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Creating a USP 800 Compliant Cleanroom

A well-designed hazardous drug (HD) cleanroom must account for a variety of factors. In addition to physical plant and equipment considerations, the effective design must incorporate workflow requirements, such as owning procedures and storage and receiving activity. While regulatory guidance is proscriptive, not all HD cleanrooms will be identical; rather, each will need to accommodate the various conditions and restrictions that are unique to the facility. The following guidance for creating a USP 800 compliant HD cleanroom includes a direct reference to USP Chapters 797 and 795. Since this discussion focuses on compounding sterile preparations, Chapter 797 is the supporting reference. Note that the changes to 797 and 795 that were scheduled to take effect in December 2019 have been put on hold pending the outcome of appeals. The outstanding appeals may result in discrete changes to the chapters, but the facilities sections of the chapters will not be affected. Additionally, 800 is not under review; the published version is its final form. When designing a new facility, it makes sense to consider what is coming in the standards, not what was. As such, this paper focuses on the 2019 version of the chapters, where applicable.

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