New Scope of Reusable Medical Device Cleaning Validations is Examined in New White Paper from Microtest Laboratories

AGAWAM, MASS. – October 2, 2012 – The new scope of cleaning validations for the manufacturers of reusable medical devices is examined in a white paper available for download from http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

“Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead,” writes white paper author Patrick Kenny, Manager of Analytical Services, Microtest Laboratories.

In the new white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” Kenny notes that “although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples.”

“An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device’s submission,” Kenny notes.

The paper discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. Recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release.

Download the white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” from the Microtest Laboratories website at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

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

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.

Microtest Labs is a Leader in Cleaning Validation Studies for Medical Devices Designed for Reuse

AGAWAM, MASS. – April 21, 2010 – Microtest Laboratories is a leader with 20 years of industry experience in providing cleaning validation studies of medical devices designed and labeled for reuse.

Microtest Labs will highlight its expertise in providing cleaning validation studies at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Microtest bases its cleaning validation studies on the recommendations of the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), and the American Society for Testing and Materials (ASTM).

In doing so, Microtest can document, with a high level of assurance, that a given cleaning process used on a given device will clean it effectively — to parameters predetermined by the manufacturer — after each use.

Services include AAMI TIR12 and AAMI TIR30 cleaning validation.

At Microtest, the studies are conducted according to a thorough, multi-step process. The device is first inoculated with a biological challenge organism — a spore strip or liquid spore inoculum — used as an indicator. Recommendations of the United States Pharmacopeia (USP) and Association for the Advancement of Medical Instrumentation (AAMI) suggest organisms with high resistance to the given sterilization process. The device is then cleaned, and tested for recovery of the indicator.

If the indicator hasn’t been reduced by at least a factor of 3 logs, the cleaning cycle fails the test. Valid devices must pass three consecutive cleaning cycles to be considered validated.

Testing uses spore strips with 106 spores per strip, or liquid suspensions. Inoculated devices are cultured under an ISO Class 5 (Class 100) laminar airflow hood, using aseptic technique, determination of recovery factors, and traditional culture/enrichment techniques to optimize indicator recovery.

Test controls include the following:

• All culture media undergo USP Growth Promotion Testing (GPT) and sterility assurance to ensure optimal recovery and sterility
• Incubators are calibrated and monitored 24/7 via an advanced SCADA system
• Bacterial spore populations used in biological challenges are controlled and verified per USP prior to use
• Each sample is tested with positive and negative controls

Microtest possesses the knowledge, experience, specialized equipment and techniques, and strict adherence to protocols required to provide the highest level assurance of required for cleaning validation studies of medical devices designed and labeled for reuse.

For more information, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston.

Or, visit the Microtest website at http://www.microtestlabs.com/medical-device-testing/reusable-device-testing/cleaning-validation.html or call 1-800-631-1680.

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.