Microtest Labs Highlights 20 Years’ Experience as Leader in Cleaning Validation Studies for Medical Devices Designed for Reuse
AGAWAM, MASS. – June 8, 2010 – Microtest Laboratories will highlight its 20 years of experience in providing cleaning validation studies of medical devices designed and labeled for reuse at the Medical Design & Manufacturing East /MD&M East Exposition, booth #1251, June 8-10, 2010 in New York City.
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 MD&M East, booth #1251, June 8-10, 2010 in New York City.
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.
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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 MD&M East, booth #1251, June 8-10, 2010 in New York City.
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.
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Labels: cleaning validation studies, East, manufacturing, MDM, Medical Design, Medical Devices, Microtest Laboratories
posted by Microtest Laboratories at
2:18 PM
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