Key Differences Between USP 1115, USP 1116 and USP 1211
Learn about USP regulations regarding non-sterile and aseptic processes, and sterility assurance and how these relate to regulatory testing requirements.
Learn about USP regulations regarding non-sterile and aseptic processes, and sterility assurance and how these relate to regulatory testing requirements.
Learn the differences between microbial aerosol challenge testing and bioburden testing for combination products as well as parenteral products.
Learn about sterilizing bacterial spores, why they are hard to kill, and how to create sterilization processes to fully sterilize your medical devices.
Learn about sterilization methods, microbial death kinetics, and the three types of microorganisms medical devices and products must sterilize against.
Learn about microbial death kinetics and calculations for bioburden, D values and Z values, and what these values mean when it comes to sterilization.
Learn about bioburden testing , different methods of sterilization, and what are bioburden limits based on USP 1111 guidelines considerations.
Learn about how bioburden and biofilms relate, and how bioburden and biofilms relate to biocompatibility requirements for medical devices.
Learn how bioburden testing compares to environmental monitoring and how these tests relate to regulatory testing for your medical device or product.
Learn how bioburden compares to sterilization validations and how these tests relate to regulatory testing for your medical device or medical product.
Learn how bioburden testing compares to microbiology testing and how these tests relate to regulatory testing for medical devices.