QCS Session #8 - Sterility Assurance using Sterile Compounding Automation and Technology

Activities related to sterile, nonsterile, and hazardous drug compounding for humans and animals. This includes best practices and USP quality assurance standards, environmental testing and control, record keeping, error detection and reporting, and continuous quality improvement processes. Sterile compounding involves myriad of environmental, equipment, and product influences that can impact the sterility of a compounded sterile preparation (CSP). Implementation of interrelated controls addressing all of these influences will ultimately determine the success of a sterility assurance program. Due to the limitations of destructive end-product sterility testing, there exists a need for heighted controls, including the use of compounding automation and separative technologies, to ensure a high level of confidence in the sterility of all CSPs. Both pharmacists and pharmacy technicians have a role in successful implementation of compounding automation and separative technologies to improve patient care.