafish Embryos

AGAWAM, MASS. - July 6, 2011 - Microtest Laboratories has announced a new fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos (Danio rerio), a technique already widely utilized in drug development studies.

zebrafish“Testing has revealed that Zebrafish embryos are highly susceptible to toxins. In fact, Zebrafish labs are ubiquitous in most universities and research hospitals,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and former U.S. Food & Drug Administration (FDA) official.

“We’ve confirmed the application of Zebrafish embryos in the toxicity testing of materials used in medical devices,” Dr. Richter said. “With our in-vitro test, manufacturers and bio materials researchers can screen thousands of polymers in less than a week – yielding significant economic savings in both the time and expense of medical device testing.”

In its research, Microtest Laboratories found that the current “gold standard” USP Cytotoxicity Assay, which utilizes live mouse fibroblasts (L929) cells in culture, failed to detect the toxicity of a BPA extract during testing – while Microtest’s new Zebrafish embryo screen succeeded.

BPA (bis-phenol A) is a suspected toxic polymer assumed as having both carcinogenic and teratogenic effects on humans. The U.S. Environmental Protection Agency (EPA) has indicated that BPA will be slated for screening soon.

“Microtest’s new Zebrafish embryo assay has better sensitivity and generates more scientific data than the small animal tests currently recommended by the FDA,” Dr. Richter said.

“The use of Zebrafish embryos will reduce or eliminate the current animal testing required for all medical devices testing. This important vertebrate model has demonstrated similarities to mammalian models and humans in toxicity testing,” he noted.

Microtest Laboratories’ new Zebrafish embryo assay for the toxicity testing of medical devices is immediately available. For more information, visit http://www.microtestlabs.com/zebrafish-embryos-testing or call 1-413-786-1680 or toll-free 1-800-631-1680

About Microtest Laboratories

Microtest Laboratories is a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., 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.

# # #

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

Download high resolution image from: http://www.microtestlabs.com/photos

Bookmark and Share

Tags: , , ,
Posted in Biosciences, Health/Medical, Life Sciences |


Tuesday, June 7th, 2011

New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

A free white paper that guides manufacturers of medical devices in the validation of their cleaning processes is available from Microtest Laboratories.

It is available for download from: http://microtestlabs.com/cleaning-validation-paper

As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must be cleaned to ensure both patient safety and the continuing functionality of the device.

In the white paper titled, “Five Steps to Validating the Cleaning Process of Medical Devices,” Patrick Kenny, Manager of Analytical Services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation.

Several sections of Part 820 can be directly related to medical device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe.

In the paper, Kenny presents a five-step process that provides a framework to assist manufacturers of medical devices in their cleaning validation efforts:
#1: Evaluate the Process, Determine the Potential Contaminants
#2: Determine the Limits
#3: Identify the Analytical Test
#4: Validate the Method for Use
#5: Validate the Cleaning Process

Download a free copy of “Five Steps to Validating the Cleaning Process of Medical Devices,” at http://microtestlabs.com/cleaning-validation-paper.

At Microtest Labs, Kenny leads the services group performing medical device and pharmaceutical analytical testing. He holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories.

About Microtest Laboratories
Microtest Labs 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://microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs

Bookmark and Share

Tags: , ,
Posted in Health/Medical, Manufacturing |

« Older Entries

Industry PR is proudly powered by WordPress.
WordPress