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

Posts Tagged ‘cleaning validation’


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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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, 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


Tuesday, February 8th, 2011

White Paper Outlines Disinfection Testing, Cleaning Validation Studies Requirements for Reusable Medical Devices

AGAWAM, MASS. – February 8, 2011 – A new, free white paper outlining the application of disinfection and cleaning validation requirements for reusable medical devices in line with U.S. Food and Drug Administration (FDA) regulations is now available from Microtest Laboratories (http://www.microtestlabs.com/medical-disinfection-paper).

Titled “Reusable Medical Device Disinfection and Cleaning Validation Requirements,” the paper outlines the salient aspects of validating that a medical device can be safely reused; addresses disinfection studies and processes, rather than sterilization; and provides cleaning validation information germane to all reusable medical devices.

The author of the paper is Steven Richter, Ph.D., president and scientific director of Microtest Laboratories. Richter is himself a former FDA official.

“Reusable medical devices come in all shapes and sizes – from specula to colonoscopes. Generally, these devices have expensive components that require them to be cleaned and disinfected or sterilized,” Dr. Richter notes.

“Recently, the FDA began requiring additional information on 510(k) submissions, demanding clarity in the options afforded to practitioners. Microbiologists generally treat all medical devices equally, even though many devices require special treatment.

“Historically, manufacturers were not required to validate that cleaning and disinfection processes were effective in reducing microbial and protein loads to safe levels. The FDA may have asked manufacturers for data regarding disinfectant use during reprocessing, but manufacturers would often simply perform cursory simulated-use tests that might not pass muster with FDA reviewers today.

“Currently, the FDA requires validation studies for both disinfection and cleaning. Both disinfection testing validation and cleaning validation studies are important to the manufacturer because they will validate the safety and efficacy of the disinfection process. It is important to qualify both the cleaning and disinfecting processes prior to validation activities.

“This new white paper is aimed at helping practitioners determine the best practices for performing these critical disinfection testing and cleaning validation studies,” Dr. Richter states.

Download a free copy of the white paper Reusable Medical Device Disinfection and Cleaning Validation Requirementsfrom http://www.microtestlabs.com/medical-disinfection-paper.

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.

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, 781-793-9380, dgoncalves@tizinc.com


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