Sterile compounding compliance standards reach beyond the hood, or cleanroom. Standards are often overlooked in other areas where sterile compounding may occur, such as anesthesia, ICU, emergency department, other procedural areas, oncology clinics, and other ambulatory areas. In addition, sterile compounding compliance impacts personnel competency and safety, and how the healthcare facility manages ongoing monitoring. New standards also impact the sterile compounding of hazardous medications.
Many factors impact the integrity of sterile preparations, such as air flow, pressure gradients, temperature, humidity and particle counts.
Our Sterile Compounding Assessment focuses on three major areas:
- The facility itself: including the IV room and other locations where sterile preparations are mixed
- Personnel-related areas: including education, training, garbing, and documented competence required; based on facility policy, USP <797> requirements, and observation of operations
- How the pharmacy conducts ongoing monitoring: including personnel and healthcare facility; assessment of the organization’s certification report, results of environmental monitoring, and reporting to the Infection Control Committee
Our experts can give you peace of mind
Cardinal Health brings over 45 years of hospital pharmacy operations expertise, including the management of sterile preparations at hundreds of hospital sites. Our dedicated team of expert USP <797> and <800> consultants include an industry-leading subject matter expert who is a member of the USP Compounding Expert Committee, and Chair of the USP Hazardous Drug Subcommittee and Expert Panel.
Contact us today
We use the advantage of our breadth of experience to develop best practices, provide solutions that deliver speed to impact, and bring you innovative ideas and insights. To learn more, call us at 877.300.9180.