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Posts Tagged ‘Manufacturing’


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


Wednesday, October 2nd, 2013

“Combination Products: What You Need to Know” Seminar for Medical Device, Pharmaceutical Manufacturers is Scheduled for October 31st in Boston

AGAWAM, MASS. — October 2, 2013 — A full-day technical seminar designed to assist medical device and pharmaceuticals with what they need to know about manufacturing combinations products, including best practices and applicable FDA regulations, is scheduled for Thursday, October 31st, in Waltham, Mass., just outside Boston.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent more than 30% of all new FDA product submissions. But for manufacturers, the convergence of drugs, biologics, and devices presents a host of best practice and regulatory issues.

Titled “Combination Products: What You Need to Know,” the seminar will outline a realistic approach for manufacturers to navigate the testing, production, and regulatory standards related to the manufacture of combination products. Topics will include:

  • Combination Products —What You Need To Know: Overview of regulatory hurdles for combination products highlighting the determination of PMOA.
  • Applications of Lean to Combination Product Manufacturing: Case studies specific to applying lean to manufacturing of combo products for clinical use.
  • In-Process and Release Testing PTC: Outline of in-process and release testing points to consider during development and specification determination.
  • EM Monitoring of GMP Manufacturing Space: Current EM procedures for setting up GMP manufacturing.
  • Choosing the Right CMO: Discussion of best practices to determine a right fit CMO.

Combination Products: What You Need to Know,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. The seminar will be held at the Conference Center at Waltham Woods in Waltham, Mass., just outside Boston, on Thursday, October 31, 2013, from 9:00 a.m. to 3:00 p.m. Registration is at 9:00 a.m. Continental breakfast, break refreshments and luncheon is included.

To register, download the form at http://www.microtestlabs.com. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

The seminar is one in a continuing series of technical events presented by Microtest Laboratories for medical device and pharmaceutical manufacturers. The seminars tend to fill up quickly so please register early! Follow Microtest Laboratories on Facebook at http://goo.gl/pHNP63, on LinkedIn at http://goo.gl/H8ZLnM or on Twitter @MicrotestLabs.

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.


Tuesday, September 3rd, 2013

New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos to be Discussed at AMI’s Medical Grade Polymers 2013

AGAWAM, MASS. – September 3, 2013 – A new test that utilizes Zebrafish (Danio rerio) embryos to screen plastics, composites, and polymers for toxicity in medical device manufacturing will be featured at AMI’s Medical Grade Polymers 2013 technical conference in September.

“The U.S. Food and Drug Administration (FDA) requires testing to assess medical device toxicology and describes which situations may trigger the need for manufacturers to repeat testing or undertake new programs. The dynamics of such testing are rapidly evolving,” according to Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, and a former FDA official.

Dr. Richter developed the new “ZET™ Medical Device Polymer Biocompatibility Screen Test,” at Microtest Laboratories for use by medical device manufacturers and bio-material researchers.

 

“Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times. The Zebrafish test demonstrates similarities to mammalian models and humans. Its unique approach to fast-track medical device toxicity screens will save manufacturers time and reduce expenses,” he said.

 

“Moreover, Microtest’s ZET Test sensitivity has proven to be greater than the USP gold standard test for BPA. In addition, the benefits of ZET surpass both USP cytotoxicity testing and mouse embryo toxicity tests,” he said.

 

Dr. Richter will present details of the new ZET Test in his presentation, “Biocompatibility Testing: Past, Present, and Future,” on Tuesday, Sept. 17, at 10:10 a.m., at the Applied Market Information LLC (AMI) Medical Grade Polymers 2013 conference. The conference runs Sept. 17-18, at the Crowne Plaza, Boston/Woburn, Mass. For more information, visit http://goo.gl/o9edjx.

For more information about Microtest Laboratories’ new ZET Test, download the white paper, New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),from http://www.microtestlabs.com/zebrafish-test-paper.

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, 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.


Friday, April 19th, 2013

Microbiology Quality Control Seminar to Assist Medical Device Manufacturers Validate Sterilization, Cleaning Processes

A seminar on microbiology quality control — designed to help medical device manufacturers validate sterilization and cleaning processes, and maintain controlled environments — will be held on Thursday, May 16, in Boston.

“For today’s medical device manufacturers, the challenge is to validate their sterilization and cleaning processes to ensure patient safety and product integrity. This seminar will focus on a host of issues pertaining to the sterilization of medical devices including sterilization validation, bioburden, sterility, and endotoxin testing, as well as submitting samples to a contract testing laboratory,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, which is hosting the event.

Topics at the “Microbiology Quality Control Seminar will include:

  • MICRO 101
  • Sterilization Validation
  • Bioburden Testing
  • Sterility Testing
  • Endotoxin Testing
  • Testing Sample Submissions

The event will be held at the MIT Endicott House in Boston, Mass., on Thursday, May 16, 2013, from 9 a.m. to 3:30 p.m. Registration is 9 a.m. to 9:45 a.m. A networking reception and lunch are included.

To register, download the form from http://www.microtestlabs.com/pdfs/seminar-registration-form_1305.pdf. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

The event is one in a series of technical seminars and workshops for medical device and pharmaceutical manufacturers presented by Microtest Laboratories, a Mass.-based, FDA-audited company with a history of exceptional regulatory compliance.

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.


Tuesday, September 18th, 2012

Cost-Efficient Manufacturing Practices for Military and Aerospace Products Are Outlined in New Management Brief

CRANSTON, RI — Sept. 18 , 2012 — By adopting best practices from non-military markets, and adapting them to defense and aerospace applications, military original equipment manufacturers (OEMs) can accelerate the reengineering process and reduce the time it takes to realize the cost reduction benefits, according to a new management brief available to download from Federal Electronics at http://www.federalelec.com/militarybrief.

Outsourcing of manufactured products at all levels has been an integral part of commercial and industrial OEM supply chain strategies for literally decades. But only recently has it gained traction with military contractors. To avoid an array of issues that may hamper outsourcing efforts, the brief, titled, “Cost-Efficient Manufacturing for Military and Aerospace Products,” recommends a series of common practices that promote cost efficiency and process agility. They include:

  • Establishing outsourced product transfer procedures that build upon the current state of the manufacturing process.
  • Implementing product/process documentation programs that promote collaboration in the supply chain.
  • Opening reviews of new designs to key suppliers as early in the design phase as possible.
  • Identifying non-critical, high-labor content elements of the product and introducing low-cost region manufacturing into the supply chain.
  • Selecting an EMS provider who straddles the line between military and industrial applications.
  • Accentuating current supply chain staffs with individuals whose skill sets were honed in the commercial, industrial, and medical environments.

According to the brief, prime contractors, tasked with wringing costs and delays out of their product development and fulfillment processes, will continue to harvest proven, best-in-class practices from non-military OEMs. Expanding the use of outsourcing methodologies with a properly aligned and sized supply chain will provide significant opportunity to achieve the levels of cost reduction and business process acceleration that are required to support defense and aerospace customers in the future, the brief states.

Download the new management brief, “Cost-Efficient Manufacturing for Military and Aerospace Products,” from http://www.federalelec.com/militarybrief.

About Federal Electronics

Founded in 1948, Federal Electronics, Inc., is a leading vertically-integrated electronics manufacturing services (EMS) provider. Service offerings include advanced technology circuit card assembly, cable and wire harness assembly, fiber optic interconnect assembly and functionally tested higher level assemblies and system level integration. Based in Cranston, Rhode Island, and Hermosillo, Mexico, the electronics contract manufacturer serves the needs of military prime contractors and original equipment manufacturers by providing comprehensive production solutions that lower cycle times, control and reduce costs, and create flexible supply chains that are responsive to volume variability. For more information, visit http://www.federalelec.com.


Tuesday, July 24th, 2012

New White Paper, “Five Biggest Myths about Medical Products Outsourcing,” Finds OEM’s Concerns are Often Unfounded

BILLERICA, MA — July 24 2012 — A new white paper, “The Five Biggest Myths about Medical Products Outsourcing,” examines the reasons why five typical areas of concern about outsourcing medical products manufacturing are often unfounded. In addition, the paper outlines the advantages that outsourcing can provide original equipment manufacturers (OEMs) in terms of delivering quality products on time and on budget. The paper is available now for download at http://resources.labmedical.com/medical-products-outsourcing from LAB Medical Manufacturing.

Outsourcing medical product manufacturing is a thriving industry. In the U.S. alone, more than 3,000 firms offer their services as a contract manufacturer (CM) for medical devices, instruments, and implants. Most leading original equipment manufacturers (OEMs) of medical products employ at least some CMs; many have made them permanent parts of their manufacturing resource strategy.

However, some OEM planners resist using CMs, or have difficulty selecting the right one.

The white paper, titled “The Five Biggest Myths about Medical Products Outsourcing,” discusses the five top myths about outsourcing medical product manufacturing that lure OEMs into falling prey to misunderstandings or concerns. These include cost, quality, or product complexity, or about maintaining control of intellectual property, or feel insecure about utilizing any but the very largest CMs.

The five myths are:

  • Myth #1: The lowest purchase price equals the lowest cost.
  • Myth #2: Every source offers the same quality.
  • Myth #3: You can only outsource the simple stuff.
  • Myth #4: Outsourcing equals losing control.
  • Myth #5: Size matters most.

OEMs may entertain several fears that make them reluctant to use new contract manufacturers, or indeed to employ CMs at all, according to the white paper. However, the right CM, with the relevant resources and with experience in a given product type, can often be a good fit to an OEMs’ requirements.

A nimble, right-sized CM can offer a fruitful collaboration that produces improved medical instruments and implants — on time and on budget — to achieve enhanced patient outcomes, the white paper reports.

Download the new white paper, “The Five Biggest Myths about Medical Products Outsourcing,” from http://resources.labmedical.com/medical-products-outsourcing.

About LAB Medical Manufacturing

LAB Medical Manufacturing, Inc., is a world-class contract manufacturer of high-precision medical devices and implants for leading original equipment manufacturers (OEMs). Its high-quality, cost-effective solutions help achieve better patient outcomes while reducing health care expenses. Founded in 1984, the company combines a passion for problem-solving with comprehensive in-house resources; exceptional engineering; unmatched application expertise; and flexible, integrated manufacturing. It is ISO 13485:2003 certified and FDA registered as a contract manufacturer. LAB Medical maintains facilities in Billerica, Massachusetts, USA, and Nowa Deba, Poland. Visit the company website at http://www.labmedical.com.


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.


Monday, April 2nd, 2012

“Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing” is Subject of New Management Brief

AGAWAM, MASS. – April 4, 2012 – The new scope of biologics sterility testing, resulting from the U.S. Food and Drug Administration’s (FDA) proposed changes to 21 CFR 610, is discussed in a new management brief from Microtest Laboratories. Download the brief from http://www.microtestlabs.com/21-cfr-610-paper.

The FDA’s proposed amendments to 21 CFR Parts 600, 610, and 680, published in the Federal Register on June 21, 2011, for review and comment, are focused on expanding the scope of the current sections to allow for greater flexibility in testing methodology.

“Through these changes, the FDA is embracing the emergence of new non-culture based technologies. If approved, they will provide the opportunity to utilize these methods as alternatives to culture-based sterility tests,” explains James E.T. Gebo, B.S., M.P.A., RM (NRCM), Technical Representative, Laboratory Services, Microtest Laboratories, in the brief, “Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing.”

“The most significant proposed revision is the elimination of the specified sterility test methods,” writes Gebo. “But while the proposed changes seem extreme at first glance, in the grand scheme they are beneficial for all interested parties.”

The brief discusses the potential benefits, including the opportunity for manufacturers and quality control laboratories to streamline their testing and adopt new emerging sterility test technologies — such as rapid testing methods employing PCR — that will further support the drive to achieve quicker product release.

Download the new free management brief, “Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing,” at http://www.microtestlabs.com/21-cfr-610-paper.

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


Tuesday, February 14th, 2012

White paper Details New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos

AGAWAM, MASS. – February 13, 2012 – A new white paper detailing the new ZET™ medical device polymer biocompatibility screening test using Zebrafish embryos is available to download from Microtest Laboratories at http://www.microtestlabs.com/zebrafish-test-paper.

The new ZET test was developed by Microtest Laboratories for medical device manufacturers and biomaterials researchers. It utilizes Zebrafish (Danio rerio) to screen plastics, composites, and polymers for toxicity.

“Zebrafish are extensively used in drug development studies due to their transparent embryos and fast development times,” writes white paper author Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and former FDA official. “The Zebrafish test demonstrates similarities to mammalian models and humans. Its unique approach to fast-track medical device toxicity screens will save manufacturers time and reduce expenses.”

In the new white paper, “New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),” Richter discusses U.S. Food and Drug Administration (FDA) testing requirements to assess medical device toxicology and describes which situations may trigger the need for manufacturers to repeat testing or undertake new programs.

Richter also provides background facts about Zebrafish and details the company’s testing that revealed ZET sensitivity is greater than USP gold standard test for BPA. In addition, he outlines the benefits of ZET versus USP cytotoxicity testing and ZET versus mouse embryo toxicity tests.

Download the white paper, New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio),” fromhttp://www.microtestlabs.com/zebrafish-test-paper.

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, 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.

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

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

 


 

 

 

 

 

 

 

 

 

 

 

 


Monday, September 26th, 2011

Fluid Automation: Unsung Contributor to Plant Economic Performance — New Management Brief from ASCO Numatics

FLORHAM PARK, N.J. — Sept. 26, 2011 — While fluid automation products — valves, pneumatics actuators, and similar components — control the flow of a process liquid or a supply of compressed air, they can also help control the flow of profits, according to a new management brief from ASCO Numatics.  Titled “Fluid Automation: The Unsung Contributor to Plant Economic Performance,” the brief is available for download at http://goo.gl/9MMkH.

The speed and reliability of fluid control products can provide competitive economic advantages in industrial operations worldwide. This is due to their ability to extend overall equipment service life, reduce warranty costs, cut maintenance/repair/operations (MRO) inventories, and increase production uptime and productivity.

But the choice of fluid automation technology is critical. For end users, judicious selection of fluid automation components must play a key role in their performance improvement plans. For original equipment manufacturers (OEMs), the right fluid automation choices provide significant cost, time-to-market, and product competitive advantages.

The new management brief examines available solutions and discusses how they  have maximized both speed and reliability — and provided surprisingly strong contributions to the economic performance of industrial operations.

The contents of the brief include:

  • Changing the Rhythm
  • Feeding the Bottom Line
  • The Benefits of Reliability
  • The Power of Speeds
  • Advantages for the OEM
  • Advances for the End User

Download the new management brief, “Fluid Automation: The Unsung Contributor to Plant Economic Performance,” from http://goo.gl/9MMkH.

Follow ASCO Valve on Twitter at http://twitter.com/ascovalve and on Facebook at http://www.facebook.com/ascovalve.

About ASCO Numatics

ASCO Numatics, a division of Emerson, offers comprehensive fluid automation solutions, including fluid control and fluid power 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 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

 


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