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Posts Tagged ‘medical device manufacturers’


Monday, May 19th, 2014

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

AGAWAM, MASS. — May 19, 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.


Tuesday, September 25th, 2012

Boston Seminar to Assist Medical Device & Pharmaceutical Manufacturers with Environmental Monitoring, Risk-Assessment

Microtest Laboratories will present an environmental monitoring seminar and risk-assessment workshop to assist medical device and pharmaceutical manufacturers with building, validating, and maintaining their clean rooms and sterile manufacturing environments.

Titled “Environmental Monitoring Seminar and Risk-Assessment Workshop,” the event will provide practical information and the latest techniques on cleaning and disinfection programs designed to maintain aseptic conditions and prevent microbial contamination.

The event will be held at the MIT Endicott House in Dedham, Mass. — just outside Boston — on Wednesday, October 24, 2012, from 10 a.m. to 2 p.m.

At the event, attendees will:

  • Participate in a hands-on workshop that focuses on risk assessment in the clean room
  • Discover the best practices for qualifying and maintaining a clean room facility
  • Identify and assess the risks commonly found in a clean room environment
  • Test the information they’ve learned in a mock clean room floor plan exercise

A networking reception, and lunch, is included. For more information, or to RSVP, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. Registration for the event 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. Microtest’s environmental sciences group helps its clients maintain control of theircontrolled 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.

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.

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Tuesday, November 16th, 2010

New White Paper: Having a Solid Package Validation Program Can Prevent Failure of Combination Products

AGAWAM, MASS. – November 16, 2010 – A new white paper urges medical device and combination product manufacturers to employ a solid package validation program as a means of preventing the failure of combination products.

“FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs,” said Steven Richter, Ph.D., founder, president and chief scientific officer of Microtest Laboratories in Agawam, Mass.

Richter is author of the new white paper that provides insight into the general requirements in a microbiological and physical testing program. In it, he discusses how combination products pose a unique set of challenges to package validation engineers.

Titled, “Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products,” the paper is available for download from: http://www.microtestlabs.com/packaging-validation-paper.

In the white paper, Richter discusses the challenges of packaging validation and some of the options for testing. He provides a summary of the standardized test methods commonly used in the U.S. for satisfying ANSI/AAMI/ISO 11607 requirements, and outlines the steps in the packaging validation process. He also focuses on the points to consider during packaging validation studies for cell therapy products.

“All device and combination product manufacturers are required to have a robust package validation program, and medical device stability package validation programs should be designed to encompass the overt product storage and shipment conditions,” Richter said. “The necessity to develop a robust packaging validation regimen cannot be overstated. A comprehensive regulatory approach to validation during early product development can save many weeks of redevelopment and testing activities.

“This white paper is presented to give medical device and combination product manufacturers a starting point for package validation programs,” he said.

Download the new, free white paper, Get with the Program: Having a Solid Package Validation Program Can Prevent Failure of Combination Products,” from: http://www.microtestlabs.com/packaging-validation-paper.

Steven Richter, Ph.D., is founder, president, and chief scientific officer of Microtest Laboratories, Inc., in Agawam, Mass. Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest has provided the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

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


Monday, November 10th, 2008

Free Seminar for Medical Device Makers on Importance of Sterile Package Validation Set for Nov. 12th

AGAWAM, MASS. – Nov. 10, 2008 – A free morning-long seminar to help New England-based medical device manufacturers negotiate the increasingly important – and complex – challenges of sterile package validation is scheduled for November 12th in Agawam, Mass.

“FDA concerns regarding terminally sterilized medical products are based on years of data that implicates failures in primary packaging. The majority of failures occur because of inadequate package validation programs,” says Steven Richter, Ph. D., president and CEO of Microtest, a leader in medical device testing services, including medical device package stability and validation testing.

The seminar will detail the necessary sterilization processes and test methods that should be part of any reliable validation program to avoid such failures, Richter said.

Titled “Package Validation Requirements for Medical Devices and Combinatory Products,” the seminar will detail the general concepts and problems associated with medical device packaging testing as well as reviewing different testing methodologies. Specific topics will include:

  • ISO 11607 Overview
  • Physical Package tests vs Microbial
  • Stability & Accelerated Aging
  • Combinatory Products
  • Flexible Packaging
  • ISTA Shipping Testing

The seminar will be held Nov. 12, 2008, from 10 a.m. through Lunch at Microtest Laboratories, Inc., 104 Gold St., Agawam, Mass. The seminar is free and lunch will be provided.

The seminar is free, but prior registration is required. To register, visit www.microtestlabs.com/packagingseminar or call toll-free 1-800-631-1680.

For directions to Microtest, visit http://www.microtestlabs.com/contact-us/index.html.

About Microtest
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. 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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