The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
The changing regulatory landscape and innovation of medical products is driving an interest in additional options for medical product sterilization. One non-traditional way manufacturers can sterilize medical products that is becoming increasingly popular is with sterilizers that use vaporized hydrogen...
Ensuring that reusable medical devices can be properly cleaned, disinfected, and/or sterilized is imperative to ensure patient safety and to minimize healthcare-acquired infections, corrective actions, and recalls. Regulatory agencies and healthcare facilities are increasingly concerned about the spread of diseases,...
When validating the steam sterilization instructions for a reusable medical device, first-time pass rates are important to manufacturers. Failures in validation testing require resolution, adding to the total validation time, which can result in a delay to regulatory submission, getting...
Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential. Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal...
It has been a challenge for the industry to stay current on the regulatory landscape as it relates to reusable device sterilization validation. FDA expectations tend to change so frequently, it can be difficult to keep up, but it is critical...
