Clean Room Design: Pharmacy Flow with USP 797 and USP 800 Standards

by | Oct 29, 2019

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

00:02
the realm of compounding pharmacy design
00:05
is intricate nuanced and precise the
00:07
requirements of USP 797 and USB 800
00:10
contain a number of aspects that require
00:12
careful coordination of systems
00:13
equipment and space to comply with as a
00:16
result of addressing these requirements
00:17
we have developed a kit of parts to meet
00:19
Board of Pharmacy regulations USP
00:21
requirements and our clients needs
00:22
this kit consists of three parts
00:24
specific adjacency requirements
00:26
prescribed workflows and specialized
00:28
finishes adjacencies are the building
00:31
blocks of laying out of pharmacy and
00:33
this begins with the ante room the
00:34
composition of the programmatic elements
00:36
are driven by the workflow and function
00:38
of the space using the anteroom as the
00:40
center from there the hood rooms are
00:43
entered off of this space on either side
00:45
to keep the separation of the two rooms
00:47
and maintain the clean and dirty sides
00:48
of the anteroom the workspace is placed
00:51
with enough overlap between hood rooms
00:53
to facilitate visual connectivity with
00:55
these spaces laid out we’ve set the
00:57
stage for the pressure relationship
00:58
between the different rooms this is
01:00
comprised of four components room
01:02
pressurization door swings pass-through
01:04
cabinets and HEPA filtration regarding
01:07
pressurization the USP 797 room begins
01:10
as the most positive space and as we
01:11
move through the anteroom and into the
01:13
work area the air flow becomes
01:15
progressively more and more neutral due
01:17
to the nature of the drugs being
01:18
compounded in the USB 800 room the space
01:21
is required to be negatively pressurized
01:23
this room is then directly exhausted to
01:25
the exterior of the building
01:26
pressurization in the rooms is monitored
01:29
and displayed so that staff are able to
01:30
quickly and accurately document this
01:32
information without having to pass into
01:34
the restricted zone doors for each of
01:36
these rooms swing in the path of the
01:38
airflow in order to minimize cross
01:40
contamination passed through cabinets
01:41
are designed to be interlocking as an
01:43
added measure to maintain the proper
01:45
room pressurization between spaces hepa
01:48
filtration is installed inside each of
01:50
the compounding rooms and ante room to
01:52
meet particulate counts we touched on
01:54
the concept of the separation between
01:55
clean and dirty and if we take a more
01:58
in-depth look at the ante room we can
02:00
see that the segregation of the room
02:01
into these two sections is critical for
02:03
proper operation a point of demarcation
02:05
by a physical red line in the floor
02:08
separates the two sides this allows the
02:10
users to properly garb up you
02:12
correct PPE procedures on the dirty side
02:14
before transitioning to the clean side
02:17
for hand washing and scrubbing equipment
02:19
placement in this space aides in the
02:21
doffing process and maintains the flow
02:23
of dirty to clean the use of scrub sinks
02:25
clean room dispensers PPE devices and
02:27
hands-free elements help workflow and
02:29
maintain cleanliness as we move from the
02:32
anteroom into the hood room there’s
02:34
equal attention paid to the location and
02:36
placement of equipment for optimal flow
02:38
compounding workstations are set up with
02:41
the intention of one person working at
02:43
the hood at a time although this space
02:45
may look small or cramped it is designed
02:47
with the intention that pharmacists and
02:48
techs have access to 90% of the tools
02:51
they need from a centralized seated
02:53
position with the goal of increasing
02:54
workflow efficiency and decreasing the
02:57
risk of errors or cross-contamination
02:59
the second component of the kit of parts
03:01
is workflow and a crucial component of
03:03
this is visual acuity pharmacists use
03:06
systems like dosage with cameras and
03:08
physical windows into the hood rooms
03:10
that allow for cross-checking work this
03:12
transparency allows for visual
03:14
communication to occur between
03:15
pharmacists and techs without entering
03:17
the restricted zones telephones in the
03:19
hood rooms and walkie-talkie systems
03:21
like Bose era are used to aid in
03:23
facilitating communication so that large
03:25
volumes can be processed efficiently
03:26
without the need for additional doffing
03:29
additionally pass-through cabinets are
03:31
used to transfer finished medications
03:33
from the restricted zone to the work
03:35
area for final processing creating a
03:37
physical connection between these
03:39
different spaces this results in
03:41
increased workflow efficiency and
03:43
decreases the risk of
03:44
cross-contamination the final component
03:47
of the kiddo parts are the finishes
03:48
finishes are first determined by the
03:51
classification of the space the work
03:53
room is considered an unrestricted zone
03:55
the ante room acts as a transition space
03:58
or a semi restricted zone and the hood
04:01
rooms are classified as restricted zones
04:04
in terms of flooring resilient sheet
04:06
products with heat welded seams are used
04:08
throughout in conjunction with six inch
04:10
in a row code base the transition of the
04:13
flooring into the wall creates a slope
04:15
which facilitates ease of cleaning as
04:17
mentioned earlier the physical redline
04:19
in the floor of the anteroom serves as a
04:21
physical reminder of the
04:23
process when it comes to walls
04:25
determinations for the level of finish
04:27
are based on the classification of the
04:29
space in unrestricted zones walls are
04:32
treated with a level for finish in an
04:34
epoxy pane for easier cleaning in semi
04:37
restricted and restricted zones walls
04:39
are constructed with high-impact wall
04:41
covering that has heat welded seams and
04:43
a beveled polished edge capable of
04:46
withstanding the rigorous cleaning
04:47
process these spaces require special
04:50
sealants are used which when dry are
04:52
hard to the touch and in accordance with
04:54
Board of Pharmacy requirements in
04:56
conclusion this kit of parts has been
04:59
intentionally designed to comply with
05:00
the requirements of both USP 797 and 800
05:03
in addition to creating an efficient
05:06
workflow that expedites the compounding
05:08
process while maintaining a highly clean
05:10
environment effective at protecting the
05:12
safety of both patients and providers
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