Sterilization And Cleaning Validations of Reusable Devices
Cleaning validations are performed for reusable medical devices to ensure proper removal of contaminants from reusable or reprocessed medical devices. These procedures vary in complexity corresponding to the devices that are part of the proposed surgical instrument system. Millstone Testing Services offers a validation that is customized to your medical device, whether single-use or reusable. To facilitate this process, our professionals work directly with clients to make sure we are incorporating any variables that come with sufficient reprocessing. Consultation is also available to assist with manual cleaning variables that come with sufficient reprocessing. Consultation is also available to assist with manual cleaning instruction development. FDA guidance is followed closely to aid clients in their pursuit of a 510k certification. Testing under these guidelines can also be translated to a thorough study of cleaning efficacy for research and development or clinical marketing purposes. Along with FDA guidance, our expertise in AAMI and ISO standards contribute to a seamless and comprehensive validation process.
Simulating use of are usable device will require multiple and complete reprocessing cycles to account for sterilization/disinfection mediated coagulation of contaminants. Any residual contaminates left on the device after simulation are quantified in forms of protein and hemoglobin concentration. These are two primary markers for the assessment of cleaning efficacy for critical medical devices.
Protein Residual Testing
Hemoglobin Residual Testing
Critical Device Manual Cleaning Validation
STEAM STERILIZATION VALIDATION
Validation of the steam sterilization process for reusable medical devices is a key step in the advancement of medical technology. With rising complexity in design engineering and multi-functioning systems, it is important to evaluate proper sterilization of all materials and instruments within a system. A steam sterilization validation will assess sufficiency of the proposed cycle parameters to eliminate microorganisms and completely dry all instrumentation.
Millstone Testing Services provides consultation and study development to ensure sterilization compliance with all the latest guidelines. Both gravity and pre-vacuum validations are available depending on your testing needs. Each validation is tailored to your medical device with our expertise in FDA guidance, AAMI, and ISO standards. Our professionals work directly with clients to evaluate any sterilization challenges with surgical systems for individually marketed devices as well as devices in a perforated sterilization case or rigid sterilization container. Direct measurements of accumulated lethality throughout steam sterilization provide us with an immediate assessment of your surgical system coupled with biological indicator placement to analyze its Sterility Assurance Level (SAL).
Pre-Vacuum Steam Sterilization Validation
Gravity Steam Sterilization Validation
Pre-Vacuum Dry Time Validation
Gravity Dry Time Validation
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
Experience you can trust
Millstone Testing Services offers comprehensive regulatory testing services backed by more than 90 years of combined experience in the medical device and pharmaceutical sectors.