Cleaning Validation Studies
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) shape the Microtest cleaning validation studies processes. This testing applies to medical devices designed and labeled for reuse. It documents 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. Our work includes AAMI TIR12 and AAMI TIR30 cleaning validation.
Microtest possesses the knowledge, experience, specialized equipment and techniques, and strict adherence to protocols required for this assured cleaning validation.
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 hasnt 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.
- 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