USP <800> Compounding Cleanrooms

Facilities and operations staff at hazardous compounding facilities often call us with a bundle of questions, sometimes in a feverish hurry to understand what upgrades their facility requires for USP 800 compliance. Storage conditions, ventilation, anterooms, isolator upgrades: unpacking USP 800 is complex. But, it doesn't need to be overwhelming.

Why USP 800? Why Now?

Occupational exposure to hazardous drugs (HDs) poses serious health risks, such as reproductive toxicity, genotoxicity, and cancer. To protect the millions of healthcare workers who may handle HDs each year, USP 800 sets enforceable standards for safe handling throughout their lifecycle, including receipt, storage, compounding, administration, transport, and disposal.

Chapter 800 Requirements Overview

USP 800 is now fully enforced alongside USP 795 and 797, requiring all facilities that handle HDs to meet its safety and containment standards. The chapter covers a wide range of requirements, including facility and cleanroom design, personnel training and competency, maintaining an HD list, conducting risk assessments (AORs), implementing engineering controls, managing spills, performing cleaning and deactivation, and keeping comprehensive documentation and policies. Learn more.

Implementing USP 800 is a key protection for healthcare workers and the immediate environment. Organizations processing hazardous and nonhazardous drugs, both sterile and nonsterile, face the most adverse impact. Some may struggle with renovation downtime, budget allocation, outlining key compliance changes, optimal equipment use, or identifying a project lead.

Notably, facility or engineering changes may require 12 to 18 months to complete for traditional "stick built" cleanrooms. Many facilities have already taken necessary actions for procedural and facility upgrades, or are well on their way.

Upgrading a USP 797 Cleanroom to USP 800?

If a facility was initially designed for USP 797 sterile compounding, transitioning to fully compliant hazardous drug (HD) compounding under USP 800 often requires significant modifications. These may include installing externally vented containment primary engineering controls (C-PECs), converting rooms into negative-pressure containment secondary engineering control (C-SEC) suites, upgrading exhaust ductwork and HEPA filtration systems, establishing dedicated HD storage areas, improving airflow and pressure-differential monitoring, and updating standard operating procedures to meet containment and safety standards. Learn more.

Is Your Facility Ready?

If you find yourself overwhelmed in a jungle of acronyms, terminology, and technical cleanroom specs, there might be a better way. CleanPro® helps you achieve the correct pressurization differentials, ACPH and ISO classification requirements (i.e., cleanroom construction, retrofitting, HVAC, HEPA filters, temperature/humidity gauges) for each space. Our engineering team conducts preliminary research to determine what types of facility changes you will need to upgrade from USP 795 or USP 797 compliance.