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HealthTrust & TechSafety present…”USP <797>/<800>: Cleanroom Design & Environmental Monitoring”

While USP (United States Pharmacopeia) <797> previously established requirements for hazardous drug compounding, its latest revision—<800>—clarifies and expands upon sterile and non-sterile hazardous drug compounding. Enhanced engineering and procedural controls extend protection to operators and environments when packaging, handling and compounding hazardous substances (including 2018 updates to the National Institute for Occupational Safety and Health list). Many sterile compounding pharmacies are unfamiliar with the certification requirements for their facilities and are unsure how to interpret the data they receive from testing. This presentation will provide a background to the creation of USP chapters <797> and <800>, describe the cleanroom requirements for both hazardous and non-hazardous sterile compounding areas, describe the testing requirements to demonstrate compliance and review corrective actions for areas commonly found to be non-compliant.

Learning Objectives for Pharmacist member attendees:

At the end of this session, participants should be able to:

1. Discuss the requirements for environmental controls in sterile compounding environments.
2. Recall the required tests to prove compliance with USP <797> & <800>.
3. Plan corrective actions for non-compliance issues often found in sterile compounding clean areas.

 Learning Objectives for Pharmacy Technician member attendees:

At the end of this session, participants should be able to:

1. Define the environmental controls required to maintain sterility in USP <797> compliant cleanrooms.
2. Recall principles of Environmental Monitoring and Personnel Monitoring as it relates to USP <797>.

Presenter:

Andrew King, RCCP-SCF, is the USP <797> specialist  at Technical Safety Services, LLC. He is accredited as a Registered Cleanroom Certification Professional for Sterile Compounding Facilities.  King’s focus is on certification and compliance for sterile compounding cleanrooms and equipment.  He earned his undergraduate degree from the University of Rochester.

Target Audience:  Pharmacists and Pharmacy Technicians:

Continuing Education Information: 1.0 contact hours for Pharmacists and Pharmacy Technicians. Belmont University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The ACPE Universal Activity Number for this activity is 0863-0000-18-101-L07-P and 0863-0000-18-101-L07-T. The activity will provide 1 hour (.1 CEUs) of continuing education credit to pharmacists and technicians who attend the webinar and complete the online evaluation.

Note: No group credit is available. HealthTrust’s CE credit provider requires that each participant register and join the actual webinar event individually.