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Posts Tagged ‘medical device’


Tuesday, January 14th, 2014

Fundamentals of Endotoxin Testing for Medical Device Manufacturers are Detailed in New Technical Brief

AGAWAM, MASS. — January 14, 2014 — The fundamentals of endotoxin testing for medical device manufacturers — from definition to assay acceptance criteria —are detailed in new technical brief available from Microtest Laboratories.

Bacterial endotoxins cause fever, septic shock, and other disease symptoms — and thus attract considerable regulatory scrutiny from such organizations as the U.S. Food & Drug Administration (FDA) and the United States Pharmacopeial Convention. Regulations require that devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

The Fundamentals of Endotoxin Testing,” available for download at http://microtestlabs.com/endotoxin-testing, is a step-by-step information resource for medical device manufacturers discussing and detailing the:

  • Definition of endotoxins;
  • Various tests used for their detection;
  • Use of depyrogenation and other ways to remove endotoxins;
  • Types of devices that should be tested;
  • Preparation and testing of samples;
  • Options for sampling containers;
  • Acceptance criteria for each of the assays; and
  • Sources of official information, reference, and guidance.

The Fundamentals of Endotoxin Testing” is authored by Steven Richter, Ph.D., said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official.

Download the brief from: http://microtestlabs.com/endotoxin-testing.

The paper is one in a series about testing, manufacturing, and regulatory issues of concern for medical device manufacturers from Microtest Laboratories, a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. It was founded in 1984. The company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption. Microtest’s unique single-source capability to provide testing and manufacturing solutions allows the firm to support a full pharmaceutical or medical device product release. The company’s facilities in Agawam, Massachusetts, USA 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. 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 on Facebook at http://goo.gl/TndoBg.

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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.


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, August 14th, 2012

Use Notebook Studies to Ensure Successful Reusable Device Cleaning Validations, Recommends Microtest Laboratories

AGAWAM, MASS. —August 14, 2012 — A new management brief from Microtest Laboratories recommends that medical device manufacturers use notebook studies to help ensure successful reusable device cleaning validations. The lab bases the advice on its performance of validations for various types of medical instruments over the years.

The brief discusses the document, “FDA Draft Guidance for Industry and Staff, Processing /Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” which was released in May 2011.

“Even though it’s labeled as a draft, experience has shown that most reusable device cleaning validations are being evaluated based on this document,” said Patrick Kenny, manager of analytical services at Microtest Laboratories — and author of the new brief titled, “Notebook Studies to Ensure Successful Reusable Device Cleaning Validations.”

Kenny’s brief focuses on areas of the FDA guidance document that are causing difficulties in cleaning validations, and demonstrates how pre-validation laboratory work can help save time and money. It also identifies areas that can cause issues during validations if they are not thoroughly addressed prior to initiating the protocol. These include:

  • The use of worst-case conditions
  • The switch from microbial-based assays to chemical-based assays
  • The determination of an acceptable residual level
  • The validation of a reusable device’s cleaning instructions

“The good news is that almost all of these issues can be eliminated with some up-front work,” Kenny said. “And this preparatory work can best be performed by notebook studies prior to initiating GLP studies. The information obtained in these relatively quick studies often saves significant time later in the filing process.”

“In short, we recommend the use of notebook studies prior to beginning the validation to eliminate as many unknowns as possible,” he said.

To obtain a copy of the new management brief, “Notebook Studies to Ensure Successful Reusable Device Cleaning Validations,” visit http://www.microtestlabs.com/notebook-studies-brief or call 1-413-786-1680, or toll-free 1-800-631-1680.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

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 on Twitter at http://twitter.com/MicrotestLabs.

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Press Contact: Don Goncalves, Tiziani Whitmyre, 781-793-9380, dgoncalves@tizinc.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 30th, 2012

Industry Perspective on Reusable Medical Device Cleaning and Validation Requirements Outlined in New Management Brief

AGAWAM, MASS. — April 30, 2012 — A new management brief discusses the potential impact on reusable medical device cleaning validations and testing requirements resulting from the US Food & Drug Administration’s (FDA) draft guidance document, “Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The new brief is available from Microtest Laboratories at http://www.microtestlabs.com/reusable-med-device-brief.

“Although the FDA guidance document is not legally enforceable, it describes the agency’s ‘current thinking and should be viewed as recommendations,’” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — a former FDA official — and author of the brief.

In his brief titled “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” Richter discusses a variety of issues raised by the document which the FDA released last May for industry comment. The issues include:

  • “Spore tag reduction” and Hucker’s soil challenges
  • Cleaning methods using protein, carbohydrates, red blood cells and lipids
  • Separation of cleaning, disinfectant and sterilization validation activities
  • ASTM Simulated Use Test
  • Three log reduction for cleaning validations
  • Empirical data in 510(k) submissions
  • Reducing manufacturing materials to “safe levels”

While Richter emphasized that “the FDA document was issued for comment and is not for implementation, the medical device industry understands that changes from current best practices will be required immediately.”

His brief seeks to “raise the industry discussion of issues that must be anticipated, discussed, and thoroughly evaluated for the time when implementation is required,” he said.

Dr. Richter founded Microtest Laboratories in 1984 after a distinguished career at the FDA. Under his leadership, Microtest Laboratories provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Download a copy of the management brief, “Reusable Medical Device Cleaning Validation and Testing Requirements (An Industry Perspective),” from http://www.microtestlabs.com/reusable-med-device-brief.

Microtest Laboratories, based in Agawam, Massachusetts, is a full-service medical device testing laboratory and a leader in medical device testing and related services for the medical device, pharmaceutical, and biotechnology industries. Testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

For more information, visit Microtest’s web site at http://www.microtestlabs.com or call 1-413-786-1680, or toll-free 1-800-631-1680.

 


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

 


 

 

 

 

 

 

 

 

 

 

 

 


Wednesday, June 2nd, 2010

New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

microtest-logo1

AGAWAM, MASS. – June 2, 2010 – A new free, white paper that guides medical device manufacturers in the validation of their cleaning processes is now available from Microtest Laboratories.

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 a new 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. (Download from: http://www.microtestlabs.com/cleaning-validation-paper.)

Several sections of Part 820 can be directly related to 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 medical device manufacturers 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,” from http://www.microtestlabs.com/cleaning-validation-paper.

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

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

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

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


Thursday, January 29th, 2009

Microtest Labs Offers Free Microbial Identification Testing, Free Shipping on Other Tests, to MD&M West Attendees

AGAWAM, MASS. – January 29, 2009 – To highlight its 20 years of experience as a leader in medical device testing services, Microtest Laboratories (www.microtestlabs.com) is offering free microbial identification testing, along with free shipping on other lab tests, to eligible attendees visiting the Microtest exhibit, #828, at MD&M West 2009 in February.

The free offers highlight Microtest’s wide range of laboratory testing and validation services – and problem solving approach – that combine to assist medical device manufacturers to gain a competitive marketplace advantage.

“We work with our clients throughout the testing and validation process to help reduce down-time, lower costs and risk, speed regulatory approvals and time to market, and minimize schedule disruptions,” said Dr. Steven Richter, Microtest President and Chief Scientific Officer.

The free microbial identification offer demonstrates the fast, precise and reliable bacteria, mycoplasma, and mold identification services that Microtest provides by utilizing its two in-house MicroSeq® Microbial Identification Systems.

With two MicroSeq systems, Microtest delivers precise and reliable test results in a 24-hour time period – rather than traditional testing that’s often less accurate and requires a week or more turn around. Microtest is one of only a few labs in its area with such technology.

Microtest is also offering one year of free standard ground shipping to spotlight the dozens of other medical device testing services it offers, including Gamma/ethylene oxide (EO) sterilization validation, and Reusables, Endotoxin, and Sterility testing and related services.

To receive any of the free offers, companies must register at the Microtest exhibit (booth #828) during the MD&M West 2009 Expo. Current Microtest clients are not eligible.

Microtest’s medical device testing facilities are ISO 9001 and ISO 17025:2005 certified, and U.S. FDA-regulated, meeting all GLP/GMP standards. For more information, visit Microtest at MD&M West 2009 in booth #828, on the Web at www.microtestlabs.com, or call 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/pr-boston-public-relations/


Monday, January 12th, 2009

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

AGAWAM, MASS. – January 12, 2009 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest (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.

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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