USP 800 Cleanroom Design
USP Chapter 800 Cleanroom Requirements
USP 800 Cleanroom Standards Overview
USP 800 is a cleanroom standard issued in March of 2014 by the United States Pharmacopeial Convention (USP). The deadline for compliance may change, at the time of this article’s publication the deadline is scheduled for December 2019. The date and scope of adoption may differ on a state-by-state basis, thus consulting with a compliance specialist is encouraged.
Chapter 800 expands the safety of healthcare workers, patients, and the environment for processing hazardous drugs. It reflects a number of stages in the delivery of sterile and non-sterile compounds, including:
- Receipt and unpacking of hazardous drugs
- Storage of hazardous drugs
- Non-sterile hazardous drug compounding (if performed)
- Sterile hazardous drug compounding (if performed)
General Chapter <800>
USP 800 expands controls for the protection of workers and environments against hazardous drug compounds. In contrast to USP 797, which only remedies sterile compounding activities, USP 800 takes a 360-degree approach for processing hazardous drugs.
Its predecessor, USP 797, is narrower in scope, and focused on sterile compounding preparations. USP 800 defines new controls over compounding environments and equipment that apply to both sterile and non-sterile compounding, hazardous and non-hazardous.
The USP 800 compliance deadline accompanies a USP suggestion for early organizational adoption. Diligent protection of healthcare practitioners and others when handling hazardous drugs is a clear priority. Achieving new standards set forth by USP 800 may require retrofitting an existing structure, which is where consulting a team of architects and engineers is ideal.
USP 800 STD Hazardous Compounding Risk Assessment
The takeaway from USP 800 cleanroom requirements is that exposing workers to hazardous compounds is not an acceptable risk. USP 800 environments mitigate the risk of harm to both the environment and workers when compounding or packaging hazardous drugs. That could include antineoplastic drugs, hormonal therapies, radiopharmaceuticals, bacteria, and viruses. Primarily, negative pressure cleanrooms and dedicated ventilation systems account for the greater portion of improved safety and thus the majority of required changes.
USP 800 compliant cleanrooms protect healthcare personnel, patients, and the environment when handling hazardous drugs as seen on the NIOSH hazardous-drug list. In contrast to USP 797, which upgrades process controls of sterile compounds, USP 800 expands specifically on the compounding of hazardous drugs (HDs).
Basic Requirements for USP 800 Cleanroom Compliance
Connected, adjacent cleanroom designs with negative pressure and exhaust containment systems prevent contaminated air from recirculating or escaping when mixing HDs, both sterile and non-sterile. USP 800 requires external venting within the primary engineering controls for hazardous drugs, and will have the most impact on facilities handling both hazardous and nonhazardous drugs.
For some healthcare facilities, upgrading or retrofitting a cleanroom for USP 800 compliance requires infrastructural and mechanical modifications. Small modifications may include equipment upgrades while more extensive upgrades may include expanding cleanrooms, new ductwork, and dedicated exhaust systems. Learn more.
The content provided is for informational purposes only. It does not constitute a recommendation for your facility or organization. This post serves as a general guideline and summary. At time of publication, the information is in good faith, critically reviewed, and accords to the most concurrent information available. Compliance requires temporal evaluation on a case-by-case basis according to state and federal law. The content herein, linked content, or other web content provided by Production Automation Corporation (PAC) makes no claims as to the final interpretations or implementation of regulatory documents provided by the FDA, State Board of Pharmacy, or United States Pharmacopeia (USP). For this reason, PAC provides licensed engineers who are experts in regulatory and application compliance. They are available every business day, toll free (888) 903-0333 for consultation at no cost, no obligation.