CASE STUDY
www.baxter.com
IV workflow management systems that use
gravimetric analysis prevent users from creating
master formulation records for preparations
that are outside the system’s tolerance limits,
and if staff attempt to weigh a volume outside
the integrated scale’s tolerance limit the IV
workflow management system alerts the user.
IV workflow management systems document
all steps and components of the compounding
process (e.g., products used, the practitioner
who performed the compounding, the primary
engineering control, machine readable code scans,
date and time of preparation, alerts or warnings
presented during the process, the practitioner
who verified the preparation), and the information
is available to users in a log and/or report.
IV workflow management systems allow for
remote verification using video or image capture,
and, when used, gravimetric analysis.
IV workflow management systems track beyond-use
dating of opened or reconstituted products to warn
practitioners and prevent use of an expired product.
IV workflow management systems allow
for customization of labels (e.g., tall man
lettering, color print, reverse print, electronic
health record compatible barcode).
IV workflow management systems limit
the printing of the dispensing label until the
compounding process is complete.
Workload (e.g., incoming load) is documented
by the technology and captured in a report to
inform and facilitate operational improvement.
Close-call compounding events (e.g., wrong
drug scans) intercepted by the technology are
captured in a report to facilitate compounding
error analysis and process improvement.
Data in vendor reports are provided in a
useful format and do not require significant
manipulation by the end user.
When a system update is available, IV
workflow management system vendors
ensure all customers receive and install the
update in a reasonable timeframe.
2022 ISwMP Guidelines for Sterile Compounding and the Safe Use of Sterile Compounding Technology
A - Can be obtained from DoseEdge Technical Support
The use of IVWFM systems to help meet the Chapter <797>
standards is discussed far less, if at all. However, given the
broad functionality of some of these systems, such as the
DoseEdge system, they can influence pharmacy procedures and
documentation practices etc. which can directly or indirectly support
these requirements.
The following are many of the standards from the 2023 version of
USP <797> that could potentially be supported by using IVWFM
systems5.
USP Chapter <797> Standards
How DoseEdge
Functionality Could
Provide Support
3. PERSONAL HYGIENE AND GARBING
Personal hygiene and garbing are
essential to maintain microbial control of
the environment. Most microorganisms
detected in cleanrooms are transferred
from individuals. Squamous cells are
normally shed from the human body
at a rate of 106 or more per hour, and
those skin particles are covered with
microorganisms. Individuals entering a
compounding area must be properly garbed
and must maintain proper personal hygiene
to minimize the risk of contamination
to the environment and/or CSPs.
Individuals that may have a higher risk of
contaminating the CSP and the environment
(e.g., personnel with rashes, recent tattoos,
oozing sores, conjunctivitis, or active
respiratory infections) must report these
conditions to the designated person(s).
The designated person(s) is responsible for
evaluating whether these individuals should
be excluded from working in compounding
areas before their conditions have resolved
because of the risk of contaminating
the CSPs and the environment.
Remote verification
could help decrease
the number of
pharmacists required
to enter the cleanroom
to verify doses
including in-process
and final checks.
This can be especially
beneficial on off-shifts
when staffing may
be lower or when
pharmacist verifiers
with higher risks
for contamination
may be the only
pharmacist on duty.
4. FACILITIES AND
ENGINEERING CONTROLS
The design of the facility should
take into account the number of
personnel and their movements.
4.1 Protection from Airborne Contaminants
Proper design and controls are required
to minimize the risk of exposure of
CSPs to airborne contaminants.
Total airborne particle counts by ISO
classification must not be exceeded:
ISO 5 = 3520 particles/m3
ISO 7 = 352,000 particles/m3
Remote verification
can help minimize
the number of
pharmacist verifiers
needing to enter the
cleanroom which
may be able to affect
the overall design.
This decrease in
staff needing to enter
the cleanroom can
also be used as a
control mechanism
to decrease airborne
contaminants.