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

Posts Tagged ‘cleaning processes’


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The brief discusses the document, “FDA Draft Guidance for Industry and Staff, Processing /Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” which was released in May 2011.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


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


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


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