Clean Room Design: Pharmacy Flow with USP 797 and USP 800 Standards
Clean Room Design: Pharmacy Flow with USP 797 and USP 800 Standards.
Cleanroom Design is one of the most important phases to the cleanroom implementation process, providing the strategy for the operation, people flow and overall cleanliness of the cleanroom. It’s the cleanest room in a hospital, but most of us will never step foot in it. Pharmacies and compounding laboratories are a hot topic in the health care world as the US Pharmacopeial Convention’s (USP) revised guidelines necessitate new pharmacy design to meet USP 797 and USP 800 compliance.
Clean Room Design Video Script
Clean Room Design Video Script
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the realm of compounding pharmacy design
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is intricate nuanced and precise the
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requirements of USP 797 and USB 800
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contain a number of aspects that require
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careful coordination of systems
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equipment and space to comply with as a
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result of addressing these requirements
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we have developed a kit of parts to meet
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Board of Pharmacy regulations USP
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requirements and our clients needs
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this kit consists of three parts
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specific adjacency requirements
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prescribed workflows and specialized
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finishes adjacencies are the building
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blocks of laying out of pharmacy and
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this begins with the ante room the
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composition of the programmatic elements
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are driven by the workflow and function
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of the space using the anteroom as the
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center from there the hood rooms are
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entered off of this space on either side
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to keep the separation of the two rooms
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and maintain the clean and dirty sides
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of the anteroom the workspace is placed
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with enough overlap between hood rooms
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to facilitate visual connectivity with
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these spaces laid out we’ve set the
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stage for the pressure relationship
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between the different rooms this is
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comprised of four components room
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pressurization door swings pass-through
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cabinets and HEPA filtration regarding
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pressurization the USP 797 room begins
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as the most positive space and as we
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move through the anteroom and into the
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work area the air flow becomes
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progressively more and more neutral due
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to the nature of the drugs being
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compounded in the USB 800 room the space
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is required to be negatively pressurized
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this room is then directly exhausted to
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the exterior of the building
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pressurization in the rooms is monitored
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and displayed so that staff are able to
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quickly and accurately document this
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information without having to pass into
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the restricted zone doors for each of
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these rooms swing in the path of the
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airflow in order to minimize cross
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contamination passed through cabinets
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are designed to be interlocking as an
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added measure to maintain the proper
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room pressurization between spaces hepa
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filtration is installed inside each of
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the compounding rooms and ante room to
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meet particulate counts we touched on
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the concept of the separation between
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clean and dirty and if we take a more
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in-depth look at the ante room we can
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see that the segregation of the room
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into these two sections is critical for
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proper operation a point of demarcation
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by a physical red line in the floor
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separates the two sides this allows the
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users to properly garb up you
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correct PPE procedures on the dirty side
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before transitioning to the clean side
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for hand washing and scrubbing equipment
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placement in this space aides in the
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doffing process and maintains the flow
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of dirty to clean the use of scrub sinks
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clean room dispensers PPE devices and
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hands-free elements help workflow and
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maintain cleanliness as we move from the
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anteroom into the hood room there’s
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equal attention paid to the location and
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placement of equipment for optimal flow
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compounding workstations are set up with
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the intention of one person working at
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the hood at a time although this space
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may look small or cramped it is designed
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with the intention that pharmacists and
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techs have access to 90% of the tools
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they need from a centralized seated
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position with the goal of increasing
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workflow efficiency and decreasing the
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risk of errors or cross-contamination
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the second component of the kit of parts
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is workflow and a crucial component of
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this is visual acuity pharmacists use
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systems like dosage with cameras and
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physical windows into the hood rooms
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that allow for cross-checking work this
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transparency allows for visual
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communication to occur between
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pharmacists and techs without entering
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the restricted zones telephones in the
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hood rooms and walkie-talkie systems
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like Bose era are used to aid in
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facilitating communication so that large
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volumes can be processed efficiently
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without the need for additional doffing
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additionally pass-through cabinets are
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used to transfer finished medications
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from the restricted zone to the work
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area for final processing creating a
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physical connection between these
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different spaces this results in
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increased workflow efficiency and
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decreases the risk of
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cross-contamination the final component
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of the kiddo parts are the finishes
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finishes are first determined by the
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classification of the space the work
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room is considered an unrestricted zone
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the ante room acts as a transition space
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or a semi restricted zone and the hood
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rooms are classified as restricted zones
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in terms of flooring resilient sheet
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products with heat welded seams are used
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throughout in conjunction with six inch
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in a row code base the transition of the
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flooring into the wall creates a slope
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which facilitates ease of cleaning as
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mentioned earlier the physical redline
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in the floor of the anteroom serves as a
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physical reminder of the
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process when it comes to walls
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determinations for the level of finish
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are based on the classification of the
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space in unrestricted zones walls are
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treated with a level for finish in an
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epoxy pane for easier cleaning in semi
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restricted and restricted zones walls
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are constructed with high-impact wall
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covering that has heat welded seams and
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a beveled polished edge capable of
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withstanding the rigorous cleaning
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process these spaces require special
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sealants are used which when dry are
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hard to the touch and in accordance with
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Board of Pharmacy requirements in
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conclusion this kit of parts has been
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intentionally designed to comply with
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the requirements of both USP 797 and 800
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in addition to creating an efficient
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workflow that expedites the compounding
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process while maintaining a highly clean
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environment effective at protecting the
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safety of both patients and providers
